3644 Ultrasonic Therapy Product Report

Submission Report
Section: Main Menu
Welcome

Welcome to the CDRH Electronic
Submissions Software (CeSub)
This software application is intended to automate the current paper submission process.
This software contains a number of data capturing tools and helpful dialog boxes to
reduce redundant responses for you, and to allow us to capture data in a more useful,
structured format. These benefits will enable CDRH to improve our review process and
reduce lengthy review times.
For your convenience, an email account has been established to support any questions
that you may have regarding the use of this software. Please email any questions or
comments to the CeSub team at: [email protected]. Please be sure to include your
name, company name and contact information in the email.
Thank you again for using our electronic product reporting software. We look forward to
hearing from you soon.
What type of product is this submission referring to?

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Radiation Emitting Product (OMB No. 0910-0025; Expiration Date: December 31, 2006)

Welcome (Cont.)

Department of Health and Human Services
Food and Drug Administration

Form Approved:
OMB Number 0910-0025
Expiration Date: December 31, 2006
Section: eRadHealth Menu
Role
What is your role?

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Manufacturer

Submission Information
What Type of Submission is this? (Supplements should be submitted selecting the same document type as the original
report.)

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Radiation Safety Report (Product Report)
What Type of Product is this Annual Report about?

What Type of Correspondence is this?

What Type of Product is this Radiation Safety Report about?
Therapy Ultrasound Products
What Type of Product is this Variance Request about?

What Laser Light Show Documents are you filing?

Section: Manufacturer Data
Introduction

Electronic Product Radiation Safety
Reporting Form
This software application is intended to automate the hard copy product reporting forms
in the effort of the Center for Devices and Radiological Health (CDRH) to become
capable of accepting electronic submissions from industry and to improve our review
process. This CDRH Electronic Submission (CeSub) software is the next version of the
application the CDRH is developing to allow us to accept all Radiological Health reports
and other submissions electronically and improve the ability of CDRH to accomplish its
mandated product and industry evaluations in a timely and efficient manner.
We have already received many electronic submissions and are looking forward to
receiving more in the future. With this new release of the software we have updated our
procedures for packaging a submission to make this a smoother process for all. All
electronic reports (your new CD-ROMs) and any other documents you are submitting in
hard copy because they cannot be provided in an acceptable electronic format must be
mailed to CDRH. A signed hard copy of the submittal letter generated by the submission
software, should be printed out and included with your electronic submission. This
printed documentation will provide the Document Control Room with enough
information to log the submission. The electronic submissions should be sent directly to
the Document Control room, which is the same process for the standard paper

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submission.
The submission must be addressed to:
Electronic Product Document Control (HFZ-309), Attn: CeSub Team, Center for
Devices and Radiological Health, 2094 Gaither Road, Rockville, MD 20850
After sending your submission to the Document Control Room, please send an email to
the [email protected] email account so we will know that your submission is
forthcoming. Please remember that all correspondence concerning your submission
MUST be sent to the Electronic Product Document Control (HFZ-309), at the above
letterhead address. Correspondence sent to any address other than the one above will not
be considered as part of your official notification submission. Please refer to this
guidance for information on current fax and e-mail practices at
www.fda.gov/cdrh/ode/a02-01.html. You should also be familiar with the regulatory
requirements for radiological products at www.fda.gov/cdrh/comp/eprc.html and medical
devices available at Device Advice www.fda.gov/cdrh/devadvice/.
If you have specific questions regarding the software, please contact the CeSub team by
email at: [email protected].
Thank you for using our electronic product reporting software. Please communicate your
comments and criticisms to the CeSub team as often as you like.
Thank you for your continued support of the CDRH eSubmission Pilot Program.
General Information

General Information for Radiological
Health Products
Manufacturers of products subject to performance standards under the Federal Food,
Drug, and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product
Radiation Control are required to furnish various reports to the Center for Devices and
Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product
and Annual reports. This application will assist manufacturers of electronic products that
emit radiation in providing adequate reporting of radiation safety testing and compliance
with federal performance standards. Title 21 of the Code of Federal Regulations (CFR),
Parts 1002 and 1003 specify Reporting and Notification requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate

form (21 CFR 1002.7). This software application serves the same report responsibility, so
long as the submitter or manufacturer prints out the cover letter and sends it in along with
the CD containing the report files. The submitter of the report will receive an
acknowledgment letter (or email message) with the accession number that CDRH assigns
to the report. Please reference this accession number in the future when providing
additional information about this model family in either a supplement or the annual
report. If a report is incomplete or inadequate CDRH may reject it and return it for
completion. CDRH will not enter a rejected report into our database.
CDRH DOES NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING
REPORTED. It is the manufacturer's responsibility to certify that their products comply
with all applicable standards (21 CFR 1010 - 1050), based on a testing program in
accordance with good manufacturing practices. Prior to the shipment of products in
interstate commerce, 21 CFR 1002 requires the manufacturer to submit the product and
Annual Reports and to comply with all applicable importation requirements (21CFR
1005). If there are deficiencies, CDRH may disapprove the firm's quality control and
testing program, determine that the product contains a radiation defect, or determine that
the product fails to comply with a standard. CDRH will notify the manufacturer if we
make such a determination. CDRH may require the manufacturer to cease introduction
into U.S. commerce until deficiencies are corrected, and to initiate a corrective action
program (21CFR 1003 - 1004) for products already introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all
attachments are PDF files only, and the cover letter is printed out and included with a real
signature. Translate any text that appears in a language other than English into English in
a complete and accurate manner. Keep a copy (save a copy to your hard drive) of the
completed report in your records.
We are providing our new software applications for the old reporting forms upon request
during this beta testing period of development in Spring, 2005. Other regulatory
information is still available on the Internet under
http://www.fda.gov/cdrh/comp/eprc.html. No copyright exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms,
website, or future electronic submissions, you may direct the comments to the address
below.
A complete Product Report is required for each product model or model family. Product
Reports are now more generally referred to as Radiation Safety Reports to distinguish the
Radiological Health submissions from medical device submissions. CDRH suggests that
a complete report on one model of a family be submitted, with a separate Supplemental
Report for each of the other models in the family. The Supplemental Report should
respond in detail to the parts of the form where there are differences to report, referencing
the number of the affected item. Items that are unchanged will still appear in the
supplement from the original report.

When new models of a product are introduced, if the models satisfy the criteria for an
established reporting exemption or if the new models do not involve changes in radiation
emission or performance requirements, then the manufacturer need not report the models
prior to introduction into commerce. Rather, the manufacturer is only required to identify
them in the annual report, or in quarterly updates to the annual report. Quarterly updates
to annual reports may be submitted using the Annual Report software included in this
application. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and
consistently used. Please use the terms as defined in Section 1040.10(b) and in the IEEE
Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).
Definitions

Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing,
assembling, or importing of electronic products (21 CFR1000.3(n)). Manufacturers of
electronic products subject to 21CFR1000-1050 must:
•
•
•
•
•

•
•
•

Design and manufacture their products to be in compliance with applicable
performance standards;
Test their products to assure compliance;
Certify compliance of their products;
Maintain test and distribution records and a file of correspondence concerning
radiation safety, safety complaints, and inquiries;
Use the published reporting forms or electronic software application to submit
reports to CDRH, including Product reports describing the manner of compliance
of the product design and testing program and Annual Reports summarizing their
compliance testing;
Report accidental radiation occurrences (i.e., possible, suspected,or known
exposures);
Report any radiation defects or noncompliances; and
Recall (i.e., repair, replace, or refund the purchase price of) defective or
noncompliant products.

Accidental Radiation Occurrences
An accidental radiation occurrence means a single event or series of events that has/have
resulted in injurious or potentially injurious exposure of any person to electronic product

radiation as a result of the manufacturing, testing, or use of an electronic product.

Importers
Importer is any person of organization engaged in the business of importing electronic
products. An importer is considered to be a manufacturer. The requirements for
Manufacturers given above also apply to importers if the requirements have not been
done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
Every manufacturer of electronic products, prior to offering such product for importation
into the United States, shall designate a permanent resident of the United States as the
manufacturer`s agent upon whom service of all processes, notices, orders, decisions, and
requirements may be made for and on behalf of the manufacturer as provided in section
536(d) of the Radiation Control for Health and Safety Act of 1968 (21U.S.C. 360mm(d))
and this section. The agent maybe an individual, a firm, or a domestic corporation. For
purposes of this section, any number of manufacturers may designate the same agent.

From The Federal Food, Drug, and Cosmetic Act
Sec 536 [21 U.S.C. 360mm](d) Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic product for importation
into the United States to designate in writing an agent upon whom service of all
administrative and judicial processes, notices, orders, decisions, and requirements may be
made for and on behalf of said manufacturer, and to file such designation with the
Secretary, which designation may from time to time be changed by like writing, similarly
filed. Service of all administrative and judicial processes, notices, orders, decisions, and
requirements may be made upon said manufacturer by service upon such designated
agent at his office or usual place of residence with like effect as if made personally upon
said manufacturer, and in default of such designation of such agent, service of process,
notice, order, requirement, or decision in any proceeding before the Secretary or in any
judicial proceeding for enforcement of this part or any standards prescribed pursuant to
this part may be made by posting such process, notice, order, requirement, or decision in
the Office of the Secretary or in a place designated by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic
product as the result of the operation of an electronic circuit in such product.

Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or
acts as part of an electronic circuit and (ii) emits (or in the absence of effective
shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component,
part, or accessory of a product described in clause (A) and which when in operation
emits (or in the absence of effective shielding or other controls would emit) such
radiation.
Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 24 hours
per response, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, completing, and reviewing the
collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to:
Food and Drug Administration CDRH (HFZ-240)
1350 Piccard Drive Rockville, MD 20850

Please DO NOT RETURN this application to this address.
"An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number."
Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the performance standard. This
firm develops and maintains the quality control and testing program that is the basis for the certification of this
product. Additionally, this firm usually is the owner of the product design and manufacturing process design.

Copy from the establishment address book
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number

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Fax Number
Mailing Location:
Address

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with this
establishment.

Copy from contact address book

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing all
aspects of the testing and quality control procedures for certification as reported to FDA in the product report.
Documentation of changes intesting and quality control procedures submitted to FDA must be signed by this
individual.

Copy from contact address book
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

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Electronic Signature
Electronic signature (not available in this release of the software)

File Attachment

Report Submitter
Note:

The submittermaybe a consulting individual or firm providing assistance in report preparation and
maintenance. All documents prepared by the submitter must have the manufacturer's reporting official
signature for authenticity of submitted documentation.

Copy from contact address list

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Parent Establishment
Is there a parent establishment?
Copy from contact address book
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:

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Address

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

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Section: Product Data
Product Type Reported
What product type is being reported? *Please note that this list of 66 product types are grouped according to their radiation
type and applicable regulations (e.g., laser products, microwave products, ionizing products, etc.)

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What is the product code?

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If you know the three letter code, enter it in the space provided.
If you do not,
- Click the filter search icon (next to the trash can). You will see a product code filter dialog box.
-Enter a keyword to search the database. You will be provided a list of product codes from which to choose.
(If you are not finding the correct product, try other words and/or variations of the keywords.)
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
- If you do not find the code that you are looking for, use RZZ (Other)
Product Code
Device Class
Classification Panel
C.F.R. Section
If Other, please identify the specific product type.

Report Information
Is this the first time you've submitted a report on the particular type of product selected in the
Product Type Reported section?

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Since this is not the first time you've reported on this type of product, then is this a report supplement to
a previously reported model family?
Provide the Accession Number of the report for which this is a supplement (Do not enter any Device
Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs, etc.):
Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

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If you are requesting a renewal, extension, or amendment, please provide the variance number that
was issued by CDRH.
Error:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance Request
separate from this report. To do this, open a new report (File > New) and select either "Laser Light Show
Variance Request" or "Variance Request, Other" as your Type of Submission in the Submission Information
Screen. If you select "Variance Request, Other" you must select the product for which you are requesting a
variance at the end of the screen.

Noncompliances or Defects
Does this document or any of its attachments contain:
A self-declaration or notification of noncompliance or defect?

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Provide an explanation:

Responses to Noncompliances or Defects
Does this documentor any of its attachments contain:
A refutation of noncompliances?

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A request for an exemption from notification and corrective action?

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Information on corrective actions you may be conducting?

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A description of any design changes for future production?

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Provide an explanation:

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (1010.5)?

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Exemption for products for government use from reporting and recordkeeping (1002.51)?

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Special exemption of products from reporting and/or recordkeeping (1002.50)?

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Request for approval of alternate labeling?

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Application for alternate test procedures (1010.13)?

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Provide an explanation:

Attach any necessary files.

File Attachment

Variance Requests
Message:

Click the "Add" button to select the desired requirement from which you are seeking a variance.

This submission includes an application for a variance from certain requirements.
Item
Provide an explanation and attach supporting files, if necessary. Click on the Add... button below to attach files.
Details
File Attachment

Error:

In addition to the electronic copy of this submission, please be sure to submit one hard-copy of the signed
variance request document to the following address:
Division of Dockets Management (HFA-305)
Food and Drug Administration
Rm 1061, 5630 Fishers Lane
Rockville, MD 20852

Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an inspection?

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What was the date of the inspection?
A response to a warning letter from the Food and Drug Administration (FDA)?

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What was the date of the Warning Letter?
A response to a report review inquiry from the Center for Devices and Radiological Health (CDRH) (the
inquiry may have been in the form of a letter, email, or phone call)?

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What was the date of the inquiry?
A response to any other communication from FDA?
What was the date of the communication?
Provide an explanation:

Use Environment
Who are the intended users?
[
[
[
[
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff
] Patients
] Other

What is the use environment?
[
[
[
[
[
[
[
[
[
[

] Consumer Home
] Hospital or Clinic
] Industrial Facility or Factory
] Office/Warehouse/Store
] Outdoors
] Public Arena
] Schools, Gymnasium/Auditorium
] Lab or Research Facility
] Transportation Facility
] Other

Please select the best match for the affected population:
[
[
[
[
[
[
[

] Children and/or Youth
] Consumers
] Elderly
] Employees/Workers
] Engineers or Scientists
] General Public
] Medical Staff

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[ ] Patients
[ ] Other

Additional Information
Is there any other relevant information or additional comments that would help expedite the review of this submission? Click the
Add... button below to attach any supporting files.
File Attachment
Details

Private Labeling
Is the product sold by other companies under different brand names?

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Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these numbers has
been assigned by FDA yet.

If it has not been assigned yet, provide an explanation and submit it as soon as you receive such a filing number.

Electromagnetic Compatibility and Interference

Electromagnetic Compatibility with other Products
Provide description of analysis and indicate any shielding you have for your product to protect other products from EMI:

Susceptibility to EMI from other Products
Provide description of analysis and indicate any protective shielding your product has to protect it from EMI:

Section: Ultrasonic Therapy Product
Product Classification
Indicate below the type of product or family of products covered by this report.
This report covers:
Is your system a continuous-wave (CW) unit or an amplitude-modulated (AM) unit?

Performance Specifications

Note:

The information reported in this section will be used to determine whether the product complies with the
requirements set forth in 21 CFR 1050.10(c). Several items must be reported in terms of definitions that are
provided by the standard; please refer to 21 CFR Part 1050.10 for these definitions.

Frequency of Operation
Note:

Provide the following data for operating frequency(ies) in MHz for either fixed, variable, or multiple frequency
systems.

Fixed at _____ MHz:
_____ MHz:
Variable, from _____ MHz to _____ MHz:
Minimum MHz:
Maximum MHz:
Multiple, fixed at _____ MHz, _____ MHz, and _____ MHz:
_____ MHz:
_____ MHz:
_____ MHz:
Operating frequency (ies) are indicated to the user by:

Output Parameters for Continuous-Wave Units
Temporal-average ultrasonic power:
Message:

Variable, from _____ Watts to _____ Watts:

Minimum Watts:
Maximum Watts:
Indicated to the user by:
Temporal-average effective intensity:
Message:

Variable, from _____ W/cm² to _____ W/cm²:

Minimum W/cm²:
Maximum W/cm²:
Indicated to the user by:

Output Parameters for Amplitude-Modulated Units
Temporal-maximum ultrasonic power:
Message:

Variable, from _____ Watts to _____ Watts:

Minimum Watts:
Maximum Watts:
Indicated to the user by:
Temporal-maximum effective intensity:
Message:

Variable, from _____ W/cm² to _____ W/cm²:

Minimum W/cm²:
Maximum W/cm²:
Indicated to the user by:
Output pulse width:
Message:

Fixed at _____ milliseconds:

_____ milliseconds:
Message:

Variable from _____ milliseconds to _____ milliseconds:

Minimum milliseconds:
Maximum milliseconds:
Indicated to the user by:
Output pulse repetition rate:
Message:

Fixed at _____ pulses/second:

_____ pulses/second:
Message:

Variable, from ______ to ______ pulses/second:

Minimum pulses/second:
Maximum pulses/second:
Message:

User selected from the available settings (list available settings):

Setting 1:
Setting 2:
Setting 3:
Indicated to the user by:

Timer Specifications
Timer accuracy for settings of:
Less than 5 minutes:
Provide the number of minutes: (+/- ______ minutes)
Between 5 and 10 minutes:
Provide the number of minutes as a percent: (+/- ______ percent)
Greater than 10 minutes:
Provide the number of minutes: (+/- ______ minutes)

Maximum timer setting: ( ____ minutes)
How does ultrasonic emission automatically terminate at the end of preset time?

How can ultrasonic emission be terminated prior to the end of the preset time?

How is radiation emission routinely terminated?

Applicators
Type of applicators:
Collimating, with an effective radiating area (ERA) of _____ cm²:
Diverging, with an effective radiating area (ERA) of _____ cm²:
Focusing, with focal area of _____ cm² and a focal length of _____ cm:
Transducer Configuration:
Single Crystal (specify material):
For multiple elements, describe each element, the manner in which connected, and the resulting effect on the radiated field.

Cables
How is application of electrical power to the transducer indicated to the user?

How is a broken cable or open connection indicated to the user?

Labeling Requirements
Note:

The information reported in this section will be used to determine whether the product complies with the
requirements set forth in 21 CFR Parts 801, 1010.2, 1010.3 and 1050.10(d). Most of the items below require
that a copy of the label be attached; if labels are unavailable at the time of reporting, please provide a
specification control drawing.

Certification
Note:

Part 1010.2 of 21 CFR requires that the product (generator and applicator, if detachable) bear a permanently
affixed tag or label certifying that it complies with the provisions of Part 1050.10. Provide the following
information concerning the certification label:

The manner in which the label is attached:

The location of the label:

Attach a sample of the label.
File Attachment
Details

Identification
Note:

Part 1010.3 of 21 CFR requires that the product (generator and applicator, if detachable) bear a permanently
affixed tag or label giving the following information:(a) The name and address of the manufacturer. (Where the
product is sold under a name other than that of the manufacturer, the name and address of the individual or
company under whose name the product is sold may be given on the label, provided that such individual or
company has previously supplied the CDRH with the name and address of the manufacturer.)(b) The place,

month, and year of manufacture. (The place of manufacture may appear in coded form if the manufacturer has
previously supplied the CDRH with the codes and their meaning). The month and year of manufacture must
be given without abbreviation and with the year as a four-digit number (for example: Manufactured: September
1978.)
Message:

Provide the following information concerning the identification label:

The manner in which the label is attached:

The location of the label:

Attach a sample of the label.
File Attachment
Details

Generator Labels
Note:

Part 1050.10(d)(3) of 21 CFR requires that each ultrasonic therapy generator bear a label giving the following
information:
(a) The brand name, model designation, and serial number of the generator.
(b) The ultrasonic frequency (unless variable, and indicated on the controls).
(c) The type of waveform (continuous wave or amplitude modulated).
In addition to the above, generators employing amplitude modulated waveforms are required to bear
additional labeling giving the following information:
(a) Pulse duration and repetition rate (unless variable, and indicated on the controls).
(b) An illustration of the waveform.
(c) The ratio of the temporal-maximum effective intensity to the temporal-average effective intensity. If this
ratio is a function of any operation control setting, then the range of the ratio shall be given, and the waveform
illustration shall be for the maximum value of this ratio.

Message:

Provide the following information concerning the generator label:

The manner in which the label is attached:

The location of the label:

Attach a sample of the label.
File Attachment
Details

Applicator Labels
Note:

Part 1050.10(d)(4) of 21 CFR requires that each ultrasonic therapy applicator bear a label giving the following
information:(a) The brand name, model designation, and serial number of the applicator.(b) Thedesignation of
the generator for which the applicator is intended.(c) The ultrasonic frequency, effective radiating area,
maximum beam nonuniformity ratio, type of applicator (focusing, collimating, diverging), and, for focusing
applicators, the focal length and focal area.

Message:

Provide the following information concerning the applicator label:

The manner in which the label is attached:

Attach a sample of the label.
File Attachment
Details

Operation Controls
Note:

Part 1050.10(d)(1) of 21 CFR requires that each operation control be clearly labeled, identifying the function
controlled and, where appropriate, the units of measure of that function. If a separate control and indicator are
associated with the same function, labeling the units of measure of that function is required for the indicator
but not for the control.

Provide drawings, photographs, or other documents, which show clearly the location and labeling of all such controls. Click on the
Add... button below to attach and select the files.
File Attachment
Details

Service Controls
Note:

Part 1050.10(d)(2) of 21 CFR requires that each service control that is accessible without displacement or
removal of any part of the product be clearly labeled, identifying the function controlled and including the
phrase for service adjustment only.

Provide drawings, photographs, or other documents, which show clearly the location and labeling of all such controls. Click on the
Add... button below to attach and select the files.
File Attachment
Details

Information Requirements
Note:

Provide the following information regarding servicing information, user information, and product description.

Servicing Information
Note:

Part 1050.10(f) (1) of 21 CFR requires a manufacturer to provide to servicing dealers and distributors
adequate instructions for operation, service, and calibration of the product. This must include:(a) A description
of those controls and procedures that could be used to increase radiation emission levels.(b) A schedule of
maintenance necessary to keep the product in compliance with 21 CFR 1050.10.(c) Any safety precautions
that may be necessary regarding ultrasonic exposure.

Attach a copy of the servicing information clearly identified above. Click on the Add... button below to attach and select the files.
File Attachment
Details

User Information
Note:

Part 1050.10(f)(2) of 21 CFR requires a manufacturer to provide users with adequate instructions for
assembly, operation, and safe use of the product. This must include:
(a) A discussion of all operation controls and a description of the effect of each control.

(b) A schedule of maintenance necessary to keep the product in compliance with 21 CFR 1050.10.
(c) Any safety precautions that may be necessary regarding ultrasound exposure.
(d) A description (including textual discussion and diagrams, plots or photographs) of the spatial distribution of
the radiated field. The description must include the statement that it applies for the radiation emitted into the
equivalent of an infinite medium of distilled, degassed water at 30°C and with line voltage variations in the
range of ± 10%, or the rated value.
(e) The uncertainties in magnitude, expressed in percentage error, of the ultrasonic frequency, effective
radiating area, and (when applicable) the ratio of the temporal-maximum to temporal-average effective
intensity, pulse duration, pulse repetition rate, focal area, and focal length.
(f) The error in indication of radiated power and intensity.
(g) The error in indication of present treatment time.
(h) A listing of all controls, adjustments, and procedures for operation and maintenance, including the warning
"Caution -- use of controls or adjustments or performance of procedures other than those specified herein may
result in hazardous exposure to ultrasonic energy."
Attach a copy of the user information to the preceding sections, clearly identified above. Click on the Add... button below to attach
and select the files.
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Product Description
Note:

In order to adequately review a manufacturer's product, CDRH requires that a product report provide a
thorough physical description of the product. Such a description must include:(a) Photographs or drawings or
the generator and applicator.(b) A complete schematic diagram of the product.

Provide the information listed above as attachments. Click on the Add... button below to attach and select the files.
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Testing Programs
Note:

The information reported in this section will be used to determine whether the manufacturer's testing programs
are adequate for certification (21 CFR 1010.2) and that the products are in compliance with the performance
standard. Each item in this section must be addressed individually and in detail.

Incoming Component Testing
Note:

Fully describe all tests that are performed on components whose perfomance can affect compliance with this
standard. This description should include but is not limited to:(a) Identify the component tested and its
function.(b) State whether the component is tested on a 100 percent or sampling basis. If tested on a sampling
basis, provide all sampling parameters and the basis for selecting the Acceptable Quality Level.(c) Describe
the corrective action taken following unit or lot rejection (i.e., return component to manufacturer, test 100
percent of components, increasesampling level). If the sampling level is increased, provide the complete
rationale for this procedure, and any revised acceptance criteria.

Provide the above information as an attachment for each tested component. For example, if transducer crystals and timers are
among the components tested, attach the description of the testing of crystals as one file attachment and the description of the
testing of timers as the second file attachment, and so forth. Click on the Add... button to add and select the files to be attached.
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Calibration of Test Instruments
Note:

Fully describe the instruments used in any test conducted to ensure compliance with this standard. This
should include, but is not limited to, the following:(a) The manufacturer, model number, type (e.g., radiation
force), accuracy, and resolution of the instrument used to measure ultrasonic power.(b) The procedure by
which the above instrument is calibrated. Include a description of any calibrated source used, stating the
accuracy and by whom calibrated.(c) The manufacturer, model number, and complete specifications of the
hydrophone used to measure ultrasonic intensity.(d) A description of the scanning apparatus used to measure
the spatial distribution of the radiated field.(e) A description of, and calibration procedures for, any other
instrument used for compliance testing.

Provide the above information as attachments below. Click on the Add... button to add and select the files to be attached.
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Production Testing
Note:

Fully describe all tests that are performed on the product during or after production to ensure compliance with
this standard. The description of each test must include, but is not limited to, items (a) through (e) below. Note
that part 1050.10(e) of 21 CFR requires that measurements of ultrasonic radiation be made with the radiation
emitted into the equivalent of an infinite medium of distilled, degassed water at 30°C, and with line voltage
variations in the range of ±10% of the rated value.
(a) Identify all instruments reported in the Calibration of Test Instruments section above that are used for the
test.
(b) State the sources and magnitudes of uncertainty in the test.
(c) State whether the component or parameter is tested 100 percent or sampling basis. If tested on a sampling
basis, include lot size, proportion of total production tested, method of sample selection to ensure
randomness, and the rationale for sampling rather than testing on a 100 percent basis. It must be clearly
demonstrated that such a sampling program will ensure compliance of all certified products.
(d) Decribe the test procedure in detail, including any assumptions that are taken from the results. For
example, in the description of the test for accuracy of indicated power, state the specific power levels at which
the measurement is made, the error in indicated power at each point, and the range over which the average
error is assumed to hold.
(e) Describe the corrective action taken following unit or lot rejection (i.e., Increase sampling, test 100
percent).

Provide the above information as an attachment for each parameter tested. For example, present the description of the test for
error in indicated power as a file attachment. Click on the Add... button to add and select the files to be attached. The parameters
tested during production should include, but are not limited to:
(a) Error in indication of temporal-average ultrasonic power (CW units).
(b) Error in indication of temporal-maximum ultrasonic power (pulsed units).
(c) Error in measured value of effective radiating area.
(d) Error in the determination of the ratio of temporal-maximum effective intensity to temporal-average effective intensity.
(e) Error in indication of preset treatment time.

(f) Proper operation of manual and automatic treatment termination devices.(g) Proper operation of visual "ultrasound on"
indicator.
(h) Proper operation of indicators of pulse duration, pulse repetition rate, and ultrasonic frequency (where applicable).
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Life Testing

Note:

Fully describe all tests that are performed on the product to ensure that it is capable of complying with the
standard throughout its life. This should include, but is not limited to:(a) Sample size, frequency of sampling,
and selection criteria.(b) Description of the test, including the sources and magnitudes of error, parameters
measured or monitored, instruments used, and length of test or equivalent length of test.

Provide the above information as an attachment. Click on the Add... button below to add and select the files to be attached.
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Provide an estimate of the useful life of the product (in years):
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Form FDA 3644 Guide for Preparing Product Reports for Ultrasonic Therapy Products (03/06)