SW ULTRASOUND, MODELS 331, 311, 333

K991613 · Starbene · IMI · Dec 8, 2000 · Physical Medicine

Device Facts

• Record ID: K991613
• Device Name: SW ULTRASOUND, MODELS 331, 311, 333
• Applicant: Starbene
• Product Code: IMI · Physical Medicine
• Decision Date: Dec 8, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SW Ultrasound Line is intended for use in applying therapeutic deep heat for selected medical conditions.

Device Story

The SW Ultrasound Line (Models 331, 311, 333) is a therapeutic ultrasonic diathermy device. It applies ultrasonic energy at frequencies exceeding 20 kHz to specific body areas to generate deep heat. The device is intended for use by healthcare professionals to treat pain, muscle spasms, and joint contractures. It is not indicated for treating malignancies. The device operates by converting electrical energy into ultrasonic waves, which penetrate tissue to produce thermal effects. Clinical benefit is derived from the therapeutic application of deep heat to the affected tissues. The device is used in clinical settings.

Clinical Evidence

Bench testing only. Testing included electrical safety, electromagnetic compatibility, and comparative temperature rise measurements in a phantom model between the subject device and the predicate device. Compliance with 21 CFR 1050.1 was verified.

Technological Characteristics

Ultrasonic diathermy device; operates at frequencies >20 kHz. Class II device. Technological characteristics and principles of operation are identical to the predicate. Testing performed for electrical safety and electromagnetic compatibility.

Indications for Use

Indicated for patients requiring therapeutic deep heat for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures. Contraindicated for the treatment of malignancies.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Predicate Devices

• DYNATRON 125

Submission Summary (Full Text)

{0}------------------------------------------------

DEC - 8 2000

1000 STARBENE 510K NOTIFICATION SW ULTRASOUND

# 510(k) SUMMARY ( As required by 210 CFR 807.92)

Trade Name :

Common / Classification Name :

Marketed by:

#### SW ULTRASOUND

Ultrasonic Diathermy

STARBENE David Luque 519 5000- Cordoba Argentina 54-351-4240051 T.E: FAX: [phone]

Dated Prepared : Additional Information : April 23rd , 1999 September 17TH , 1999

Contact:

Miss Judith Niztzschmamn International Regulations Department

# A- LEGALLY MARKETED PREDICATE DEVICE

The SW ULTRASOUND LINE equipment is substantially equivalent to the following devices marketed:

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>TT TT TT CITY<br>.<br>NAME A LA MINING AND CLAIM AND CLAIM CONNECT | --------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Yr 's Tr T's<br><br>A Commonstration Commission Comprehend Courtes of Children<br>Status and States of Children of Children of Children of Children of | montance and control and the transition to the state of the states of the same<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> | .<br>. | |
| would been a l<br>DYNATRON 125<br>T<br>A MAR IN A MARKER AN ANNALIZA AND OR AND EN LE BOOK A BRONAL A<br>Contraction Company a Limitel and I age | 70/100<br>A B A B A B A L A - L - L - L - L - L - L - L - L - L - L - L - L - L - L - L - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -<br>. The state of the prise and the state of the state of the first of the secures | |

{1}------------------------------------------------

K991616
20F3

STARBENE 510K NOTIFICATION SW ULTRASOUND

## B- DEVICE DESCRIPTION

The SW Ultrasound Line is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain , muscle spasms, and joint contractures , but not for the treatment of malignancies .

#### C- INTENDED USE

The SW Ultrasound Line is intended for use in applying therapeutic deep heat for selected medical conditions.

### INDICATIONS FOR USE

# INDICATIONS FOR ULTRASOUND USE

Ultrasound therapy is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures , but not for the treatment of malignancies ( 21 CFR 890.5300)

## D- TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the SW Ultrasound device are the same as those of the predicate device.

#### E- TESTING

Starbene carried out testing to address the following issues

- 1- Electrical safety
- 2- Electromagnetic compatibility
- 3- Temperature rise in a phantom during SW Ultrasound procedures
- 4- Temperature rise in a phantom using the predicate devices
- 5- Compliance with the 21 CFR 1050.1

{2}------------------------------------------------

K99 1613
3 OF 3

STARBENE 510K NOTIFICATION SW ULTRASOUND

## E- CONCLUSIONS

The SW Ultrasound Line has the same intended use and target population as the predicate device.

Starbene has demonstrated through its performance tests on the SW Ultrasound Line equipment and its comparison with those of the predicate device that the SW Ultrasound device is substantially equivalent to the predicate device.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a double helix-like design, representing the structure of DNA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 8 2000

Ms. Judith Niztzschmamn STARBENE International Regulations Department David Luque 519 Cordoba, Pvcia, Cordoba, Argentina

Re: K991613

Trade Name: SW Ultrsound, Models 331, 311, 333 Regulatory Class: II Product Code: IMI Dated: September 15, 2000 Received: September 22, 2000

Dear Ms. Judith Niztzschmamn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{4}------------------------------------------------

#### Page 2 -- Ms. Judith Niztzschmamn

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

गै

510(k) Number (if known ) _K991613

Device Name: SW ULTRASOUND

Indications For Use:

IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR ION THEFULL LONSE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991613
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)