DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM

K052934 · S.O.R. Internacional, S.A. · IMI · Jun 12, 2006 · Physical Medicine

Device Facts

• Record ID: K052934
• Device Name: DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
• Applicant: S.O.R. Internacional, S.A.
• Product Code: IMI · Physical Medicine
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

a. Therapeutic Massager: Provides temporary relief of minor muscle aches and pains; Relieves muscle spasms; Temporarily improves local blood circulation; Temporarily reduces the appearance of cellulite. b. Ultrasonic Diathermy: Relief of pain; Muscle spasms; Joint contractures; NOT for the treatment of malignancies.

Device Story

Dermosonic is a mobile, cart-mounted therapeutic device combining vacuum suction massage and ultrasonic diathermy. The therapeutic massager uses a motor-driven vacuum (max 820 mbar, 3,500 L/hr airflow) with continuous or pulsed modes, delivered via stainless steel ball-bearing application heads. The ultrasonic diathermy component utilizes a 3 MHz ultrasound head with an AL 6063 aluminum crystal, offering continuous or pulsed emission (0.5–2 msec pulse duration). Operated by clinicians in a clinic setting, the device features a control panel for parameter selection and monitoring. The device is used to provide temporary relief of muscle aches, spasms, and joint contractures, improve circulation, and reduce cellulite appearance. It benefits patients by providing non-invasive physical therapy for musculoskeletal conditions.

Clinical Evidence

No clinical data provided. Safety and performance testing was completed to demonstrate equivalence to the predicate device.

Technological Characteristics

Mobile cart-mounted unit with injected plastic housing. Therapeutic massager: motor-driven vacuum (max 820 mbar), stainless steel ball-bearing heads. Ultrasonic diathermy: 3 MHz ultrasound head, AL 6063 aluminum crystal. Energy: electrical power, ultrasonic energy. Modes: continuous and pulsed. No software-based algorithm or connectivity described.

Indications for Use

Indicated for patients requiring relief of minor muscle aches, pains, and spasms; improvement of local blood circulation; reduction in the appearance of cellulite; and treatment of 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

• Dermosonic Non- Invasive Subdermal Therapy System (K024307)

Submission Summary (Full Text)

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S.O.R. Internacional, S.A. 510(k) Premarket Submission Dermosonic

K052934

JUN 1 2 2006

# SECTION 5 - 510(k) SUMMARY

| Submission Correspondent:<br>Address: | Emergo Group, Inc.<br>2454 McMullen Booth Road<br>Suite 427 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | Clearwater, FL 33759<br>[phone]<br>[phone] |
| Contact: | Mr. Ian Gordon |
| Submission Sponsor: | S.O.R. Internacional, S.A.<br>Moines, 13-Pol. Ind. C'an Cassablancas<br>08192 Sant Quirze del Valles (Barcelona) Spain |
| Date Prepared: | October 17, 2005, Revised April 4, 2006 |
| Trade Name: | Dermosonic |
| Common Name: | Therapeutic Massager/Ultrasound Diathermy |

| Classification: | Regulation # | Product Code |
|-----------------------|--------------|--------------|
| Massager, Therapeutic | 890.5660 | 89-ISA |
| Diathermy, Ultrasonic | 890.5300 | 90-IMI |

Class II device

Description: The Dermosonic unit is housed in an injected plastic cabinet. Control panels at the top of the cabinet incorporate all the elements required to operate the unit and control and view the various treatment parameters. Below the control panels are spaces to hold the various accessories. There are wheels at the bottom so the device can be easily moved from place to place. Technical specifications for primary components of the devices are:

- 1. Therapeutic Massager: The device incorporates a motor powered vacuum suction modality with a maximum suction power of 820 milli-bars (mbar). The airflow is rated at 3.500 liters per hour. The device has two suction modes: Continuous and Pulsed. In the Continuous Mode, the suction is constant. In the Pulsed Mode, the suction is intermittent. The suction therapy is delivered to the body with three different size application heads to treat different parts of the body which utilize stainless steel ball bearings to allow the heads to be easily moved over the body. The head are

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S.O.R. Internacional, S.A. 510(k) Premarket Submission Dermosonic

> moved over the body in different patterns and directions to achieve varying treatment objectives.

- 2. Ultrasonic diathermy (US-6000): The device utilizes a 3 MHz ultrasound head. The applicator crystal is made of AL 6063 (a special type of aluminum commonly used in heat sink material and in CPU cooling fans). Ultrasonic energy can be emitted continuously or intermittently with pulses of limited duration. In the pulse mode, the duration of the pulse (or pulse time) varies from 0.5 milliseconds (msec) to 2 msec. The device allows the operator to select any one of four available ultrasonic emission modes.
Intended Use:

The indications for use include the following: a. Therapeutic Massager:

- Provides temporary relief of minor muscle aches and pains I.
- Relieves muscle spasms ii .
- Temporarily improves local blood circulation iii.
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy:
- Relief of pain i.
- ii. Muscle spasms
- Joint contractures iii.
- NOT for the treatment of malignancies iv.

Predicate Devices: The predicate device referenced in this submission is:

Sybaritic. Inc.

Dermosonic Non- Invasive Subdermal Therapy System 510(k) K024307

### Safety and Effectiveness:

Safety and performance testing has been completed on the S.O.R. Internacional, S.A. Dermosonic.

The S.O.R. Internacional, S.A. Dermosonic is identical to the Sybaritic, Inc. Dermosonic Non-Invasive Subdermal Therapy System, 510(k) K024307.

There are no differences between the S.O.R. Internacional, S.A. Dermosonic specifications and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness.

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### Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

There are no differences between the S.O.R. Internacional, S.A. Dermosonic specifications and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness. There are no differences in the technological characteristics or in the intended use of these devices.

The S.O.R. Internacional, S.A. Dermosonic device is identical to the predicate device, and therefore we have determined this device to be substantially equivalent to the referenced predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three lines that appear to be flowing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

S.O.R. Internacional, S.A. c/o Mr. Ian Gordon Emergo Group, Inc. 2454 McMullen Booth Road, Suite 427 Clearwater, FL 33759

Re: K052934

Trade/Device Name: Dermosonic Regulation Number: 21 CFR 890.5300(a) Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Codes: IMI, ISA Dated: April 7, 2006 Received: April 10, 2006

Dear Mr. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Mr. Ian Gordon

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hebert Lermerino
Mark N. Mellion

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

K052934 510(k) Number (if known): __

Device Name: Dermosonic

The indications for use include the following:

a. Therapeutic Massager:

Provides temporary relief of minor muscle aches and pains; Relieves muscle spasms; Temporarily improves local blood circulation; Temporarily reduces the appearance of cellulite.

b. Ultrasonic Diathermy:

Relief of pain; Muscle spasms; Joint contractures; NOT for the treatment of malignancies.

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

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

Hubert Henning

(Division Sign-Off) (Division of General, Restorative,
Division of General, Revices Division of Gent
and Neurological Devices
and Neurological Devices

510(k) Number Ko 52934