ACCOUSONIC PLUS, MODEL AP-170

K030410 · Metron Medical Australia, Pty, Ltd. · IMI · Feb 20, 2003 · Physical Medicine

Device Facts

• Record ID: K030410
• Device Name: ACCOUSONIC PLUS, MODEL AP-170
• Applicant: Metron Medical Australia, Pty, Ltd.
• Product Code: IMI · Physical Medicine
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use are: - Relief or reduction of pain; 1. - 2. Reduction of muscle spasm; - Joint contracture; and 3. - Local increase in circulation. 4.

Device Story

AP170 Accusonic Plus is an ultrasonic diathermy device. It delivers ultrasonic energy to tissues to generate heat for therapeutic purposes. Used in clinical settings by healthcare professionals. Output effects include pain relief, muscle spasm reduction, joint contracture management, and increased local circulation. Device operates via ultrasonic waves to induce deep tissue heating.

Technological Characteristics

Ultrasonic diathermy device; Class II; Product Code IMI; 21 CFR 890.5300.

Indications for Use

Indicated for relief or reduction of pain, reduction of muscle spasm, treatment of joint contracture, and local increase in circulation.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Dave Toman Technical Director Metron Medical Australia Pty. Ltd. 57 Aster Avenue, P.O. Box 2164 Carrum Downs Victoria, Australia 3201

Re: K030410

Trade/Device Name: AP170 Accusonic Plus Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: January 31, 2003 Received: February 7, 2003

Dear Mr. Toman:

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

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Page 2 – Mr. Dave Toman

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. 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milkerson

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

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510 (k) NUMBER (IF KNOWN):

DEVICE NAME:

Accusonic Plus - AP 170

INDICATIONS FOR USE:

The indications for use are:

- Relief or reduction of pain; 1.
- 2. Reduction of muscle spasm;
- Joint contracture; and 3.
- Local increase in circulation. 4.

Mark N. Milliman

vision Division of General, Restorative and Neurological Devices

KOSO410 510(k) Number __

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)