ACCUSONIC ADVANTAGE

K120171 · Metron Medical Australia, Pty, Ltd. · IMI · May 4, 2012 · Physical Medicine

Device Facts

• Record ID: K120171
• Device Name: ACCUSONIC ADVANTAGE
• Applicant: Metron Medical Australia, Pty, Ltd.
• Product Code: IMI · Physical Medicine
• Decision Date: May 4, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Accusonic Advantage – AA 170 is an ultrasonic diathermy device. It delivers ultrasonic energy to deep tissues to generate heat. Used by clinicians for therapeutic purposes including pain relief, muscle spasm reduction, joint contracture management, and circulation improvement. Operates via ultrasonic transducer application to the patient's skin. Device provides thermal effects to target tissues to facilitate therapeutic outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultrasonic diathermy device; Class II; Product Code IMI; 21 CFR 890.5300. Operates by generating ultrasonic energy for deep tissue heating.

Indications for Use

Indicated for the 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Metron Medical Australia Pty. Ltd % Mr. David Mitchell Manager, R & D 57 Aster Avenue Carrum Downs, Victoria 3201 Australia

4 2012 MAY

Re: K120171

Trade/Device Name: Accusonic Advantage – AA 170 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI Dated: April 4, 2012 Received: April 4, 2012

Dear Mr. Mitchell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. David Mitchell

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

for

Sincerely yours.

Einel Keith

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

Enclosure

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# 510 (k) NUMBER (IF KNOWN): DEVICE NAME:

## K120171 Accusonic Advantage - AA 170

### INDICATIONS FOR USE:

The indications for use are:

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

Over-The-Counter-Use NO AND/OR YES Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off

(Division Sign-Off) (Division Sign of Surgical, Orthopedic, Divisionative Devices

510(k) Number K120171