MULTISTIM

K132137 · Metron Medical Australia, Pty, Ltd. · IPF · Sep 12, 2013 · Physical Medicine

Device Facts

• Record ID: K132137
• Device Name: MULTISTIM
• Applicant: Metron Medical Australia, Pty, Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, TNS and Microcurrent waveforms); 2. Relaxation of muscle spasm (all waveforms except Microcurrent); 3. Prevention or retardation of disuse atrophy (all waveforms except Microcurrent); 4. Increasing local blood flow (all waveforms except Microcurrent); 5. Muscle re-education (all waveforms except Microcurrent); 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and 7. Maintaining or increasing range of motion (all waveforms except Microcurrent).

Device Story

Metron Multi-Stim Model MS-100A is a powered muscle stimulator; delivers Interferential, TNS, and Microcurrent electrical waveforms to patient via electrodes. Device used for pain management, muscle rehabilitation, and circulatory support. Operated by clinicians or patients (prescription use). Device transforms electrical energy into therapeutic stimulation pulses; output parameters controlled by user settings. Benefits include pain relief, muscle function restoration, and prevention of post-surgical complications like venous thrombosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Powered muscle stimulator; delivers Interferential, TNS, and Microcurrent waveforms. Class II device (21 CFR 890.5850). Product codes: IPF, GZJ, LIH.

Indications for Use

Indicated for patients requiring relief of chronic intractable, acute post-traumatic, or acute post-surgical pain; relaxation of muscle spasms; prevention/retardation of disuse atrophy; increased local blood flow; muscle re-education; prevention of venous thrombosis via calf muscle stimulation; and maintenance/increase of range of motion.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Golb. Silver Spring, MD 20993-0002

#### September 12, 2013 `

Metron Medical Australia Ptv Ltd c/o David Mitchell. Manager Research and Development 57 Aster Avenue Carrum Downs. Victoria 3201 Australia

Re: K132137

Trade/Device Name: Metron Multi-Stim Model MS-100A Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF. GZJ, LIH Dated: August 8, 2013 Received: August 13. 2013

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 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. Ilsting 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.

1f your device is classified (see above) into cither class 11 (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 – 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Joyce M. Whang -S

for

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):_K132137

Device Name: Metron Multi-Stim Model MS-100A

Indications For Use:

- I. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, TNS and Microcurrent waveforms);
- 2. Relaxation of muscle spasm (all waveforms except Microcurrent);
- 3. Prevention or retardation of disuse atrophy (all waveforms except Microcurrent);
- 4. Increasing local blood flow (all waveforms except Microcurrent);
- 5. Muscle re-education (all waveforms except Microcurrent);
- 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and
- 7. Maintaining or increasing range of motion (all waveforms except Microcurrent).

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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