(63 days)
- I. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, TNS and Microcurrent waveforms);
-
- Relaxation of muscle spasm (all waveforms except Microcurrent);
-
- Prevention or retardation of disuse atrophy (all waveforms except Microcurrent);
-
- Increasing local blood flow (all waveforms except Microcurrent);
-
- Muscle re-education (all waveforms except Microcurrent);
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and
-
- Maintaining or increasing range of motion (all waveforms except Microcurrent).
Not Found
This FDA 510(k) clearance letter for the Metron Multi-Stim Model MS-100A does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on a comparison to existing devices, and typically involves demonstrating similar technological characteristics and performance specifications. However, the letter itself does not provide the details of those performance specifications or the studies conducted to demonstrate them.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them because that information is not present in the provided text.
The document states: "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..." This indicates a comparison to predicate devices, but the specifics of how that substantial equivalence was demonstrated (i.e., performance criteria and study results) are not elaborated upon in this letter.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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);
-
- Relaxation of muscle spasm (all waveforms except Microcurrent);
-
- Prevention or retardation of disuse atrophy (all waveforms except Microcurrent);
-
- Increasing local blood flow (all waveforms except Microcurrent);
-
- Muscle re-education (all waveforms except Microcurrent);
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and
-
- 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
Page 1 of _ 1 _
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).