VECTORSURGE 5 MODEL 470

• K Number: K030648
• Device Name: VECTORSURGE 5 MODEL 470
• Manufacturer: METRON MEDICAL AUSTRALIA PTY LTD
• Date Cleared: 2003-03-28 ( 28 days)
• Product Code: IPF , GZJ , LIH
• Regulation Number: 890.5850
• Type: Special
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The indications for use are:

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

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, I cannot answer your question. The document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Vectorsurge 5 Model VS 470." It discusses regulatory classifications, general controls, and indications for use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case comparative effectiveness study or standalone algorithm performance.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.

Summary

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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular pattern around the top half of the seal. In the center of the seal is a stylized image of an eagle.

OCT 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030648

Trade/Device Name: Vectorsurge 5 Model VS 470 Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II

Product Codes: IPF, GZJ, LIH Dated: February 25, 2003 Received: February 28, 2003

Dear Mr. Toman:

This letter corrects our substantially equivalent letter of March 28, 2003.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In

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Page 2 -- Mr. David Toman

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.

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely yours,

barbarefmeim

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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510 (k) NUMBER (IF KNOWN):

K 030648

DEVICE NAME:

Metron Vectorsurge 5 Model VS-470

INDICATIONS FOR USE:

The indications for use are:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

OR

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

Barbara Michto
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K030648
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Regulation Number and Section

§ 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).