VECTORSURGE 5 MODEL 470

K030648 · Metron Medical Australia, Pty, Ltd. · IPF · Mar 28, 2003 · Physical Medicine

Device Facts

• Record ID: K030648
• Device Name: VECTORSURGE 5 MODEL 470
• Applicant: Metron Medical Australia, Pty, Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Vectorsurge 5 Model VS-470 is a powered muscle stimulator and transcutaneous electrical nerve stimulator (TENS). Device delivers electrical impulses to patient tissues via electrodes. Operates in TNS mode for pain management and Interferential mode for muscle-related therapeutic applications. Used in clinical settings by healthcare professionals to treat muscle spasms, prevent atrophy, increase local blood flow, re-educate muscles, prevent venous thrombosis, and maintain range of motion. Output parameters are controlled by the clinician to achieve desired physiological effects. Benefits include non-pharmacological pain relief and physical therapy support for muscle function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator and TENS device. Operates via electrical stimulation. Class II device under 21 CFR 890.5850 and 21 CFR 882.5890. Product codes: IPF, GZJ, LIH.

Indications for Use

Indicated for patients requiring pain relief (chronic intractable, acute post-traumatic, or post-surgical) via TNS mode, or muscle stimulation (spasm relaxation, atrophy prevention, blood flow increase, re-education, venous thrombosis prevention, or range of motion maintenance) via Interferential mode.

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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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 | <div style="text-decoration: overline;">X</div> |
|----------------------|-------------------------------------------------|
| (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 | <div style="text-decoration: overline;">K030648</div> |
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