VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT

K993821 · Metron Medical Australia, Pty, Ltd. · IPF · Dec 9, 1999 · Physical Medicine

Device Facts

• Record ID: K993821
• Device Name: VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
• Applicant: Metron Medical Australia, Pty, Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use of this device are: - Relaxation of muscle spasm. 1. - Prevention or retardation of disuse atrophy. 2. - Increasing local blood circulation. 3. - Muscle re-education. 4. - Immediate post-surgical stimulation of calf muscles to prevent venous 5. thrombosis. - Maintaining or increasing range of motion. 6.

Device Story

Vectorsurge 4 is an interferential therapy unit used in clinical settings by healthcare professionals. Device delivers electrical stimulation to muscles and tissues to achieve therapeutic effects including spasm relaxation, atrophy prevention, circulation improvement, and muscle re-education. Operates by generating interferential currents; output parameters controlled by clinician to suit patient needs. Clinical benefit derived from muscle stimulation and physiological response to electrical current. Device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Interferential therapy unit; electrical stimulation device. Class II medical device. Operates via electrical current delivery for muscle stimulation. Specific materials, dimensions, and software details not provided in the source document.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

Mr. R.H. Hopkins Technical Director Metron Medical Australia Pty. Ltd. 57 Aster Avenue Carrum Downs, Victoria, Australia 3201

Re: K993821

Trade Name: Vectorsurge 4 Interferential Therapy Unit Regulatory Class: II Product Codes: IRO Dated: November 9, 1999 Received: November 12, 1999

Dear Mr. Hopkins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. R. H. Hopkins

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Nil RP. Galang

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment Ib

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1 . . .

510(k) Number (if known): K 99382 |

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Vectorsurge 4 ________________________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

The indications for use of this device are:

- Relaxation of muscle spasm. 1.
- Prevention or retardation of disuse atrophy. 2.
- Increasing local blood circulation. 3.
- Muscle re-education. 4.
- Immediate post-surgical stimulation of calf muscles to prevent venous 5. thrombosis.
- Maintaining or increasing range of motion. 6.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | PROF |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993821 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR

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