MEDSTAR 100 INTERFERENTIAL STIMLATOR

K013082 · Mednet Services, Inc. · LIH · Nov 16, 2001 · Neurology

Device Facts

• Record ID: K013082
• Device Name: MEDSTAR 100 INTERFERENTIAL STIMLATOR
• Applicant: Mednet Services, Inc.
• Product Code: LIH · Neurology
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are: - symptomatic relief and management of chronic pain . and/or - an adjunctive treatment in the management of post . surgical and posttraumatic acute pain.

Device Story

MEDSTAR 100 is a DC battery-powered interferential stimulator; generates small electrical current pulses. Device delivers pulses via lead cables to skin-surface electrodes; pulses activate underlying nerves to provide pain relief. Used under medical supervision for chronic pain management or post-surgical/post-traumatic acute pain. Healthcare provider applies electrodes and manages therapy settings. Output provides therapeutic electrical stimulation to patient.

Clinical Evidence

Bench testing only. Functional and safety testing performed using a signal generator, voltmeter, and 420-ohm resistor to verify electrical performance and electrode impedance.

Technological Characteristics

DC battery-powered interferential stimulator. Delivers electrical pulses via lead cables and skin electrodes. Electrical performance verified via impedance calculation (Z = V7/V1 x R).

Indications for Use

Indicated for symptomatic relief and management of chronic pain and/or as adjunctive treatment for post-surgical and post-traumatic acute pain under medical supervision.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• HMP 4000 Interferential Stimulator (K924961)

Submission Summary (Full Text)

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# NOV 1 6 2001

#### SUMMARY AND CERTIFICATION Section 2.

The MEDSTAR 100 Interferential Stimulator is a Class II device. The 510(k) Summary is provided in Subsection A on the following page, in accordance with 21 CFR Part 807.

Because this is not a Class III device, nor is it substantially equivalent to a Class III device, the Literature Search and Certification requirement by the Safe Medical Devices Amendments (SMDA) is not applicable.

#### A. 510(k) Summary

### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

| SUBMITTER: | MedNet Services, Inc.<br>2855 Anthony Lane, Suite B-10<br>St. Anthony, MN 55418<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | David L. Mathews |
| TITLE: | President |
| DATE PREPARED: | September 11, 2001 |
| TRADE NAME: | MEDSTAR™ 100 Interferential Stimulator |
| COMMON NAME: | Interferential Stimulator (LIH) |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | LIH |
| PREDICATE DEVICE (S): | HMP 4000 Interferential Stimulator (K924961) |
| DEVICE DESCRIPTION: | The MEDSTAR 100 is a DC battery powered device<br>that generates small pulses of electric current. These<br>small pulses of electrical current are delivered through<br>leads cables to electrodes placed on the skin. These<br>electrical pulses pass through the skin and activate<br>underlying nerves. |

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K013082
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#### INTENDED USE:

Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:

- symptomatic relief and management of chronic pain . and/or
- an adjunctive treatment in the management of post . surgical and posttraumatic acute pain.

### FUNCTIONAL & SAFETY TESTING:

Was performed with a signal generator voltmeter, 420 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V1 was set at approximately 2 volts. The voltage drop across the electrodes (V7) was measured and the impedance of the electrodes calculation is as follows:

Impedance (Z) = V7/V1 x R Where V2 and V1 are the voltage meter readings.

Refer to section 6 for further details.

#### CONCLUSION:

The MEDSTAR™ 100 Interferential Stimulator is substantially equivalent to the HMP 4000 Interferential Stimulator for intended use, design, and electrical performance.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David L. Mathews President MedNet Services, Inc. 2855 Anthony Lane, Suite B-10 St. Anthony, Minnesota 55418

NOV 1 6 2001

Re: K013082

Trade/Device Name: MEDSTAR 100 Interferential Stimulator Regulatory Class: Unclassified Product Code: LIH Dated: September 11, 2001 Received: September 14, 2001

Dear Mr. Mathews:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 2017 3) in accordance with the provisions of the Federal Food, Drug, de riccs that have been roomsomed in avere approval of a premarket approval application (PMA). and Cosmetic Act (7107 that do not required to the general controls provisions of the Act. The 1 ou may, dicrorolo, manel and act include requirements for annual registration, listing of general oonly of the results, 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 If your device is chassinod (600 a00 royals. Existing major regulations affecting your device can thay be subject to sublications, 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 I loast of advisou that I Dri over device complies with other requirements of the Act that I Dr Has intact a and regulations administered by other Federal agencies. You must or any I odetar bakated and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, laooiing (21 CFR Part 820); and if applicable, the electronic form in the quality of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. David L. Mathews

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin manieting your and equivalence of your device to a legally premarket notification: "The PDA miding of backing of backed 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 and II you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHC rate 007.10 for mirally, for questions on the promotion and advertising of Compliance at [phone] - 128288 Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). It guilation chittica, "Misoranang of esponsibilities under the Act may be obtained from the Other general information on your responsible 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,

sincerely, yours,

Mark n Melkison

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 6 2001

K013082

## Indications For Use Page

510(k) number: To be Assigned

Device Name: MEDSTAR 100 Interferential Stimulator

#### Indications For Use:

The MEDSTAR 100 Interferential Stimulator should only be used under the supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:

- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute . pain.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milhisan

Division of General, Restorative and Neurological Devices

510(k) Number K013082