HANDMASTER NMS1

K982482 · N.E.S.S. Nuromuscular Electrical Stimulation Syst · IPF · Sep 30, 1998 · Physical Medicine

Device Facts

• Record ID: K982482
• Device Name: HANDMASTER NMS1
• Applicant: N.E.S.S. Nuromuscular Electrical Stimulation Syst
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The HANDMASTER NMS1 is intended to be used to exercise the lower arm and hand by activating the muscles thereof with electrical stimulation. As a powered muscle stimulator, the HANDMASTER NMS1 is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

Device Story

Handmaster NMS1 is a portable, single-channel neuromuscular electrical stimulator for personal use; exercises upper extremities. Device consists of a control unit and a splint worn on the hand/forearm; five surface electrodes held by splint deliver stimulation. Input: user-selected stimulation programs (cyclic or continuous) via control unit buttons. Operation: microprocessor-controlled switching of stimulation between electrodes; constant-voltage symmetrical biphasic Russian waveform (11,000 Hz carrier). Output: finger/thumb extension and flexion. Clinician sets maximum current limits and timing factors; user adjusts intensity (10 levels) and triggers stimulation. Benefits: muscle conditioning, spasm reduction, and improved circulation for patients with paralysis. Powered by rechargeable NiCd batteries.

Clinical Evidence

Bench testing only. Oscilloscope tracing specification tests were performed per FDA guidance for powered muscle stimulators to measure output at various intensity levels, loads, and operating modes.

Technological Characteristics

Portable, single-channel neuromuscular stimulator. Splint: fiber-reinforced plastic with polyurethane cushions. Electrodes: metal foil coated with carbon-impregnated polymer; water-soaked cloth pads. Energy: rechargeable NiCd batteries. Waveform: constant-voltage symmetrical biphasic Russian waveform (11,000 Hz carrier). Control: microprocessor-based firmware. Connectivity: standalone.

Indications for Use

Indicated for patients with upper limb paralysis due to central nervous system injury or disease (e.g., cervical spinal cord injury, stroke) requiring maintenance/increase of range of motion, reduction of muscle spasm, prevention/retardation of disuse atrophy, muscle reeducation, or increased local blood circulation.

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.

Predicate Devices

• HANDMASTER NMS1 (K952273)

Submission Summary (Full Text)

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K982/482

SEP 3 0 1998

## 510(K) SUMMARY

## N.E.S.S. NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS LTD.'S MODIFIED HANDMASTER NMS1 POWERED MUSCLE STIMULATOR

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter:

N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. 19 Ha-Haroshet Street Keidar Center Suite 207 P.O. Box 2500 Industrial Zone Ra'anana, 43465 ISRAEL

Phone: [phone] Facsimile: 011-972-7485740

Contact Persons:

Giora Arbel N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. 19 Ha-Haroshet Street Keidar Center Suite 207 P.O. Box 2500 Industrial Zone Ra'anana, 43465 ISRAEL

011-972-7485738 Phone: Facsimile: 011-972-7485740

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Phone: [phone] Facsimile: 202-637-5910

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July 16, 1998 Date Prepared:

# Name of Device and Name/Address of Sponsor

The HANDMASTER NMS1

N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. 19 Ha-Haroshet Street Keidar Center Suite 207 P.O. Box 2500 Industrial Zone Ra'anana, 43465 ISRAEL

Phone: [phone] Facsimile: 011-972-7485740

## Common or Usual Name

External Neuromuscular Stimulator

#### Classification Name

Powered Muscle Stimulator

### Predicate Devices

N.E.S.S. Neuromuscular Electrical Stimulation Systems HANDMASTER NMS1 (K952273).

#### Intended Use

The HANDMASTER NMS1 is intended to be used to exercise the lower arm and hand by activating the muscles thereof with electrical stimulation. As a powered muscle stimulator, the HANDMASTER NMS1 is intended to be used for the following indications: maintenance or increase of range of motion, reduction of

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muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

### Technological Characteristics and Substantial Equivalence

The HANDMASTER NMS1 is a portable, one-channel electrical neuromuscular stimulator for personal use in exercising the upper extremity. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable.

The HANDMASTER NMS1 is used for exercising the hand, conditioning selected muscles of the forearm and hand. It is intended for use by patients suffering from upper limb paralysis due to injury or disease of the central nervous system such as cervical spinal cord injuries or stroke.

A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.

The electrode locations allow the HANDMASTER NMS1 to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The active mode is displayed by a light glowing next to the labeled mode. When the device is

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The stimulation programs are supplied as stimulating, the light flashes. microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors.

The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment display.

During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion.

The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately.by switching OFF the device.

The HANDMASTER NMS1 splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a

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conductive interface with the skin. A sponge-capped bottle is provided to facilitate wetting of the electrode pads.

Rechargeable nickel-cadmium batteries power the device. Battery status can be displayed both during device operation and while recharging the batteries. Both visual and audio battery-low warnings are provided. It is necessary to disconnect splint/electrodes in order to recharge the batteries, as the same socket is used for both.

The modified HANDMASTER NMS1 is substantially equivalent to the original HANDMASTER NMS1, a marketed powered muscle stimulator. The modified HANDMASTER NMS1 and its predicate device have the same intended use, which is to exercise the limb by activating the muscles with electrical stimulation. Like the modified HANDMASTER NMS1, the predicate device is capable of delivering electrical stimulation to surface electrodes positioned on the skin surface of the limb. In addition, both the modified HANDMASTER NMS1 and the predicate device are operated either in flexion/extension cyclic mode or in a continuous mode.

The modification to the original HANDMASTER NMS1 will not alter the cleared device's intended use or indications for use. The sole change to be made is that the modified device would produce a higher frequency carrier wave than the original HANDMASTER NMS1. The currently cleared HANDMASTER NMS1 has a carrier wave frequency of 5,000 Hz, and the proposed modification would increase the carrier wave frequency to 11,000 Hz. No other changes will be made to the

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amplitude or shape of the waveform, or any other technological characteristics. Importantly, the modification to the HANDMASTER NMS1 could not impact safety or effectiveness because it is well recognized in the medical literature that the stimulation frequency, not the carrier wave frequency, determines the effect and comfort of the stimulation. Hence, according to FDA's framework for substantial equivalence, the 11,000 Hz device is substantially equivalent to the 5,000 Hz device.

## Performance Data

Oscilloscope Tracing Specification tests have been carried out on the modified HANDMASTER NMS1 per Section 1 of the Draft FDA Guidance entitled "Technological Reporting for Powered Muscle Stimulators". This testing measured the stimulator output for the modified HANDMASTER NMS1 at various intensity levels, output loads and operating modes.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the profiles of three people facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Neuromuscular Electrical Stimulation System (N.E.S.S.) Ltd. c/o Mr. Jonathan S. Kahan Partner Hogan & Hartson 555 Thirteenth Street NW Columbia Square Washington, DC 20004-1109

Re: K982482 Trade Name: Handmaster NMS1 Regulatory Class: II Product Code: IPF Dated: July 16, 1998 Received: July 16, 1998

Dear Mr. Kahan:

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. Jonathan S. Kahan

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 your 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 yours,

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

Radiological Health

Enclosure

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Pevice Name: HANDMASTER NMS1

Prescr

Indications For Use: The HANDMASTER is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K982482 |

Prescription Use

OR
Over-The-Counter Use

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(Optional Formst 1-2-96)