MODIFICATION TO HANDMASTER

K012823 · Ness-Neuromuscular Electrical Stimulation Systems · GZI · Nov 14, 2001 · Neurology

Device Facts

• Record ID: K012823
• Device Name: MODIFICATION TO HANDMASTER
• Applicant: Ness-Neuromuscular Electrical Stimulation Systems
• Product Code: GZI · Neurology
• Decision Date: Nov 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.

Device Story

Handmaster is a portable, one-channel functional neuromuscular stimulator for personal use. System consists of a control unit and a splint housing five surface electrodes. Splint, constructed of fiber-reinforced plastic with polyurethane cushions, holds wrist at 20° extension and positions electrodes on hand/forearm. Electrodes are metal foil coated with carbon-impregnated polymer, using water-soaked cloth pads as conductive interface. Device delivers constant-voltage symmetrical biphasic Russian waveform stimulation. Microprocessor-controlled switching activates muscles in combinations (cyclic or continuous) for finger/thumb extension and flexion. User selects programs via mode button; intensity adjusted via +/- buttons (10 levels). Clinician-accessible panel allows adjustment of maximum current and global timing factor. Powered by rechargeable Ni-Cd batteries. Used by patients for home-based therapy to improve hand function and range of motion; clinician sets initial parameters.

Clinical Evidence

Clinical data provided to support the expanded indication for hemiplegic patients. No specific study metrics (e.g., p-values, CIs) reported in the summary; evidence demonstrates safe and effective use for the expanded indication.

Technological Characteristics

Portable one-channel neuromuscular stimulator. Constant-voltage symmetrical biphasic Russian waveform. Fiber-reinforced plastic splint with polyurethane cushions. Electrodes: metal foil with carbon-impregnated polymer and water-soaked cloth pads. Rechargeable Ni-Cd batteries. Microprocessor-controlled stimulation switching and intensity adjustment. Seven-segment display for intensity levels.

Indications for Use

Indicated for patients with upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke requiring maintenance/increase of range of motion, reduction of muscle spasm, prevention/retardation of disuse atrophy, muscle reeducation, increased local blood circulation, and restoration of hand function.

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• N.E.S.S. Handmaster (K952273, K982482, and K010837)
• DanMed, Inc. AM800 Automove Electrical Muscle Stimulator (K972997)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(K) SUMMARY

## N.E.S.S. NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS LTD. HANDMASTER 12823

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

## Contact Persons:

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone]

Handmaster Trade Name:

Common/Usual Name: External Functional Neuromuscular Stimulator

External Powered Muscle Stimulator and Classification Name: Functional Neuromuscular Stimulator

## Predicate Devices

Systems Neuromuscular Electrical Stimulation N.E.S.S. Handmaster (K952273, K982482, and K010837); DanMed, Inc. AM800 Automove Electrical Muscle Stimulator (K972997).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with "K012823" on the top line. Below this, there is a second line that reads "20F=3". The handwriting is somewhat rough, but the characters are generally legible.

## Intended 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. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.

## Device Description

one-channel electrical a portable, is The Handmaster neuromuscular stimulator for personal use. 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.

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 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 stimulating, the light flashes. The stimulation programs are They comprise either cyclic or supplied as microprocessor firmware. 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. The intensity is This alters the duration of the stimulation pulse. 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

{2}------------------------------------------------

with a global timing factor which increases or decreases the duration of the with a giobal villing offectively speeding or slowing the cyclic hand motion.

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

The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the comfortable oncerce and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony with bols poly arounded are made from metal foil coated with carbonimpregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A over and crood 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 butteries. 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.

## Performance Data & Substantial Equivalence

The Handmaster subject of this submission is exactly the same device in all aspects to the market-cleared Handmaster. The only difference between the devices is the expansion of the indication to include the ability of the Handmaster to provide hemiplegic patients with active range of motion and hand function. This expansion is supported by clinical data that demonstrates that the Handmaster can be safely and effectively used for this indication, like for the other device indications, without presenting any unreasonable risk of illness or injury. Therefore, the Company believes that substantial equivalence has been demonstrated without raising any new safety and/or effectiveness issue.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows a logo with two distinct elements. On the left, there is a circular seal with text around the perimeter, likely the name of an organization. To the right of the seal, there is a stylized graphic consisting of three curved lines stacked vertically, resembling a bird in flight or a flowing ribbon. The logo appears to be a symbol representing a department or agency, possibly related to health or government services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2001

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Representing N.E.S.S., Ltd. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K012823

Trade/Device Name: Handmaster Regulation Numbers: 21 CFR 890.5850 and 21 CFR 882.5810 Regulation Names: Powered Muscle Stimulator and External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Codes: IPF and GZI Dated: August 16, 2001 Received: August 16, 2001

Dear Mr. Kahan:

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 application (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 such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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

{4}------------------------------------------------

Page 2 - Jonathan S. Kahan, Esq.

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 begin 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

R. Muli n-Millen

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

{5}------------------------------------------------

NOV 1 4 2001

## INDICATIONS FOR USE STATEMENT

# 510(k) Number:_K 0/2823

Device Name:

Handmaster

## 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. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.

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

510(k) Number K012823

**Prescription Use**
(Per 21 CFR 801.109)

ຂອງເຂົາ ໄຂວາງບຸດໄວພາອັກ ນັກສ of Alabola of Creacanti, Restorative 100-60 3 2010. -

OR

7-7

Over the Counter Use

510(x) Number

Mark N. Melkerson

vision of General. Restorative and Neurological Devices

510(k) Number -

K012823

11/DC - 64270/1 - #1379228 v1