WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000

K052329 · Innovative Neurotronics, Inc. · GZI · Sep 21, 2005 · Neurology

Device Facts

• Record ID: K052329
• Device Name: WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
• Applicant: Innovative Neurotronics, Inc.
• Product Code: GZI · Neurology
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Device Story

WalkAide is an external functional electrical stimulator worn on the leg below the knee near the fibula head. Device detects gait cycle phases to trigger electrical stimulation of the common peroneal nerve, innervating the tibialis anterior and associated muscles to induce ankle dorsiflexion. System includes a Patient Kit for home use and a Clinician Kit for setup by orthotic specialists, physiotherapists, or occupational therapists. Stimulation aims to improve gait, prevent disuse atrophy, increase local blood flow, facilitate muscle re-education, and maintain/increase joint range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence based on performance and safety testing of technological and functional characteristics.

Technological Characteristics

External functional neuromuscular stimulator (21 CFR 882.5810). Device features include pulse shape, pulse width, and pulse intensity modulation. Worn below the knee near the fibula head. Operates as an electrical stimulator for the common peroneal nerve.

Indications for Use

Indicated for patients with lack of ankle dorsiflexion due to upper motor neuron damage or spinal cord pathway injury. Used to improve gait during swing phase via functional electrical stimulation.

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

• Neuromotion WalkAide System (K974514)

Submission Summary (Full Text)

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K052329

# 510(k) Summary for the Innovative Neurotronics, Inc. WalkAide System

#### SPONSOR 1.

Innovative Neurotronics, Inc. Two Bethesda Metro Center, Suite 1200 Bethesda, Maryland

| Contact Person: | Fayyaz Memon – Director of Quality and Manufacturing |
|-----------------|------------------------------------------------------|
| Telephone: | 1-888-884-6462 ext. 1005 |

August 25, 2005 Date Prepared:

#### DEVICE NAME 2.

| Proprietary Name: | WalkAide |
|------------------------|----------------------------------------------|
| Common/Usual Name: | External Neuromuscular Functional Stimulator |
| Classification Names: | External Neuromuscular Functional Stimulator |
| Classification Number: | 21 CFR 882.5810 |
| Product Code: | GZI |

#### PREDICATE DEVICES 3.

Neuromotion WalkAide System-K974514

#### INTENDED USE 4.

The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

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### DEVICE DESCRIPTION ડ.

The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.

## BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The intended use and technological characteristics such as pulse shape, pulse width, pulse intensity, stimulation trigger mechanism, and other characteristics of the proposed WalkAide are either identical or substantially equivalent to the parent WalkAide devices.

Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification. Any design modifications do not raise any safety or effectiveness issues.

## CONCLUSIONS 7.

Based on the information provided in this premarket notification, Innovative Neurotronics believes that the proposed WalkAide is substantially equivalent to the parent Walk-Aide.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fayyaz Memon Director of Quality and Manufacturing Innovative Neurotronics, Inc. Two Bethesda Metro Center, Suite 1200 Bethesda, Maryland 20814

Re: K052329

Trade/Device Name: Walk Aide External Dunctional Neuromuscular Stimulator Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 25, 2005 Received: August 25, 2005

Dear Mr. Memon:

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 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.

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Page 2 - Mr. Fayyaz Memon

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with a finding of substantial equivalence of your device of your device to a legally promatics notineted 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/industry/support/index.html

Sincerely yours,

Signature

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number : _ _ (1)53337

Device Name: Innovative Neurotronics, Inc., WalkAide External Functional Neuromuscular Stimulator

Indications for Use:

The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/ retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K052329

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