THE ODFS DROPPED FOOT STIMULATOR

K050991 · Department of Medical Physics and Biomedical Eng. · GZI · Jul 15, 2005 · Neurology

Device Facts

• Record ID: K050991
• Device Name: THE ODFS DROPPED FOOT STIMULATOR
• Applicant: Department of Medical Physics and Biomedical Eng.
• Product Code: GZI · Neurology
• Decision Date: Jul 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow. The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Device Story

ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional neuromuscular stimulator (FES). Device inputs: gait signals from a belt-worn heel switch. Principle of operation: electrical stimulation of common peroneal nerve and tibialis anterior motor point via skin-surface electrodes to induce ankle dorsiflexion during gait swing phase. Output: biphasic electrical pulses (symmetrical or balanced asymmetrical). Used in clinical or home settings under medical supervision. Healthcare providers use device to improve patient gait and provide secondary benefits like muscle re-education and atrophy prevention. Patient wears device on belt with electrodes on lower leg; stimulation timing is synchronized to gait via heel switch.

Clinical Evidence

Bench testing only. Verification testing confirmed device output and operational characteristics met specifications. Compliance with IEC 60601-1 (general safety), IEC 60601-2-10 (nerve and muscle stimulators), and ISO 60601-1-2 (electromagnetic compatibility) was demonstrated.

Technological Characteristics

External FES; belt-worn, single-channel stimulator. Waveform: Biphasic (symmetrical and balanced asymmetrical). Pulse width: 7-365 µsec; Frequency: 40 Hz. Connectivity: Wired heel switch. Power: Battery-operated. Standards: IEC 60601-1, IEC 60601-2-10, ISO 60601-1-2. Software: Version 6.2.

Indications for Use

Indicated for individuals with dropped foot following upper motor neuron injury. Provides ankle dorsiflexion during swing phase of gait to improve gait. Benefits include muscle re-education, prevention/retardation of disuse atrophy, maintenance/increase of joint range of motion, and increased local blood flow. Requires medical supervision.

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

• EMPI Focus Model 795 (K951951)
• WalkAide (K974514)

Submission Summary (Full Text)

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K050991

JUL 1 5 2005

# 510(k) Summary For The ODFS Dropped Foot Stimulator

#### 1. SPONSOR

Department of Medical Physics and Biomedical Engineering Salisbury Heath Care NHS Trust Salisbury District Hospital Salisbury Wiltshire SP2 8BJ United Kingdom

Tina E. Lechman, NDI Medical Contact Person: 216-378-9106 ext. 101 Telephone:

April 15, 2005 Date Prepared:

NDI Medical (US Agent) One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, OH 44122 Telephone: [phone] Fax: [phone]

# Device Name 2.

| Trade/Proprietary Name: | The ODFS Dropped Foot Stimulator |
|-------------------------|----------------------------------------------------------------------------------------|
| Common/Usual Name: | External Functional Neuromuscular Stimulator (FES) |
| Classification Name: | External Functional Neuromuscular Stimulator (FES)<br>Powered Muscle Stimulator (NMES) |
| Classification Code: | Class II |
| Product Codes: | GZI and IPF |

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### 3. PREDICATE DEVICES

| Predicate Name | Company | K Number |
|----------------------|-------------|----------|
| EMPI Focus Model 795 | EMPI | K951951 |
| WalkAide | NeuroMotion | K974514 |

### DEVICE DESCRIPTION 4.

The ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional neuromuscular stimulator. The ODFS Dropped Foot Stimulator electrically stimulates the common peroneal nerve which may produce contraction of the appropriate muscles that cause dorsiflexion of the ankle in individuals who have lost the ability to do so following neurological injury.

The device is comprised of a small belt-worn, single-channel, foot-switch controlled stimulator used with skin-surface stimulating electrodes. The surface electrodes are typically placed over the common peroneal nerve as it passes near the head of the fibula and the motor point of the tibialis anterior in the lower leg. The heel switch allows the delivery of stimulation to be triggered according to the gait of the user.

# ട. INTENDED USE

The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.

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| Feature | ODFS | EMPI Focus Model 795 | WalkAide |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform | Biphasic<br>(Symmetrical and<br>Balanced Asymmetrical) | Biphasic<br>(Symmetrical and<br>Balanced Asymmetrical) | Not available |
| Pulse Width | 7 (±4) to 365(±20) µsec<br>(patient selectable) | 300 µsec | 200 µsec |
| Frequency (Hz) | 40 (±4) Hz | 25, 30, 35, 45, 50, 80 Hz | 25 Hz |
| Indications for Use | To provide ankle<br>dorsiflexion in individuals<br>with dropped foot following<br>an upper motor neuron<br>injury. During the swing<br>phase of gait, the ODFS<br>electrically stimulates<br>muscles in the leg and ankle<br>of partially paralyzed<br>individuals to provide<br>flexion of the foot and may<br>thus improve the individual's<br>gait. Additional benefits of<br>Functional Electrical<br>Stimulation (FES) may<br>include muscle re-education,<br>prevention/retardation of<br>disuse atrophy, maintained<br>or increased joint range of<br>motion, and increased local<br>blood flow. | As a TENS device:<br>Symptomatic relief and management<br>of chronic intractable pain;<br>adjunctive treatment for post-<br>surgical and post-trauma acute pain<br>As a NMS/NMES device:.<br>Relaxation of muscle spasm;<br>prevention or retardation of disuse<br>atrophy; increasing local blood<br>circulation; muscle re-education;<br>immediate post-surgical stimulation<br>of the calf muscles to prevent<br>venous thrombosis; maintaining or<br>increasing range of motion.<br>As a FES device:<br>Stimulating muscles in the leg and<br>ankle of partially paralyzed patients<br>to provide flexion of the foot and<br>thus improve the patient's gait. | To address the lack of<br>ankle dorsiflexion in<br>patients who have<br>sustained damage to upper<br>motor neurons or<br>pathways to the spinal<br>cord. During the swing<br>phase of gait, the<br>WalkAide electrically<br>stimulates the appropriate<br>muscles that cause ankle<br>dorsiflexion and may thus<br>improve the patient's gait.<br>Medical benefits of FES<br>may include<br>prevention/retardation of<br>disuse atrophy, increased<br>local blood flow, muscle<br>re-education, and<br>maintained or increased<br>joint range of motion. |
| Accessories | Heel switch | Heel switch, Hand switch | Heel switch, Tilt sensor |
| Electrode Size and<br>Shape | 5.0 cm x5.0cm square = 25 cm2<br>4cm x 6.4 cm oval = 20 cm2 | 5.1cm2 | 2.5cm round |

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

# 7. PERFORMANCE TESTING

The ODFS system has been subjected to testing to verify that the device meets its key output specifications. All units tested met product specifications.

Testing included:

- Functional verification testing of output and operational characteristics .
- IEC 60601-1 (EN 60601-1:1988 with amendments of 1991 & 1995). .
- IEC 60601-2-10 (as applicable). ●
- ISO 60601-1-2 (as applicable). .

Based on the information provided, the ODFS Dropped Foot System is substantially equivalent to legally marketed predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Department of Medical Physics and Biomedical Eng. Salisbury Health Care NHS Trust c/o Ms. Tina E. Lechman Clinical Project Manager, US Agent NDI Medical One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, Ohio 44122

JUL 1 5 2005

Re: K050991

Trade/Device Name: ODFS Dropped Foot Stimulator Regulation Number: 21 CF 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: July 8, 2005 Received: July 11, 2005

Dear Ms. Lechman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarer of the device is substantially equivalent (for the indications felerenced above and nave develomined by marketed predicate devices marketed in interstate for use stated in the enorosure) (3 16gars) in the Medical Device Amendments, or to commerce prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices mat nave occh rechasined in assere approval of a premarket approval application (PMA). alle Costile Act (110.) that to hovice, subject to the general controls provisions of the Act. The r ou may, mercere, mainer of the Act include requirements for annual registration, listing of general controlly provisions of ractice, 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 olassined (too as corrols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actived that it is mination that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any I each statutes and streequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quant) by by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Ms. Tina E. Lechman

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieming your and equivalence of your device to a legally premarket notheadon: "The PDF milling of east will be 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 If you desire specific advice for your accept 2011 276-0120. Also, please note the regulation entitled, program and Colliact the Orition of Compilance and (21CFR Part 807.97). You may obtain Misofanung by reference to premainentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Miriam C. Provost, Ph.D 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 (if known): K050991

Device Name: ODFS Dropped Foot Stimulator

Indications for Use:

The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the morradaze with the ODFS electrically stimulates muscles in the leg and ankle of swing prace or grouped individuals to provide flexion of the foot and may thus improve partially paral's gait. Additional benefits of Functional Electrical Stimulation (FES) the marriadal s garrestion, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.

The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

19131011 Sign-Off) Ivision of General, Restorative and Neurological Devices

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