MODIFICATION TO:NESS L300

K080219 · Ness-Neuromuscular Electrical Stimulation Systems · GZI · Feb 28, 2008 · Neurology

Device Facts

• Record ID: K080219
• Device Name: MODIFICATION TO:NESS L300
• Applicant: Ness-Neuromuscular Electrical Stimulation Systems
• Product Code: GZI · Neurology
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.

Device Story

Neuroprosthesis for drop foot; consists of RF foot sensor, waist-mounted control unit, and below-knee orthosis with electrodes/RF stimulator. Sensor detects 'heel off' and 'heel contact' gait events; transmits data to stimulator. Stimulator triggers foot dorsiflexion during swing phase; ensures proper foot clearance and placement. Used by patients; clinician programs device via PDA interface. Benefits include improved gait, muscle re-education, atrophy prevention, and increased blood flow.

Clinical Evidence

No clinical data provided; substantial equivalence supported by performance data regarding hardware and software modifications.

Technological Characteristics

External functional neuromuscular stimulator. Components: lower leg orthosis with integrated RF stimulator/electrodes, waist-mounted control unit, RF foot sensor, and clinician PDA. Connectivity via RF communication. Powered by rechargeable batteries (orthosis/control unit) and non-rechargeable coin battery (sensor).

Indications for Use

Indicated for individuals with drop foot secondary to upper motor neuron injury or disease. Used to provide ankle dorsiflexion, improve gait, facilitate muscle re-education, prevent/retard disused atrophy, maintain/increase joint range of motion, and increase local blood flow.

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

• NESS L300 (K053468)

Submission Summary (Full Text)

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K080219

ﻥ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﻧﺘﻈﺎﻣﯿﺎﺕ ﮐﮯ ﺷﮩﺮ

## 510(k) SUMMARY

# NESS, Ltd.'s NESS L300

# 510(k) Summary:

NESS L300

# Company Name:

NESS-Neuromuscular Electrical Stimulation Systems, Ltd.

# Contact Person:

Amit Dar R&D and Clinical Manager

| Telephone: | [phone] |
|------------|-----------------|
| Fax: | [phone] |
| E-mail: | [e-mail] |

# Authorized US Agent:

Bioness, Inc. 25103 Rye Canyon Loop Valencia, CA 91355

#### Date prepared:

January 29, 2008

#### Trade Name:

NESS L300

#### Classification name:

External functional neuromuscular stimulator

# Class: II

Panel identification: Neurological devices

#### Product code:

GZI and IPF

#### Regulation number:

882.5810 External functional neuromuscular stimulator 890.5850 Powered Muscle Stimulator

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## Predicate Devices:

Neuromuscular Electrical Stimulation Systems, Ltd.'s NESS L300 (K053468)

# Purpose of the Special 510(k) notice.

The NESS L300 is a modification to the NESS L300 (K053468).

### Device description:

This neuroprosthesis device consists of a RF foot sensor (Intelli-sense gait sensor), RF control unit (waist mounted / neck strap / in pocket), and a below the knee orthosis containing electrodes and a RF controlled stimulation unit (RF stim unit).

The Intelli-gait sensor detects "heel off" and "heel contact" events during gait and transmits signals to the RF stim unit. Accordingly, the RF stim unit initiates and pauses the stimulation, activating the foot dorsiflexors to ensure proper foot clearance during the swing phase and proper foot placement during the stance phase.

The NESS L300 comprises of 4 main parts:

- 1. A lower leg orthosis with integrated RF stim unit and electrodes, RF communication, and rechargeable battery,
- 2. A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
- 3. Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
- 4. Clinician Programmer Handheld computer (PDA)

#### Indications for Use:

The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.

#### Substantial Equivalence:

The modified NESS L300 has the same intended use and similar indications, principles of operation, and technological characteristics as the original, cleared NESS L300. The minor differences in the embedded software, the Intelli-Gait (PDA) software, the hardware, and the accessories do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device. Thus, the NESS L300 is substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

FEB 28 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuromuscular Electrical Stimulation Systems % Dr. Evan Rosenfeld Bioness Incorporated 25103 Rye Canyon Loop Valencia, CA 91355

Re: K080219 Trade/Device Name: Modification to NESS L300 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: January 29, 2008 Received: January 29, 2008

Dear Dr. Rosenfeld:

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 - Dr. Evan Rosenfeld

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark M. Millman

Mark N. Melkerson 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 Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K080219

Device Name: NESS L300

Indications for Use:

The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.

Prescription Use X (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Millerson

Division of General, Restorative,

and i

K08021

510(k) Number