NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT

K122784 · Bioness, Inc. · GZI · Dec 27, 2012 · Neurology

Device Facts

• Record ID: K122784
• Device Name: NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
• Applicant: Bioness, Inc.
• Product Code: GZI · Neurology
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop 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. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

Device Story

The L300 Foot Drop System is an external functional neuromuscular stimulator; it utilizes an Intelli-Sense Gait Sensor to detect gait phases and a Control Unit to trigger electrical stimulation. The system stimulates muscles in the affected leg to provide ankle dorsiflexion during the swing phase of gait. It is intended for use by patients with foot drop following upper motor neuron injury or disease. The device aims to improve gait, facilitate muscle re-education, prevent disuse atrophy, maintain joint range of motion, and increase local blood flow. The system is designed for clinical or home use.

Clinical Evidence

No new clinical data was provided. Substantial equivalence is based on the identical technological characteristics to the predicate L300 System and the established clinical use of functional electrical stimulation for the indicated patient population.

Technological Characteristics

External functional neuromuscular stimulator; consists of a Control Unit and an Intelli-Sense Gait Sensor. Operates via electrical stimulation of muscles to induce dorsiflexion. Class II device.

Indications for Use

Indicated for adults and pediatric patients with foot drop secondary to upper motor neuron injury or disease to provide ankle dorsiflexion during the swing phase of gait.

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 System (K120853)
• Innovative Neurotronics Walkaide System (K052329)

Submission Summary (Full Text)

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K122784

Image /page/0/Picture/1 description: The image shows the logo for Bioness Neuromodulation. The logo consists of a stylized sun-like symbol on the left, followed by the word "Bioness" in bold, sans-serif font. Below "Bioness" is the word "Neuromodulation" in a smaller, serif font. The logo is simple and modern, with a focus on the company name.

Section 5 510(k) Summary

# 510(k) Summary

# DEC 2 7 2012

| 510(k) Summary | L300® System |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Company name | Bioness Inc. |
| Contact persons | Kim Tompkins, VP, Regulatory and Clinical Affairs<br>Office phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date prepared | October 30, 2012 |
| Trade Name | L300® Foot Drop System or NESS L300 Foot Drop System |
| Classification name | External functional neuromuscular stimulator |
| Classification | II |
| Panel Identification | Neurology |
| Product code(s) | GZI and IPF |
| Regulation numbers | 882.5810 External functional neuromuscular stimulators<br>890.5850 Powered muscle stimulators |
| Purpose of the 510(k) | To modify the indications for use |

## Predicate devices

- 1. NESS (Neuromuscular Electrical Stimulation Systems) Ltd. (currently known as Bioness Neuromodulation Ltd., a Bioness Inc. Company) NESS L300 System (K120853, SE 4.20.2012)
- 2. Innovative Neurotronics Walkaide System (K052329, SE 9.21.2005)

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Image /page/1/Picture/0 description: The image shows the logo for Bioness Neuromodulation. The logo consists of a symbol on the left, followed by the word "Bioness" in a bold, sans-serif font. Below "Bioness" is the word "Neuromodulation" in a smaller, serif font. The symbol on the left appears to be a stylized representation of a neural network or a similar concept related to neuromodulation.

## Device description

The L300 Foot Drop System consists of

- ්‍රි
- Control Unit .
- . Intelli-Sense Gait Sensor

# Indications for use

The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop 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. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

#### Substantial Equivalence

The L300 System subject device is identical to the L300 System (K120853). It is similar to the Walkaide System (K052329) currently marketed for pediatric use. Electrical stimulation is well documented in the literature and confirmed in clinical performance as a safe and effective treatment for functional electrical stimulation.

#### Conclusion

The L300 System modified indications for use is substantially equivalent to the cleared L300 System and the cleared Walkaide System.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Bioness. Inc. % Ms. Kim Tompkins VP of Regulatory and Clinical Affairs 25103 Rye Canyon Loop Valencia, CA 91355

Re: K122784 ·

Trade Name: NESS L300® System Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator. Regulatory Class: Class II Product Code: GZI & IPF Dated: November 2, 2012 Received: November 5, 2012

Dear Ms. Tompkins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

**DEC 27 2012**

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Page 2 - Ms. Kim Tompkins

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Tina Kiang

Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Bioness Neuromodulation. The logo consists of a stylized starburst symbol to the left of the word "Bioness" in a bold, sans-serif font. Below "Bioness" is the word "Neuromodulation" in a smaller font size. The logo is black and white.

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: NESS L300® System

#### Indications for Use:

The NESS L300 Foot Drop System is intended to provide ankle dorsifiexion in individuals (adults and pediatrics) who have foot drop 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. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

Prescription Use : _ X

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|-----------------------------------------------------------------------|--------------------------------------------------------|
| (Division/Sign-Off) | |
| Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices | |
| 510(k) Number | K122784 |

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