H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE

K123636 · Bioness, Inc. · GZI · May 1, 2013 · Neurology

Device Facts

• Record ID: K123636
• Device Name: H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
• Applicant: Bioness, Inc.
• Product Code: GZI · Neurology
• Decision Date: May 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NESS H200 Wireless Hand Rehabilitation System is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES): - Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES): - Maintenance and/or increase of hand range of motion. - Prevention and/or retardation of disuse atrophy. - Increase in local blood circulation. - Reduction of muscle spasm. - Re-education of muscles. The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless Orthosis through simple jaw movements.

Device Story

NESS H200 Wireless Hand Rehabilitation System provides functional electrical stimulation (FES) and neuromuscular electrical stimulation (NMES) to hand/forearm muscles. System includes FS orthosis with RF stim unit, control unit, and optional Intelli-Connect earpiece. Intelli-Connect detects jaw movement (tooth clicking) via accelerometer/sensor; wirelessly transmits trigger signal to H200 orthosis via proprietary RF protocol. Enables hands-free activation of stimulation sequences for patients with limited hand function. Used in clinical or home settings; operated by patient. Provides independence by allowing unassisted control of stimulation. Benefits include improved hand function, increased circulation, reduced atrophy, and muscle re-education.

Clinical Evidence

Bench testing only. Verification included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), battery safety (IEC 62133), FCC Part 15 compliance, biocompatibility (ISO 10993), and software/firmware verification. User specification testing confirmed consistent detection of jaw movements, fit, and handling.

Technological Characteristics

System comprises FS orthosis, control unit, and optional earpiece. Earpiece contains lithium-polymer battery, accelerometer for jaw movement detection, and proprietary RF transmitter. Materials meet ISO 10993 biocompatibility standards. Connectivity via proprietary RF protocol. Software-controlled stimulation. Sterilization not specified.

Indications for Use

Indicated for patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury to improve hand function, active range of motion, maintain/increase range of motion, prevent/retard disuse atrophy, increase local blood circulation, reduce muscle spasm, and for muscle re-education.

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 H200 Wireless Hand Device (K111767)

Submission Summary (Full Text)

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# MAY 0 1 2013

Section 5 510(k) Summary

# K123636 Summary NESS H200® Wireless Hand Rehabilitation System with optional Intelli-Connect Earpiece Triggering Device

| Company name | Bioness Inc. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kim Tompkins<br>VP of Regulatory and Clinical Affairs<br>Bioness, Inc.<br>25103 Rye Canyon Loop, Valencia, CA 91355 USA<br>Office phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date prepared | April 23, 2013 |
| Trade name | NESS H200® Wireless Hand Rehabilitation System with optional<br>Intelli-connect, trade name subject to change |
| Classification name | External functional neuromuscular stimulator |
| Class | II |
| Panel identification | Neurology |
| Product code | GZI and IPF |
| Regulation number | 882.5810 External functional neuromuscular stimulators<br>890.5850 Powered muscle stimulators |
| Predicate device | NESS H200 Wireless Hand Device K111767 |

Purpose: This is a product line extension to add an optional hands-free trigger for functional stimulation of the H200 Wireless System.

### Device description

The NESS H200 System consists of the following components:

- Functional Stimulation (FS) Orthosis with a Radio Frequency (RF) Stim Unit .
- Control Unit .
- . Intelli-Connect triggering device optional accessory, consisting of an earpiece, a charger and connecting cable

The Intelli-Connect Earpiece triggering device is fitted over the ear and detects clicks of the teeth to wirelessly trigger the stimulation unit of the H200 Wireless orthosis. Software built into the Intelli-Connect earpiece is designed to register and work exclusively with the patient's orthosis. The Earpiece is rechargeable with a lithium-polymer battery. It is FCC identified and meets part 15 of the FCC regulations. Once the earpiece is turned on, Intelli-Connect will trigger stimulation when teeth are clicked together.

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Image /page/1/Picture/0 description: The image shows the logo for Bioness. The logo consists of a star-like symbol on the left, followed by the word "Bioness" in a sans-serif font. Below the word "Bioness" is the text "LiveOn" in a smaller font. The logo is simple and modern, and the use of the star-like symbol suggests innovation and technology.

#### Section 5 510(k) Summary

## Indications for use

The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

- Improvement of hand function and active range of motion in patients with hemiplegia । due to stroke or upper limb paralysis due to C5 spinal cord injury
NeuroMuscular Electrical Stimulation (NMES):

- Maintenance and/or increase of range of motion -
- Prevention and/or retardation of disuse atrophy l
- Increase of local blood circulation -
- Reduction of muscle spasm —
- Muscle re-education |

The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless System. The Intelli-Connect is used to trigger the H200 Wireless Orthosis through simple jaw movements.

#### Substantial Equivalence

The H200 Wireless System is identical to the previously cleared system. The optional Intelli-Connect triggering device detailed in this submission was designed for use in the same target population. This accessory allows potentially more independence in the target population by allowing patients to turn on/off their H200 functional stimulation unit unassisted-contributing to more independence. A comparison of the predicate and subject triggering follows:

| | H200 Wireless<br>handheld triggering device<br>K111767 (Predicate) | H200 Wireless<br>with Intelli-Connect<br>(Subject) |
|------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Effect of the trigger<br>detection | Triggering the pre-determined<br>stimulation sequence at the<br>H200W orthosis | Same |
| Communication with<br>the H200W orthosis | Wireless, using proprietary RF<br>communication protocol | Same |
| Registration to the<br>H200W system | Wireless, using proprietary RF<br>communication protocol | Same |
| Power source | Rechargeable battery | Same |
| Trigger event | Pressing button on the control unit<br>with the unaffected hand | Detecting vibrations<br>associated with tooth<br>clicking without using a<br>hand |

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Image /page/2/Picture/0 description: The image shows the logo for Bioness LiveOn. The logo consists of a stylized star-like symbol on the left, followed by the word "Bioness" in a bold, outlined font. Below "Bioness" is the word "LiveOn" in a smaller font with a plus sign next to it.

# Performance Testing Summary

| Purpose | Testing | Results |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Verify that the Intelli-<br>Connect complies with<br>60601-1 general<br>requirements for basic safety<br>and essential performance | Power input, leakage current, dielectric<br>strength, mechanical strength, physical<br>stability, excessive temperature, humidity,<br>ingress of liquids, cleaning, mechanical<br>abuse, stress relief | Pass |
| Verify that Intelli-Connect<br>system complies with EMC<br>requirements of 60601-1-2 | Radiated emissions, AC mains, electrostatic<br>discharge, immunity to surge, RF field<br>immunity, magnetic field immunity,<br>interruptions immunity | Pass |
| Verify that the battery<br>satisfies IEC 62133:2202 | Vibration, temperature cycling, external short<br>circuit, free fall, crash hazard | Pass |
| Verify conformance with<br>FCC Part 15 Class B | Field strength, bandwidth, spurious<br>emissions, AC mains emissions, antenna<br>requirement, | Pass |
| Verify conformance to<br>biocompatibility (ISO 10993)<br>requirements | Sensitization, cytotoxicity, irritation | Pass |
| Verify software meets<br>requirements | Hardware verification, module verification,<br>internal peripherals, settings, accelerometers,<br>initialization, watch dog timer, charging,<br>battery capacity, registration, LED behavior,<br>state machine, trigger commands | Pass |
| Verify user specifications are<br>met | Weight, charge access, insertion, donning<br>and doffing, handling, talking, with glasses,<br>consistent detection, roll and pitch, fit,<br>cleaning | Pass |

#### Conclusion

The H200 Wireless System with optional Intelli-Connect does not raise any new questions of safety and effectiveness and therefore is substantially equivalent to the cleared H200 Wireless System (K111767 SE 9.15.11).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The image is in black and white.

Public Health Service

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

May 01,2013

Bioness, Inc. % Kim Tompkins 25103 Rye Canyon Loop Valencia, CA 91355

Re: K123636

Trade/Device Name: NESS H200 Wireless Hand Rehabilitation System with optional Intelli-Connect Earpiece Triggering Device

Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: March 15. 2013 Received: March 22, 2013

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Kim Tompkins

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.

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,

Joyce M. Whang -S

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

Enclosure

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Attachment A

# Indications for Use

510(k) Number (if known): K123636

Device Name: Bioness H200 Wireless Hand Rehabilitation System with

Indications for Use:

The [NESS] H200 Wireless System is an electrical stimulation device indicated for the following uses:

- . Functional Electrical Stimulation (FES).
- Improvement of hand function and active range of motion in patients with o hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
- NeuroMuscular Electrical Stimulation (NMES). .
- Maintenance and/or increase of hand range of motion. O
- Prevention and/or retardation of disuse atrophy. o
- Increase in local blood circulation. O
- Reduction of muscle spasm. 0
- Re-education of muscles. O

The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless Orthosis through simple jaw movements.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

Division of Neurological and Physical Medicine Devices 510(k) Number: K123636

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