(159 days)
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.
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.
The provided document is a 510(k) Summary for the Bioness NESS H200 Wireless Hand Rehabilitation System with an optional Intelli-Connect Earpiece Triggering Device. It details various performance tests conducted to demonstrate the device's compliance and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Purpose (Acceptance Criteria) | Testing (Method to meet criteria) | Reported Performance (Results) |
|---|---|---|
| Verify that the Intelli-Connect complies with 60601-1 general requirements for basic safety and essential performance | Power input, leakage current, dielectric strength, mechanical strength, physical stability, excessive temperature, humidity, ingress of liquids, cleaning, mechanical abuse, stress relief | Pass |
| Verify that Intelli-Connect system complies with EMC requirements of 60601-1-2 | Radiated emissions, AC mains, electrostatic discharge, immunity to surge, RF field immunity, magnetic field immunity, interruptions immunity | Pass |
| Verify that the battery satisfies IEC 62133:2202 | Vibration, temperature cycling, external short circuit, free fall, crash hazard | Pass |
| Verify conformance with FCC Part 15 Class B | Field strength, bandwidth, spurious emissions, AC mains emissions, antenna requirement, | Pass |
| Verify conformance to biocompatibility (ISO 10993) requirements | Sensitization, cytotoxicity, irritation | Pass |
| Verify software meets requirements | Hardware verification, module verification, internal peripherals, settings, accelerometers, initialization, watch dog timer, charging, battery capacity, registration, LED behavior, state machine, trigger commands | Pass |
| Verify user specifications are met | Weight, charge access, insertion, donning and doffing, handling, talking, with glasses, consistent detection, roll and pitch, fit, cleaning | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the test sets used in any of the performance verification tests (e.g., how many units were tested for electrical safety, EMC, battery, software, or user specifications). The provenance of the data (country of origin, retrospective or prospective) is also not mentioned. These tests appear to be bench or engineering tests rather than clinical studies with human participants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are engineering and safety standard compliance tests, not clinical performance evaluations that would typically involve expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test sets. Given the nature of the tests (compliance with standards), adjudication by multiple experts is not typically applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. The device is a physical rehabilitation system accessory (a hands-free trigger), not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the Intelli-Connect earpiece. The Intelli-Connect is designed to work in conjunction with the H200 Wireless System to trigger functional stimulation based on jaw movements (teeth clicks). Its standalone performance relates to its ability to reliably detect these clicks and wirelessly transmit the trigger command, which is covered by the mentioned software and user specification verification tests. There isn't an "algorithm only" performance that would be separate from its intended human-in-the-loop use (as a trigger for a patient's rehabilitation).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" is defined by the technical specifications and requirements of the referenced standards (e.g., IEC 60601-1, FCC Part 15, IEC 62133, ISO 10993) and the user specifications defined by the manufacturer. These are objective engineering criteria rather than clinical ground truth established by experts or pathology.
8. The sample size for the training set
The document does not mention any training set. This is a medical device accessory and its performance is validated through engineering, regulatory, and user specification testing, not typically through machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
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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 TompkinsVP of Regulatory and Clinical AffairsBioness, Inc.25103 Rye Canyon Loop, Valencia, CA 91355 USAOffice phone: (661) 362-5968Fax: (661) 362-6661Email: Kim.Tompkins@bioness.com |
| Date prepared | April 23, 2013 |
| Trade name | NESS H200® Wireless Hand Rehabilitation System with optionalIntelli-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 stimulators890.5850 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 Wirelesshandheld triggering deviceK111767 (Predicate) | H200 Wirelesswith Intelli-Connect(Subject) | |
|---|---|---|
| Effect of the triggerdetection | Triggering the pre-determinedstimulation sequence at theH200W orthosis | Same |
| Communication withthe H200W orthosis | Wireless, using proprietary RFcommunication protocol | Same |
| Registration to theH200W system | Wireless, using proprietary RFcommunication protocol | Same |
| Power source | Rechargeable battery | Same |
| Trigger event | Pressing button on the control unitwith the unaffected hand | Detecting vibrationsassociated with toothclicking without using ahand |
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Performance Testing Summary
| Purpose | Testing | Results |
|---|---|---|
| Verify that the Intelli-Connect complies with60601-1 generalrequirements for basic safetyand essential performance | Power input, leakage current, dielectricstrength, mechanical strength, physicalstability, excessive temperature, humidity,ingress of liquids, cleaning, mechanicalabuse, stress relief | Pass |
| Verify that Intelli-Connectsystem complies with EMCrequirements of 60601-1-2 | Radiated emissions, AC mains, electrostaticdischarge, immunity to surge, RF fieldimmunity, magnetic field immunity,interruptions immunity | Pass |
| Verify that the batterysatisfies IEC 62133:2202 | Vibration, temperature cycling, external shortcircuit, free fall, crash hazard | Pass |
| Verify conformance withFCC Part 15 Class B | Field strength, bandwidth, spuriousemissions, AC mains emissions, antennarequirement, | Pass |
| Verify conformance tobiocompatibility (ISO 10993)requirements | Sensitization, cytotoxicity, irritation | Pass |
| Verify software meetsrequirements | Hardware verification, module verification,internal peripherals, settings, accelerometers,initialization, watch dog timer, charging,battery capacity, registration, LED behavior,state machine, trigger commands | Pass |
| Verify user specifications aremet | Weight, charge access, insertion, donningand doffing, handling, talking, with glasses,consistent detection, roll and pitch, fit,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
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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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1
§ 882.5810 External functional neuromuscular stimulator.
(a)
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.(b)
Classification. Class II (performance standards).