(84 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
- Increase of local blood circulation -
- Reduction of muscle spasm -
- -Muscle re-education
The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device.
The provided text is an FDA 510(k) clearance letter for the NESS H200 Wireless Hand Rehabilitation System. This document grants market clearance based on substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.
The document discusses the regulatory classification, indications for use, and general controls for the device. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about test and training sets.
- Information about expert involvement for ground truth establishment or adjudication methods.
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used for any performance evaluation.
- Sample sizes or ground truth establishment for a training set.
Therefore, I cannot extract the requested information from the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Bioness, Inc. % Ms. Kim Tompkins Vice President of Regulatory and Clinical Affairs 25103 Rve Canyon Loop Valencia, CA 91355
1 5 2011
Re: K111767
Trade/Device Name: NESS H200 Wireless Hand Rehabilitation System Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: August 10, 2011 Received: August 15, 2011
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 of medical device
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related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eithman
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K | | 7 6 7
Device Name:
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
- Increase of local blood circulation -
- Reduction of muscle spasm -
- -Muscle re-education
| 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 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 Y111767
§ 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).