(274 days)
NeMa-st is intended for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. NeMa-st is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain.
The NeMa-st is a pain relief treatment console, which includes Screen, Mouse, Kevboard, Processor, embedded Software, Power Supplies and the stimulator circuitry and probes.
The provided text describes a 510(k) submission for the "NeMa-st" device, a Transcutaneous Electrical Nerve Stimulator (TENS) for back pain relief. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The 510(k) submission primarily focuses on:
- Device Description: What the NeMa-st is (console, screen, mouse, keyboard, processor, embedded software, power supplies, stimulator circuitry and probes).
- Intended Use and Indications for Use: TENS for back pain relief (chronic, intractable, post-surgical, post-trauma back pain).
- Safety & Effectiveness Statement: The device was designed, verified, and validated according to 21CFR 820.30 and certified to IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-10 safety standards. It states that "This certification and the results of performance bench and validation testing demonstrate the device safety and effectiveness." However, no specific performance data or acceptance criteria from these tests are provided.
- Substantial Equivalency: Comparison to predicate devices (K062354 Vectra Genisys, K060517 Pointer Excel). This is a regulatory pathway, not a performance study in itself.
Therefore, I cannot provide the requested table and study details because the information is not present in the given text.
Summary of missing information based on your request:
- Table of acceptance criteria and reported device performance: Not provided.
- Sample size used for the test set and data provenance: Not provided (no specific performance study details).
- Number of experts used to establish ground truth and their qualifications: Not applicable, as no ground truth is established for device performance in this document.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The device is a TENS unit, not an imaging or diagnostic AI.
- Standalone performance study: Not detailed beyond a general statement of "performance bench and validation testing." Specific results are absent.
- Type of ground truth used: Not applicable (no ground truth data discussed for performance).
- Sample size for the training set: Not applicable (no AI training mentioned, device is a TENS unit).
- How ground truth for the training set was established: Not applicable.
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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
DEC 8 2010
Device Name Proprietary Device Name: NeMa-st
Establishment Name and Registration Number of Submitter
Name: Nevomatrix Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
Product Code: CFR section: Panel Identification: Device Description: Classification:
GZJ 882.5890 Neurology Stimulator, nerve, transcutaneous, for pain relief Class II Product
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Predicate Devices
K062354 Vectra Genisys K060517 Pointer Excel
Device Description
The NeMa-st is a pain relief treatment console, which includes Screen, Mouse, Kevboard, Processor, embedded Software, Power Supplies and the stimulator circuitry and probes.
Intended use and indications for Use
NeMa-st is intended for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. NeMa-st is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain.
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device has been certified to IEC 60601-1, IEC 60601-1-2 & IEC 606012- 10 Safety standards. This certification and the results of performance bench and validation testing demonstrate the device safety and effectiveness.
Substantial Equivalency
It is Nervomatrix opinion that the NeMa-st is substantially equivalent in terms of safety and effectiveness to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes. The bird is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Nervomatrix Ltd. c/o Mr. Dan Laor Sireni 6. Haifa 32972 Israel
DEC ~ 8 2010
Re: K100668
Trade/Device Name: NeMa-st, model v1.0.2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: unclassified Product Code: GZJ Dated: November 14, 2010 Received: November 18, 2010
Dear Mr. Laor:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
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Page 2 - Mr. Dan Laor
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,
Kesia Alexander
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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Indications for Use
510(k) Number (if known):
Device Name: Nema -st model v1.0.2
Indications For Use:
NeMa-st is intended for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. NeMa-st is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Tisu.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100668
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).