(274 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard TENS technology components.
Yes
The device is intended for the relief and management of symptomatic chronic or intractable back pain, indicating a therapeutic purpose.
No
The device is described as a pain relief treatment console intended for Transcutaneous Electrical Nerve Stimulation (TENS) to alleviate back pain. Its purpose is treatment and management of pain, not diagnosis.
No
The device description explicitly lists hardware components such as Screen, Mouse, Keyboard, Processor, Power Supplies, stimulator circuitry, and probes, indicating it is not a software-only device.
Based on the provided information, the NeMa-st device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. This is a therapeutic treatment applied to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a console with components for delivering electrical stimulation. This aligns with a therapeutic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The NeMa-st's function is to provide pain relief through electrical stimulation, which is a therapeutic intervention.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062354 Vectra Genisys, K060517 Pointer Excel
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
3
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