(307 days)
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Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description (electrode system) does not inherently suggest AI/ML functionality.
No
The device is described as being for electromyographic recording, stimulating, and referencing, which are diagnostic functions, not therapeutic ones.
Yes
The device is used for electromyographic recording and stimulating in motor and sensory nerve conduction, which are diagnostic procedures to evaluate the function of nerves and muscles.
No
The intended use describes an "Electrode System," which inherently implies hardware components (electrodes) are part of the device. The summary does not provide a device description, but the term "Electrode System" is sufficient to indicate it is not software-only.
Based on the provided information, the NCS Electrode System 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography." This describes a device used for in vivo (within a living organism) physiological measurements, not for testing samples taken from the body (in vitro).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the NCS Electrode System 2000 is a device used for neurological diagnostic procedures performed directly on a patient, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.
Product codes
GXY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James P. Hurlman Manager, Quality Assurance and Regulatory Affairs Medelec, Inc. d.b.a TECA Corporation Three Campus Drive 10570 Pleasantville, New York
MAR 2 6 1998
Re: K971914 TECA NCS Electrode System 2000 Requlatory Class: II Product Code: GXY December 22, 1997 Dated: Received: December 29, 1997
Dear Mr. Hurlman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with ... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. James P. Hurlman
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_1_of_1
510(k) Number (if known):
Device Name: TECA NCS Electrode System 2000
Indications For Use:
The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
Division of General Restorative Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
OVER-the-Counter dose
(Optional Format 1-2-96)