(307 days)
The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "TECA NCS Electrode System 2000." This document primarily addresses the regulatory approval process and states that the device is substantially equivalent to a predicate device.
Crucially, this document does NOT contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance study results that would typically be found in a clinical trial report or a comprehensive technical specification.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document confirms the device's clearance for marketing but does not delve into the detailed performance data that you are asking for.
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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.
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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
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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)
§ 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).