NC-STAT

{0}------------------------------------------------ Image /page/0/Picture/3 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '982359'. The characters are written in a cursive style, with some connections between the numbers. 510(k) Summary for NC-stat 1. SPONSOK > NeuroMetrix, Inc. One Memorial Drive Cambridge. MA 02142 Contact Person: Telephone: Shai N. Gozani, M.D., Ph.D. CEO 617-225-7774 Date Prepared: September 28, 199 2. DEVICE NAME : . . . . . .. | Proprietary Name: | NC-stat | |----------------------|----------------------------------------------| | Common/Usual Name: | Nerve Conduction Monitoring System | | Classification Name: | Nerve Conduction Velocity Measurement Device | ### PREDICATE DEVICES 3. The NeuroMetrix NC-stat is substantlally equivalent to the following devices: - Neurotron Neurometer Premarket Notification K853608 - TECA TD-10/TD-20 EMG Premarket Notification K802637 - 4. DEVICE DESCRIPTION The NC-stat cousings of a hand-held, battery-operated monitor and a disposable sensor. The NC-star measures two median nerve electrophysiological parameters, the distal motor latency (DML) and the median F-wave latency (F-LAT). The DML is the interval, in milliseconds, between the onset of the stimulus and the onsel of the resultant compound muscle action potential (CMAP) in the thenar muscles. The F-LAT is the median interval, in milliseconds, between the onset of the stimulus and the onset of a CMAP in the thenar muscle resulting from NeuroMctrix, Inc. - K982359 9/28/98 Request for Add'1 Info (phone conversation on 9/25/98) Attachment 2, Page 1 16. 1000 million and the consistence in the 10th 13th 13th 13th 13th 13 {1}------------------------------------------------ antidromic activation of the motor neurons in the spinal cord. The primary and scondary functions of the NC-stat are controlled by software routines. The primary function of the NC-stat software is to carry out nerve conduction measurements. Secondary functions of the software include displaying previously acquired measurement data, communicating stored data to an external target such as a printer and operating hardware diagnostics when the device is initially powered on. The single-use disposable seusor, containing a proprietary electrode array, is placed on the patient's wrist in alignment with the distal most wrist crease and connected to the monitor non-invasively stimulates the patient's median nerve and detects the subsequent CMAP as an electrical potential on the skin, via the sensor. The sensor also contains a temperature electrode that monitors surface temperature of the patient's skin. All this data is analyzed and digitally stored in a non-volatile manner by the monitor. The resulting DML and F-LAT are displayed on the NC .- stat I .C.T. #### INTENDED USE 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. The NC-stat is intended to be used as an adjunct to and not a replacement for conventional clectrodiagnostic measurements. #### હં. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE NeuroMetrix, Inc. believes that the descriptive information and performance rest summaries provided in this premarket notification are precise enough to demonstrate the substantial equivalence of the NC-star to the identified predicate devices. The reasoning process for making the assessment that the devices are substantially equivalent in intended use and technological characteristics are outlined below. The NC-stat has similar technological characteristics when compared to the two predicate devices listed above. For example, like the TECA TD-10/TD-20 and the Neurotron device, the NC-stat measures the M response and uses this measurement to calculate the DML. In addition, like the TECA TD-10/TD-20, the NC-stat measures the F response and uses this measurement to calculate the F-LAT. All NeuroMetrix, Inc. - K982359 9/28/98 Request for Add'1 Info (phone conversation on 9/25/98) Attachment 2, Page 2 Miral ... .. .. .. . . . . . . . . . . . {2}------------------------------------------------ three devices use electrodes to stimulate the nerve and to detect the resulting CMAP. Although the TECA and Neurotron sensor material is unknown, the NCstat material has been thoroughly tested and found to fulfill the ISO-10993 criteria for biocompatibility for surface device in contact with skin. NeuroMetrix, Inc. believes that the descriptive characteristics and performance data provided in this premarket notification are precise enough to ensure substantial equivalence. #### PERFORMANCE TESTING 7. System testing was performed on the NC-stat in which several complete tests were simulated to obtain all possible test outcomes. The System Level Testing was divided into six test protocols: evaluation of circuit operation, operation al testing, response to normal, pathologic and marginal data, system response to user error, system response to defective and malfunctioning disposable sensors, and evaluation of measurement data download. In addition, an evaluation of DMLs acquired by volume conduction and those signals acquired and measured using conventional methods was conducted. These tests demonstrate that the NC-stat vields the appropriate outcome with a high probability. They also demonstrate that the NCstat conforms to the safety related system and software requirements. NeuroMetrix, Inc. - K982359 9/28/98 Request for Add'l Info (phone conversation on 9/25/98) Allachment 2, Page 3 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an image of an abstract eagle with three heads. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 1998 NeuroMetrix, Inc. c/o Ms. Renee J. Thibeault Associate Consultant Medical Device Consultants, Inc. 49 Plain St. North Attleboro, Massachusetts 02760 Re: K982359 Trade Name: NC-STAT Regulatory Class: II Product Code: JXE Dated: July 01, 1998 Received: July 06, 1998 ## Dear Ms. Thibeault: 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 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. 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations. {4}------------------------------------------------ # Page 2 - Ms. Renee J. Thibeault 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 one regaration onorouse) (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.gov/cdrh/dsmamain.html". Sincerely yours, Colia M. Witten, Ph.D., M 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 {5}------------------------------------------------ 510(k) Number (if known): K982359 Device Name: _ NC-stat Indications For Use: The NeuroMetrix NC-stat is intended to measure neurouncetizen. The NC-stal is The Neurometrix NC-Ital is intension is interestment neuropathies. The NC-stal is in diagnosing and evaluating systemic and entrapped comment conventions) in diagnosing and evaluating systemic and not a replacement for conventional clectrodiagnostic measurements. (PLEASE DO NOT WRITE BELOW THIS 1.INF . CONTINUE ON ANOTHER PAGE IN NECESSARY Concurrents of CDRH, Office of Device Evaluation (ODB) Pcolls vision of General 510/k) Numbe Presoription Use (Per 21 CFR 801 109) 11 ાર Over-The-Counter Use (Optional Format 1-2-96) 9/28/98 NeuroMetrix, Inc. - K982359 Request for Add'1 Info (phone conversation on 9/25/98) Attachmont 1, Page 1