(146 days)
Not Found
No
The description focuses on standard electronic circuitry, software for signal processing and analysis, and data transmission, without mentioning any AI or ML techniques for interpretation or diagnosis.
No.
The device's stated intended use is to "stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entraponent neuropathies", which is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "useful in diagnosing and evaluating systemic and entraponent neuropathies."
No
The device description clearly outlines multiple hardware components: an instrument with electronic circuitry, a stationary docking station, and single-use disposable biosensors. While software is mentioned as part of the instrument, it is integrated with and dependent on these physical components for its function.
Based on the provided information, the NeuroMetrix NC-stat is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NC-stat Function: The NC-stat system stimulates and measures neuromuscular signals directly from the nerves within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to diagnose and evaluate neuropathies by measuring nerve conduction, which is a physiological process, not a characteristic of a biological sample.
- Device Description: The components described (instrument, docking station, biosensors, information system) are all focused on stimulating nerves and measuring the resulting electrical signals in vivo.
Therefore, the NeuroMetrix NC-stat is a device used for in vivo (within the living body) diagnostic testing, not in vitro (in glass, or outside the living body) diagnostic testing.
N/A
Intended Use / Indications for Use
The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entraponent neuropathies.
Product codes (comma separated list FDA assigned to the subject device)
JXE, IKN
Device Description
The NC-stat system consists of the following four components:
- An instrument that contains the electronic circuitry and software required to control a nerve conduction study, including determination of the supramaximal stimulus intensity, acquisition and analysis of motor and sensory waveforms, and display of latency/conduction velocity, amplitude and response configuration parameters. The instrument saves patient and study data for optional transmission to a docking station for real-time hard copy report generation. The instrument displays nerve conduction data in real-time on the LCD readout, including the distal motor latency (DML), Compound Muscle Action Potential (CMAP) amplitude, CMAP duration, CMAP area, motor conduction velocity (CV), F-wave latency, distal sensory latency (DSL), the Sensory Nerve Action Potential (SNAP) amplitude, SNAP duration, sensory CV, limb indicator (left or right), low battery indicator, the memory slot being used to store the test data, and user messages (menu selections, sensor serial numbers, device status, operator instructions, and error conditions).
- A stationary docking station is used to download the test data from the instrument via an infra-red communication link to the onCall Information System via an analog phone line. The docking station is non-transportable and connected to both a power outlet and an analog phone line.
- Single-use, disposable biosensors are available for the median motor, ulnar motor, median motor & sensory, ulnar motor & sensory, deep peroneal, posterior tibial, and sural nerves. The biosensors contain electrodes for nerve stimulation, response detection, and skin surface temperature measurement.
- The onCall Information System for automatic generation of the hardcopy patient test report, which includes test results (DML, Compound Muscle Action Potential - CMAP- amplitude, DSL, SNAP amplitude, conduction velocity, F-wave latency, and associated response waveforms) and comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Clinical data submitted in the 510(k) demonstrates that nerve conduction measurements obtained using the NCstat are comparable to those obtained using conventional nerve conduction measurement equipment.
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.
K982359, K000565, K003508, K013459, K041320, K802637
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
§ 882.1550 Nerve conduction velocity measurement device.
(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).
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510(k) Summary for NeuroMetrix NC-stat
JUL 3 1 2006
1. SPONSOR
NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451
Contact Person: Rainer Maas Telephone: (781) 314-2781
Date Prepared: July 26, 2006
2. DEVICE NAME
| Proprietary Name: | NC-stat |
|---|---|
| Common/Usual Name: | Nerve Conduction Testing System |
| Classification Name: | Nerve Conduction Velocity Measuring Device |
3. PREDICATE DEVICES
4. INTENDED USE
The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entraponent neuropathies.
ട. DEVICE DESCRIPTION
The NC-stat system consists of the following four components:
- An instrument that contains the electronic circuitry and software required 5.1 to control a nerve conduction study, including determination of the supramaximal stimulus intensity, acquisition and analysis of motor and -
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sensory waveforms, and display of latency/conduction velocity, amplitude and response configuration parameters. The instrument saves patient and study data for optional transmission to a docking station for real-time hard copy report generation. The instrument displays nerve conduction data in real-time on the LCD readout, including the distal motor latency (DML), Compound Muscle Action Potential (CMAP) amplitude, CMAP duration, CMAP area, motor conduction velocity (CV), F-wave latency, distal sensory latency (DSL), the Sensory Nerve Action Potential (SNAP) amplitude, SNAP duration, sensory CV, limb indicator (left or right), low battery indicator, the memory slot being used to store the test data, and user messages (menu selections, sensor serial numbers, device status, operator instructions, and error conditions).
- A stationary docking station is used to download the test data from the 5.2 instrument via an infra-red communication link to the onCall Information System via an analog phone line. The docking station is non-transportable and connected to both a power outlet and an analog phone line.
- Single-use, disposable biosensors are available for the median motor, 5.3 ulnar motor, median motor & sensory, ulnar motor & sensory, deep peroneal, posterior tibial, and sural nerves. The biosensors contain electrodes for nerve stimulation, response detection, and skin surface temperature measurement.
- The onCall Information System for automatic generation of the hardcopy 5.4 patient test report, which includes test results (DML, Compound Muscle Action Potential - CMAP- amplitude, DSL, SNAP amplitude, conduction velocity, F-wave latency, and associated response waveforms) and comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The NC-stat that is the subject of this 510(k) Premarket Notification is substantially equivalent to the NC-stat as previously cleared for marketing and to the TECA TD-10/TD-20 EMG and nerve conduction velocity measurement device. The purpose of this 510(k) is to describe changes made to the NC-stat, including:
- Addition of the modified median motor-sensory biosensor for use in 6.1 diagnosing neuropathies affecting the median motor-sensory nerves.
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6.2 Modifications to the labeling.
None of the changes to the NC-stat have altered the intended use of the device, the basic device design or the device operation. Clinical data submitted in the 510(k) demonstrates that nerve conduction measurements obtained using the NCstat are comparable to those obtained using conventional nerve conduction measurement equipment.
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the words "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three wavy lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
NeuroMetrix, Inc. % Rainer Maas Director, Quality Assurance and Regulatory Affairs Associate 62 Fourth Avenue Waltham, Massachusetts 02451
Re: K060584 Trade/Device Name: NC-stat Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXE, IKN Dated: July 5, 2006 Received: July 6, 2006
Dcar Rainer Maas:
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. Drue, 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. Iisting 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 (PMA), 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 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); good manufacturing practice requirements as set
4
Page 2 - Rainer Maas
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Helmut Lachenmann
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Intended Use
510(k) Number (if known): K060584
Device Name: NC-stat
Intended Use:
The NeuroMetrix NC-stat is intended to to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulbert Brewer
(Division Simmal 317 Division of General, Restorative, and Neurologica. Devices
510(k) Number Ko 60584
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