(332 days)
K843924A
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No
The description focuses on traditional signal processing and waveform display, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a monitor used for diagnosis and does not provide therapy.
Yes
The device is described as "intended to be used as a waveform display nerve conduction monitor" and that "The latency value is important in the diagnosis of median nerve dysfunction." Additionally, it states that "The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration." These functionalities directly support the diagnosis of medical conditions.
No
The summary describes a device that displays waveforms derived from an electroneurometer (a hardware device). While the ViewScope itself might be software, the core function relies on data generated by a physical medical device, making it part of a system that includes hardware. The summary does not explicitly state the ViewScope is software-only and the description of its function points to it being a display component for a hardware device.
Based on the provided information, the Nervepace® ViewScope 200VS 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.
- Nervepace® ViewScope 200VS function: The description clearly states that the device is a "waveform display nerve conduction monitor." It works by analyzing electrical signals generated by the median nerve in response to a stimulus. This is a direct measurement of physiological activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is to assist a physician in diagnosing median nerve dysfunction by examining the characteristics of the nerve's electrical waveform. This is a diagnostic process based on in vivo measurements.
Therefore, the Nervepace® ViewScope 200VS falls under the category of a medical device used for physiological monitoring and diagnosis based on in vivo measurements, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nervepace® ViewScope 200VS is intended to be used as a waveform display nerve conduction monitor. Currently the digital electroneurometer (K843924A ) displays the latency value derived from an action potential. This is accomplished by setting a threshold value into the circuitry and when the onset of the action potential reaches the threshold value it trips the timing circuit and the display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry of the electroneurometer has the complete waveform from which the latency value was derived and this can be delivered to a digital storage oscilloscope for complete waveform display. The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration.
Product codes
84JXE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K843924A
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/10 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL | 4 1997
Mr.. Jack Guldalian Neurotron Medical P.O. Box 6480 Lawrenceville, New Jersey 08648
Re: K963208 NERVEPACE ViewScope Model 200VS Trade Name: Regulatory Class: II Product Code: 84JXE Dated: April 24, 1997 Received: April 29, 1997
Dear Mr. Guldalian:
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 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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.
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Page 2 - Mr. Jack Guldalian
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 803.10 for in_yitro 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
4963208
Device Name: NERVEPACE ViewScope Model 200VS
Indications For Use:
The Nervepace® ViewScope 200VS is intended to be used as a waveform display nerve conduction monitor. Currently the digital electroneurometer (K843924A ) displays the latency value derived from an action potential. This is accomplished by setting a threshold value into the circuitry and when the onset of the action potential reaches the threshold value it trips the timing circuit and the display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry of the electroneurometer has the complete waveform from which the latency value was derived and this can be delivered to a digital storage oscilloscope for complete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration.
(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 Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K963208 |
Prescription Use
(Per 21 CFR 801.109)
Over The Counter Use
(Optional Format 1-2-96)