(202 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description points to a nerve monitor, which is a standard type of medical device.
No
The device is described as a "Motor Nerve Monitor" used to "locate and identify cranial and peripheral motor nerves during surgery." This function is for monitoring and identifying, not for treating a disease or condition.
No
The device is described as a "Motor Nerve Monitor" used to "locate and identify cranial and peripheral motor nerves during surgery." This indicates a monitoring or localization function rather than a diagnostic one. It helps in identifying existing structures, not in diagnosing disease or conditions.
No
The device description explicitly states "Neurosign 800. 8 Channel Motor Nerve Monitor," which strongly suggests a hardware component (an 8-channel monitor) is part of the device. The intended use also implies interaction with the patient's nervous system during surgery, which would typically require hardware for signal acquisition and monitoring.
Based on the provided information, the Neurosign 800 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "locate and identify cranial and peripheral motor nerves during surgery." This is a procedure performed in vivo (within a living organism) on the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
The Neurosign 800 is a device used directly on the patient during surgery, not for analyzing samples taken from the patient. Therefore, it falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.
Product codes
ETN
Device Description
Neurosign 800. 8 Channel Motor Nerve Monitor
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
cranial and peripheral motor nerves, spinal nerve roots
Indicated Patient Age Range
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Intended User / Care Setting
surgery
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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 1998
Mr. Chris Hovey Product Manager The Magstim Company, Ltd. Spring Gardens, Whitland Carmarthenshire, SA34 OHR Wales, United Kingdom
Re: K980148 Trade Name: Neurosign 800. 8 Channel Motor Nerve Monitor Regulatory Class: II Product Code: ETN Dated: July 29, 1998 Received: July 29, 1998
Dear Mr. Chris Hovey:
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 (OS) 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 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 - Chris Hovey
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) 594-4595. 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,
ia 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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Page 1 of 1
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Neurosign_800
Indications For Use:
To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.
(PLEASE UU NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K98048 |
| Prescription Use ✓
(Per 21 CFR 801.109) | OR | Over-The-Counter Use _
(Optional Format 1-2-96) |
| --------------------------------------------------------------------------------------------- | ---- | ----------------------------------------------------------------------------------------------------- |
|---|