(185 days)
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No
The summary describes a standard electromyograph system for intra-operative monitoring and makes no mention of AI or ML capabilities.
No
The device is used for monitoring physiological signals (EMG, EEG, Evoked Potentials, ECG, NCV) during surgery (Intra-Operative Monitoring), not for treating a condition or disease.
Yes
The device is an electromyograph providing facilities for EMG, EEG, Evoked Potentials, ECG, and NCV testing, which are all diagnostic procedures used for Intra-Operative Monitoring.
No
The device description explicitly states it is a "2, 5, or 10 channel electromyograph," which is a hardware device used for measuring electrical activity. The summary does not indicate it is solely software.
Based on the provided information, the Synergy IOM System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Intra-Operative Monitoring" and lists various physiological tests (EMG, EEG, Evoked Potentials, ECG, NCV). These are all tests performed on a living patient to monitor their physiological responses during surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The Synergy IOM System does not perform tests on such samples.
- Device Description: The device is described as an electromyograph, which is a device used to measure electrical activity in muscles and nerves in vivo.
Therefore, the Synergy IOM System is a medical device used for physiological monitoring in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.
Product codes
IKN, CAB
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body.
Public Health Service
MAY 17 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oxford Instruments Medical Systems c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton. Maryland 21114
Re: K984052
Trade Name: Oxford Instruments Synergy IOM System Regulatory Class: II Product Code: IKN and CAB Dated: February 15, 1999 Received: February 16, 1999
Dear Mr. Smith:
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 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 - Mr. E.J. Smith
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,
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: Oxford Instruments Synergy IOM System
Classification Panel:
Indications for Use: ・ 球
The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDHR, Office of Device Evaluation (ODE) | |
|---|---|
| Perscription Use | ✓ |
| or | Over-the-Counter Use ______ |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K984052 |
|---|---|
| --------------- | --------- |
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