(185 days)
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.
The Synergy IOM System is a 2, 5, or 10 channel electromyograph.
The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for the "Oxford Instruments Synergy IOM System". This type of document generally confirms that a device is substantially equivalent to a predicate device and can be marketed. It does not typically contain detailed information about specific acceptance criteria or the study data used to demonstrate performance against those criteria in the way a medical device performance study report would.
Therefore,Based on the provided text, the following information is not available:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity, F1 score).
- Sample size used for the test set and the data provenance: No information about a test set, its size, or country of origin (e.g., retrospective or prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: No details on adjudication are available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This document does not mention such a study or its results.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The Synergy IOM System is described as an electromyograph for various physiological signal testing, implying it's a diagnostic tool that likely requires human interpretation, rather than a standalone AI algorithm. No AI algorithm performance is discussed.
- The type of ground truth used: Ground truth definition is not discussed.
- The sample size for the training set: There is no mention of a training set, as this is not an AI/ML device in the context of the document.
- How the ground truth for the training set was established: Not applicable, as no training set is discussed.
What is available from the text:
- Device Name: Oxford Instruments Synergy IOM System
- Regulatory Class: II
- Product Code: IKN and CAB
- 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."
- Study described: The document is a 510(k) premarket notification response, indicating that the device has been found "substantially equivalent" to legally marketed predicate devices. This equivalence is the basis for its clearance, rather than a specific performance study against defined acceptance criteria (as would be seen for novel devices or AI/ML components).
- Ground Truth (implied): For a 510(k) clearance based on substantial equivalence, the "ground truth" and performance of the predicate device (which is not explicitly named in this excerpt but would have been part of the 510(k) submission) serve as the benchmark. The implication is that the Synergy IOM System performs comparably to the predicate for the stated indications.
{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.
{1}------------------------------------------------
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
{2}------------------------------------------------
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 |
|---|---|
| --------------- | --------- |
- 11:00 来源:
§ 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).