(88 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, anterior neck, cervical spine, and vessels of the head and neck to the aortic arch, that can be interpreted by a trained physician.
Model HNC Neurovascular Array Coil
Regrettably, the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for the Model HNC Neurovascular Array Coil.
Here's a breakdown of what is and is not in the provided text:
Information Present:
- Device Name: Model HNC Neurovascular Array Coil
- Regulatory Class: Class II (21 CFR 892.1000/Procode: 90 MOS)
- Indications For Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, anterior neck, cervical spine, and vessels of the head and neck to the aortic arch, that can be interpreted by a trained physician."
- FDA Determination: The device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This means the FDA believes the device is as safe and effective as a legally marketed predicate device, but it does not typically mean a full clinical efficacy study with specific acceptance criteria was conducted or reviewed by the FDA as part of the 510(k) clearance process.
Information NOT Present (and why it's not typically in a 510(k) clearance letter):
- A table of acceptance criteria and reported device performance: 510(k) clearances usually rely on demonstrating substantial equivalence to a predicate device, often through bench testing and sometimes limited clinical data, but not typically a full-scale clinical trial with predefined acceptance criteria for performance metrics like sensitivity, specificity, or AUC, as would be expected for a novel AI device.
- Sample size and data provenance for a test set: This level of detail on a specific study is absent.
- Number and qualifications of experts for ground truth: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: This device is a hardware component (a coil for an MRI scanner), not an AI algorithm, so this concept is not applicable.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable for a hardware device.
- How the ground truth for the training set was established: Not applicable for a hardware device.
Conclusion:
The provided FDA letter for the Model HNC Neurovascular Array Coil is a 510(k) clearance letter. For devices cleared via the 510(k) pathway, the primary mechanism for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than a de novo clinical trial with specific performance-based acceptance criteria against a defined ground truth, as would be common for AI/ML devices. Therefore, the document does not contain the information you requested about detailed acceptance criteria and a study proving a device meets them in the way described for an AI/ML product.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1997 JUN
Thomas Schubert President MRI Devices Corporation N8 W22520-K Johnson Drive Waukesha, WI 53186
Re: K970868
Model HNC Neurovascular Array Coil Dated: March 1, 1997 Received: March 10, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Schubert: 14
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 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 III (Prematket 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 not: this response to your premarket notification 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.
This letter will allow you to begin marketing your device as described in your 510(k) premattet notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 - 14 4 "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Fox
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 510(K) notification, Model HNC Neurovascular Array Coil March 1, 1997
510(K) Number (if known)
Device Name:
Model HNC Neurovascular Array Coil
Indications For Use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, anterior neck, cervical spine, and vessels of the head and neck to the aortic arch, that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.