(30 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Model OSC-63-INT Shoulder Array Coil
This document is a 510(k) clearance letter for the "Model OSC-63-INT Shoulder Array Coil" from MRI Devices Corporation. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.
The letter primarily focuses on the regulatory clearance process and does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way described in the prompt. The device in question is a magnetic resonance diagnostic device (a coil used with an MRI scanner), not an AI or algorithm-based diagnostic tool that would typically undergo performance studies with the detailed metrics requested.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance is not available in this document.
The only relevant information regarding performance and intended use is:
- Indications for use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician."
- Regulatory Classification: Class II, Product Code 90 MOS (Magnetic Resonance Diagnostic Device). This implies general controls and potentially special controls, but the specifics of how performance is measured are not in this document.
Summary of unavailable information from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document is about regulatory clearance, not performance metrics.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is hardware, not an AI, so such a study would not apply in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is hardware.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
In essence, this document is a regulatory approval notice, not a clinical study report.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle's body is formed by three curved lines.
OCT 03 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive · WAUKESHA WI 53186
Re: K022910
Trade/Device Name: Model OSC-63-INT Shoulder Array Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 30, 2002 Received: September 3, 2002
Dear Mr. Schubert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section C – Statement of Indications for Use:
Applicant: MRI Devices Corporation 510(k) number (if known): K0229/6 Model QSC-63-INT Shoulder Array Coil Set Device Name:
Indications for use:
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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kari A. Slayton
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022910
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use or (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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.