(20 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician.
QWH-250 PAN Wrist Wrist Array Coil
This is a 510(k) clearance letter from the FDA for a device called the "QWH-250 PAN Wrist Wrist Array Coil," which is a magnetic resonance diagnostic device used to produce diagnostic images of the wrist and hand.
The provided text is an FDA clearance letter and does not contain information about acceptance criteria, study design, or performance metrics in the way you've outlined for AI/ML device evaluations.
FDA 510(k) clearances for devices like MRI coils typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria and ground truth validation that are common for AI/ML algorithms.
Therefore, for your requested information, I must state:
- A table of acceptance criteria and the reported device performance: Not available in this document. The letter indicates the device is substantially equivalent to a predicate.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is not an AI/ML device needing ground truth establishment in this context.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 applicable, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
What the document does provide is:
- Device Name: QWH-250 PAN Wrist Wrist Array Coil
- Regulation Number: 21 CFR 892.1000
- Regulation Name: Magnetic resonance diagnostic device
- Regulatory Class: II
- Product Code: 90 MOS
- Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician."
This letter confirms that the FDA found the MRI coil substantially equivalent to existing predicate devices, meaning it is considered as safe and effective as those already on the market without requiring new clinical efficacy trials in the way an AI/ML product might.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
Mr. Thomas Schubert President MRI Devices Corp. 1515 Paramount Drive WAUKESHA WI 53186 Re: K024209 Trade/Device Name: QWH-250 PAN Wrist Wrist Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: December 17, 2002 Received: December 20, 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):_ Ko > 420 9 Model QWH-250-PAN Wrist Array Coil Device Name:
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Segerm
Division Sign-Off)
Division of Reproductive, Abdominal.
Division of Reproductive, Abdominal,
and Radiological Devices K024209
510(k) Number
Prescription Use Over-The-Counter 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.