(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the elbow that can be interpreted by a trained physician.
EXS-63 Small Extremity Array Coil
This is a 510(k) clearance letter from the FDA for a Magnetic Resonance (MR) coil, specifically the EXS-63 Small Extremity Array Coil. This type of device is an accessory to a larger imaging system (an MRI scanner) and is primarily judged on its safety and effectiveness as an imaging component, rather than through complex AI performance metrics.
Therefore, the requested information about acceptance criteria, study details for AI performance, sample sizes for training/test sets, ground truth establishment, and expert involvement is not applicable to this document or the device it describes.
This document confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is expected to be similar to existing, approved devices that have already demonstrated safety and effectiveness for diagnostic imaging of the elbow. The "acceptance criteria" here implicitly refer to meeting the established standards for such MR coils at the time of clearance (2002).
Key takeaways from the document regarding "acceptance" and "proof":
- Acceptance Criteria (Implicit):
- Safety: The device must be safe for use in conjunction with an MRI scanner.
- Effectiveness: The device must be capable of producing diagnostic images of the elbow when used with an MRI scanner that can be interpreted by a trained physician.
- Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.
- Study Proving Acceptance (Implicit):
- The "study" is the 510(k) premarket notification submitted by MRI Devices Corporation.
- This notification would have included information demonstrating how the EXS-63 coil is substantially equivalent to a predicate device. This typically involves:
- Comparison of Technical Specifications: Demonstrating similar materials, design, operating principles, and performance characteristics (e.g., signal-to-noise ratio, homogeneity, imaging capabilities) to the predicate device.
- Performance Testing: Bench testing or phantom studies to show that the coil meets basic performance expectations for an MRI coil.
- Risk Assessment: Demonstrating that any risks associated with the device are comparable to or less than those of the predicate device.
- Clinical Data (if necessary): While often not required for substantial equivalence for accessories like coils if technical equivalence is strong, some observational or limited clinical data might be presented to support image quality if differences from the predicate are significant. However, based on the document, it's highly likely this was a technical substantial equivalence determination.
Summary of requested information in context of this document:
- Table of acceptance criteria and reported device performance: Not explicitly stated as specific metrics for this device type in this document. The "performance" is implicitly its ability to produce diagnostic images of the elbow, demonstrated by substantial equivalence to a predicate.
- Sample size for the test set and data provenance: Not applicable. No "test set" in the context of AI performance is mentioned.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for AI algorithms is not relevant here.
- Adjudication method for the test set: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is not an AI device.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is not an AI device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In essence, this document is a regulatory approval for a medical device accessory based on its physical and functional characteristics, not on software algorithm performance or AI metrics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 1 2002
Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K020036
Trade/Device Name: EXS-63 Small Extremity Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 3, 2002 Received: January 4, 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 If you desire 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 of responsibilities under the Act may be obtained from the Division of Small Manufacturers, J & Lotice 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 2 cou 3 G Model EXS-63 Small Extremity Array Coil Device Name:
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the elbow that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | or | Over-The-Counter Use ______ | |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproduction, Abdominal,
and Radiological Devices
| 510(k) Number | K020036 |
|---|---|
| --------------- | --------- |
§ 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.