2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) by ELSCINT, INC.

The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (K944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems.

AI/ML Overview

Here's an analysis of the provided information, describing the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for a modification to an existing device, a Flex Coil for MRI systems. As such, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness, rather than meeting specific quantifiable performance metrics for a novel diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance and Evidence (Flex Coil)
Safety	No adverse impact on MRI safety parameters (SAR, dB/dt, Bo, acoustic noise).	* MRI safety parameters (`SAR`, `dB/dt`, `Bo`, acoustic noise) do not apply to passive coils.
	Avoidance of electric shock hazards.	* Enclosures designed to comply with clause 16 of IEC-601-1 safety standard.
	Avoidance of injury from rough surfaces, sharp corners, and edges.	* Design according to clause 23 of the IEC-601-1 standard.
	Coil enclosures and protective covers meet flammability standards.	* Flame rated better than CPAI-84.
	No software modifications.	* No software modifications have been made.
	Patient contacting materials are identical to predicate device.	* All patient contacting materials are identical to those used in the predicate Flexible Coil (K944331).
	No impact on site planning, installation, service manuals, or safety labeling.	* Current modifications do not affect site planning, installation, service manuals, and do not require new safety labeling.
Effectiveness	Acceptable uniformity.	* The Elscint 0.5T and 2T Flex Coils have acceptable uniformity. (Specific quantifiable metrics for "acceptable" are not provided in this summary.)
	Higher Signal-to-Noise Ratio (SNR) compared to the predicate Shoulder Coil.	* The Elscint 0.5T and 2T Flex Coils have higher SNR than the Shoulder Coil. (Specific quantitative SNR values or improvement percentages are not provided.)
	Improved image quality compared to the predicate Shoulder Coil.	* The images produced by the Flex Coils are better than those produced using the Shoulder Coils on the same systems. (This is a subjective assessment of image quality, without further detail on how "better" was defined or measured.)
Substantial Equivalence	The device is substantially equivalent to predicate devices in terms of safety and effectiveness, including the frequency specified for the 2 Tesla model.	* The device is "substantially equivalent to the predicate devices in terms of safety and effectiveness," with the specific note that the modification mainly involves the frequency for the 2 Tesla model since the predicate was for 0.5T, 1.0T, and 1.5T. Implicitly, by accepting the 510(k), the FDA agreed with this assessment.

Study Details Proving Acceptance Criteria

The provided document is a summary of a 510(k) premarket notification. It does not describe a formal scientific "study" in the way one might evaluate a new diagnostic algorithm. Instead, it demonstrates substantial equivalence through a comparison to existing, legally marketed predicate devices and by outlining compliance with relevant safety standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set sample size" or "data provenance" in terms of patient data. The evaluation appears to be based on:

Engineering Analysis and Compliance: Demonstrating adherence to IEC safety standards.
Bench Testing/Performance Evaluation: Stating "acceptable uniformity," "higher SNR," and "better images" compared to the Shoulder Coil. This would imply some form of imaging or phantom tests, but no specifics are given regarding the number of images, phantoms, or human subjects used.
Comparison to Predicate: The primary "test" is a comparison of the modified device's characteristics against those of the predicate devices.

Given the context of a 510(k) for a coil modification, it's highly likely that this involved a limited number of phantom images and possibly images from volunteer subjects, but no large-scale patient study aiming for statistical significance is described.

Data Provenance: Not specified, but likely internal testing by Elscint. Retrospective or prospective nature is not indicated for any observed performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not Applicable in the traditional sense. For a device like a new MRI coil, "ground truth" isn't typically established by expert consensus on clinical diagnoses within a test set. Instead, performance metrics like uniformity and SNR are objectively measured. Subjective "better images" assessment might involve internal engineers or physicists, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not Applicable. As there's no defined "test set" requiring clinical diagnosis or interpretation, no adjudication method would have been used. Performance metrics like SNR and uniformity are objectively measured characteristics of the coil's physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not done. The effectiveness claims ("higher SNR," "better images") are implicitly based on direct comparison to the predicate shoulder coil, likely through technical specifications or qualitative review, not a formal multi-reader study.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

Yes (Implicitly). The evaluation of the coil's physical performance characteristics (uniformity, SNR) is a standalone assessment of the device hardware. The statement "The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil" indicates a standalone assessment of the coil's imaging capabilities without human interpretation influencing the raw metrics. The claim of "better images" is a subjective standalone assessment.

7. The Type of Ground Truth Used

For safety: Compliance with international safety standards (IEC-601-1) and material specifications (CPAI-84).
For effectiveness: Objective physical measurements (e.g., uniformity, SNR, though specific metrics are not provided) and qualitative comparative assessment ("better images") against a predicate device.

8. The Sample Size for the Training Set

Not Applicable. The device is a hardware component (an MRI coil), not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, there is no ground truth established for one.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

K972592

Device Name: Flex Coil for the Prestige, Privilege, and Gyrex V-EP.

1.2 Classification Name: Magnetic Resonance Diagnostic Device

1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601

1.4 510(k) Number:____________________________________________________________________________________________________________________________________________________________ SEP 1 5 127

Device Modification Description

Predicate Devices: The predicate devices are the 2T Prestige (K945791), Privilege (K954039), and Gyrex V-EP (K962618) systems with their shoulder coils, and the General Purspose Flex Coil (K944331).

4. Safety

The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, do not apply to . passive coils.
Electric shock hazards are avoided by enclosures designed to comply with clause . 16 of the IEC-601-1 safety standard.
Rough surfaces and sharp corners and edges which may cause injury or damage . are avoided by design according to clause 23 of the IEC-601-1 standard.
. The coil enclosures and protective covers are flame rated better than CPAI-84.
. No software modifications have been made.
. All of the patient contacting materials are identical to those used in the predicate Flexible Coil (K944331).
The current modifications do not affect the site planning, installation, or service . manuals, and do not require any new safety labeling.

5. Effectiveness

The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil. The images produced by the Flex Coils are better than those produced using the Shoulder Coils on the same systems.

6. Substantial Equivalency Statement

Based on the above, it is Elscint's opinion that the 2T-Prestige, Privilege, and Gyrex V-EP systems with their new Flex Coils are substantially, equivalent to the predicate devices in terms of safetv and effectiveness.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1997

Benv Sherer Safety Officer Elscint, Inc. 505 Main Street Hackensack, NJ 07601 K972592 Flex Coil for Gyrex 0.5T and 2.0T MRI System Dated: July 10, 1997 Received: July 11, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Sherer:

We have reviewed your Section SI0(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, 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 (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 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) 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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

W. Liao Yu
Lillian Yiu, Ph.D.

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 ____ of ____ of__________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Flex Coil for Gyrex 0.5T and 2T Systems Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Magnetic Resonance Imaging of small extremity joints.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K972592
Prescription Use (Per 21 CFR 801.109)	OR Over-The-Counter Use _______ (Optional Format 1-2-96)

Regulation Number and Section

§ 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.