GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 by ELSCINT, INC.

What the user provided is a comprehensive overview of a medical device, which contains the intended use/indications for use. When asked to output the intended use as it appears in this document, the following is provided:

Whole Body Magnet Resonance Imaging

Device Description

The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Elscint EPI for the Gyrex Prestige and Privilege Systems, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Safety:
- Adherence to FDA recommended SAR (Specific Absorption Rate) limits for MRI.	The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, are unchanged by the current modification. This implies that the device continues to meet the FDA safety limits as the predicate devices.
- Adherence to FDA recommended dB/dt limits for MRI.	Unchanged.
- Adherence to FDA recommended Bo limits for MRI.	Unchanged.
- Adherence to FDA recommended acoustic noise limits for MRI.	Unchanged.
- No new electrical, mechanical, or biocompatibility safety issues introduced.	Electrical, mechanical, and biocompatibility safety issues do not apply to the current modification.
- No new software hazards introduced.	No new software hazards have been introduced, so the software level of concern remains minor.
- No impact on site planning, installation, or service manuals.	The current modifications do not affect the site planning, installation, or service manuals.
- No new safety labeling required.	Do not require any new safety labeling.
Effectiveness:
- EPI sequences produce images comparable with other imaging sequences.	The EPI sequences produce images that are comparable with those produced using other imaging sequences.
- Utility for particular applications due to faster imaging.	The EPI sequences are limited in resolution, but they are faster than other imaging sequences which makes them useful for particular applications.

Study Information

Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to "images that are comparable with those produced using other imaging sequences" but does not detail a specific test set. This suggests a more general comparison rather than a formal study with a defined test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment for a specific test set is not described. The evaluation appears to be a general assessment of image comparability.
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. This device is an imaging sequence modification, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging sequence modification, not an algorithm with standalone performance metrics. The effectiveness is assessed by the quality and utility of the generated images.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "effectiveness" section states that EPI sequences produce images that are "comparable with those produced using other imaging sequences." This implies a qualitative assessment of image quality and diagnostic information content, likely against established clinical standards or the predicate device's image quality. It's an assessment of image fidelity rather than a ground truth for a diagnostic task.
The sample size for the training set: Not applicable. This document describes a modification to an MRI system's imaging sequence, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Elscint EPI for the Gyrex Prestige and Privilege Systems

K96504

JUN 1 6 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name: EPI for the Gyrex Prestige and Privilege systems.

1.2 Classification Name: Magnetic Resonance Diagnostic Device

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

1.4 510(k) Number:____________________________________________________________________________________________________________________________________________________________

Device Modification Description

Predicate Devices: Gyrex 2T Prestige system (K945791), Gyrex Privilege system (K954039).
Safety

{

The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, are unchanged by the . current modification.
Electrical, mechanical, and biocompatibility safety issues do not apply to the current . modification.
No new software hazards have been introduced, so the software level of concern remains . minor.
The current modifications do not affect the site planning, installation, or service . manuals, and do not require any new safety labeling.

5. Effectiveness

The EPI sequences produce images that are comparable with those produced using other imaging sequences. The EPI sequences are limited in resolution, but they are faster than other imaging sequences which makes them useful for particular applications.

Substantial Equivalency Statement

The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the modified devices is similar to that of the predicate devices. It is Elscint's opinion that the Prestige and Privilege systems with the new EPI sequences are substantially equivalent to their predicate devices in terms of safety and effectiveness.

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JUN 16 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Beny Sherer Safety Officer Elscint, Inc. 86 Orchard Street Hackensack, NJ 07601

Re: K965044

EPI for Gyrex Prestige and Privilege MRI Systems Dated: March 24, 1997 Received: March 25, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Sherer:

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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 note: this response to your premarket notification does not affect any obligation you might have under sections 51 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) 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 and additionally 809.10 for in yritro 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 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

William M

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

Enclosure

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Page _ / of _ /

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_EPI for the Gyrex Prestige and Privilege MRI Systems

Indications For Use:

学

Whole Body Magnet Resonance Imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Seymon

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
O(k) Number K965044

X Prescription Use_ (Per 21 CFR 801.109) 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.