GYREX PRIMA 1TG 1.0T MRI SYSTEM by ELSCINT MR, INC.

The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

Device Description

The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

AI/ML Overview

The provided text describes a 510(k) submission for the Elscint Gyrex Prima 1TG 1.0T MRI System, asserting its substantial equivalence to a predicate device, the Prestige 2.0T MRI System. However, this document does not contain explicit acceptance criteria or a dedicated study section demonstrating the device meets such criteria.

The core of this submission is a declaration of substantial equivalence rather than presenting a performance study against specific, quantified acceptance criteria.

Here's an analysis based on the information not present in the document:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states that the new device has "changes to RF Coils, sequences and system electronics" and is "substantially equivalent" to the predicate. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, resolution, signal-to-noise ratio) presented for either the new device or against any defined acceptance criteria.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No test set or associated data is described. The submission focuses on device modifications and substantial equivalence.
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 provided. No test set or ground truth establishment is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. No test set or adjudication method is mentioned.
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 provided. No MRMC study is mentioned. This device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be applicable in this context. The document does mention "Operator selectable application of the Context Vision™ A imaqe filter," which might involve some image processing, but it's not framed as an AI assistance study for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent to its imaging capabilities, which are asserted as substantially equivalent to a predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No ground truth is mentioned as there is no specific performance study described.
The sample size for the training set:
- Not applicable/Not provided. As a medical imaging device rather than a machine learning algorithm, the concept of a "training set" in the AI/ML sense is not relevant here. The device's design is likely based on engineering principles and prior knowledge of MRI technology.
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, a training set with established ground truth, in the context of AI/ML, is not relevant to this device's submission.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new MRI system to an existing one, rather than a detailed report of a performance study against specific acceptance criteria. It highlights changes in hardware components (magnet, gradient system, coils) and a selectable image filter, asserting that these do not introduce new indications or hazards beyond the predicate device.

Summary

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KG70990

Summary of Safety and Effectiveness

The following information is made available pursuant to the requirements of the Safe Medical devices Act of 1990.

1.	Submitter:	Elscint MR, Inc.2555 Midpoint DriveFort Collins, CO 80521Tel: (970) 498-8088Fax: (970) 498-8098	AUG 25 1997
	Contact:	Elizabeth F. Lowder, Director of Quality and Programs
	Date:	March 13, 1997

Elscint Gyrex Prima 1TG 1.0T MRI System Product Identification: 2.
Predicate device: Prestige 2.0T MRI System 3.
Device Description and Indications for Use: 4.

Comparison to Predicate Device ഗ്
The major components changed or updated over that described in the predicate device submission are:
A superconducting actively shielded 900mm bore 1.0T A maqnet
A switching gradient amplifier and dual gradient coil A
- 7 combining to produce slew rates of 42 mT/m/msec and 72 m Thisec dependent on operational mode. This design is known as the Twin Gradient subsystem.
Local phased array coils for imaging the shoulder and wrist A
Operator selectable application of the Context Vision™ A imaqe filter

In addition, changes to RF Coils, sequences and system electronics have been performed to allow operation at 1.0T.

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Conclusion: ୍.

lt is the opinion of Elscint MR, Inc. that the Prima 1TG MR system is substantially equivalent to the Prestige MR system. The Prima 1TG does not include any new indications for use, nor does use of this device result in any new potential hazards.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle, with its wings spread. The overall design is simple and professional, reflecting the official nature of the organization.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1997

Re:

Elizabeth Lowder Director, Quality and Programs Elscint MR, Inc. 2555 Midnoint Drive Fort Collins, CO 80525

K970990 Gyrex Prima ITG 1. 0T MRI System Dated: June 25, 1997 Received: June 30, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Lowder:

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 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, 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 (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 (OS) 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 801 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.

h.7.Liau Yi

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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Elscint

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510(k) number ================================================================================================================================================================

Device Name: Gyrex Prima 1TG 1.0T MRI System

Indications for Use:

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

Concurrence of GDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number	K970990
Prescription Use	OR	Over-the Counter Use
(Per CRF 801.109)
X		(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.