The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

The Signa CVMR System is a modification to the Signa Horizon MR Systems which utilize a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Horizon operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa CVMR operator has the ability for shorter scan times due to expanded gradient capabilities. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GE Signa CVMR Magnetic Resonance System. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically seen for autonomous AI/ML devices. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance standards.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance table. The "performance" assessment is framed in terms of compliance with established medical device standards and comparison to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with NEMA performance standards	Evaluated to appropriate NEMA performance standards
Compliance with IEC 601-1 International medical equipment safety standard	Evaluated to IEC 601-1 International medical equipment safety standard
Compliance with IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis	Evaluated to IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
Substantial equivalence to predicate device (Signa Horizon System) in terms of safety and effectiveness for diagnostic imaging	Deemed substantially equivalent with no new hazards or indications for use. Main difference is the Body/Gradient coil to enable shorter scan times.
Production of transverse, sagittal, coronal, and oblique images of internal structures of the head or body	Indicated for use as a diagnostic imaging device to produce these images.
Images reflecting spatial distribution of protons based on proton density, T1, T2, and flow	Images produced by the system reflect these properties.
Images providing information useful in determining a diagnosis when interpreted by a trained physician	Indicated for this purpose.

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

Not applicable. This submission doesn't describe a clinical study of "test set" data for evaluating an algorithm's performance. The evaluation is focused on engineering and safety standards, and comparative equivalence to an existing device.

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

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

5. 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

No. This document describes a traditional medical imaging device (MR system) and not an AI/ML diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML evaluation. The "ground truth" for this device's safety and effectiveness relies on:

Engineering and electrical safety standards (NEMA, IEC).
Demonstrated performance characteristics inherent to MR technology (e.g., ability to acquire T1/T2 weighted images, proton density).
Clinical acceptance of the predicate device (Signa Horizon System) for its diagnostic capabilities when interpreted by trained physicians.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm, so there is no "training set."

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

Not applicable. See point 8.

Summary of the Study (as described in the document):

The "study" described in this 510(k) submission is primarily a technical and regulatory evaluation to demonstrate substantial equivalence to a previously cleared predicate device, the Signa Horizon System.

Objective: To show that the Signa CVMR System is as safe and effective as the predicate device and does not raise new questions of safety and effectiveness.
Methodology:
- Comparison with Predicate: The Signa CVMR System was compared to the Signa Horizon Systems, with the primary difference identified as a modified Body/Gradient coil allowing for expanded gradient capabilities and shorter scan times. The submission asserts that no new indications for use or potential hazards are introduced.
- Compliance with Standards: The device was evaluated against:
  - Appropriate NEMA performance standards.
  - IEC 601-1 International medical equipment safety standard.
  - IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
Conclusion: GE concluded that the Signa CVMR System is substantially equivalent to the Signa Horizon MR Systems. The FDA, based on this submission, concurred with the substantial equivalence finding.

Summary

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K98 0 11

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has decorative elements around the edge, and a line extends from the bottom of the circle.

page 1 of 2

GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

MAR 3 0 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
0 Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, January 8, 1998
o Identification of the Product Signa CVMR Magnetic Resonance System

Manufactured by:

GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188

o Marketed Devices

The Signa CVMR System is substantially equivalent to the currently marketed Signa Horizon System with the only difference being a different Body/Gradient coil.

o Device Description

o Indications for Use

The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

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GE Medical Systems

Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. There are three decorative flourishes extending from the circle's edge, adding a touch of elegance to the design. The logo is presented in black and white.

page 2 of 2

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

SUMMARY OF SAFETY AND EFFECTIVENESS

o Comparison with Predicate

The Signa CVMR System is comparable to the Signa Horizon Systems with the main difference being with the Body/Gradient coil which allows for expanded gradient capabilities, enabling shorter scan times.

o Summary of Studies

The Signa CVMR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The Signa CVMR System is comparable to the Signa Horizon MR Systems.

Conclusions

It is the opinion of GE that the Signa CVMR System is substantially equivalent to the Signa Horizon MR Systems. The Signa CVMR Magnetic Resonance System 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the people served by the department. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1998

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201

Re:

K980114 Signa CVMR Magnetic Resonance System Dated: January 12, 1998 Received: January 13, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Kroger:

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 (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 requirements, 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 coucerning 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 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 vito 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/cdrb/dsmaldsmam.html".

Sincerely yours,

Kiliai Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_ K98 0114

Device Name: Signa CVMR System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Seysom

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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.