The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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 3.0T Signa VH/i Magnetic Resonance System is a modification to the Signa CV// Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D singleslice and multi-slice, and 3D volume images. The GE 3T Signa VH/i MR System is a high resolution, head imaging system operating at 3 Tesla. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and shorter scan times.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Medical Systems 3.0T Signa VH/i Magnetic Resonance System:

Summary:
The provided 510(k) submission for the GE 3.0T Signa VH/i MR System is a "Summary of Safety and Effectiveness" report from 1999. It focuses on demonstrating substantial equivalence to a predicate device (Signa CV/i Magnetic Resonance System) rather than presenting a detailed clinical study with specific acceptance criteria related to diagnostic performance. The key "study" described is compliance with established performance and safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with NEMA Performance Standards	Evaluated to appropriate NEMA performance standards. (Specific standards or results not detailed in submission)
Compliance with IEC 601-1 Safety Standard	Evaluated to IEC 601-1 International medical equipment safety standard. (Specific results not detailed in submission)
Compliance with IEC 601-2-33 Safety Standard	Evaluated to IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. (Specific results not detailed in submission)
Substantial Equivalence to Predicate Device	Determined to be substantially equivalent to the Signa CV/i Magnetic Resonance System (1.5T whole-body scanner), differing primarily in field strength (3.0T) and being head-only.
No new indications for use	The 3.0T Signa VH/i system's indications for use are consistent with the predicate device.
No new potential hazards	It is the opinion of GE that the 3.0T Signa VH/i System does not result in any new potential hazards.

Explanation: The document does not specify quantitative acceptance criteria or clinical performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capability. Instead, it relies on demonstrating compliance with existing industry standards and substantial equivalence to a previously cleared device.

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

The document does not mention a specific test set of patient data or images used for evaluating diagnostic performance. The "study" described is primarily focused on engineering compliance and comparison to a predicate device's specifications.

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

Since no specific test set or clinical performance evaluation is described, there's no mention of experts used to establish ground truth.

4. Adjudication Method for the Test Set

As no test set for diagnostic performance is described, there is no adjudication method mentioned.

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

No MRMC comparative effectiveness study was done or reported in this submission. The submission is focused on device equivalence and safety standards, not on evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an MRI scanner, a hardware diagnostic imaging device, not an AI algorithm. Therefore, no standalone performance study was conducted in the sense of an algorithm operating independently for diagnosis. The performance evaluation relates to its physical and imaging capabilities.

7. The Type of Ground Truth Used

The primary "ground truth" implicitly used for this submission is:

Compliance with established engineering and safety standards (NEMA, IEC 601-1, IEC 601-2-33).
The performance and safety profile of the predicate device (Signa CV/i Magnetic Resonance System).

There is no mention of pathology, expert consensus on patient diagnoses, or outcomes data being used as ground truth for a clinical performance study.

8. The Sample Size for the Training Set

This document describes a medical imaging device (MRI scanner), not an AI system that undergoes training. Therefore, there is no concept of a "training set" as would be applicable to machine learning algorithms.

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

As this is not an AI/ML device, this question is not applicable.

Summary

{0}------------------------------------------------

K 990550

GE Medical Systems

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

MAY 1 1 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, February 19, 1999
o Identification of the Product 3.0T Signa VH/i Magnetic Resonance System

Manufactured by:

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

o Marketed Devices

The 3.0T Signa VH/i Magnetic Resonance System is substantially equivalent to the currently marketed Signa CV// Magnetic Resonance System with the only difference being a different magnetic field strength. The Signa CV/i Magnetic Resonance System has a magnetic field strength of 1.5Tesla and is a whole body scanner while the 3.0T Signa VH// Magnetic Resonance System has a magnetic field strength of 3.0T and is a head only scanner.

o Device Description

o Indications for Use
The Signa VH/i System is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH// 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.

Image /page/0/Picture/16 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are four small, teardrop-shaped elements evenly spaced around the outside of the circle.

page 1 of 2

{1}------------------------------------------------

GE Medical Systems

page 2 of 2

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

SUMMARY OF SAFETY AND EFFECTIVENESS

o Comparison with Predicate

The 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System with the main differences being the higher magnetic field strength and no body coil since the 3.0T Signa VH// System is a head only scanner.

o Summary of Studies

The 3.0T Signa VH/i Magnetic Resonance 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 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System.

o Conclusions

It is the opinion of GE that the 3.0T Signa VH/i Magnetic Resonance System is substantially equivalent to the Signa CV/i Magnetic Resonance System. The 3.0T Signa VH/i Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.

Image /page/1/Picture/10 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circle. The circle has small, leaf-like shapes around its perimeter, adding a decorative element to the design. The logo is black and white.

{2}------------------------------------------------

Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 1999

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

Re:

K990550 3.0T Signa VH/I magnetic Resonance System Dated: February 19, 1999 Received: February 22, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. 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 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: 3.0T Signa VH/i MR 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)

Thind A. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Deyic 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.