The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa® OpenSpeed with Excite Magnetic Resonance 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.

Due to the 'open' design of the Signa 0.7T Signa® OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as. in-room display and MR safe biopsy needles

Device Description

The 0.7T Signa® OpenSpeed with Excite Maqnetic Resonance System is a modification to the 0.7T Signa® OpenSpeed Magnetic Resonance System (K012875) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System features a superconducting magnet operating at 0.7T. 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, short scan times, and multinuclear spectroscopy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the GE 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System:

Based on the provided 510(k) summary, this document is a notification for a modification to an existing device (Signa® 0.7T OpenSpeed MR System, K012875), not a brand-new device. Therefore, the "acceptance criteria" discussed are primarily related to meeting performance standards and establishing substantial equivalence to the predicate device, rather than explicit diagnostic performance metrics (e.g., sensitivity, specificity) for a disease state. The study is focused on demonstrating that the modified device performs comparably and safely.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for a modification to a predicate device)	Reported Device Performance (from "Summary of Studies")
Compliance with NEMA Performance Standards	"The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System was evaluated to the appropriate NEMA performance standards." (Details of specific NEMA standards and quantitative results are not provided in this summary but are implied to have been met.)
Compliance with IEC Safety Standards (IEC 601-1 and IEC 601-2-33)	"The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System was evaluated to... the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis." (Details of specific outcomes are not provided, but compliance is implicit.)
Substantial Equivalence to Predicate Device (Signa® 0.7T OpenSpeed, K012875)	"The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is comparable to the currently marketed Signa® 0.7T Open Speed Magnetic Resonance System.""It is the opinion of GE that the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is substantially equivalent to the Signa® 0.7T OpenSpeed Magnetic Resonance System. Usage of the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System does not result in any new potential hazards." (The core of the submission is to demonstrate this equivalence, driven by the technical comparisons of added receive channels and improved gradient performance.)
No new potential hazards introduced	"Usage of the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System does not result in any new potential hazards."
Support improved higher resolution imaging and shorter scan times	Indicated in the "Indications for Use" as a design goal: "designed to support improved higher resolution imaging and shorter scan times." While this is an "indication," the testing indirectly supports this through the improvements (eight independent receive channels and updated gradient amplifier performance) claimed to improve performance, although explicit quantitative measures of image resolution improvement or scan time reduction are not provided in this summary.

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

This is not a clinical study involving a "test set" of patient data in the typical sense for AI/diagnostic algorithms. The evaluation described ("Summary of Studies") refers to engineering and performance testing against industry standards (NEMA, IEC) for the device itself. Therefore, concepts like sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) summary. The "test set" would be the device under various operational conditions.

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

Since this is not a diagnostic algorithm dependent on human interpretation for its performance evaluation against a specific disease, the concept of "experts" establishing a ground truth for a test set is not applicable. The "ground truth" here is adherence to technical specifications and safety standards, determined through engineering measurements and tests.

4. Adjudication Method for the Test Set

As this is not a study involving human readers or a diagnostic "ground truth," an adjudication method is not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided summary. This type of study typically assesses the diagnostic accuracy of human readers with and without an AI assistant. The 510(k) here is for a hardware modification to an MRI system, not an AI software.

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

No, a standalone performance study (algorithm only) was not done. This 510(k) is for a hardware medical device (MRI system), not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on engineering specifications, compliance with recognized performance standards (NEMA), and safety standards (IEC). These standards define the expected performance and safety characteristics of an MRI system. There is no mention of pathology, outcomes data, or expert consensus on clinical cases as the ground truth for this submission, as it relates to the device's fundamental operational characteristics.

8. The Sample Size for the Training Set

No "training set" is mentioned or implied. This is a submission for a hardware modification, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this device modification.

Summary

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Ko32795

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and appear to be handwritten. The logo is black and white.

GE Medical Systems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

OCT - 8 2003

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Larry A. Kroger Ph.D.Manager, Regulatory Programs
Telephone:	262- 544-3894
Fax:	262- 548-4768
Date Prepared:	September 4, 2003

Device Name:

GE 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Marketed Device:

The GE 0.7T Signa® OpenSpeed with Excite MR System is substantially equivalent to the currently marketed Signa® 0.7T OpenSpeed MR System (K012875) with the main differences being an addition of eight independent receive channels and an update to the performance of the gradient amplifiers.

Device Description:

Indications for Use:

The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.7T Signa® OpenSpeed with Excite Magnetic Resonance 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-

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters are stylized and have a classic, vintage appearance. The logo is black and white.

GE Medical Systems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Due to the 'open' design of the 0.7T Signa® OpenSpeed with Excite may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles

Comparison with Predicate Device:

The GE 0.7T Signa® OpenSpeed with Excite MR System is a modification of the Signa® OpenSpeed MR system (K012875) with the main differences being the addition of eight independent receive channels and the addition of the improved gradient performance.

Summary of Studies:

The 0.7T Signa® OpenSpeed with Excite 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 Safety of Magnetic Resonance Equipment for Medical Diagnosis. The 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is comparable to the currently marketed Signa® 0.7T Open Speed Magnetic Resonance System.

Conclusion:

It is the opinion of GE that the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System is substantially equivalent to the Signa® 0.7T OpenSpeed Magnetic Resonance System. Usage of the 0.7T Signa® OpenSpeed with Excite Magnetic Resonance System does not result in any new potential hazards.

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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 8 2003

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-400 MILWAUKEE WI 53201

Re: K032795

Trade/Device Name: GE 0.7T Signa® OpenSpeed with Excite MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: September 4, 2003 Received: September 9, 2003

Dear Dr. Kroger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GE Medical Svstems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

STATEMENT OF INTENDED USE

510(k) Number (if known):

Device Name: GE 0.7T Signa® OpenSpeed with Excite MR System

Indications for Use

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .....

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.