The Signa Profile/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i 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 musculocskelatal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/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.

Due to the 'open' design of the system, the Profile/i may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Device Description

The Signa Profile// System is a modification to the Signa ProfielMR Systems which utilizes a permanent 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 Profile operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa Profile// operator has the ability for shorter scan due to expanded gradient capabilities. Imaging options such as cardiac gating, times peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.

AI/ML Overview

This 510(k) premarket notification for the Signa Profile/i Magnetic Resonance System (K992135) does not contain a study that demonstrates the device meets specific acceptance criteria in the way you've described.

Instead, this submission is centered on demonstrating substantial equivalence to a previously marketed device, the Signa Profile System. The core of this type of submission is to show that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a predicate device.

Therefore, many of the requested elements for describing a study that proves a device meets acceptance criteria are not present in this document.

Here's why and what information can be extracted:

Why the requested information is largely absent:

Substantial Equivalence vs. Performance Study: A 510(k) for substantial equivalence doesn't typically require a de novo clinical or performance study with defined acceptance criteria and statistical analysis to prove improved performance or diagnostic accuracy. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Focus on Technical Characteristics and Safety: The "Summary of Safety and Effectiveness" focuses on comparing the technical specifications (e.g., gradient coil, slew rate, imaging options) and ensuring compliance with general safety standards (NEMA, IEC 601-1, IEC 601-2-33). It does not outline specific diagnostic performance metrics (like sensitivity, specificity, or AUC) that the device must achieve.
"Acceptance Criteria" in this context: The "acceptance criteria" here are implicitly tied to meeting NEMA performance standards and safety standards, and demonstrating that the changes (e.g., improved gradient capabilities, interventional application) do not introduce new hazards or alter the intended diagnostic use in a way that would require new clinical proof of efficacy.

Information that can be extracted or inferred:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with NEMA performance standards	The Signa Profile/i System was "evaluated to the appropriate NEMA performance standards." (No specific NEMA standard ID or detailed performance results provided in this summary)
Compliance with IEC 601-1 International medical equipment safety standard	The Signa Profile/i System was "evaluated to... the IEC 601-1 International medical equipment safety standard." (No specific sections or detailed results provided)
Compliance with IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis	The Signa Profile/i System was "evaluated to... IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis." (No specific sections or detailed results provided)
Substantial Equivalence to Predicate Device	"It is the opinion of GE that the Signa Profile/i System is substantially equivalent to the Signa Profile MR Systems." The FDA concurred: "We have determined the device is substantially equivalent... to legally marketed predicate devices."
No new indications for use	"The Signa Profile/i Magnetic Resonance System does not include any new indications for use..." (However, it adds the capability for interventional procedures when used with MR compatible devices, which is presented as an extension of existing use rather than a 'new' indication demanding separate clinical validation of its diagnostic efficacy for that specific use).
No new potential hazards	"... nor does use of this device result in any new potential hazards."
Improved higher resolution imaging and shorter scan times	"The Signa Profile/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times." This is a design goal/claim, implied to be met by the expanded gradient capabilities, but no quantitative performance data is provided to "prove" this claim beyond the technical enhancements.

Sample size used for the test set and the data provenance: Not applicable. No "test set" of clinical data (e.g., patient images) was used for evaluating diagnostic performance against specific acceptance criteria. The evaluation was against technical and safety standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts was used for this type of submission.
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 MRI system, not an AI-powered diagnostic algorithm, and no such study was conducted or required for this 510(k).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission revolves around engineering specifications, safety standards, and the technical characteristics of the device being comparable to the predicate.
The sample size for the training set: Not applicable. This device is an MRI system, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary: This 510(k) demonstrates the Signa Profile/i Magnetic Resonance System's substantial equivalence to an existing device by showing adherence to technical and safety standards, and confirming that its technological changes (primarily an enhanced gradient coil for flexibility and efficiency) do not introduce new safety concerns or alter its fundamental diagnostic function. It does not present a clinical study with detailed performance acceptance criteria.

Summary

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

K 99 2135

8 1999

page 1 of 2

GE Medical Systems

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

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).
o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, June 18, 1999
o Identification of the Product Signa Profile// Magnetic Resonance System

Manufacturer Address:

GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan

0 Marketed Devices

The Signa Profile/ System is substantially equivalent to the currently marketed Signa Profile System. The Signa Profile// Magnetic Resonance System adds interventional applications capability and a new Gradient Coil with a slew rate of 25 mT/m/sec.

o Device Description

Indications for Use

The Signa Profile// system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile// 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 musculocskelatal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/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.

Image /page/0/Picture/17 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular border. The letters are stylized and connected, with the 'G' and 'E' flowing together in a cursive-like manner. The circular border has decorative swirls or flourishes around the letters, adding to the logo's distinctive design.

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

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and appear to be handwritten, with decorative flourishes. The logo is black and white.

page 2 of 2

GE Medical Systems

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

SUMMARY OF SAFETY AND EFFECTIVENESS

Due to the 'open' design of the Profile/i can also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, nad MR safe biopsy needles.

0 Comparison with Predicate

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

o Summary of Studies

The Signa Profile// 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 Profile/i System is comparable to the Signa Profile MR Systems.

o Conclusions

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

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

Public Health Service

8 1999

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

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K992135 Signa Profile/I Magnetic Resonance System Dated: June 18, 1999 Received: June 24, 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). 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 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 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 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 Radioloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 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 an abstract symbol resembling an eagle or bird with three stylized human profiles incorporated into its design.

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

510(k) Number (if known): K 992135

Device Name: Signa Profile/i Magnetic Resonance 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 A. Seyram

vision of Reproductive, Abdominal, EN and Radiological Devi

510(k) Number K992135

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.