The Indications for Use for the Mobile Siting option of Signa Profile System is the same as for a Fixed Site System. The Wrist Coil expands the capability of the Signa Profile System. It accommodates and improves imaging of the wrist and surrounding structures.

Device Description

The Signa Profile System is identical for both the Mobile and Fixed Site options. The Wrist Coil option is a quadrature receive only coil. The coil comes with an adjustable positioning base and patient comfort pads for support. It is designed for use with a vertical magnetic field MR imaging system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Signa Profile Wrist Coil and Mobile Siting Options:

Unfortunately, the provided text does not contain sufficiently detailed information to fill out most of the requested fields. The summary of safety and effectiveness primarily focuses on establishing substantial equivalence to existing devices rather than presenting specifics of performance testing against explicit acceptance criteria.

Key Findings from the Document:

The submission is for the Signa Profile Wrist Coil and Mobile Siting Options for the GE Signa Profile MR System.
The manufacturer is GE Yokogawa Medical Systems, Ltd. (Japan).
The primary argument for safety and effectiveness is substantial equivalence to the currently marketed Signa Profile System (software and electronics) and the Signa Profile Extremity Coil.
"Summary of Studies" section states: "The Wrist Coil and a Mobile Sited Signa Profile System were evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Both options performed to stated specifications." This is the only mention of performance evaluation, but it lacks specific criteria or detailed results.

Inferences and Missing Information:

Acceptance Criteria & Reported Performance: The document only vaguely states "performed to stated specifications" based on NEMA and IEC standards. The specific criteria (e.g., signal-to-noise ratio, field homogeneity, image uniformity, resolution) and the numerical results are not provided.
Sample Size, Ground Truth, Adjudication, MRMC/Standalone Studies, Training Set: There is no mention of patient data, clinical studies, expert review, or any AI/algorithm component. This submission is for hardware (MRI coil, mobile siting) and its performance against engineering/safety standards, not diagnostic algorithm performance on medical images.

Detailed Breakdown based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
General: Conformity to NEMA performance standards	"Performed to stated specifications"
General: Conformity to IEC 601-1 International medical equipment safety standard	"Performed to stated specifications"
Specific performance metrics (e.g., SNR, resolution, uniformity, specific safety parameters)	Not provided in the document.

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not mentioned. The evaluation appears to be based on engineering tests against standards, not clinical patient test sets.
- Data Provenance: Not applicable/Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" in the clinical sense (e.g., disease presence/absence in images) was established as this was not a clinical effectiveness trial for a diagnostic algorithm. The evaluation was against engineering and safety standards.
Adjudication method for the test set:
- Not applicable. There was no clinical ground truth requiring adjudication.
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 coil and mobile system, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device contains no standalone algorithm.
The type of ground truth used:
- The "ground truth" for this submission refers to the specifications and requirements defined by NEMA performance standards and the IEC 601-1 safety standard. These are technical specifications and safety benchmarks, not clinical ground truth like pathology or expert consensus.
The sample size for the training set:
- Not applicable. This device does not involve a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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K71668

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are three small, stylized shapes resembling droplets or flourishes positioned around the top of the circle, adding a decorative element to the design.

page 1 of 2

GE Medical Systems

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

JUL 2 4 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is O 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. Mav 2, 1997
0 Identification of the Product Signa Profile Wrist Coil and Mobile Siting Options

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

O Marketed Devices
The Signa Profile MR System with the Wrist Coil and the Mobile Siting Options are substantially equivalent to the currently marketed Signa Profile System (software and electronics).
o Device Description
0

Indications for Use The Indications for Use for the Mobile Siting option of Signa Profile System is the same as for a Fixed Site System. The Wrist Coil expands the capability of the Signa Profile System. It accommodates and improves imaging of the wrist and surrounding structures.

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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 within a circular border. The letters and the border are solid black, creating a high-contrast design. The logo is simple and recognizable, representing the well-known multinational conglomerate.

Image /page/1/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K971668' and are written in black ink on a white background. The handwriting style is cursive, and the characters are connected to each other. The image appears to be a close-up of the characters.

GE Medical Systems

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

SUMMARY OF SAFETY AND EFFECTIVENESS

Comparison with Predicate

There are no differences between a Signa Profile System when in a Mobile or Fixed site. The Wrist Coil is similar to the Extremity Coil with the biggest difference being in dimensions, the Wrist Coil being smaller.

Summary of Studies

The Wrist Coil and a Mobile Sited Signa Profile System were evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Both options performed to stated specifications.

Conclusions

It is the opinion of GE that the Signa Profile System with the Wrist Coil and Mobile Siting options are substantially equivalent to the presently marketed fixed site Signa Profile and the Signa Profile Extremity Coil. These options do not result in any new potential hazards.

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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HU" and "N SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 4 1997

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

Re: K971668 Signa Profile Wrist Coil and Mobile Siting Options Dated: April 30, 1997 Received: May 6, 1997 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 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 marked 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 question 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. Wiau Yu

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Signa Profile Wrist Coil and Mobile Siting Options

Indications For Use:

The Indications for Use for the Mobile Siting option of Signa Profile System is the ... . . . . same as for a Fixed Site System. The Wrist Coil expands the capability of the Signa Profile System. It accommodates and improves imaging of the wrist and surrounding structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number:	K971668
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Prescription Use (Per 21 CFR 801.109)		OR	Over-The-Counter Use
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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.