The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.

Device Description

The GE 8CH Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Protor nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.

The GE 8CH Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table.

The GE 8CH Foot Ankle Coil is 8-element phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission. This coil is designed based on the same technology as the predicate device.

AI/ML Overview

The provided GE Healthcare 510(k) Premarket Notification Submission (K122694) details the substantial equivalence of the GE 8CH Foot Ankle Coil to a predicate device. This submission focuses on the safety and effectiveness of the coil itself, rather than the performance of an AI algorithm. Therefore, many of the requested details, such as AI model performance metrics (sensitivity, specificity, AUC), ground truth establishment for AI, sample sizes for test and training sets for AI, expert qualifications, and MRMC studies, are not applicable to this type of medical device submission.

The acceptance criteria and "study" described herein relate to the verification testing of the hardware device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance / Outcome
Biocompatibility Testing (Section 15)	Performed; documented in submission.
IEC 60601-1-2 testing (Section 17)	Performed; documented in submission.
	Fulfilled (NRTL certification to UL 60601-1).
IEC 60601-1 testing and NRTL certification to UL 60601-1 (Section 17)	Performed; documented in submission.
IEC60601-2-33 testing (Section 17)	Withstood maximum B1 peak fields and high B1 field energy concentrations without arcing or voltage breakdown; documented in submission.
Maximum B1 Peak test (Section 18)	Achieved according to NEMA standard; documented in submission.
Signal to Noise ratio and uniformity test (NEMA standard) (Section 18)	Effectiveness of blocking networks determined; ensured safety and minimized B1 distortion; documented in submission.
Blocking Network analysis (Section 18)	Passed under normal conditions; documented in submission.
Surface temperature test normal condition (Section 18)	Passed under unplugged conditions; documented in submission.
Surface temperature test unplugged condition (Section 18)	As safe, as effective, and performance substantially equivalent to the predicate device.
Clinical Image Review (Section 20)

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

This submission does not discuss a "test set" in the context of an AI algorithm. Instead, it refers to "Sample clinical images" that were performed implicitly as part of the validation of the physical coil's performance.

Sample Size: Not explicitly stated as a number of images or cases. The document mentions "Sample clinical images included in Section 20 Performance Testing - clinical."
Data Provenance: The clinical images were "performed within GE Healthcare facilities." This implies a prospective or controlled retrospective acquisition within GE's own environment for verification purposes. The country of origin is not specified, but GE Healthcare has global operations.

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

Not applicable. This is a hardware device submission, not an AI algorithm submission that requires expert-established ground truth for image interpretation. The verification tests are primarily engineering and safety-related.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-read interpretation or adjudication process for the clinical images in the context of establishing ground truth for an algorithm. The clinical images were used to demonstrate the qualitative performance of the coil.

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

Not applicable. This is a submission for an MRI coil, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no AI algorithm involved in this submission.

7. The Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" is defined by the technical standards (e.g., NEMA standards, IEC standards) and the physical properties and performance characteristics of the coil itself (e.g., signal-to-noise ratio, uniformity, temperature limits, B1 field tolerance). For the clinical images, the "ground truth" is the visual quality and diagnostic utility of the images produced by the coil, implicitly evaluated by GE's internal experts against established image quality criteria, though specific details of this evaluation are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm or training set discussed in this submission.

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

Not applicable. There is no AI algorithm or training set discussed in this submission.

Summary

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长1226 ക്കുന്നു.
അവലംബം കേരള കേരള കാലാക്കും അത്തരം അതിനു അവലംബം കേരള

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

OCT 2 5 2012

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	August 15, 2012
Submitter:	GE Hangwei Medical Systems Co.,Ltd.No.2, Yong Chang North RoadEcon. & Tech. Development ZoneBeijing, 100176, P.R.China
Primary Contact Person:	Ms. Zhirong HuangRegulatory Affairs LeaderGE Hangwei Medical Systems Co., Ltd.Phone: +86 10 58068888 70236Fax: +86 10 67803267Email: Zhirong.Huang@ge.com
Secondary Contact Person:	Mr. Glen SabinRegulatory Affairs DirectorGE Healthcare (GE Medical Systems, LLC)3200N Grandview Blvd., Mail Coil-W-827Waukesha, WI 53188, USAPhone: +1 262 521 6848Fax: +1 262 521 6439Email: Glen.sabin@ge.com
Device: Trade Name:	GE 8CH Foot Ankle Coil
Common/Usual Name:	Coil, magnetic resonance, specialty
Classification Names:	21CFR 892.1000, Magnetic resonance diagnostic device
Product Code:	90MOS
Predicate Device(s):	K050514, Foot Ankle coil (MRI Devices Corporation,which known as Invivo Corporation )
Device Description:	The GE 8CH Foot Ankle Coil is a surface coil used forMagnetic Resonance Imaging. It's tuned to image Protor

Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.

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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 have a vintage look.

GE Healthcare

510(k) Premarket Notification Submission

nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.

Summary of Non-Clinical Tests:

Verification testing has been performed and is documented in the sections noted below of this submission. The following

verification tests have been performed:

Biocompatibility Testing (section 15) 1.
IEC 60601-1-2 testing (section 17) 2.
IEC 60601-1 testing and NRTL certification to UL 3. 60601-1 (section 17)
1. IEC60601-2-33 testing (section17)
ડા Maximum B1 Peak test - This test is to verify the coil's ability to withstand maximum B1 peak fields and high B1 field energy concentrations without posing a risk to safety through arcing or voltage breakdown. (section 18)
1. Signal to Noise ratio and uniformity test according to

Intended Use:

Technology:

Determination of Substantial Equivalence:

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, creating a strong contrast against the white background.

GE Healthcare

510(k) Premarket Notification Submission

NEMA standard (section 18)

Blocking Network analysis This test determines the 7. effectiveness of the blocking networks(s) for transmit decoupling to ensure safety and to minimize B1 distortion. (section 18)
Surface temperature test normal condition (section 8. 18)
Surface temperature test unplugged condition 9. (section 18)

Summary of Clinical Tests:

Sample clinical images included in Section20 Performance Testing-clinical were performed within GE Healthcare facilities under the control of GE Global Research Study Work Instruction.

Conclusion:

GE Healthcare considers the GE 8CH Foot Ankle Coil for 1.5T MRI systems to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and conveys a sense of authority and professionalism.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

GE HANGWEI Medical Systems Co., Ltd. % Mr. Glen Sabin Regulatory Affairs Director GE Medical Systems, LLC 3200 N. Grandview Blvd. Mail Code-W-827 WAUKESHA WI 53188

Re: K122694

Trade/Device Name: GE 8CH Foot Ankle Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 15, 2012 Received: September 6, 2012

OCT 25 2012

Dear Mr. Sabin:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_ K122694

GE 8CH Foot Ankle Coil Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D'Amico

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51004 JK122694

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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.