The 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited is hydrogen.

Device Description

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

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for a medical device: "8 Channel Cardiac Phased Array Coil." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a study with detailed performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be present in this document as it pertains to a different type of regulatory submission (e.g., PMA, or specific performance testing for novel devices).

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or specific performance metrics as it's a 510(k) submission. A 510(k) aims to demonstrate substantial equivalence to an existing predicate device rather than meeting predefined, numerical performance criteria. The device is considered to have comparable indications for use, safety, and effectiveness to its predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a "test set" in the context of performance evaluation with a defined sample size for a study. This is a regulatory submission for device clearance based on equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is described.

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 device is a hardware component (an MRI coil), not an AI-powered diagnostic tool. Therefore, MRMC studies comparing human readers with and without AI assistance are irrelevant and not described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an MRI coil, a hardware component for imaging, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth, in the context of diagnostic performance, is not discussed for this device. The evaluation is based on demonstrating equivalence in terms of safety and technical specifications for an MRI coil.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an algorithm being developed.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary of the Study/Submission:

This document is a 510(k) Premarket Notification for the 8 Channel Cardiac Phased Array Coil. The "study" described is a regulatory comparison against predicate devices to demonstrate substantial equivalence.

Device Description: The 8 Channel Cardiac Phased Array Coil is a receive-only RF coil for Magnetic Resonance Imaging (MRI), tuned to image Proton nuclei. It consists of individual phased array coil elements with integrated preamplifiers to improve image quality, and its geometry is optimized for parallel imaging techniques.
Intended Use: For use with 1.5T MRI systems manufactured by GE Healthcare to image the heart, mediastinum, and pelvis regions for 2D and 3D MRI, exciting hydrogen nuclei.
Predicate Devices:
1. K032045, 8 Channel Cardiac Phased Array Coil
2. K052584, 1.5T 12 Channel Body Array
Basis for Substantial Equivalence:
- The 8 Channel Cardiac Phased Array Coil is essentially the same device as the predicate K032045, with no modifications to accommodate new anatomical regions (the initial submission for K032045 likely covered only cardiac, and this submission seeks to expand to mediastinum and pelvis).
- Comparison with the 1.5T 12 Channel Body Array Coil (K052584) establishes that the 8 Channel Cardiac Phased Array Coil (an existing device) will now have similar indications for use, particularly for the mediastinum and pelvis, as are covered by the body array coil.
Conclusion: GE Healthcare considers the 8 Channel Cardiac Phased Array Coil to be as safe, as effective, and its performance substantially equivalent to the predicate devices. The FDA confirmed this finding of substantial equivalence.

In essence, the "study" is a regulatory review illustrating that a specific MRI coil is technologically and functionally equivalent to previously cleared devices for imaging the specified anatomical regions, thus not requiring new, extensive clinical performance studies.

Summary

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KIDI492

510(k) Premarket Notification Submission

JUN 2:3 2010

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	April 6, 2010
Submitter:	GE Healthcare Coils (USA Instruments, Inc.)1515 Danner Dr.Aurora, OH 44202
Primary Contact Person:	Mr. Michael S. PretoRegulatory Affairs Leader, MRGE Healthcare Coils (USA Instruments, Inc.)+1 330 995-8333+1 330 562-1422
Secondary Contact Person:	Mr. Glen SabinRegulatory Affairs Director, MRGE Healthcare (GE Medical Systems, LLC)Establishment Registration Number: 21835533200 N Grandview Blvd., Mail Code - W-827Waukesha, WI 53188, USAPhone: 262-521-6848Fax: 262-521-6439
Device: Trade Name:	8 Channel Cardiac Phased Array Coil
Common/Usual Name:	Coil, magnetic resonance, specialty
Classification Names:	21 CFR 892.1000, Magnetic resonance diagnostic device
Product Code:	90MOS
Predicate Device(s):	(1) K032045, 8 Channel Cardiac Phased Array Coil(2) K052584, 1.5T 12 Channel Body Array
Device Description:	The 8 Channel Cardiac Phased Array Coil is a surface coil usedfor Magnetic Resonance Imaging. It is tuned to image Protonnuclei in a receive-only configuration. It is comprised ofindividual Phased Array coil elements each utilizing an integratedpreamplifier to improve image quality. The geometry isoptimized for use with parallel imaging techniques.
Intended Use:	The 8 Channel Cardiac Phased Array Coil is a receive-only RFCoil designed for use with 1.5T MRI systems manufactured byGE Healthcare. The indications for use include imaging of theheart, mediastinum, and pelvis regions for 2D and 3D MagneticResonance imaging. The nucleus excited is hydrogen.

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K101492
page 2/2

GE Healthcare 510(k) Premarket Notification Submission

The 8 Channel Cardiac Phased Array Coil has not been modified Technology: to accommodate the new anatomical region.

Determination of Substantial Equivalence:

The 8 Channel Cardiac Phased Array Coil has comparable indications for use as its predicate devices:

Comparison with original & Channel Cardiac Phased Array Coil submission (K32045):

The 8 Channel Cardiac Phased Array Coil has not been modified to accommodate the new anatomical region.

Comparison with 1.5T 12 Channel Body Array Coil (K052584):

The 8 Channel Cardiac Phased Array Coil is an existing device which will now have indications for use that are similar to the existing 1.5T 12 Channel Body Array Coil.

GE Healthcare considers the 8 Channel Cardiac Phased Array Conclusion: Coil to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes extending from its back, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Roon1 - WO66-G609 Silver Spring, MD 20993-0002

JUN 2 3 2010

GE Healthcare Coils (USA Instruments, Inc.) % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K101492

Trade/Device Name: 8 Channel Cardiac Phased Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 28, 2010 Received: June 1, 2010

Dear Mr. Lehtonen:

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,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

8 Channel Cardiac Phased Array Coil

Indications for Use:

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert H. Baker
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K10/4/92

Page 1 of _

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.