CARDIAC PHASED ARRAY COIL by GE MEDICAL SYSTEMS

Here's an analysis of the provided documents regarding the GE Medical Systems Cardiac Phased Array Coil, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document K971667 is a 510(k) summary for a medical device cleared in 1997. It is important to note that the level of detail regarding performance studies and acceptance criteria in 510(k) summaries from that era is significantly less comprehensive than what is typically expected for modern AI/ML device submissions. Therefore, many of the specific details requested in your prompt (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications for AI studies, MRMC studies, standalone performance) are not present in this document, as they are not applicable to the type of device (a medical coil) or the regulatory standards of that time.

Acceptance Criteria and Reported Device Performance

The Cardiac Phased Array Coil is a receive-only coil intended for use in MRI of the heart and mediastinum. Its substantial equivalence to predicate devices is based on similar construction, circuitry, and adherence to established performance standards for such equipment.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Comments
Safety Standard	IEC 601-1	Evaluated to IEC 601-1 standard	This is a general international electrical safety standard for medical equipment. Specific metrics are not detailed in the summary.
Performance Standard	NEMA performance standard MS#6 for Special Purpose Coils	Evaluated to NEMA MS#6 standard	NEMA MS#6 defines performance characteristics for MR coils. Specific metrics (e.g., SNR, uniformity) are not detailed in the summary.
Substantial Equivalence	Similar construction to predicate devices (ScanMed Cardiac/Vascular Coil, GE Pelvic Phased Array Coil)	Similar in construction. Circuitry similar to GE Pelvic Phased Array Coil.	This is the primary regulatory pathway for 510(k) clearance, asserting that the new device is as safe and effective as existing legally marketed devices.
Intended Use	For 2D and 3D imaging in the heart and mediastinum regions.	Intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.	The declared intended use aligns with the capabilities of this type of MRI coil.
New Potential Hazards	No new potential hazards identified compared to predicate devices.	The use of this Coil does not result in any new potential hazards.	This is a key finding for substantial equivalence.

Details on the Study Proving Device Meets Acceptance Criteria

Given that this is a 510(k) summary for an MRI coil from 1997, the "study" referred to is primarily the testing against established engineering and safety standards, and a comparative analysis against predicate devices. It is not a clinical trial or performance study in the sense of evaluating an AI algorithm's diagnostic accuracy.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. For an MRI coil, "testing" would involve physical and electrical measurements of the coil's performance. The specific number of coils tested or the "sample size" of signal acquisitions performed during testing are not detailed but would be standard engineering validation activities.
- Data Provenance: Not applicable in the context of AI/ML. The device itself is hardware. Testing would be performed in a controlled laboratory or clinical environment. Information on country of origin or retrospective/prospective nature is not provided, and not relevant for this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI, refers to medically confirmed diagnoses or annotations. For an MRI coil, "ground truth" would relate to accurate physical measurements and adherence to engineering specifications, typically established by engineers and technicians.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation studies. This is not relevant for an MRI coil.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is designed to assess the impact of a new diagnostic tool (often software or an AI algorithm) on human reader performance. This device is an MRI coil, a hardware component, not a diagnostic software tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is also highly relevant for AI algorithms. The Cardiac Phased Array Coil does not have "standalone" performance in the AI sense, as it is a component of an MRI system. Its performance is measured by its electrical characteristics and image quality contribution when integrated into the MRI system.
The type of ground truth used:
- For this device, "ground truth" would refer to engineering specifications, electrical measurement standards, and safety standards. For example, the "ground truth" for SNR would be a defined measurement protocol and a target value based on NEMA MS#6. The "ground truth" for electrical safety would be adherence to the limits set by IEC 601-1. This is not pathology, outcomes data, or expert consensus in the diagnostic sense.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.

Summary Specific to K971667:

The provided document indicates that the GE Medical Systems Cardiac Phased Array Coil was evaluated against the NEMA performance standard MS#6 for Special Purpose Coils and the IEC 601-1 International medical equipment safety standard. The "study" consisted of these evaluations and a comparison to predicate devices (ScanMed Cardiac/Vascular Coil and GE Pelvic Phased Array Coil) to establish substantial equivalence. The document explicitly states: "The Coil is comparable to the predicate devices." No clinical performance data, AI algorithm evaluations, or specific numerical performance metrics are provided in this summary, as these were not typically required or relevant for MRI coil 510(k) submissions in 1997. The acceptance criteria were met by demonstrating adherence to these established hardware performance and safety standards, and by showing equivalence to already marketed devices.

Summary

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K971667

GE Medical Systems

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

July 23, 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in o accordance with the requirements of 21 CFR Part 807.87(h).
o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, April 29, 1997
o Identification of the Product Cardiac Phased Array Coil

Manufacturer Address:

GE Medical Systems 3200 N. Grandview Blvd. Waukesha, Wi 53188

o Marketed Device The Cardiac Phased Array Coil is substantially equivalent to the currently marketed ScanMed Cardiac/Vascular Coil and the GE Pelvic Phased Array Coil.
0 Device Description The Cardlac Phased Array Coil is a receive only coil with two separate coils matched with a front and a back (anterior and posterior) section.
0 Indications for Use It is intended to be used in the heart and mediastinum regions for 2D and 3D imaging.
o Comparison with Predicate

The Cardiac Phased Array Coll is similar in construction to the both predicate devices. The circuitry on the Cardiac Phased Array Coil is similar to the circuitry of the GE Pelvic Phased Array Coil.

o Summary of Studies
The Cardiac Phased Array Coil was evaluated to NEMA performance standard MS#6 for Special Purpose Coils as well as the IEC 601-1 International medical equipment safety standard. The Coil is comparable to the predicate devices.
0 Conclusions
It is the opinion of GE that the Cardiac Phased Array Coil is substantially equivalent to the ScanMed CardiacVascular Coll and the GE Pelvic Phased Array Coil. The use of this Coil does not result in any new potential hazards.

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Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 1997

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

Re: K971667

Cardiac Phased Array Surface Coil Dated: April 29, 1997 Received: May 6, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

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 practice, labeling, and prohibitions sgainst 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 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 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 market 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 yim 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/dsmamain html".

Sincerely yours,

h. Niau 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): _ K 97 1467

Device Name: Cardiac Phased Array Coil

Indications For Use:

ﺎ ﺍﻟﻤﺠﺎ

It is intended to be used in the heart and mediastinum regions for 2D and 3D .. . . . . . . Magnetic Resonance imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Grayson

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number

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.