Intended Use: The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system. The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for Use: The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen.

Device Description

The Picker Phased Array Flexible Cardiac Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Phased Array Flexible Cardiac Coil," seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating equivalence rather than establishing new acceptance criteria and conducting a study to prove they are met in the same way a de novo or PMA submission would.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific effect sizes, and how training ground truth was established) are not applicable to this 510(k) submission as these types of detailed studies are not typically required for a substantial equivalence determination based on device components and intended use.

Here's an analysis based on the provided information, focusing on what is available:

Acceptance Criteria and Device Performance Study for the Phased Array Flexible Cardiac Coil

This submission is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device rather than setting new, specific performance acceptance criteria and then proving the device meets them through a dedicated primary effectiveness study. The "acceptance criteria" here are implicitly satisfied by demonstrating equivalence to the predicate device across key parameters.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k), 'acceptance criteria' are primarily alignment with the predicate device's specifications and performance where direct comparison is relevant. Since no specific performance metrics like sensitivity, specificity, or accuracy are provided, the table below focuses on the comparative parameters used to demonstrate substantial equivalence to the predicate device (Picker Phased Array Flexible Body Coil, K962117).

Parameter	Acceptance 'Criteria' (Predicate Device Value)	Reported Device Performance (Phased Array Flexible Cardiac Coil)
Compatible MRI Systems	Picker International 1.5T Systems	Same. (Picker International 1.5T Systems)
Mode of Operation	Receive-Only	Same. (Receive-Only)
Antenna Configuration	Co-rotating saddle coils and loops	Two anterior loops and two posterior loops. (This is the only parameter where there is a stated difference, implying it's acceptable for the intended use.)
Tuning/Impedance Matching	Fixed tuning and matching. Factory set.	Same. (Fixed tuning and matching. Factory set.)
Method of Decoupling	Active PIN diode decoupling	Same. (Active PIN diode decoupling)
Coil Enclosure	Flame rated foam and fabric	Same. (Flame rated foam and fabric)
Number of Receive Channels	Four	Same. (Four)
Intended Use	The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, T1, T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.	Same. (The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T Edge Eclipse system, which has the same general intended use as described for the predicate.)
Indications for Use	Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures. Nuclei Excited: Hydrogen.	Anatomic Regions: Heart and associated structures in the thoracic region. Nuclei Excited: Hydrogen. (The anatomic region is different but specified for cardiac use, matching the device name and intended clinical application, and is considered substantially equivalent to a body coil for different regions.)

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

Not Applicable. This 510(k) submission does not describe a clinical study with a test set in the traditional sense for evaluating device performance against pre-defined metrics. Substantial equivalence is demonstrated through comparison of technical characteristics and intended use to an already cleared device.

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 explicit ground truth establishment or expert review for a test set is documented in this 510(k) summary. The comparison is based on technical specifications and intended use.

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

Not Applicable. No test set or adjudication method 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 is a hardware component (MRI coil), not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

Not Applicable. This is a hardware component (MRI coil), not a software algorithm.

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

Not Applicable. No clinical ground truth is established for this submission. The "ground truth" for substantial equivalence is the technical specifications and intended use of the legally marketed predicate device.

8. The sample size for the training set

Not Applicable. This is a hardware component; there is no "training set" in the context of machine learning or algorithm development.

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

Not Applicable. As there is no training set, this is not applicable.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

K98 4588

General Information 1.

Classification:	Class IIMagnetic Resonance Imaging (MRI) Accessory
Common/Usual Name:	Magnetic Resonance Imaging (MRI) Coil
Proprietary Name:	Phased Array Flexible Cardiac Coil
Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards:	Not Applicable.

2. Intended Uses

The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T Edge Eclipse system.

The 1.5T Edge Eclipse system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Heart and associated structures in the thoracic region. Anatomic Regions:

Nuclei Excited: Hydrogen.

【 - 【 12/23/98 PICKER INTERNATIONAL, INC. (CARDIAC)

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Device Description 3.

Safety and Effectiveness 4.

The Picker Phased Array Cardiac Coil is substantially equivalent to the Picker Phased Array Flexible Body Coil (K962117) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.

Parameter	Phased Array FlexibleCardiac Coil	Predicate Device: Phased ArrayFlexible Body Coil (K962117)
Compatible MRISystems	Same.	Picker International 1.5T Systems
Mode of Operation	Same.	Receive-Only
Antenna Configuration	Two anterior loops andtwo posterior loops.	Co-rotating saddle coils and loops
Tuning/ImpedanceMatching	Same.	Fixed tuning and matching. Factoryset.
Method of Decoupling	Same.	Active PIN diode decoupling
Coil Enclosure	Same.	Flame rated foam and fabric
Number of ReceiveChannels	Same.	Four
Intended Use	Same.	The 1.5T EDGE system is intendedfor use as a NMR device thatproduces images that: (1) correspondto the distribution of protonsexhibiting NMR, (2) depend uponNMR parameters (proton density,flow velocity, spin-lattice relaxationtime T1, spin-spin relaxation time T2)and (3) display the soft tissuestructure of the head and whole body.When interpreted by a trainedphysician, these images yieldinformation that can be useful in thedetermination of a diagnosis.

PICKER INTERNATIONAL, INC.

(CARDIAC)

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Parameter	Phased Array FlexibleCardiac Coil	Predicate Device: Phased ArrayFlexible Body Coil (K962117)
Indications for Use	The Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:	The Flexible Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:
	Anatomic Regions: Heart and associated structures in the thoracic region.	Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures.
	Nuclei Excited: Hydrogen	Nuclei Excited: Hydrogen.

・

(CARDIAC)

I - 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 FEB

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re:

K984588 Phased Array Flexible Cardiac Coil Dated: December 23, 1998 Received: December 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Dr. Keeler:

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 II (Special Controls) or 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,

R. I. R. U.S.I. M.P.

Capt. Daniel G. Schultz. M.D. Acting 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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Page 1 of 1

510(k) Number (if known):

Phased Array Flexible Cardiac Coil Device Name:

Indications for Use:

Intended Use

The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system.

The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for Use

The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Heart and associated structures in the thoracic region.

Nuclei Excited: Hydrogen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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.