The 3.0T HD Breast Array is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.

Device Description

The 3.0T HD Breast Array is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The 3.0T HD Breast Array is designed to offer optimized imaging capabilities and maximum lateral and medial access to each breast for biopsy procedures.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "3.0T HD Breast Array." This device is a receive-only RF coil for MRI, intended for obtaining MR images of the breast and axillary tissue. The submission aims to demonstrate substantial equivalence to a previously cleared device (1.5T Liberty 9000 8-channel Breast coil).

It is important to note that a 510(k) submission for a device like an MRI coil typically focuses on physical and electrical performance rather than diagnostic accuracy as a standalone algorithm would. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted in the context of a medical device hardware submission, not an AI/algorithm submission. Many of the requested fields are specifically related to AI/algorithm performance studies and will likely be "Not applicable" or "Not provided" for this type of device submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria." However, specific acceptance criteria and reported device performance metrics are not detailed in the provided text. The overall "performance" claimed is substantial equivalence to the predicate device.

Acceptance Criteria Category	Specific Criteria (Not detailed in submission)	Reported Device Performance (Not detailed in submission)
Electrical Performance	Expected criteria for an RF coil (e.g., Signal-to-Noise Ratio (SNR), homogeneity, impedance matching, RF safety).	The submission implies that these criteria were met to demonstrate substantial equivalence to the predicate device.
Mechanical Performance	Expected criteria for device durability, patient positioning, biopsy access, etc.	The submission implies that these criteria were met to demonstrate substantial equivalence to the predicate device.
Safety	Expected criteria for electrical safety, heating, biocompatibility (if applicable to patient contact surfaces).	The submission states: "Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards."
Compatibility	Compatibility with the 3.0T Signa Excite MRI scanner.	The device is "designed for use with the 3.0T Signa Excite MRI scanner."

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

This information is Not Applicable / Not Provided in the context of an MRI coil hardware submission. There isn't an "algorithm" being tested with a dataset of medical images. The testing would be on the physical device itself.

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

This information is Not Applicable / Not Provided. Ground truth, in the sense of expert annotation of medical images, is not relevant for the performance testing of an MRI coil.

4. Adjudication Method for the Test Set

This information is Not Applicable / Not Provided. Adjudication methods are used for resolving disagreements among experts annotating medical data; this is not relevant for an MRI coil hardware test.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done/not described for this device. Such studies are typically for evaluating the diagnostic performance of software or imaging modalities, often with human readers involved. This submission is for an MRI coil.

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

This information is Not Applicable / Not Provided. This is an MRI coil, not an algorithm.

7. The Type of Ground Truth Used

This information is Not Applicable / Not Provided. Ground truth, in the sense of pathology, expert consensus, or outcomes data, is not relevant for the performance testing of an MRI coil. The "ground truth" for this device's performance would be engineering specifications and safety standards.

8. The Sample Size for the Training Set

This information is Not Applicable / Not Provided. There is no "training set" in the context of an MRI coil hardware submission.

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

This information is Not Applicable / Not Provided. There is no "training set" or corresponding ground truth for this type of device.

Summary of the Study Proving Substantial Equivalence (as described in the text):

The provided text states: "Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria." The study's objective was to demonstrate substantial equivalence to the predicate device, the "1.5T Liberty 9000 8-channel Breast coil (K041695)." The main difference being the coil was "retuned for operation in a 3.0T magnetic field instead of a 1.5T field strength."

The conclusion drawn from this testing was: "It is the opinion of USA Instruments that the 3.0T HD Breast Array is substantially equivalent to the USA Instruments 1.5T Liberty 9000 8 channel Breast Array (K041695). Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards."

While the specifics of the tests performed (e.g., SNR measurements, SAR testing, mechanical durability tests) are not detailed in the provided summary, the FDA's clearance letter indicates that they found the device substantially equivalent. The "acceptance criteria" would have been a set of engineering and safety specifications that the 3.0T HD Breast Array needed to meet, demonstrating that its performance and safety profile were comparable to the predicate device, given the change in magnetic field strength.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

1. Device Name:	Magnetic Resonance Imaging Accessory
2. Proprietary Name:	3.0T HD Breast Array
3. Classification:	Class II
4. Establishment Registration #:	1529041
5. Manufacture Facility Location:	USA Instruments, Inc.1515 Danner Drive,Aurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422.
6. Performance Standard:	No applicable performance standards have been issued underSection 514 of the Food, Drug and Cosmetic Act.
7. Intended Use:	The 3.0T HD Breast Array is a receive-only RF coil, used forobtaining MR images of the breast and axillary tissue. The biopsyplates allow access to the breast anatomy during biopsyprocedures. No biopsy needles are included with, or packagedwith the 3.0T HD Breast Array. The indications for use are thesame as for standard MR Imaging. The 3.0T HD Breast Array isdesigned for use with the 3.0T Signa Excite MRI scanner,manufactured by General Electric Healthcare.
8. Device Description:	The 3.0T HD Breast Array is a phased array, receive-only MRIcoil. The coil consists of a main supporting base with a coilchamber in the middle section. A sternum bridge and two lateralwings divide the chamber into two segments, one to receive eachbreast. Each of the hollow coil segments houses four coil elementsthat are insulated from the patient by a rigid plastic housing. Thecoil housing is made of plastic materials, which are fire rated andhave high impact and tensile strength. The 3.0T HD Breast Arrayis designed to offer optimized imaging capabilities and maximumlateral and medial access to each breast for biopsy procedures.
9. Marketed Device:10. Comparison with Predicate:	3.0T HD Breast ArrayThe 3.0T HD Breast Array is a modification of the existing cleared1.5T Liberty 9000 8-channel Breast coil (K041695), with the maindifference being the coil has been retuned for operation in a 3.0Tmagnetic field instead of a 1.5T field strength
11. Summary of Studies:	Testing was performed to demonstrate that the designmodifications to the 3.0T HD Breast Array meet predeterminedacceptance criteria.

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Conclusion:

It is the opinion of USA Instruments that the 3.0T HD Breast Array is substantially equivalent to the USA Instruments 1.5T Liberty 9000 8 channel Breast Array (K041695). Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing protection and service. The eagle is a prominent symbol of the United States.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Brown Manager, Quality Assurance/ Regulatory Affairs USA Instruments 1515 Danner Drive AURORA OH 44202

Re: K052585

OCT 4 - 2005

Trade/Device Name: 3,OT HD Breast Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 16, 2005 Received: September 20, 2005

Dear Mr. Brown:

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 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premanted notificate 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), please If you desire specific at ne of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 601:57). I Camay Coums Sturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INTENDED USE

K052585 510(k) Number (if known): ___

Device Name: 3.0T HD Breast Array

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801-109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

David R. Ingram

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.