The 16 Breast Coil for Canon 1.5T MRI Scanners are designed to provide magnetic resonance images of breast anatomy when used in conjunction with a magnetic resonance scanner. These images are interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

Device Description

The 16 Breast Coil is a receive-only coil to be used with 1.5T Orian and Fortian Canon MR scanners. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The 16 Breast Coil is a phased array design consisting of patient support with three different coil combinations (2, 10 or 16 channels). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The 16 Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the 16 Breast Coil allows each imaging element to be independently positioned and configured for each patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject 16 Breast Coil also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s).

AI/ML Overview

This looks like a 510(k) summary for a medical device, specifically an MRI breast coil. These summaries often describe equivalence to a predicate device rather than presenting detailed "acceptance criteria" and "device performance" in the way one might expect for a novel AI algorithm or a diagnostic test with specific sensitivity/specificity targets.

Based on the provided text, the device is an MRI Receive-only Coil, and its clearance is based on the Safety and Performance Based Pathway for magnetic resonance (MR) receive-only coils. This pathway emphasizes demonstrating that the device is as safe, as effective, and performs as well as or better than a predicate device by meeting criteria outlined in specific FDA guidance documents.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific quantitative acceptance criteria (e.g., SNR values, uniformity percentages) in a table format that would typically be found in a performance study for a novel diagnostic device. Instead, it states that the device demonstrated substantial equivalence by "meeting all criterion in the guidance 'Magnetic Resonance (MR) Receive-only Coil -Performance Criteria for Safety and Performance Based Pathway' issued on December 11. 2020."

The performance parameters studied are:

Acceptance Criterion (Guidance)	Reported Device Performance (Summary of results)
Non-Clinical Performance Testing:
IEC 60601-1 General electrical/mechanical safety	Met (Implied by "safety and effectiveness requirements...were met")
IEC 60601-1-6 Usability	Met (Implied by "safety and effectiveness requirements...were met")
IEC 60601-1-2 EMC - Immunity, ESD	Met (Implied by "safety and effectiveness requirements...were met")
IEC 60601-2-33 Basic safety and essential performance of MR equipment	Met (Implied by "safety and effectiveness requirements...were met")
NEMA MS 1, 3, 9 Image signal-to-noise (SNR) and Image uniformity	Met (Implied by "safety and effectiveness requirements...were met" and "images produced...are of sufficient quality")
NEMA MS 14 Surface heating	Met (Implied by "safety and effectiveness requirements...were met")
ISO 10993-1 Biological safety evaluation	Met (Implied by "safety and effectiveness requirements...were met")
ISO 17664-2 Cleaning and disinfection validations	Met (Implied by "safety and effectiveness requirements...were met")
Clinical Performance Testing:
Acquired Image quality (for diagnostic use)	Assessed by U.S. Board Certified radiologist to confirm images are of sufficient quality for diagnostic use.

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

The document mentions "Performance Testing - Clinical," where "Acquired Image quality was assessed by the U.S. Board Certified radiologist." However, it does not specify the sample size (number of patients or scans) used for this clinical assessment, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The text states: "Acquired Image quality was assessed by the U.S. Board Certified radiologist".

Number of experts: Singular - "radiologist" (implies one, though it's possible it refers to a group in singular form).
Qualifications: "U.S. Board Certified radiologist". No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical image quality assessment. It simply states the images were "assessed by the U.S. Board Certified radiologist."

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

No. The document describes a study focused on the performance of the device itself (the breast coil) to demonstrate substantial equivalence to a predicate device, not an AI algorithm assisting human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed/reported here.

6. If a Standalone (Algorithm Only) Performance Was Done

No. This device is an MRI receive-only coil, a hardware component. It is not an AI algorithm, so the concept of standalone (algorithm only) performance is not applicable. The performance described relates to image acquisition quality.

7. The Type of Ground Truth Used

For the clinical assessment of image quality, the "ground truth" was indirectly established by the expert opinion/assessment of a U.S. Board Certified radiologist confirming "images produced on the subject coil are of sufficient quality for diagnostic use." This is an expert consensus on image utility, not an objective "ground truth" diagnosis like pathology.

8. The Sample Size for the Training Set

Not applicable. This is a hardware component (MRI coil), not an AI algorithm requiring a training set.

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

Not applicable, as there is no AI algorithm training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

October 24, 2023

Philips Medical System Nederlands B.V. Shruti Sancheti Regulatory Affairs Manager Veenpluis 6 Best, Noord-Brabant 5684 PC Netherlands

Re: K233348

Trade/Device Name: 16 Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: September 29, 2023 Received: September 29, 2023

Dear Shruti Sancheti:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233348

Device Name

16 BREAST COIL

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

The 510(k) Summary was prepared in accordance with 21 CFR §807.92.

Preparation date:	September 29, 2023
510(k) Owner:	Philips Medical Systems Nederland B.V.Veenpluis 65684 PC BestThe NetherlandsEstablishment Registration # 3003768277
Contact person:	Shruti SanchetiRegulatory Affairs ManagerPhilips Medical Systems Nederland B.V.Phone: +91 9518546814
Subject Device Trade Name:	16 Breast Coil
Classification Name:	Coil, Magnetic Resonance, Specialty
Regulation Number:	21 CFR 892.1000
Review Panel:	Radiology
Device Class:	Class II
Product Code:	MOS
Predicate Device Trade Name:	dS Sentinelle Breast 16ch 1.5T Coil (K213735)
Classification Name:	Coil, Magnetic Resonance, Specialty
Regulation Number:	21 CFR 892.1000
Review Panel:	Radiology
Device Class:	Class II
Product Code:	MOS

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Device description

The 16 Breast Coil is a receive-only coil to be used with 1.5T Orian and Fortian Canon MR scanners. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength.

The 16 Breast Coil is a phased array design consisting of patient support with three different coil combinations (2, 10 or 16 channels):

1. 16Ch for diagnostic imaging: performed in 16ch combination that consists of two 4ch Lateral coils and the 8ch Medial array coil.
1. 10ch for bilateral interventional procedures requiring lateral access: performed in 10ch configuration that consists of the 8ch Medial array coil and two 1ch Loop coils (right and left).
1. 2ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2ch configuration that consists of two 1ch Loop coils (right and left) and medial pluq.

The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.

Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy.

The 16 Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

The Variable Coil Geometry design of the 16 Breast Coil allows each imaging element to be independently positioned and configured for each patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning.

The subject 16 Breast Coil also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

Indications for use

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Both the subject and predicate devices are 16 channel coils and intended to be used in conjunction with a 1.5T Magnetic Resonance Scanner(s) to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures. The indications for use of the new device falls within the intended use of the predicate device and, therefore, the two devices have the same intended use.

The minor modifications in the indications for use statement for the subject 16 Breast Coil in comparison to dS Sentinelle Breast 16ch 1.5T Coil are as below:

a) New device trade name, b) Compatibility with 1.5T Orian and Fortian Canon MR scanners.

Fundamental Scientific Technology:

Based on the information provided above, the subject 16 Breast Coil is considered substantially equivalent to the primary predicate device dS Sentinelle Breast 16ch 1.5T Coil (K213735) in terms of fundamental design, materials and scientific technology. At a high level, the 16 Breast Coil and the predicate coil are based on the following equivalent elements:

Principle of operation, ●
Prescription Use Only, .
Anatomy of interest is the breast, .
Same magnetic field strength (1.5T), .
2/10/16-Channel combinations, receive only phased-array coil with decoupling . methodology.
. Rigid housing design that allows each imaging element to be independently positioned and configured for each patient,
Compression plates supported by the device are used to immobilize the breast ● tissue.
Patient support to allow for three different imaging combinations, .
Energy source from the MR scanner. ●
Designed to support access to the breast anatomy for both diagnostic breast . imaging and interventional exams.

The following technological differences exist between the subject and predicate devices:

The subject device is compatible with 1.5T Orian and Fortian Canon MR scanners, . whereas the predicate device is compatible with the 70 cm bore Philips Ingenia 1.5T MR system; different system interface connector and geometry for Canon MR scanners' tabletop;
Different fabrics used for support pads in subject and predicate devices. .

Clinical and non-clinical testing demonstrates that the safety and effectiveness requirements as outlined in FDA quidance Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020 were met. No new safety or efficacy concerns are raised as a result of these differences.

Summary of Non- Clinical and Clinical Performance Data:

The subject 16 Breast Coil has undergone the following testing in accordance with FDArecognized consensus standards and as recommended in FDA quidance documents Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016 and Magnetic Resonance (MR) Receive-only Coil – Performance Criteria

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for Safety and Performance Based Pathwav, issued December 11, 2020:

Performance Testing - Non-Clinical:

IEC 60601-1 General electrical/mechanical safety .
. IEC 60601-1-6 General requirements for basic safety and essential performance -Collateral standard: Usability
IEC 60601-1-2 EMC - Immunity, electrostatic discharge
. IEC 60601-2-33 Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diaqnosis
. NEMA MS 1, 3, 9 Image signal-to-noise (SNR) and Image uniformity
NEMA MS 14 Surface heating
ISO 10993-1 Biological safety evaluation ●
ISO 17664-2 Cleaning and disinfection validations to support reprocessing instructions ●

Performance Testing - Clinical:

Acquired Image quality was assessed by the U.S. Board Certified radiologist to confirm images produced on the subject coil are of sufficient quality for diagnostic use.

Substantial Equivalence Conclusion:

Substantial equivalence of the 16 Breast Coil is demonstrated through the Safety and Performance Based Pathway for magnetic resonance (MR) receive-only coils.

The subject device has substantially equivalent indications for use and technological characteristics as the predicate device. Substantially equivalent performance is demonstrated by meeting all criterion in the guidance "Magnetic Resonance (MR) Receiveonly Coil -Performance Criteria for Safety and Performance Based Pathway" issued on December 11. 2020.

The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device according to 807.92(b)(3).

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.