The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T Magnetic Resonance Scanners 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.

Device Description

The dS Sentinelle Breast 16 Ch 3.0T MR Coils is a receive only coil to be used on a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designed to correspond with the scanner strength.

The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels):

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

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.

The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils.

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

The dS Sentinelle Breast 16Ch 3T Coil is tuned to receive RF frequency corresponding to the proton precession in a 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.

The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T Coil allows each imaging element to be independently positioned and configured for each patient. 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 dS Sentinelle Breast Coil system 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.

AI/ML Overview

Based on the provided text, the device in question is the dS Sentinelle Breast 16ch 3.0T Coil, which is a receive-only MR coil. The acceptance criteria and the study proving the device meets them are described in the "Summary of Non-Clinical and Clinical Performance Data" section.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document references "FDA guidance Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" for the acceptance criteria. While the specific numerical thresholds for these criteria are not explicitly detailed in the provided text, the document states that these requirements were met. It lists the types of performance tests conducted.

Acceptance Criteria (Criteria from FDA Guidance: Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway)	Reported Device Performance
Non-Clinical Performance Criteria:
Basic Safety (IEC 60601-1)	Met
Usability (IEC 60601-1-6)	Met
EMC Immunity, electrostatic discharge (IEC 60601-1-2)	Met
Basic Safety and essential performance of MR equipment (IEC 60601-2-33)	Met
Image uniformity and signal-to-noise ratio (NEMA-MS-1,3,6,9)	Met
Determination of essential image quality parameters (IEC62464-1)	Met
Biological safety (ISO 10993-1)	Met
Cleaning and disinfection validations (ISO 17664)	Met
Clinical Performance Criteria:
Sufficient image quality for diagnostic use by a trained physician	Met (confirmed by a U.S. Board Certified radiologist)

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

Test Set Sample Size: The document does not specify a numerical sample size for the clinical performance testing.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that images were "Acquired." Given the context of FDA clearance for a medical device, it's generally expected to be prospective data collected for regulatory submission, but this is not explicitly stated.

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

Number of Experts: The document states "a U.S. Board Certified radiologist." This implies only one expert was used for the clinical image quality assessment.
Qualifications of Experts: The expert was a "U.S. Board Certified radiologist." No information about their years of experience is provided.

4. Adjudication Method for the Test Set

Adjudication Method: There was no explicit adjudication method described. With only one radiologist assessing image quality, there's no need for an adjudication process.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported or conducted. The clinical performance testing focused on assessing image quality by a single radiologist, not on comparing reader performance with or without AI assistance. The device is an MRI coil, not an AI software.

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

This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil), not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product. The testing focused on the image quality produced by the coil.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical performance assessment was the subjective interpretation of "sufficient quality for diagnostic use" by a U.S. Board Certified radiologist. This is expert consensus (albeit from a single expert). It is not based on pathology, outcomes data, or a complex consensus process.

8. The Sample Size for the Training Set

This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil). Hardware devices typically do not have "training sets" in the context of machine learning or AI models. Their performance is validated through engineering tests and clinical image quality assessment.

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

This question is not applicable for the same reason as point 8.

Summary

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August 8, 2022

Invivo Corporation (Business Trade Name: Philips) % Jennifer Conyac Regulatory Affairs Specialist 3545 SW 47th Avenue GAINESVILLE FL 32608

Re: K213727

Trade/Device Name: dS Sentinelle Breast 16ch 3.0T Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: July 1, 2022 Received: July 5, 2022

Dear Jennifer Conyac:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

for

Michael D. O'Hara, Ph.D. Deputy 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

510(k) Number (if known) K213727

Device Name dS Sentinelle Breast 16ch 3.0T 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

K213727

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

510(k) Owner:	Invivo Corporation(Business Trade Name: Philips)3545 SW 47th AveGainesville, FL 32608Establishment Registration #1056069
Contact:	Jennifer ConyacRegulatory Affairs ManagerPhone: 1 (352) 384-8629E-mail: jennifer.bonacci@philips.com
Preparation Date:	November 23, 2021
Name of Device:	dS Sentinelle Breast 16Ch 3.0T Coil
Classification:	Classification Name:	Coil, Magnetic Resonance, Specialty
	Classification Regulation:	21 CFR 892.1000
	Classification Panel:	Radiology
	Device Class:	Class II
	Product code:	MOS
Primary PredicateDevice:	Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens1.5T/3T MRI Systems (K112112 - cleared August 25, 2011)
Device Description:	The dS Sentinelle Breast 16 Ch 3.0T MR Coils is a receive only coil to be usedon a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designedto correspond with the scanner strength.The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting ofpatient support with three different coil configurations (2, 10 or 16 channels):1. 16Ch for diagnostic imaging: performed in 16Ch configuration thatconsists of two dS Sentinelle Lateral 4Ch coils and the dS SentinelleMedial 8Ch coil.2. 10Ch for bilateral interventional procedures requiring lateral access:performed in 10Ch configuration that consists of the dS SentinelleMedical 8Ch coil and two dS Sentinelle Lateral 1Ch coils (right andleft).3. 2Ch for unilateral interventional procedures allowing both lateraland medial access: performed in 2Ch configuration that consists oftwo dS Sentinelle Lateral 1Ch coils (right and left).
	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.
	The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Chright and left lateral biopsy coils.
	Images are typically generated as axial, sagittal, coronal and oblique slices andinclude full coverage of the breast anatomy.
	The dS Sentinelle Breast 16Ch 3T Coil is tuned to receive RF frequencycorresponding to the proton precession in a 3.0 tesla magnetic field(respectively), which is governed by the Larmor equation.
	The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T Coilallows each imaging element to be independently positioned and configuredfor each patient. Patients can then be positioned quickly and effectively as theimaging elements can be positioned as close to the breast as possibleoptimizing the signal-to-noise ratio for each individual patient. For clinicalimaging, coil housings are placed next to the tissue to help minimize motionartifacts due to patient motion during scanning.
	The subject dS Sentinelle Breast Coil system also includes a tabletopcompression system which facilitates immobilization of the breast for imagingand interventional procedures and serves to hold the individual imaging coilsin proximity to the breast(s). The intent of this is to reduce motion artifactsand ensure the imaging elements are positioned as close to the breast(s) aspossible to optimize signal-to-noise ratio and image quality.
Indications for Use:	The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunctionwith Philips 3.0T Magnetic Resonance Scanners to produce diagnostic imagesof the breast anatomy that can be interpreted by a trained physician. Whenused with a disposable biopsy grid, the device permits access to breast
	anatomy for biopsy and localization procedures.
FundamentalScientificTechnology:	Based on the information provided above, the subject dS Sentinelle Breast16Ch 3.0T Coils are considered substantially equivalent to the primarycurrently marketed and predicate device Sentinelle Breast MRI Tabletop with16 Channel Coil Array for Siemens 1.5T/3T MRI Systems (K112112 – clearedAugust 25, 2011) in terms of fundamental design, material and scientifictechnology. At a high level the dS Sentinelle Breast 16Ch 3T Coil and thepredicate coil are based on the following equivalent elements:The same Indications for Use Prescription Use Only Anatomy of interest is the breast Same magnetic field strength (3.0T) 2/10/16-Channel configurations, receive only phased-array coil withdecoupling methodology
Summary of Non-Clinical and ClinicalPerformance Data:	Rigid housing design that allows each imaging element to beindependently positioned and configured for each patient Compression plates supported by the device are used to immobilizethe breast tissue Patient support to allow for three different imaging configurations Energy source from the MR scanner Design features to support access to the breast anatomy forinterventional biopsy procedures The following technological differences exist between the subject andpredicate device: Compatible with different MR Scanners (Philips vs. Siemens); differentcable/connector and geometry for Philips' MR scanner tabletop The exterior housing of the subject coil is of materials that were modifiedfor Philips Branding purposes The biopsy grid plate of the subject coil is provided clean, single-use butnon-sterile Clinical and non-clinical testing demonstrates that the safety andeffectiveness requirements as outlined in FDA guidance Magnetic Resonance(MR) Receive-only Coil – Performance Criteria for Safety and PerformanceBased Pathway, issued December 11, 2020 were met. No new safety orefficacy concerns are raised as a result of these differences.The subject dS Sentinelle Breast 16Ch 3.0T Coil has undergone the followingtesting in accordance with FDA-recognized consensus standards and asrecommended in FDA guidance documents Submission of PremarketNotifications for Magnetic Resonance Diagnostic Devices, issued November 18,2016 and Magnetic Resonance (MR) Receive-only Coil – Performance Criteriafor Safety and Performance Based Pathway, 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 essentialperformance - Collateral standard: Usability IEC 60601-1-2 EMC Immunity, electrostatic discharge testing IEC 60601-2-33 Particular requirements for the basic safety andessential performance of magnetic resonance equipment for medicaldiagnosis NEMA-MS-1,3,6,9 Image uniformity and signal-to-noise ratio testing IEC62464-1 International Standard: Magnetic resonance equipmentfor medical imaging - Part 1: Determination of essential image qualityparameters ISO 10993-1 Biological safety evaluation ISO 17664 Cleaning and disinfection validations to supportreprocessing instructions Performance Testing - Clinical:
	Acquired Image quality was assessed by a U.S. Board Certified radiologist to confirm images produced on the subject coils are sufficient quality for diagnostic use.
SubstantialEquivalenceConclusion:	Substantial equivalence of the dS Sentinelle Breast 16 Ch 3.0T Coil is demonstrated through the Safety and Performance Based Pathway for magnetic resonance (MR) receive-only coils.The subject device has the same 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) Receive-only Coil –Performance Criteria for Safety and Performance Based Pathway" issued on December 11, 2020.

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PHILIPS

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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.