(252 days)
The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T 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.
The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a 70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The dS Sentinelle Breast 16ch 1.5T Coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 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). 3. 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 1.5T 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 dS Sentinelle Breast 16ch 1.5T 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 16ch 1.5T 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.
The provided document is a 510(k) Pre-market Notification for the dS Sentinelle Breast 16ch 1.5T Coil, a medical device used with MRI scanners. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's diagnostic performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/CADe device are not applicable or not present in this regulatory submission.
However, I can extract and infer some information related to the device's performance assessment and acceptance as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device meets safety and effectiveness requirements as outlined in FDA guidance: Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020. This guidance would contain specific performance criteria, but the document provided does not list them explicitly or provide a detailed table comparing them to the device's reported performance. Instead, it generally states that the criteria were met.
The performance testing mentioned includes:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Safety and Electrical/Mechanical | Met IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-33 | These are international standards for electrical, mechanical, usability, and specific safety requirements for medical electrical equipment, particularly MR equipment. The document states these were met. |
| Image Quality (Non-Clinical) | Met NEMA-MS-1,3,6,9 (Image uniformity and signal-to-noise ratio testing), IEC62464-1 (Determination of essential image quality parameters) | These are standards and guidelines for assessing various image quality parameters of MR equipment. The document states these were met. |
| Biocompatibility | Met ISO 10993-1 (Biological safety evaluation) | This is a standard for biological evaluation of medical devices. The document states this was met. |
| Reprocessing | Met ISO 17664 (Cleaning and disinfection validations to support reprocessing instructions) | This is a standard for processing of health care products. The document states this was met. |
| Diagnostic Image Quality (Clinical) | Acquired image quality assessed by a U.S. Board Certified radiologist to confirm images are sufficient quality for diagnostic use. | This is a qualitative assessment of the images produced by the coil, confirming their suitability for interpretation by a trained physician. No specific quantitative metrics like sensitivity or specificity are provided as this is a coil, not a diagnostic algorithm. |
2. Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in the context of an AI/CADe evaluation. For the "Performance Testing – Clinical" section, it only mentions that acquired image quality was assessed. It doesn't specify the number of patients/cases used for this assessment, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically not included in a 510(k) for a basic hardware component like an MRI coil.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "Performance Testing – Clinical" section, it states: "Acquired Image quality was assessed by a U.S. Board Certified radiologist...". It indicates one expert (a U.S. Board Certified radiologist), but does not specify their years of experience or if more than one assessed the images. There is no "ground truth" to be established in the context of a diagnostic outcome for a coil itself, as the coil simply produces images. The expert's role was to confirm the diagnostic usability of the images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as there isn't a "test set" and ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment described is a qualitative review of image quality by a single radiologist.
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 device is an MRI coil, a hardware component that produces images, not an AI or CADe device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an MRI coil and does not perform any diagnostic algorithm in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of a diagnostic algorithm's performance. The "ground truth" for this device's performance is whether the images it produces are of sufficient quality for diagnostic use, which was determined by a radiologist's assessment. There is no disease outcome or pathology as a "ground truth" for the coil itself.
8. The sample size for the training set:
Not applicable. This device is an MRI coil, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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August 8, 2022
Invivo Corporation (Business Trade Name: Philips) % Jennifer Conyac Regulatory Affairs Manager 3545 SW 47th Avenue GAINSVILLE FL 32608
Re: K213735
Trade/Device Name: dS Sentinelle Breast 16ch 1.5T 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) K213735
Device Name dS Sentinelle Breast 16ch 1.5T Coil
Indications for Use (Describe)
The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T 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.
| 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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4) 510(k) Summary
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 26, 2021 | |
| Name of Device: | dS Sentinelle Breast 16ch 1.5T 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 – Aug 25, 2011) | |
| Device Description: | The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in amagnetic strength (1.5T) to correspond with the scanner strength.The dS Sentinelle Breast 16ch 1.5T 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 dSSentinelle Medial 8Ch coil.2. 10Ch for bilateral interventional procedures requiring lateralaccess: performed in 10Ch configuration that consists of the dSSentinelle Medical 8ch coil and two dS Sentinelle Lateral 1ch coils(right and left).3. 2Ch for unilateral interventional procedures allowing both lateraland medial access: performed in 2Ch configuration that consistsof 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 fieldapplied 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 1.5T Coil is tuned to receive RF frequencycorresponding to the proton precession in a 1.5 tesla magnetic field, which isgoverned by the Larmor equation. | ||
| The Variable Coil Geometry design of the dS Sentinelle Breast 16ch 1.5T 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 16ch 1.5T Coil system also includes atabletop compression system which facilitates immobilization of the breastfor imaging and interventional procedures and serves to hold the individualimaging coils in proximity to the breast(s). The intent of this is to reducemotion artifacts and ensure the imaging elements are positioned as close tothe breast(s) as possible to optimize signal-to-noise ratio and image quality. | ||
| Indications for Use: | The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunctionwith Philips 1.5T 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 breastanatomy for biopsy and localization procedures. | |
| FundamentalScientificTechnology: | Based on the information provided above, the subject dS Sentinelle Breast16ch 1.5T Coil is considered substantially equivalent to the primary currentlymarketed and predicate device Sentinelle Breast MRI Tabletop with 16Channel Coil Array for Siemens 1.5T/3T MRI Systems (K112112 – Aug 25,2011) in terms of fundamental design, material and scientific technology. At ahigh level the dS Sentinelle Breast 16ch 1.5T Coil and the predicate coil arebased on the following equivalent elements:The same indications for usePrescription Use OnlyAnatomy of interest is the breastSame magnetic field strengths (1.5T)2/10/16-Channel configurations, receive only phased-array coil withdecoupling methodology |
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PHILIPS
| 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 configurations Energy source from the MR scanner Design features to support access to the breast anatomy for interventional biopsy procedures |
|---|
| The following technological differences exist between the subject and predicate device: Compatible with different MR Scanners (Philips vs. Siemens); different cable/ connector and geometry for Philips' MR scanner tabletop The exterior housing of the subject coil is of materials that were modified for Philips Branding purposes The biopsy grid plate of the subject coil is provided clean, single-use but non-sterile |
| Clinical and non-clinical testing demonstrates that the safety and effectiveness requirements as outlined in FDA guidance 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. |
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| Summary of Non-Clinical and ClinicalPerformance Data: | The subject dS Sentinelle Breast 16ch 1.5T 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 |
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| 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 16ch 1.5T 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. |
§ 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.