(255 days)
Not Found
No
The description focuses on the hardware (coil design, channels, geometry) and its function in receiving MR signals for image generation. There is no mention of software algorithms, image processing, or analysis that would typically involve AI/ML.
No
The device is intended to produce diagnostic images and facilitate biopsy and localization procedures, not to treat a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in conjunction with Philips 3.0T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy." Furthermore, the "Summary of Performance Studies" mentions "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," directly linking the device's output to diagnostic purposes.
No
The device description clearly details physical hardware components (coils, patient support, tabletop compression system) and performance testing related to electrical/mechanical safety, EMC, and biological safety, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used "to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician." It also mentions facilitating biopsy and localization procedures. This describes a device used in vivo (within the living body) for imaging and interventional procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a magnetic resonance coil that receives signals from hydrogen nuclei in the breast. This further confirms its use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the dS Sentinelle Breast 16ch 3T Coil is a medical device used for in vivo diagnostic imaging and interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
breast anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 testing
- IEC 60601-2-33 Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- NEMA-MS-1,3,6,9 Image uniformity and signal-to-noise ratio testing
- IEC62464-1 International Standard: Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
- ISO 10993-1 Biological safety evaluation
- ISO 17664 Cleaning and disinfection validations to support reprocessing 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K213727
Device Name dS Sentinelle Breast 16ch 3.0T Coil
Indications for Use (Describe)
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.
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
| 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 Ave
Gainesville, FL 32608
Establishment Registration #1056069 | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Contact: | Jennifer Conyac
Regulatory Affairs Manager
Phone: 1 (352) 384-8629
E-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 Predicate
Device: | Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens
1.5T/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 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. | |
| Indications for Use: | 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. | |
| Fundamental
Scientific
Technology: | Based on the information provided above, the subject dS Sentinelle Breast
16Ch 3.0T Coils are considered substantially equivalent to the primary
currently marketed and predicate device Sentinelle Breast MRI Tabletop with
16 Channel Coil Array for Siemens 1.5T/3T MRI Systems (K112112 – cleared
August 25, 2011) in terms of fundamental design, material and scientific
technology. At a high level the dS Sentinelle Breast 16Ch 3T Coil and the
predicate 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 with
decoupling methodology | |
| Summary of Non-Clinical and Clinical
Performance Data: | 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.
The subject dS Sentinelle Breast 16Ch 3.0T Coil has undergone the following
testing in accordance with FDA-recognized consensus standards and as
recommended in FDA guidance documents Submission of Premarket
Notifications for Magnetic Resonance Diagnostic Devices, issued November 18,
2016 and Magnetic Resonance (MR) Receive-only Coil – Performance Criteria
for 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 essential
performance - Collateral standard: Usability IEC 60601-1-2 EMC Immunity, electrostatic discharge testing IEC 60601-2-33 Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for medical
diagnosis NEMA-MS-1,3,6,9 Image uniformity and signal-to-noise ratio testing IEC62464-1 International Standard: Magnetic resonance equipment
for medical imaging - Part 1: Determination of essential image quality
parameters ISO 10993-1 Biological safety evaluation ISO 17664 Cleaning and disinfection validations to support
reprocessing 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. | |
| Substantial
Equivalence
Conclusion: | 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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