(31 days)
The Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 1.5T/3T MRI Systems is 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 sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.
The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems is a receive-only MRI imaging coil and interventional system for breast anatomy. The system consists of a tabletop which supports the patient and imaging coils which provide a means of enabling interventional device guidance. The tabletop, like other breast coils provides an aperture to admit the breasts and provides the physician access to the breast(s). This aperture enables the guidance of interventional devices (such as biopsy needles), when performing a biopsy. The tabletop's compression system facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). Compression plates (also referred to as immobilization plates) provided with the system are held in frames, which may be positioned in the left-right and anteriorposterior directions and fixed in place to gently immobilize one or both breasts for interventional procedures. When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plate (also referred to as biopsy grid) cleared under FDA 510(k) Number: K060873. The biopsy grid contains apertures that permit the physician to access the breast for intervention, while minimizing tissue motion. When performing biopsy and/or imaging of a single breast, the system may be used with two compression plates immobilizing that breast. The contralateral breast support prevents the contralateral breast from interfering with medial-approach interventions. When imaging both breasts, a medial coil element is used between the breasts in conjunction with two lateral coils. The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The Sentinelle phased array breast coil set consists of 2, 10 or 16 RF coil elements in a phased array design. The coil elements and electronics are enclosed in a rigid housing that is resistant to fluid ingress and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems
1. Table of Acceptance Criteria and Reported Device Performance
The provided document defines acceptance criteria primarily through a comparison to a predicate device and extensive verification and validation testing, ensuring safety and performance are substantially equivalent. The acceptance criteria are implicit in the comparison to the predicate and the successful completion of a comprehensive set of tests. The reported device performance is indicated by the successful completion of these tests and a finding of substantial equivalence.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Predicate and Testing) | Reported Device Performance (from Test Conclusion) |
|---|---|---|
| Intended Use | Provides magnetic resonance images of breast anatomy when used with a Magnetic Resonance Scanner; images are interpreted by a trained physician. Permits access for biopsy/localization with sterile plate. (Matches predicate) | The system performed as intended. |
| Design & Technology | Supports patient prone, receive-only antennas, compression plates for immobilization, non-ferrous materials. (Matches predicate) | Substantially equivalent to predicate. |
| Materials | Flame retardant Polycarbonate, Acetal Resin, Polyurethane; biocompatibility evaluated. (Matches predicate) | Substantially equivalent to predicate. |
| Coil Design | 16, 10, or 2 loop phased array, receive-only. (Matches predicate) | Substantially equivalent to predicate. |
| Decoupling | Active PIN Diode switching, passive blocking. (Matches predicate) | Substantially equivalent to predicate. |
| RF Burn Prevention | Cables cannot be looped. (Matches predicate) | Substantially equivalent to predicate. |
| RF Absorption | Receive-only coil, does not transmit RF power. Power deposition limited by SAR program of MRI magnet. (Matches predicate) | Substantially equivalent to predicate. |
| Resonant Loop Formation | Decoupling isolates coil elements from RF fields during transmission. (Matches predicate) | Substantially equivalent to predicate. |
| Performance Testing | Determined according to NEMA standards for MRI Coils as applicable to phased array coils. (Matches predicate) | The system performed as intended, demonstrating safety and effectiveness. |
| Safety and Effectiveness | No new safety and effectiveness issues introduced compared to predicate. | No new safety and effectiveness issues were introduced, and the device is safe and effective as the predicate. |
| Compatibility | Compatible with Siemens 1.5T (MAGNETOM Espree) and 3T (MAGNETOM TRIO) MRI Scanners. | Tests confirm compatibility and performance with specified Siemens MRI systems. |
| Specific Performance Metrics | (Implicit in various tests like SNR Evaluation, gMap, Heating & Performance Output, Passive Detuning, Field Distortions, RF Noise, Spike Noise, Switch-Over Tx-Rx, MR Signal from Housing, Body Scout, Voltage Stability) | All conducted tests showed acceptable results, supporting the conclusion of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numeric "sample size" in terms of patient cases for clinical studies for the "test set" in the traditional sense of AI/clinical trial studies. Instead, the testing involved:
- Phantoms: Used for various technical and performance evaluations (e.g., SNR, gMap, detuning, field distortions, noise).
- Volunteers: Used for "Volunteer Imaging" tests (VAR-02350 for 1.5T, VAR-02363 for 3T).
Data Provenance:
- The tests were conducted in-house by trained testing personnel.
- The use of contrast agent was not used in obtaining the images.
- The tests were performed on the proposed device.
- The nature of the testing (phantom and volunteer imaging for technical parameters) suggests this is prospective data collection specifically for device verification.
- Country of origin is not explicitly stated for individual tests but the manufacturer is based in Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish "ground truth" for the test set in the context of diagnostic accuracy, as this is a device for image acquisition, not for diagnostic interpretation. The "ground truth" here is implied by objective physical measurements (e.g., signal-to-noise ratios, field distortions) and the observed performance of the device against engineering specifications and NEMA standards.
The phrase "These images are interpreted by a trained physician" in the Indications for Use refers to the subsequent clinical use of the images, not the validation of the device itself.
4. Adjudication Method for the Test Set
Given that the testing focuses on technical performance parameters of an MRI coil rather than diagnostic interpretation, an adjudication method for a diagnostic test set is not applicable and therefore not mentioned. The tests are objective measurements (e.g., SNR values, signal measurements, scout image quality).
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. This type of study focuses on the diagnostic performance of human readers and is not relevant for the type of device (an MRI coil) described in this submission, which is about image acquisition and quality, not interpretation assistance.
6. If a Standalone Study (i.e. algorithm only without human-in-the loop performance) was Done
The entire set of tests performed (Tables 4 and 5) can be considered a standalone study of the device's technical performance. These tests evaluate the coil directly, independent of a human interpreter's diagnostic ability. For example, "SNR Evaluation," "gMap," "Heating and Performance Output," "Passive Detuning Test," "Field Distortions Test," "RF Noise Test," etc., are all standalone performance metrics of the hardware.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is based on:
- Engineering Specifications/Standards: Performance measured against NEMA standards and internal functional requirements.
- Physical Measurements: Quantifiable data from phantoms (e.g., SNR ratios, field distortion measurements).
- Visual Assessment: For aspects like "Body Scout" images and "Volunteer Imaging," the "ground truth" is the expected image quality and appearance generated by a properly functioning MRI coil.
No pathology or outcomes data is used as the device is for imaging and intervention guidance, not for diagnosis itself.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI algorithm because the device is a hardware component (an MRI coil) and not an AI-powered diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no AI algorithm or training set discussed in the document, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Sentinelle Medical. On the left is an abstract geometric shape that looks like a stylized flower or star. To the right of the shape is the word "sentinelle" in a sans-serif font, with the word "MEDICAL" stacked below it in a smaller font size.
KII2112
AUG 25 2011
510(k) Summary 7
Refer to Appendix 5
510(k) Summary of Safety and Effectiveness for: Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems
I. Manufacturer Sentinelle Medical Inc. 555 Richmond Street West, Suite 800, Toronto, ON Canada M5V 3B1
II. Contact Person Joan Medley
Director, Regulatory and Quality Tel: (647) 258-3607 Fax: (416)
III. Product Name/Classification Name
Product Name: Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems Common Name: Sentinelle Breast Coil for Siemens MRI Systems Classification Name: Magnetic Resonance Imaging Accessory Class II as described in CFR 21 892.1075 MOS
Product Code:
IV. Date Prepared July 15, 2011
V. Device Description
The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems is a receive-only MRI imaging coil and interventional system for breast anatomy. The system consists of a tabletop which supports the patient and imaging coils which provide a means of enabling interventional device guidance.
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Image /page/1/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The word "sentinelle" is in a larger font than the word "MEDICAL", which is stacked below it.
The tabletop, like other breast coils provides an aperture to admit the breasts and provides the physician access to the breast(s). This aperture enables the guidance of interventional devices (such as biopsy needles), when performing a biopsy.
The tabletop's compression system facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s).
Compression plates (also referred to as immobilization plates) provided with the system are held in frames, which may be positioned in the left-right and anteriorposterior directions and fixed in place to gently immobilize one or both breasts for interventional procedures.
When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plate (also referred to as biopsy grid) cleared under FDA 510(k) Number: K060873. The biopsy grid contains apertures that permit the physician to access the breast for intervention, while minimizing tissue motion.
When performing biopsy and/or imaging of a single breast, the system may be used with two compression plates immobilizing that breast. The contralateral breast support prevents the contralateral breast from interfering with medial-approach interventions.
When imaging both breasts, a medial coil element is used between the breasts in conjunction with two lateral coils.
The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The function of the tabletop is substantially equivalent
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Image /page/2/Picture/0 description: The image contains the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of lines and curves, and the words are in a sans-serif font.
to predicate devices used for breast MRI imaging and intervention, including our legally marketed device [510(K) Number: K100113].
The Sentinelle phased array breast coil set consists of 2, 10 or 16 RF coil elements in a phased array design. The coil elements and electronics are enclosed in a rigid housing that is resistant to fluid ingress and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.
The Sentinelle 16Ch Coil Array for Siemens 1.5/3T MRI Systems, receive-only coil provides the following benefits:
- . an increase in the Signal-to-Noise Ratio improving image detail in the breast including axilla and chest wall regions
- a decrease in imaging acquisition time resulting from enhanced parallel . imaging capability
- . allows the user to perform advanced pulse sequences including (but not limited to) diffusion weighted imaging, diffusion tensor imaging and spectroscopy imaging
- allows for the use of IPAT squared and acceleration factors up to 4 in L-R . and 2 in S-I and A-P direction in a diagnostic imaging state
This system is compatible with:
0 Siemens 16 Channel, 1.5T MRI Scanners (Siemens MAGNETOM Espree)
- C Siemens 16 Channel, 3T MRI Scanners (Siemens MAGNETOM TRIO)
A full description of the system in form and function and the accompanying technical drawings were provided in the Traditional 510(K) cleared in April 2006 under FDA 510(k) Number: K060873 and Special 510(k) cleared in April 2010 under FDA 510(k) Number: K100113.
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Image /page/3/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of several lines that intersect to form a complex design. The word "sentinelle" is in a larger font than the word "MEDICAL", which is stacked below it.
A copy of the Operator's Guide (User Manual) which details the proposed labeling (operating instructions, cautions, warnings, and indications for use) can be found in Appendix 9.
VI. Intended Use
The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5T or 3T MRI Systems is an open, receive only breast coil designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. It is intended for routine diagnostic imaging and intervention of the breast and axillary region. When used with a biopsy grid, the device permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
*Note: The intended use of this modified device, as described in its labeling has not changed as a result of the modifications.
VII. Substantial Equivalence
The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems is substantially equivalent to our legally marketed device "Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE Signa™ 1.5/3T Systems cleared under 510(k) Number: K100113.
| Device Name: | Vanguard Breast MRI Auxiliary Table with8/16 Channel Coil Array for GE 1.5/3T MRISystems |
|---|---|
| Manufacturer: | Sentinelle Medical Inc. |
| 510(k) Number: | K100113 |
| Decision Date: | April 22, 2010 |
| Decision: | Substantially Equivalent |
Table 2:
Table 3 lists the technological characteristics, as derived from the Indications for Use and the Device Description of the proposed device with the legally marketed device Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE Signa™ 1.5/3T MRI Systems.
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Image /page/4/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of several intersecting lines and curves. The word "sentinelle" is in a larger font than the word "MEDICAL".
The device labeling includes the Operator's Guide (User Manual) [Appendix 9] including indications for use, cautions, warnings, contraindications and instructions. This information assures safe and effective use of the device.
Table 3: Technological Characteristics
Comparison of Sentinelle Breast MRI Auxiliary Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems with Vanguard Breast MRI Auxiliary Table with 8/16 Channel Coil Array for GE Signa™ 1.5/3T MRI Systems
| Predicate:Vanguard Breast MRI Auxiliary Table with 8/16Channel Coil Array for GE1.5/3T MRI SystemsK100113 | Current Submission:Sentinelle Breast MRITabletop with 16 ChannelCoil Array for Siemens 1.5/3T MRI Systems |
|---|---|
| Indications for Use: Provides magneticresonance images of breast anatomy when used inconjunction with a Magnetic Resonance Scanner.These images can be interpreted by a trainedphysician. When used with the disposable sterileplate this device permits access to the breastanatomy for biopsy and localization proceduresthat can be performed by a trained physician. | Indications for Use: Provides magneticresonance images of breast anatomy whenused in conjunction with a MagneticResonance Scanner. These images can beinterpreted by a trained physician. Whenused with the disposable sterile plate thisdevice permits access to the breast anatomyfor biopsy and localization procedures thatcan be performed by a trained physician. |
| Design and Technology:The device supports a patient in a proneposition, with receive-only antennas surroundingthe breast. Compression plates supported by thedevice are used to immobilize the breast in theopening provided. Only non-ferrous materialsare used in the construction of the device.Detailed aspects of technology presented insections below | Design and Technology:The device supports a patient in a proneposition, with receive-only antennassurrounding the breast. Compression platessupported by the device are used toimmobilize the breast in the openingprovided. Only non-ferrous materials areused in the construction of the device.Detailed aspects of technology presented insections below |
| Coil Enclosure and compression platematerial: Flame retardant Polycarbonate plastic,Acetal Resin and Polyurethane. Patient contactmaterials have been evaluated forbiocompatibility. | Coil Enclosure and compression platematerial: Flame retardant Polycarbonateplastic, Acetal Resin and Polyurethane.Patient contact materials have been evaluatedfor biocompatibility. |
| Technology - Coil Design:- 16 loop phased array receive only coil design.- 10 loop phased array receive only coil design- 2 loop phased array receive only coil design | Technology - Coil Design:- 16 loop phased array receive only coildesign.- 10 loop phased array receive only coildesign- 2 loop phased array receive only coil design |
| Technology - Decoupling: Active PIN Diodeswitching blocking circuitry. Passive BlockingCircuitry. | Technology - Decoupling: Active PINDiode switching blocking circuitry. PassiveBlocking Circuitry. |
| Technology - Prevention of RF Burns: Cablescan not be looped. | Technology - Prevention of RF Burns:Cables can not be looped. |
| Technology - Radio FrequencyAbsorption: Coil is a receive-only coil and doesnot transmit RF power. Power deposition islimited by the SAR program of the MRI magnet. | Technology - Radio FrequencyAbsorption: Coil is a receive-only coil anddoes not transmit RF power. Powerdeposition is limited by the SAR program ofthe MRI magnet. |
| Technology - Formation of Resonant Loop:Decoupling isolates the coil elements from RFfields during RF transmission. | Technology - Formation of ResonantLoop: Decoupling isolates the coil elementsfrom RF fields during RF transmission. |
| Performance Testing:Performance was determined according toNEMA standards for MRI Coils as applicable tophased array coils. | Performance Testing:Performance was determined according toNEMA standards for MRI Coils as applicableto phased array coils. |
| Specifications - Mode of operation,Frequency, Field Strength : For 3 Teslavariants: Receive-only, center frequencyranging from 123.1 MHz to 127.3 MHz (FactorySet), 3 Tesla, Bilateral and unilateralapplications, Medial, Lateral and anterior access. | Specifications - Mode of operation,Frequency, Field Strength : For 3 Teslavariants: Receive-only, center frequencyranging from 122.6 MHz to 124.2 MHz(Factory Set), 3 Tesla, Bilateral and unilateralapplications, Medial, Lateral and anterioraccess. |
| Compatibility:This system is for use with GE Discovery MR750 3.0T, GE Signa HDxt 3.0T, General ElectricDiscovery MR450 1.5T, General ElectricOptima MR450w 1.5T . | Compatibility:This system is for use with SiemensMAGNETOM Espree & Siemens TRIOMRI Scanners |
| Table Specifications:For use with products specified in thecompatibility section. Max table weight verifiedper MR requirements. Relative table motion iscontrolled by MR system. | Table Specifications:For use with products specified in thecompatibility section. Max table weightverified per MR requirements. Relative tablemotion is controlled by MR system. |
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Image /page/5/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of several intersecting lines, forming a complex, symmetrical design. The word "sentinelle" is in a larger font size than "MEDICAL".
VIII: Testing and Performance Data
Testing for the Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems was performed to ensure that functional requirements have been met, and that core functions execute as expected.
The following tests were performed on the proposed device and the verification/validation results are contained in Appendix 8.
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Image /page/6/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of several intersecting lines, forming a complex, abstract design. The word "sentinelle" is in a larger font size than "MEDICAL", and the two words are stacked vertically.
Table 4: Product Under Test – Sentinelle 16CH Coil Array for 1.5T Scanners
| Test Identifier | Test Reference |
|---|---|
| DHM-00932 | Mechanical Safety Testing Summary |
| SMI-1093 | Risk Management Report for Sentinelle Vanguard 16Ch BreastSystem for Siemens MR Platform (1.5T and 3.0T) |
| SMI-1839 | Mechanical FMEA: 16 Channel for Siemens |
| SMI-0337 | FMEA Siemens Tabletop |
| RSK-00309 | Electrical FMEA: 16CH for Siemens 1.5T and 3T |
| TR-00484 | SNR Evaluation - Siemens 1.5T 16CH System |
| TR-00483 | Siemens - gMap 16CH 1.5T |
| VER-04170 | Heating and Performance Output Test for Siemens 1.5T, 16CHBreast Coil - 10CH Configuration |
| VER-04171 | Passive Detuning Test for Siemens 1.5T, 16CH Breast Coil – 10CHConfiguration |
| VER-04172 | Field Distortions Test for Siemens 1.5T, 16CH Breast Coil – 10CHConfiguration |
| VER-04173 | RF Noise Test for Siemens 1.5T, 16CH Breast Coil - 10CHConfiguration |
| VER-04174 | Switch-Over Tx-Rx for Siemens 1.5T, 16CH Breast Coil - 10CHConfiguration |
| VER-04175 | MR Signal from Housing for Siemens 1.5T, 16CH Breast Coil -10CH Configuration |
| VER-04176 | Body Scout 2 for Siemens 1.5T, 16CH Breast Coil - 10CHConfiguration |
| VER-04177 | Body Scout 1 for Siemens 1.5T, 16CH Breast Coil – 10CHConfiguration |
| VER-04178 | Voltage Stability Test for Siemens 1.5T, 16CH Breast Coil - 10CHConfiguration |
| VER-04179 | Spike Noise Test for Siemens 1.5T, 16CH Breast Coil - 10CHConfiguration |
| VER-04285 | 2CH Breast SEN QA 2011-04-27 |
| VER-04287 | 10CH Breast SEN QA 2011-04-27 |
| TR-0796 | Passive Detuning during Transmit Phase for Siemens 1.5T, 16CHBreast Coil |
| TR-0804 | Voltage Stability of Passive Decoupling for Siemens 1.5T, 16CHBreast Coil |
| TR-0781 | Heating and Performance Output Test for Siemens 1.5T, 16CHBreast Coil |
| TR-0803 | Body Scout 1 for Siemens 1.5T, 16CH Breast Coil |
| TR-0802. | Body Scout 2 for Siemens 1.5T, 16CH Breast Coil |
| TR-0797 | Measurement of Field Distortions for Siemens 1.5T, 16CH Breast Coil |
| TR-0798 | Spike Noise Test for Siemens 1.5T, 16CH Breast Coil |
| TR-0799 | Rf Noise Measurement for Siemens 1.5T, 16CH Breast Coil |
| TR-0800 | Switch-over Tx-Rx for Siemens 1.5T, 16CH Breast Coil |
| TR-0801 | MR Signal from Housing for Siemens 1.5T, 16CH Breast Coil |
| TR-00485 | SNR Comparison between 8 CH and 16CH Systems |
| VAR-02350 | Volunteer Imaging for Siemens 1.5T, 16CH Breast Coil |
| SMI-1789 | Safety & Imaging Effectiveness: Siemens 1.5T 16CH |
. '
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Image /page/7/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is made up of lines and curves, and it resembles a stylized flower or snowflake. The word "sentinelle" is in a larger font than the word "MEDICAL".
Table 5: Product Under Test – Sentinelle 16CH Coil Array for 3T Scanners
| TestIdentifier | Test Reference |
|---|---|
| VER-04180 | Heating and Performance Output Test for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04181 | Passive Detuning Test for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04182 | Field Distortion Test for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04183 | RF Noise Test for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04184 | Switch-Over Tx-Rx for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04185 | MR Signal from Housing for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04186 | Body Scout 2 for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04187 | Body Scout 1 for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04188 | Voltage Stability Test for Siemens 3T, 16CH Breast Coil – 10CH Configuration |
| VER-04189 | Spike Noise test: Siemens 16CH/3T – 10 CH Configuration |
| TR-0760 | Passive Detuning during Transmit Phase for Siemens 3T, 16CH Breast Coil |
| TR-0761 | Voltage Stability of Passive Decoupling for Siemens 3T, 16CH Breast Coil |
| TR-0769 | Heating and Performance Output Test for Siemens 3T, 16CH Breast Coil |
| TR-0771 | Body Scout 1 for Siemens 3T, 16CH Breast Coil |
| TR-0772 | Body Scout 2 for Siemens 3T, 16CH Breast Coil |
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sentinelle
MEDICAL
| TR-0773 | Measurement of Field Distortions for Siemens 3T, 16CH Breast Coil |
|---|---|
| TR-0774 | Spike Noise Test for Siemens 3T, 16CH Breast Coil |
| TR-0775 | RF Noise Measurement for Siemens 3T 16CH Breast Coil |
| TR-0776 | Switch-over Tx-Rx for Siemens 3T, 16CH Breast Coil |
| TR-0777 | MR Signal from Housing for Siemens 3T, 16CH Breast Coil |
| VER-04025 | SNR Comparison between 8 and 16 Channel Systems at 3T for Siemens Breast Coil |
| VER-04216 | gMap for Siemens 3T, 16CH Breast Coil |
| SMI-1371 | Safety & Imaging Effectiveness: Siemens 16CH/3T |
| VAR-02363 | Volunteer Imaging for Siemens 3T, 16CH Breast Coil |
Testing was conducted in-house by trained testing personnel using phantoms or volunteers to obtain the functional and accuracy test results. The use of contrast agent was not used in obtaining the images. The completed test results demonstrated that no new safety and effectiveness issues were introduced. The completed tests were conducted to ensure that the changes to the proposed device did not introduce any new issues of safety or effectiveness from our legally cleared device - K100113.
The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI System's indications for use are unchanged from our legally marketed predicate devices:
- । Vanguard Breast MRI Auxiliary Table/Tabletop Coil with 8/16 Channel Coil Array for use with GE 1.5/3T MRI Scanners [K100113].
As such, the features and functionality provided by the Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems do not raise new concerns of safety or effectiveness.
Test Conclusion
Results of the verification activities for the Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems verify that the system performed as intended, is safe and effective as our predicate device, and is substantially equivalent to our legally marketed device [K100113] .
Please refer to Appendix 8 for verification/validation results.
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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Joan Medley Director, Quality & Regulatory Sentinelle Medical, Inc. 555 Richmond Street West, Suite 800 Toronto, ON, M5V 3B1 CANADA
AUG 25 2011
Re: K112112
Trade/Device Name: Sentinelle Breast MRI Tabletop with 16Ch Coil Array for Siemens 1.5T/3T MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: July 21, 2011 Received: July 25, 2011
Dear Ms. Medley:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your dryice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary. S. Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/11/Picture/0 description: The image contains the logo for Sentinelle Medical. On the left is an abstract geometric shape that looks like a stylized flower or star. To the right of the shape is the word "sentinelle" in a sans-serif font, with the word "MEDICAL" in a smaller font below it.
Indication(s) For Use
510(k) Number:
Device Name: Sentinelle Breast MR1 Tabletop with 16Ch Coil Array for Siemens 1.5T/ST MRI Systems
Indications for Use:
The Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 1.5T/3T MRI Systems is 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 sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.
Prescription Use (Part 21 CFR 801 Subpart D):
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
hul D. O'K
(Division Sign-Off Division of Radiological Devices Diagnostic Device Evaluation and Safety Office of In
510K K112112
§ 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.