(31 days)
No
The description focuses on the hardware components (tabletop, coils, compression system) and their function in acquiring MRI images and facilitating interventions. There is no mention of software algorithms, image processing, or any terms related to AI/ML. The performance studies also focus on functional requirements and equivalence to a predicate device, not on algorithmic performance metrics.
No
The device is used for imaging and facilitating biopsies, not for treating a condition or disease.
Yes
Explanation: The device is designed to provide magnetic resonance images of breast anatomy, which are then interpreted by a trained physician for diagnostic purposes. It is a "receive-only MRI imaging coil" that helps in acquiring images.
No
The device description clearly details physical components like a tabletop, coil array, compression system, and plates, indicating it is a hardware device with associated software for imaging and potentially interventional guidance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array is a device used in conjunction with an MRI scanner to produce images of breast anatomy. It also facilitates access for biopsy and localization procedures.
- No Sample Analysis: The device itself does not analyze biological samples. It is a tool for imaging and guiding procedures on the patient's body.
Therefore, the device falls under the category of an imaging device and an interventional device accessory, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner / MRI
Anatomical Site
breast anatomy, breast and axillary region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance was determined according to NEMA standards for MRI Coils as applicable to phased array coils.
Testing conducted with phantoms or volunteers.
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.
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].
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.
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.
0
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.
1
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
2
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.
3
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 with
8/16 Channel Coil Array for GE 1.5/3T MRI
Systems |
|----------------|--------------------------------------------------------------------------------------------------|
| 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 8/16
Channel Coil Array for GE
1.5/3T MRI Systems
K100113 | Current Submission:
Sentinelle Breast MRI
Tabletop with 16 Channel
Coil Array for Siemens 1.5/3T MRI Systems |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: Provides magnetic
resonance images of breast anatomy when used in
conjunction with a Magnetic Resonance Scanner.
These images can be interpreted by a trained
physician. When used with the disposable sterile
plate this device permits access to the breast
anatomy for biopsy and localization procedures
that can be performed by a trained physician. | Indications for Use: Provides magnetic
resonance images of breast anatomy when
used in conjunction with a Magnetic
Resonance Scanner. These images can be
interpreted by a trained physician. When
used with the disposable sterile plate this
device permits access to the breast anatomy
for biopsy and localization procedures that
can be performed by a trained physician. |
| Design and Technology:
The device supports a patient in a prone
position, with receive-only antennas surrounding
the breast. Compression plates supported by the
device are used to immobilize the breast in the
opening provided. Only non-ferrous materials
are used in the construction of the device.
Detailed aspects of technology presented in
sections below | Design and Technology:
The device supports a patient in a prone
position, with receive-only antennas
surrounding the breast. Compression plates
supported by the device are used to
immobilize the breast in the opening
provided. Only non-ferrous materials are
used in the construction of the device.
Detailed aspects of technology presented in
sections below |
| Coil Enclosure and compression plate
material: Flame retardant Polycarbonate plastic,
Acetal Resin and Polyurethane. Patient contact
materials have been evaluated for
biocompatibility. | Coil Enclosure and compression plate
material: Flame retardant Polycarbonate
plastic, Acetal Resin and Polyurethane.
Patient contact materials have been evaluated
for 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 coil
design. - 10 loop phased array receive only coil
design - 2 loop phased array receive only coil design |
| Technology - Decoupling: Active PIN Diode
switching blocking circuitry. Passive Blocking
Circuitry. | Technology - Decoupling: Active PIN
Diode switching blocking circuitry. Passive
Blocking Circuitry. |
| Technology - Prevention of RF Burns: Cables
can not be looped. | Technology - Prevention of RF Burns:
Cables can not be looped. |
| Technology - Radio Frequency
Absorption: Coil is a receive-only coil and does
not transmit RF power. Power deposition is
limited by the SAR program of the MRI magnet. | Technology - Radio Frequency
Absorption: Coil is a receive-only coil and
does not transmit RF power. Power
deposition is limited by the SAR program of
the MRI magnet. |
| Technology - Formation of Resonant Loop:
Decoupling isolates the coil elements from RF
fields during RF transmission. | Technology - Formation of Resonant
Loop: Decoupling isolates the coil elements
from RF fields during RF transmission. |
| Performance Testing:
Performance was determined according to
NEMA standards for MRI Coils as applicable to
phased array coils. | Performance Testing:
Performance was determined according to
NEMA standards for MRI Coils as applicable
to phased array coils. |
| Specifications - Mode of operation,
Frequency, Field Strength : For 3 Tesla
variants: Receive-only, center frequency
ranging from 123.1 MHz to 127.3 MHz (Factory
Set), 3 Tesla, Bilateral and unilateral
applications, Medial, Lateral and anterior access. | Specifications - Mode of operation,
Frequency, Field Strength : For 3 Tesla
variants: Receive-only, center frequency
ranging from 122.6 MHz to 124.2 MHz
(Factory Set), 3 Tesla, Bilateral and unilateral
applications, Medial, Lateral and anterior
access. |
| Compatibility:
This system is for use with GE Discovery MR
750 3.0T, GE Signa HDxt 3.0T, General Electric
Discovery MR450 1.5T, General Electric
Optima MR450w 1.5T . | Compatibility:
This system is for use with Siemens
MAGNETOM Espree & Siemens TRIO
MRI Scanners |
| Table Specifications:
For use with products specified in the
compatibility section. Max table weight verified
per MR requirements. Relative table motion is
controlled by MR system. | Table Specifications:
For use with products specified in the
compatibility section. Max table weight
verified per MR requirements. Relative table
motion 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.
6
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 Breast |
| System 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, 16CH |
| Breast Coil - 10CH Configuration | |
| VER-04171 | Passive Detuning Test for Siemens 1.5T, 16CH Breast Coil – 10CH |
| Configuration | |
| VER-04172 | Field Distortions Test for Siemens 1.5T, 16CH Breast Coil – 10CH |
| Configuration | |
| VER-04173 | RF Noise Test for Siemens 1.5T, 16CH Breast Coil - 10CH |
| Configuration | |
| VER-04174 | Switch-Over Tx-Rx for Siemens 1.5T, 16CH Breast Coil - 10CH |
| Configuration | |
| 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 - 10CH |
| Configuration | |
| VER-04177 | Body Scout 1 for Siemens 1.5T, 16CH Breast Coil – 10CH |
| Configuration | |
| VER-04178 | Voltage Stability Test for Siemens 1.5T, 16CH Breast Coil - 10CH |
| Configuration | |
| VER-04179 | Spike Noise Test for Siemens 1.5T, 16CH Breast Coil - 10CH |
| Configuration | |
| 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, 16CH |
| Breast Coil | |
| TR-0804 | Voltage Stability of Passive Decoupling for Siemens 1.5T, 16CH |
| Breast Coil | |
| TR-0781 | Heating and Performance Output Test for Siemens 1.5T, 16CH |
| Breast 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
| Test
| Identifier | 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 |
.
.
7-8
.
8
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.
9
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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