(15 days)
No
The description focuses on the hardware components (coil array, table) and their function in acquiring MRI images and facilitating interventions. There is no mention of software algorithms for image processing, analysis, or interpretation, which are typically where AI/ML would be applied in this context. The performance studies focus on signal-to-noise ratio and uniformity, not on the performance of any analytical algorithms.
No
The device is used to acquire magnetic resonance images and facilitate biopsy/localization procedures, which are diagnostic and interventional, not therapeutic.
No
The device is an auxiliary table and coil array for an MRI scanner; it helps acquire magnetic resonance images but does not interpret them or provide a diagnosis itself. The images produced by this device are then "interpreted by a trained physician," indicating the diagnostic function resides with the physician, not the device.
No
The device description clearly outlines physical hardware components including a table base, tabletop, imaging coils, compression plates, and associated circuitry. It is an MRI imaging coil and interventional system, not a software-only device.
Based on the provided information, the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sentinelle Vanguard system is an accessory for an MRI scanner. Its primary function is to:
- Position and support the patient for breast MRI imaging.
- Provide imaging coils to improve image quality.
- Facilitate access for biopsy and localization procedures performed by a physician.
- No Specimen Analysis: The device itself does not analyze any biological specimens. It helps in acquiring images and providing access for procedures, but the diagnostic interpretation is done by a trained physician based on the images.
Therefore, the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array falls under the category of a medical device used for imaging and interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array is designed to provide 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 the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array is an MRI imaging coil and interventional system for breast. The system consists of a table base and a table top. The tabletop supports the patient, the imaging coils and means for modest compression/immobilization of the breast, as well as a means of enabling interventional device guidance. The table base is used to support and transport the tabletop. The table base is substantially equivalent to the table provided by General Electric with their GE Signa ® MRI machines.
The tabletop, like other breast coils provides an aperture to admit the breasts. A corresponding aperture in the table base maximizes physician access to the breast(s) when the tabletop is at the home position. This is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach.
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 plates. The fenestrated plate has apertures which permit the physician to access the breast for intervention. No biopsy needles are included with or packaged with the system.
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.
The Vanguard phased array coil set consists of 8 RF coil elements in a phased array design. The 8 coil array may be interchanged with a four coil array. The coil elements and associated circuitry are enclosed to prevent exposure to the patient or the environment. The coil electronics are enclosed in a rigid housing that is resistant to fluids 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.
This system is for use with GE Signa ® (3X-LX, Echo Speed, TwinSpeed) 1.5T Scanners. This system is compatible with GE Signa ® Excite platforms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner (MRI)
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)
Verification testing using two imaging phantoms compared the subject device to a predicate device (K993776) and also compared imaging modes within the Vanguard system.
The first test demonstrated the Vanguard coil arrangements demonstrated improved signal-to-noise over that of the predicate device (K993776). The second test demonstrated the 4 coil unilateral imaging mode demonstrated improved signal-to-noise than the 4 coil bilateral mode. From these tests the Vanguard imaging modes were shown to provide signal-to-noise exceeding the predicate device. Additional SNR and image uniformity measurements were performed for the new imaging coil and presented in this documentation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal-to-noise ratio, image uniformity
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.
K041481, K013485, K032045, K041695
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
ATTACHMENT 2: 510(k) SUMMARY
APR 1 4 2006
- A.
Proprietary Name: Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array for GE Signa TM systems. Classification Name: Magnetic Resonance Imaging Accessory Common Name: Vanguard Breast MRI System Classification: Class II Contact Person: Cameron Piron, President Date of Preparation: Dec 31st, 2005
B.
Predicate Device:
(Model OBC-300 Breast Array Coil, MRI Devices Corp, K993776) with (Breast Immobilization and Biopsy Device MR-Biopsy 160, MRI Devices Corp, K010570)
C.
Establishment Registration #: Applied for and Pending
Manufacture Facility Location:
Sentinelle Medical Inc. 3080 Yonge Street, Suite 6020, M4N 3N1 Toronto, Ontario, Canada Telephone: 416-482-3828, Fax: 416-482-3807
Performance Standard:
No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
1
Indications for use:
The Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array is designed to provide 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 the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
Device Description:
The Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array is an MRI imaging coil and interventional system for breast. The system consists of a table base and a table top. The tabletop supports the patient, the imaging coils and means for modest compression/immobilization of the breast, as well as a means of enabling interventional device guidance. The table base is used to support and transport the tabletop. The table base is substantially equivalent to the table provided by General Electric with their GE Signa ® MRI machines.
The tabletop, like other breast coils provides an aperture to admit the breasts. A corresponding aperture in the table base maximizes physician access to the breast(s) when the tabletop is at the home position. This is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach.
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 plates. The fenestrated plate has apertures which permit the
2
physician to access the breast for intervention. No biopsy needles are included with or packaged with the system.
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.
The Vanguard phased array coil set consists of 8 RF coil elements in a phased array design. The 8 coil array may be interchanged with a four coil array. The coil elements and associated circuitry are enclosed to prevent exposure to the patient or the environment. The coil electronics are enclosed in a rigid housing that is resistant to fluids 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.
This system is for use with GE Signa ® (3X-LX, Echo Speed, TwinSpeed) 1.5T Scanners. This system is compatible with GE Signa ® Excite platforms.
Safety and Effectiveness:
Equivalency Table:
| Vanguard Breast System with
8 Channel Coil Array | Comparison to predicate device or other
510K cleared products |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: The
Sentinelle Vanguard Breast
MRI Auxiliary Table with 8
Channel Coil array is designed
to provide magnetic resonance
images of breast anatomy when
used in conjunction with a | Same intended indications for use as K041481 -
BBC-127 as indicated:
Indications for Use: To be used in conjunction
with a Magnetic resonance scanner to:
- Product diagnostic images of the female
breast, chest wall and axillary tissues
that can be interpreted by a trained |
| Magnetic Resonance Scanner. | physician. |
| These images can be interpreted
by a trained physician. When
used with the disposable sterile
plate the Sentinelle Vanguard
Breast MRI Auxiliary Table
with 8 Channel Coil array
permits access to the breast
anatomy for biopsy and
localization procedures that can
be performed by a trained
physician. | 2) Permit MR-guided breast biopsy and
localization of lesions that can be
performed and interpreted by a trained
physician. |
| | The two indications for use statements are the
same in content and will be used for similar
clinical indications. This does not affect
substantial equivalence. |
| Design and Technology: | General technology and design is the same as
predicate device: K041481 - BBC-127. The
major technological difference is the integration
of the auxiliary table to the coil system. A more
detailed comparison of similarities and
differences in detailed design components are
provided in Attachment 8. The sum of these
presented differences does not affect substantial
equivalence as discussed. |
| Coil Enclosure and
compression plate material:
Flame retardant Polycarbonate
plastic and Acetal Resin. | - Acetal Resin plastic material is same as that
used for coil enclosure in K013485 -- Machnet.
- Polycarbonate plastic material is same
material as used in K041481 - BBC-127. |
| Technology - Coil Design: 8 | - A similar coil geometry is used for the 8 coil |
| loop phased array receive only
coil design.
1 lateral left, 1 lateral right, 1
medial left, 1 medial right coil
arrays. 4 loop phased array
receive only. | cardiac array (K032045). In this geometry 4
coils are formed in a linear array on two sets of
coil plates. These 2 sets of coil arrays image the
anatomy from different orientations. The size of
the coils is different for the cardiac application
as they are significantly larger. As coil
geometries need to be modified to
accommodate various anatomies, this difference
is expected for breast imaging, and does not
affect the safety of the device and does not
affect substantial equivalence to the predicate.
Modification of the coil geometry in such a
manner does not negatively affect the safety of
the proposed device and does not deviate
significantly from predicated coil designs. |
| Technology - Decoupling:
Active PIN Diode switching
blocking circuitry. Passive
Blocking Circuitry. | - Active PIN diode circuitry is used in K993776
OBC, and K041481 - BBC-127 which is also
used in the proposed device. The circuitry is
designed differently in both predicate devices
however the effect is the same. All circuits act
to detune the coil during a blocking signal
provided from the scanner. Various blocking
circuits are used in predicate devices. The
particular difference does not affect substantial
equivalence as they provide the same desired
effect. - Passive blocking Circuitry is used in K993776
OBC, and K041481 - BBC-127 which is also
used in the proposed device. The same type of
circuit is used, however the capacitor and
inductor values are different This is expected at |
| | the coil sizes are different. This difference does
not affect substantial equivalence as the same
desired outcome is accomplished. |
| Technology - Prevention of
RF Burns: Cables can not be
looped. | - Reducing the likelihood of RF burns has
enabled by increasing the stiffness of the cable.
Cable stiffness has been increased by addition
of an outer cable sheath in the predicate devices
(K993776, K041481). This is the same as the
proposed device by the use of an outer sheath.
The material used for the outer sheath is
different, but provides the same desired effect. |
| 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. | - Operation is the same as (K993776, K013485,
K041481). |
| Technology - Formation of
Resonant Loop: Decoupling
isolates the coil elements from
RF fields during RF
transmission. | - Same as K993776 – OBC, K013485 –
Machnet, K041481 - BBC-127. The decoupling
strategy is standard for many MRI coil systems. |
| Intervention: Disposable
biopsy plate material –
polycarbonate resin, 20 mm
apertures | - Same as K041695 - Liberty 9000, K041481 –
BBC-127. The similar resin and similar
structure is used. BBC-127 has same aperture
size. The geometric modification does not
affect substantial equivalence. |
| Performance Testing:
Performance was determined
according to NEMA standards | - A comparison to the predicate device
K993776 has been provided in the Verification
Reports (Attachment 5) with respect to Signal |
| for MRI Coils. | to Noise ratio and uniformity according to these |
| | standards. Additional comparison has been |
| | made in volunteers in Attachment 9. The results |
| | conclude that the performance of the proposed |
| | device is improved relative to the predicate |
| | device and offers no additional risk with respect |
| | to safety of the device. |
| Specifications - Mode of | - Same as K993776 – OBC, K041481 - BBC- |
| operation, Frequency, Field | 127, K041695 - Liberty 9000. All operated at |
| Strength : Receive-only, 63.86 | the same frequency, same field strength, and all |
| MHz Factory Set, 1.5 Telsa, 30 | all receive-only coils. Same field of view. Same |
| cm Field of View, Bilateral and | unilateral and bilateral applications. Presented |
| unilateral applications, Medial, | system has additional anterior access, while |
| Lateral and anterior access. | others only have lateral (OBC) and |
| | lateral/medial access (OBC, BBC). This access |
| | difference does not affect safety and does not |
| | affect substantial equivalence. |
| Compatibility: | - Same as K993776 – OBC, K041481 - BBC- |
| This system is for use with GE | 127, K041695. |
| Signa ® (3X-LX, Echo Speed, | |
| TwinSpeed) 1.5T Scanners. | |
| This system is compatible with | |
| GE Signa ® Excite platforms. | |
| | |
| Table Specifications: | Differs only from predicate K041476 - table |
| For use with General Electric | accessory as the table can not be raised up and |
| Signa ® MRI Systems. Max | down. This feature does not affect the safety |
| table weight 350 lbs. Patient | and effectiveness of the presented device. All |
| table driven by GE system. | safety mechanisms on the presented device |
| | function to provide the same level of safety and |
| | functionality to the predicate device. |
| | |
3
4
.
1
5
.
"
6
:
7
Testing Information and Conclusion:
There is no change to the magnet, rf system, and gradient system of the GE Signa® System by introduction of the auxiliary patient table. The receive coil system operates in a substantially equivalent manner to standard coil systems as indicated.
Operation of the GE Signa ® system with the auxiliary table is substantially equivalent to standard operation of the GE Signa ® system. The auxiliary table is docked in-place of the Signa ® system table and provides the identical docking and passive patient transfer functionalities. The functioning and safety features with the auxiliary patient table are substantially equivalent to the Signa ® system. Verification testing was performed according to internal procedures and is presented in this documentation.
Verification of imaging was performed to determine the effectiveness of the imaging system using two imaging phantoms indicative of the MRI imaging properties of a female breast. The first test compared a predicate device (K993776) signal to noise relative to the two different imaging modes of the Vanguard system. The second test used two different imaging modes of the Vanguard system (4 coil bilateral verses 4 coil unilateral) to perform a signal to noise and image uniformity comparison.
The first test demonstrated the Vanguard coil arrangements demonstrated improved signal-to-noise over that of the predicate device (K993776). The second test demonstrated the 4 coil unilateral imaging mode demonstrated improved signal-to-noise than the 4 coil bilateral mode. From these tests the Vanguard imaging modes were shown to provide signal-to-noise exceeding the predicate device.
Operation of the General Electric Signa® MRI system with the new Vanguard Breast System is substantially equivalent to standard operation of the Signa® MRI system. Additional SNR and image uniformity measurements were performed for the new imaging coil and presented in this documentation.
8
Use with MRI Models:
This system is for use with GE Signa ® (3X-LX, Echo Speed, TwinSpeed) 1.5T Scanners. This system is compatible with GE Signa ® Excite platforms.
9
Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Sentinelle Medical, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
APR 1 4 2006
Re: K060873
Trade/Device Name: Vangard Breast MRI Auxiliary Table with 8 Channel Coil Array for GE Signa™ Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 29, 2006 Received: March 30, 2006
Dear Mr. Lehtonen:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/9/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "1906-2006" at the top and "FDA Centennial" in the center. The words "Protecting and Promoting Public Health" are written below the logo. The logo is black and white.
10
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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): _ Ko b o 8 7 3
Device Name: Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array for GE Signa TM systems
Indications for Use:
The Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array is designed to provide 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 the Sentinelle Vanguard Breast MRI Auxiliary Table with 8 Channel Coil array permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
Division Sign-Off ion of Reproducti adiological Devices
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PERFOR OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)