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 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.

AI/ML Overview

The presented document is a 510(k) summary for the "Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array for GE Signa™ systems." It details the device's characteristics and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than fulfilling specific acceptance criteria in the context of a typical AI/ML device study.

Therefore, many of the requested fields related to acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC comparative effectiveness studies are not applicable to this type of submission for an MRI coil accessory. The submission focuses on technical performance and safety comparisons to predicate devices.

Here's a breakdown of the information that can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Prevention of RF Burns	Reduced likelihood of RF burns by increasing cable stiffness with an outer cable sheath, similar to predicate devices (K993776, K041481).
Safety: Prevention of RF Burns	Coil is a receive-only coil and does not transmit RF power. Power deposition is limited by the SAR program of the MRI magnet, same as predicate devices (K993776, K013485, K041481).
Effectiveness: Imaging Performance (Signal-to-Noise Ratio (SNR))	Vanguard coil arrangements demonstrated improved signal-to-noise over that of the predicate device (K993776). The 4-coil unilateral imaging mode demonstrated improved signal-to-noise than the 4-coil bilateral mode.
Effectiveness: Imaging Performance (Image Uniformity)	Image uniformity measurements were performed for the new imaging coil. (Specific quantitative results for uniformity improvement are not detailed in this summary, but it implies acceptable uniformity was achieved).
Functionality: Compatibility	Compatible with GE Signa® (3X-LX, Echo Speed, TwinSpeed) 1.5T Scanners and GE Signa® Excite platforms, same as K993776, K041481, K041695.
Functionality: Mode of Operation, Frequency, Field Strength	Receive-only, 63.86 MHz, 1.5 Tesla, same as K993776, K041481, K041695.
Biopsy Access: Anatomical Access	Offers additional anterior access compared to predicate devices which only have lateral (OBC) and lateral/medial access (OBC, BBC). This access difference does not affect safety or substantial equivalence.
Material Safety: Coil Enclosure and Compression Plate Material	Flame retardant Polycarbonate plastic and Acetal Resin. Acetal Resin is same as K013485; Polycarbonate plastic is same as K041481.
Material Safety: Disposable Biopsy Plate Material	Polycarbonate resin with 20mm apertures, same as K041695, K041481.

2. Sample size used for the test set and the data provenance

The document mentions "volunteers" for additional comparison in Attachment 9 and imaging phantoms for the primary performance tests. However, it does not specify the sample size for either the phantom tests or the volunteer study.

Data Provenance: Not explicitly stated, but given the company location (Toronto, Ontario, Canada) and the submission to the FDA, the testing was likely conducted in Canada or the USA. The data is prospective as it describes performance testing conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this submission. The device is an MRI coil accessory, and the "ground truth" for its performance is assessed through technical measurements like Signal-to-Noise Ratio (SNR) and image uniformity using phantoms, rather than expert interpretation of complex clinical cases that would require a ground truth established by experts. The indications for use state "These images can be interpreted by a trained physician," but this pertains to the use of the device in clinical practice, not to the testing of the device itself for FDA clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there were no subjective interpretations requiring adjudication. Performance was measured using objective technical metrics on phantoms.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for an MRI coil, not an AI/ML diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to objective physical measurements using imaging phantoms according to NEMA standards. For the volunteer study, the "ground truth" would be the direct physical properties of the volunteers being imaged, again assessed through objective imaging metrics. There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the device's performance.

8. The sample size for the training set

This is not applicable. The device is hardware (an MRI coil and table), not a software algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this type of device.

Summary

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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.

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Indications for use:

Device Description:

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physician to access the breast for intervention. No biopsy needles are included with or packaged with the system.

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 with8 Channel Coil Array	Comparison to predicate device or other510K cleared products
Indications for Use: TheSentinelle Vanguard BreastMRI Auxiliary Table with 8Channel Coil array is designedto provide magnetic resonanceimages of breast anatomy whenused in conjunction with a	Same intended indications for use as K041481 -BBC-127 as indicated:Indications for Use: To be used in conjunctionwith a Magnetic resonance scanner to:1) Product diagnostic images of the femalebreast, chest wall and axillary tissuesthat can be interpreted by a trained
Magnetic Resonance Scanner.	physician.
These images can be interpretedby a trained physician. Whenused with the disposable sterileplate the Sentinelle VanguardBreast MRI Auxiliary Tablewith 8 Channel Coil arraypermits access to the breastanatomy for biopsy andlocalization procedures that canbe performed by a trainedphysician.	2) Permit MR-guided breast biopsy andlocalization of lesions that can beperformed and interpreted by a trainedphysician.
	The two indications for use statements are thesame in content and will be used for similarclinical indications. This does not affectsubstantial equivalence.
Design and Technology:	General technology and design is the same aspredicate device: K041481 - BBC-127. Themajor technological difference is the integrationof the auxiliary table to the coil system. A moredetailed comparison of similarities anddifferences in detailed design components areprovided in Attachment 8. The sum of thesepresented differences does not affect substantialequivalence as discussed.
Coil Enclosure andcompression plate material:Flame retardant Polycarbonateplastic and Acetal Resin.	- Acetal Resin plastic material is same as thatused for coil enclosure in K013485 -- Machnet.- Polycarbonate plastic material is samematerial as used in K041481 - BBC-127.
Technology - Coil Design: 8	- A similar coil geometry is used for the 8 coil
loop phased array receive onlycoil design.1 lateral left, 1 lateral right, 1medial left, 1 medial right coilarrays. 4 loop phased arrayreceive only.	cardiac array (K032045). In this geometry 4coils are formed in a linear array on two sets ofcoil plates. These 2 sets of coil arrays image theanatomy from different orientations. The size ofthe coils is different for the cardiac applicationas they are significantly larger. As coilgeometries need to be modified toaccommodate various anatomies, this differenceis expected for breast imaging, and does notaffect the safety of the device and does notaffect substantial equivalence to the predicate.Modification of the coil geometry in such amanner does not negatively affect the safety ofthe proposed device and does not deviatesignificantly from predicated coil designs.
Technology - Decoupling:Active PIN Diode switchingblocking circuitry. PassiveBlocking Circuitry.	- Active PIN diode circuitry is used in K993776OBC, and K041481 - BBC-127 which is alsoused in the proposed device. The circuitry isdesigned differently in both predicate deviceshowever the effect is the same. All circuits actto detune the coil during a blocking signalprovided from the scanner. Various blockingcircuits are used in predicate devices. Theparticular difference does not affect substantialequivalence as they provide the same desiredeffect.- Passive blocking Circuitry is used in K993776OBC, and K041481 - BBC-127 which is alsoused in the proposed device. The same type ofcircuit is used, however the capacitor andinductor values are different This is expected at
	the coil sizes are different. This difference doesnot affect substantial equivalence as the samedesired outcome is accomplished.
Technology - Prevention ofRF Burns: Cables can not belooped.	- Reducing the likelihood of RF burns hasenabled by increasing the stiffness of the cable.Cable stiffness has been increased by additionof an outer cable sheath in the predicate devices(K993776, K041481). This is the same as theproposed device by the use of an outer sheath.The material used for the outer sheath isdifferent, but provides the same desired effect.
Technology - RadioFrequency Absorption: Coil isa receive-only coil and does nottransmit RF power. Powerdeposition is limited by theSAR program of the MRImagnet.	- Operation is the same as (K993776, K013485,K041481).
Technology - Formation ofResonant Loop: Decouplingisolates the coil elements fromRF fields during RFtransmission.	- Same as K993776 – OBC, K013485 –Machnet, K041481 - BBC-127. The decouplingstrategy is standard for many MRI coil systems.
Intervention: Disposablebiopsy plate material –polycarbonate resin, 20 mmapertures	- Same as K041695 - Liberty 9000, K041481 –BBC-127. The similar resin and similarstructure is used. BBC-127 has same aperturesize. The geometric modification does notaffect substantial equivalence.
Performance Testing:Performance was determinedaccording to NEMA standards	- A comparison to the predicate deviceK993776 has been provided in the VerificationReports (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.

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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.

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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.

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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.

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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

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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:

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)

Regulation Number and Section

§ 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.