(98 days)
The Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 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 can be interpreted by a trained physician. When used with a sterile fenestrated plate, this device permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
The Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems is a receive-only MRI imaging coil and interventional system for the breast anatomy. The system consists of a table base and/or a 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 (optional) is used to support and transport the tabletop. 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 table aperture is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach. 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 provided with the system are held in compression frames which may be positioned in the left-right and anterior-posterior 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 cleared under FDA 510(k) number: K060873. The fenestrated plate has 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 maging and intervention, including our legally marketed device 510(K) Number: K060873. The Vanguard phased array coil set consists of 8 or 16 RF coil elements in a phased array design. The 16 channel coil array may be interchanged with a 10 or 2-channel coil array. 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.
This document describes the Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MR Systems, designed to provide magnetic resonance images of breast anatomy and facilitate biopsy and localization procedures.
Important Note: The provided document is a 510(k) Premarket Notification summary, which focuses on device description, intended use, and substantial equivalence to a predicate device. It does not contain a detailed study report with specific acceptance criteria, device performance results, or extensive statistical analysis typically found in full clinical or performance studies. The information below is extracted based on what is available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission and not a detailed performance study, explicit, quantitative acceptance criteria and corresponding reported device performance values like sensitivity, specificity, accuracy, or reader agreement are not present in the provided text for the new device.
The submission focuses on the device's functional equivalence and improvements over an existing predicate device. The "performance" described is in terms of the intended benefits for image quality and acquisition time, which are qualitative improvements rather than specific, measurable performance metrics against a defined ground truth.
| Acceptance Criteria (Implied/Stated in 510k) | Reported Device Performance (Implied/Stated in 510k) |
|---|---|
| Ability to provide magnetic resonance images of breast anatomy. | The device is designed to provide magnetic resonance images of breast anatomy. |
| Compatibility with GE 1.5T/3T MRI Systems. | New models listed are compatible with specific GE Discovery and Signa MR systems. |
| Facilitates biopsy and localization procedures when used with a sterile fenestrated plate. | The device permits access to the breast anatomy for biopsy and localization. |
| Improved Signal-to-Noise Ratio (SNR) compared to a standard body coil. | "An increase in the Signal-to-Noise Ratio (improving image detail)." |
| Decreased imaging acquisition time due to enhanced parallel imaging capability. | "A decrease in imaging acquisition time resulting from enhanced parallel imaging capability." |
| Substantial equivalence to predicate devices (K060873) for breast MRI imaging and intervention. | Based on the 510(k) clearance, the FDA determined the device is "substantially equivalent." |
| Safety and effectiveness. | The 510(k) summary is for "Safety and Effectiveness." (Implicitly accepted by FDA clearance). |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not contain information about a dedicated "test set" with a specific sample size, data provenance (country of origin, retrospective/prospective), or a formal study design for evaluating the new device's performance against ground truth.
510(k) submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with test sets, especially for accessories like MRI coils. The improvements mentioned (SNR, acquisition time) are inherent to the coil design (e.g., more channels, phased array design) and are generally accepted principles in MRI technology, often supported by engineering tests and phantom studies, rather than large-scale patient test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since a formal "test set" or clinical study with ground truth establishment is not detailed in this 510(k) summary, this information is not provided.
4. Adjudication Method for the Test Set
As no specific test set or clinical study requiring adjudication is detailed in this 510(k) summary, this information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
An MRMC comparative effectiveness study was not mentioned or described in the provided 510(k) summary. This device is an MRI coil system, not an AI or CAD (Computer-Aided Detection) software, so an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a hardware component (MRI coil system), not a standalone algorithm or software.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Since a formal clinical study with ground truth is not detailed, the type of ground truth used is not specified in the provided 510(k) summary. The "ground truth" for demonstrating substantial equivalence primarily involves showing the new device functions similarly and safely to the predicate device, with described improvements being technical characteristics rather than diagnostic performance metrics against a clinical gold standard.
8. The Sample Size for the Training Set
The provided 510(k) summary does not describe a "training set" in the context of an algorithm or AI development. This device is a hardware component; therefore, the concept of a training set as used in AI is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no described training set, the method for establishing its ground truth is not applicable and therefore not provided in the document.
Summary of Study Context (Based on 510(k) Submission):
The document is a 510(k) Premarket Notification, which primarily aims to demonstrate substantial equivalence to a previously cleared predicate device (K060873), rather than presenting a de novo clinical study with detailed performance metrics. The improvements highlighted (increased SNR, decreased acquisition time) are technical advancements in the coil design (more channels, phased array) that are inherent to the physics of MRI and are generally accepted to enhance image quality and efficiency. The FDA's clearance indicates that the device met the regulatory requirements for safety and effectiveness through demonstration of substantial equivalence.
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KI00113
Image /page/0/Picture/1 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".
510(k) Premarket Notification Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16Ch Coil Array for 1.5T/3T MRI Systems Submitter: Sentinelle Medical Inc. March 25, 2010
7. 510(k) Summary
APR 2 2 2010
510(k) Summary of Safety and Effectiveness for: Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/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) 594-9696
III. Product Name/Classification Name
| Product Name: | Vanguard Breast 8/16 Channel, 1.5T/3T MRI Systems |
|---|---|
| Common Name: | Vanguard Breast MRI System |
| Classification Name: | Magnetic Resonance Imaging Accessory |
| Class II as described in CFR 21 892.1075 | |
| Product Code: | MOS |
IV. Date Prepared March 25, 2010
V. Device Description
The Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE
1.5T/3T MRI Systems is a receive-only MRI imaging coil and interventional system for the breast anatomy. The system consists of a table base and/or a 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 (optional) is used to support and transport the tabletop.
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 table aperture is useful for guidance of interventional devices (such as biopsy needles), especially when it is desired to perform a biopsy from a medial approach.
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Image /page/1/Picture/1 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 word "sentinelle" is in a larger font than the word "MEDICAL". The geometric shape is a complex design of intersecting lines.
510(k) Premarket Notification Vanguard Breast MRI Auxiliary Table/Tabletop with &16Ch Coil Array for 1.5T/3T MRI Systems Submitter: Sentinelle Medical Inc. March 25, 2010
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 provided with the system are held in compression frames which may be positioned in the left-right and anterior-posterior 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 cleared under FDA 510(k) number: K060873. The fenestrated plate has 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 maging and intervention, including our legally marketed device 510(K) Number: K060873.
The Vanguard phased array coil set consists of 8 or 16 RF coil elements in a phased array design. The 16 channel coil array may be interchanged with a 10 or 2-channel coil array. 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 Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems will consist of the following new models:
D Description: Sentinelle Vanguard Breast MRI Auxiliary Tabletop, 3T, 16 Channels
- o Model: 4000451
- Compatibility: General Electric Discovery MR750 3T 0
D Description: Sentinelle Vanguard Breast MRI Auxiliary Tabletop, 1.5T, 16 Channels
- Model: 4000636 0
Sentinelle Medical Inc.
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Image /page/2/Picture/1 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". The geometric shape is a complex design with multiple intersecting lines.
- Compatibility: General Electric Discovery MR450 1.5T and General Electric Optima o MR450w 1.5T
- D Description: Sentinelle Vanguard Breast MRI Auxiliary Tabletop, 3T, 8 Channels
- Model: 4000700 o
- Compatibility: General Electric Signa HDxt 3T o
- D Description: Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop, 1.5T, 8 Channels
- Model: 4000198 O
- Compatibility: General Electric Signa 1.5T Systems O
The various coil layout configurations (8/4/2 or 16/10/2) can be found in Appendix VIII.1.
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.
A representative 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 V.1.
VI. Intended Use
The Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/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. These images can be interpreted by a trained physician. When used with a sterile plate, 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.
The benefits of the Vanguard 16Ch, receive-only coil includes:
- An increase in the Signal-to-Noise Ratio (improving image detail) .
- . A decrease in imaging acquisition time resulting from enhanced parallel imaging capability
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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, Regulatory and Quality Sentinelle Medical, Inc. 555 Richmend Street West Suite 800, P.O. Box 301 Toronto, Ontario, M5V 3B1 CANADA
APR 2 2 2010
Re: K100113
Trade/Device Name: Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 channel coil array for GE 1.5T/3T MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 25, 2010 Received: March 26, 2010
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, perceits your device 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 (21 CLT 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting 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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Indications for Use
510(k) Number (if known): K100113
Device Name: _Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 channel coil array for GE 1.5T/3T MR Systems
Indications for Use:
The Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 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 can be interpreted by a trained physician. When used with a sterile fenestrated plate, this device permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert L. Becker
(Division Sign Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K100113
Page 1 of
§ 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.