(14 days)
This device provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. Supported imaging modalities include Magnetic Resonance (MR), Ultrasound (US), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CT), Positron Emission Tomography (PET), Fluoroscopy and Endoscopy. Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.
This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, guidance wires, imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications (including pelvis).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Aegis Navigation and Aegis Pelvic Application products are line-extensions to Sentinelle's medical image software product Aegis. These are also referred to below as (Aegis) plug-ins.
The products are designed to assist with multi-modality (including MRI, US, SPECT, CT, PET, Fluoroscopy, Endoscopy and others) imaging and guidance of screening and interventional procedures for anatomical structures such as head and neck, thoracic, breast, abdominal and pelvis(including prostate).
Aegis Pelvic Application is a software tool intended for analyzing multi-modality images. This plug-in also identifies where and how deeply, a biopsy or localization needle should be inserted into a region of interest (including prostate and surrounding structures) to strike a target or region of interest. Registration of target anatomy with an interventional device can be performed manually or automatically based on fiducial markers. This in turn provides a calculation of the location and depth of the targeted region of interest.
Similarly, Aegis Navigation is a software tool intended for analyzing multi-modality images. This plug-in also identifies where an imaging device (e.g. an ultrasound transducer), interventional tool (e.g. a biopsy or localization needle) or other tracked instrument should be placed in order to visualize or strike a target or region of interest. In addition, Aegis Navigation provides the user with the option to view previously acquired DICOM data (e.g. MRI data) alongside of a separate imaging modality such as Ultrasound (US) or a fluoroscopic device. In the context of US, a 3-D tracking system provides positional data regarding the transducer, which is used to guide the real-time reformatting of DICOM data to match the current US image. Interventional and imaging device operation and manipulation remains under the manual control of the trained medical professional at all times.
Additional applications of Aegis Navigation include:
- The ability to display the position of a tracked probe or instrument, overlaid on DICOM . (e.g.MR or CT) data
- The ability to track the position of an US transducer as it collects data, then retrospectively display reformatted DICOM (e.g. MR/CT) data slices oriented to match the previously acquired ultrasound images.
Here's a breakdown of the acceptance criteria and the study information for the Sentinelle Aegis Navigation and Pelvic Application, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to fulfilling functional requirements and meeting or exceeding specified accuracy criteria. The performance is gauged by comparison to the predicate device.
| Acceptance Criteria (Inferred from Text) | Reported Device Performance |
|---|---|
| Functional requirements met | All functional requirements have been met. |
| Core functions execute as expected | Core functions execute as expected. |
| Registration accuracy (MR and ultrasound) meets or exceeds specified criteria | Registration and correspondence between MR and ultrasound meets or exceeds specified criteria. |
| Needle registration and targeting results meet or exceed specified criteria | Needle registration and targeting results met or exceeded specified criteria. |
| Accuracy within specification and performs as well as, or better than Aegis predicate device | System accuracy is within specification and performs as well as, or better than Aegis, the legally marketed predicate device. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "targeting locations within a phantom" and "volunteers," but does not quantify the number of phantoms, volunteers, or the specific cases used in the accuracy and verification tests.
- Data Provenance: The tests were conducted "in-house by trained personnel in a simulated work-environment using phantoms or volunteers." This implies prospective data collection specifically for these tests. The country of origin of the data is Canada (where Sentinelle Medical Inc. is located).
3. Number of Experts and Their Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states "trained personnel" conducted the testing but does not elaborate on their clinical or expert qualifications for establishing ground truth for the device's accuracy.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Ground truth establishment appears to be based on the direct observation and measurement of the device's output against the known properties of the phantoms or volunteer setups, rather than an expert consensus process requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not mention any MRMC study comparing human readers with and without AI assistance. The testing focuses on the device's standalone accuracy and functionality.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes. The entire testing described in the document (registration accuracy, needle verification, and functional tests) describes the performance of the Aegis Navigation and Aegis Pelvic Application software itself, independent of a human operator, to verify its accuracy and functionality.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the accuracy tests was established using phantoms or volunteers with known anatomical structures and target locations. This provides a measurable, objective ground truth against which the device's calculations and guidance were compared. Specifically, "targeting locations within a phantom and confirming that the selected target location/needle location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device."
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The document describes a software plug-in whose functionality is inherited from an approved device (Sentinelle Aegis) and combines features of several predicate devices. There is no mention of a machine learning or AI model being trained, thus no explicit training set. The performance evaluation is based on verifying its compliance with specifications and equivalence to predicate devices, not on a new learning algorithm.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning model.
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Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits. The digits are 'K093672'. The numbers are written in a cursive style, with some connections between the digits.
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, bolder font than the word "MEDICAL", which is stacked below it.
510 (k) Premarket Notification Sentinelle Aegis Navigation and Pelvic Application Submitter: Sentinelle Medical Inc. November 16, 2009
510(k) Summary of Safety and Effectiveness for: Aegis Navigation and Aegis Pelvic Application
I. Manufacturer
DEC 1 1 2009
Sentinelle Medical Inc. 555 Richmond Street West. Suite 800, P.O. Box 301, Toronto, ON Canada M5V 3B1
II. Contact Person
Joan Medley Director, Regulatory and Quality Tel: (647)258-3606 Fax: (416) 594-9696
III. Product Name/Classification Name
Product Name: Aegis Navigation Aegis Pelvic Application Common Name: Medical Image Processing Software System Classification Name: Image processing system, Class II'as described in CFR 21 892.2050 Product Code: LLZ
IV. Date Prepared
November 16, 2009
V. Device Description
Aegis Navigation and Aegis Pelvic Application products are line-extensions to Sentinelle's medical image software product Aegis. These are also referred to below as (Aegis) plug-ins.
The products are designed to assist with multi-modality (including MRI, US, SPECT, CT, PET, Fluoroscopy, Endoscopy and others) imaging and guidance of screening and interventional procedures for anatomical structures such as head and neck, thoracic, breast, abdominal and pelvis(including prostate).
Aegis Pelvic Application is a software tool intended for analyzing multi-modality images. This plug-in also identifies where and how deeply, a biopsy or localization needle should be inserted into a region of interest (including prostate and surrounding structures) to strike a target or region of interest. Registration of target anatomy with an interventional device can be performed manually or automatically based on fiducial markers. This in turn provides a calculation of the location and depth of the targeted region of interest.
Similarly, Aegis Navigation is a software tool intended for analyzing multi-modality images. This plug-in also identifies where an imaging device (e.g. an ultrasound transducer), interventional tool (e.g. a biopsy or localization needle) or other tracked instrument should be placed in order to visualize or strike a target or region of interest. In addition, Aegis Navigation provides the user with the option to view previously acquired DICOM data (e.g. MRI data) alongside of a separate imaging modality such as Ultrasound (US) or a fluoroscopic device. In the context of US, a 3-D
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Image /page/1/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The word "sentinelle" is in a larger font than the word "MEDICAL", which is stacked below it. The geometric shape appears to be an abstract representation of a medical device or symbol.
510 (k) Premarket Notification Sentinelle Aegis Navigation and Pelvic Application Submitter: Sentinelle Medical Inc. November 16, 2009
tracking system provides positional data regarding the transducer, which is used to guide the real-time reformatting of DICOM data to match the current US image. Interventional and imaging device operation and manipulation remains under the manual control of the trained medical professional at all times.
Additional applications of Aegis Navigation include:
- The ability to display the position of a tracked probe or instrument, overlaid on DICOM . (e.g.MR or CT) data
- The ability to track the position of an US transducer as it collects data, then retrospectively display reformatted DICOM (e.g. MR/CT) data slices oriented to match the previously acquired ultrasound images.
VI. Intended Use
This device provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. Supported imaging modalities include Magnetic Resonance (MR), Ultresound (US), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CTT), Position Emission Tomography (PET), Fluoroscopy and Endoscopy. Images and data are receive from various imaging systems and other sources such as calibrated spatial positioning devices.
This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to biopsv needles, guidance wires, imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications (including pelvis).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA,
VII. Substantial Equivalence
| Sentinelle's Aegis Navigation and Aegis Pelvic Application are substantially equivalent to: | |
|---|---|
| --------------------------------------------------------------------------------------------- | -- |
| Device Name: | Eigen 3D-Imaging Workstation |
|---|---|
| Manufacturer: | Eigen LLC |
| 510(k) Number: | K081093 |
| Decision Date: | May 1, 2008 |
| Decision: | Substantially Equivalent |
| Device Name: | Aegis |
|---|---|
| Manufacturer: | Sentinelle Medical Inc. |
| 510(k) Number: | K070244 |
| Decision Date: | February 9, 2007 |
| Decision: | Substantially Equivalent |
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Image /page/2/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 form a three-dimensional structure. The word "sentinelle" is in a larger font than the word "MEDICAL", which is stacked below it.
510 (k) Premarket Notification Sentinelle Aegis Navigation and Pelvic Application Submitter: Sentinelle Medical Inc. November 16, 2009
| -------------------0000 | mulsionISTPA 800 400 | |
|---|---|---|
| -----------All And Allant------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 40.0014 | lecision |
Sentinelle's Aegis Navigation and Aegis Pelvic Application are software plug-ins for use in conjunction with our legally marketed device, Sentinelle Aegis [K070244]. As such, Aegis Navigation and Aegis Pelvic Application inherit much of their functionality from the approved device.
Table 2 lists the technological characteristics, as derived from the Indications for Use and the Device Description of Aegis Navigation and Aegis Pelvic relative to the Sentinelle Aegis, Eigen 3D-Imaging Workstation and Traxtal Abaris predicate devices. The technological characteristics of Aegis Navigation and Aegis Pelvic Applications are the same or equivalent to those found in the predicate devices, as demonstrated in Table 2 below.
A high level summary of the comparison is as follows:
-
- From the Aegis predicate to the current submission, clinical screening and interventional capabilities are extended to include any anatomical structures where imaging is currently used for visualizing such structures. All of the visualization, analysis, measurement and display functionality employed are equivalent to the Aegis predicate device so no new issues of safety and effectiveness arise for screening. For interventional guidance, registration of MR image DICOM coordinates to physical patient coordinates is done using the same functionality as the Aegis predicate. This, combined with the conducted test results show that the software is accurate and functions as specified, and no new issues of safety and effectiveness arise.
-
- From the Aegis predicate to the current submission, Aegis Navigation adds the ability to manipulate image display based on tracked data acquired from 3D positioning devices. The interface to the positional tracking device is accomplished in the same manner as the Abaris predicate, and the registration of spatially tracked instruments to coordinates in the image space is accomplished in the same manner as the Abaris and Eigen predicates. This, combined with the conducted registration and targeting tests of Aegis Navigation show that spatial tracking functionality is accurate, functions as specified, and no new issues of safety and effectiveness arise.
The device labeling includes the Operator's Guide (User Manual) which includes indications for use, cautions, warnings, contraindications and instructions. This information assures safe and effective use of the device.
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Image /page/3/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The word "sentinelle" is in a larger font than the word "MEDICAL", which is stacked below it. The geometric shape is made up of several lines and appears to be a stylized representation of a medical symbol.
Sentinelle Aegis Navigation and Pelvic Application Submitter: Sentinelle Medical Inc. November 16, 2009
VIII. Testing and Performance Data
Testing for Aegis Navigation and Aegis Pelvic Application was performed to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms or volunteers to obtain the functional and accuracy test results.
Registration accuracy tests were performed to ensure that the registration and correspondence between MR and ultrasound meets or exceeds specified criteria. Needle verification tests were also performed to ensure that needle registration and targeting results met or exceeded specified criteria. The test methodology employed was identical to that of the Aegis predicate device, conducted by targeting locations within a phantom and confirming that the selected target location/needle location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device. The completed test procedures and results are presented in the following appendices:
Appendix Z1a - Navigation Software Verification Specifications [SMI-0997] Appendix Z1b- Navigation Software Verification Results (SMI-0337) Appendix Z1c - Navigation System Accuracy Specifications [SMI-0258] Appendix Z1d - Navigation System Accuracy Test Results [TR-0326] Appendix Z2a & Z2b - Pelvic Software Verifications including Accuracy [SMI-917] Appendix Z2c - Pelvic Software Verification Results including Accuracy [SMI-1059]
Aegis Navigation and Aegis Pelvic Application's indications for use are a combination of the indications for use of three legally marketed predicate devices: Sentinelle's Aegis, Traxtal's Abaris and Eigen's 3D-Imaging Workstation. Aegis Navigation and Aeqis Pelvic Application combine the features of these predicate devices and do not provide novel functionality.
As such, the features provided by Aegis Navigation and Aegis Pelvic Application do not in themselves raise new concerns of safety or effectiveness.
Test Conclusion
The results of these tests demonstrate that the system accuracy is within specification and performs as well as, or better than Aegis, the legally marketed predicate device. Comparison to the other predicate devices is not directly possible since the testing methodology and accuracy specifications are not publicly available. Over two years of extensive clinical use of the Aegis predicate device shows that the specified accuracy and the accuracy testing methodology of the Aegis predicate provide safe and effective targeting of instruments to image-identified target locations.
As such, Aegis Navigation and Pelvic Application software plug-ins are as safe and effective as the predicate devices and are substantially equivalent to existing products on the market today. The software performs as well as, or better than legally marketed predicate devices.
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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
Sentinelle Medical, Inc. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K093672
Trade/Device Name: Sentinelle Aegis Navigation & Sentinelle Aegis Pelvic Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 25, 2009 Received: November 27, 2009
DEC 1 1 2009
Dear Mr. Rongero:
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 (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical
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Enclosure
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/6/Picture/0 description: The image shows the logo for Sentinelle Medical. The logo consists of a geometric shape on the left and the words "sentinelle MEDICAL" on the right. The geometric shape is a complex, three-dimensional figure made up of lines and curves. The word "sentinelle" is in a larger font than the word "MEDICAL", which is stacked below it.
510 (k) Premarket Notification Sentinelle Aegis Navigation and Pelvic Application Submitter: Sentinelle Medical Inc. October 28, 2009
Indication(s) For Use
510(k) Number:
Ko93672
Device Name:
Sentinelle Aegis Navigation & Sentinelle Aegis Pelvic Application
Indications for Use:
This device provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. Supported imaging modalities include Magnetic Resonance (MR), Ultrasound (US), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CT), Positron Emission Tomography (PET), Fluoroscopy and Endoscopy. Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.
This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, guidance wires, imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications (including pelvis).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Prescription Use (Part 21 CFR 801 Subpart D): AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
of Reproductive, Abdominal and
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).