(87 days)
The clinical application package 2D Cardiac Performance Analysis MR is indicated for cardiac quantification based on digital magnetic resonance images. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagnosis purposes of patients with suspected heart disease.
2D Cardiac Performance Analysis MR (=2D CPA MR) is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 2D CPA MR is a software for the analysis, storage and retrieval of digitized magnetic resonance (MR) images.
The data can be acquired by cardiac MR machines. The digital 2D data can be used for comprehensive functional assessment of the myocardial function.
2D CPA MR is designed to run with a TomTec Data Management Platform (Image-Arena™, their derivatives or any other platform that provides and supports the Generic CAP Interface. The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.
The TomTec Data Management Platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities.
2D CPA MR is designed for the 2-dimensional functional analysis of myocardial deformation. Based on two dimensional datasets a feature tracking algorithm supports the calculation of a 2D contour model that represents the endocardial and epicardial border. From these contours the corresponding velocities, displacement and strain can be derived.
Here's an analysis of the acceptance criteria and study information for the 2D Cardiac Performance Analysis MR 1.0 device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, or specificity values). Instead, the acceptance criteria appear to be qualitative, focusing on equivalence to predicate devices and confirmation through internal testing and literature review.
Acceptance Criteria (Implicit from the document):
- Safety and Effectiveness: The device must be as safe and effective as the predicate devices.
- Performance Equivalence: The device must perform as well as or better than the predicate devices regarding myocardial function analysis (displacement, velocity, strain, strain rate).
- Clinical Acceptance: The overall product concept must be clinically accepted.
- Risk-Benefit Assessment: The benefit of using the device must be superior to the risk (with risk being low).
- Published Data Relevance: Published data must be relevant and applicable to the device characteristics and intended medical procedure.
- Claim Substantiation: Claims made in the device labeling must be substantiated by clinical data.
- Software Verification: All software requirements are tested and meet required pass/fail criteria.
Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| As safe and effective as predicate devices. | "The conclusion states that: ... The overall product concept was clinically accepted and the clinical test results support the conclusion that the Subject Device is as safe as effective, and performs as well as the Predicate Devices." "Test results support the conclusion, that the Subject Device is as safe as effective, and performs as well as or better than the Predicate Devices." |
| Performs as well as or better than predicate devices regarding myocardial function analysis. | "The Subject Device provides measurements to analyze the myocardial function on cardiac magnetic resonance images like Predicate Device 1 (K090461) and Predicate Device 2 (K100352)." "The tracking technology of the Subject Device is sensitive enough to track the grey value patterns of regular MRI, thus eliminating the need of additional acquisition of tagged images, which are usually the basis for Predicate Device 2 (K100352)." "The tracking of the Subject Device delivers contours of different regions of the myocardium like in Predicate Device 1 (K090461) and Predicate Device 2 (K100352)." "Based on the tracking results regional measurements like strain can be derived like in Predicate Device 1 (K090461) and Predicate Device 2 (K100352)." "The 2D feature tracking method based on 2D MR image data is already published. The use is as accurate as standard procedures such as HARP (for MR) or 2D speckle tracking (for echo) and it is feasible for clinical practice." |
| Overall product concept is clinically accepted. | "The overall product concept was clinically accepted and the clinical test results support the conclusion that the Subject Device is as safe as effective, and performs as well as the Predicate Devices." |
| Benefits superior to risks. | "The Risk-Benefit Assessment shows that the benefit is superior to the risk (whereas the risk is low)." |
| Published data is relevant and applicable. | "The clinical evaluation shows that the published data are relevant and applicable to the relevant characteristics of the device under assessment and the medical procedure for which the device is intended." |
| Claims made in device labeling are substantiated. | "The claims made in the device labelling are substantiated by the clinical data." |
| All software requirements are tested and meet required pass/fail criteria (Non-clinical performance). | "Test results meet the required pass/fail criteria." "All software requirements are tested or otherwise verified." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "clinical performance data testing" and a "clinical evaluation following the literature route." However, it does not specify a sample size for a dedicated test set in the traditional sense of a clinical trial. Instead, it relies on a review of published literature and a comparison to predicate devices.
- Sample Size: Not specified for a dedicated test set. The clinical evaluation was based on a "literature route."
- Data Provenance: Not explicitly stated (e.g., country of origin). The data provenance is implied to be from published literature. The study is retrospective in the sense that it reviews existing published data.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth for a test set. Since the clinical evaluation relied on a literature review, the "ground truth" would implicitly come from the studies and methods described in the published literature, which would have their own expert-derived ground truths.
4. Adjudication Method for the Test Set
As there is no described dedicated "test set" with expert review for adjudication, no adjudication method is mentioned or applicable in the context of this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is described that measures how much human readers improve with AI vs. without AI assistance. The submission focuses on the standalone performance of the device and its comparability to predicate devices and established techniques, not on human-in-the-loop performance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance assessment was done. The document states:
- "The 2D feature tracking method based on 2D MR image data is already published. The use is as accurate as standard procedures such as HARP (for MR) or 2D speckle tracking (for echo) and it is feasible for clinical practice."
- This implies that the algorithm's performance (its accuracy) was evaluated against established "standard procedures" (like HARP for MR) in published literature. While no specific study details are given within this document, the reliance on a "literature route" for clinical evaluation suggests that earlier standalone performance studies of this 2D feature tracking method were reviewed and deemed acceptable.
7. Type of Ground Truth Used
The type of ground truth is indirectly pathology or expert consensus, derived from the "standard procedures" used in the referenced literature. The document notes that the device is "as accurate as standard procedures such as HARP (for MR)." The ground truth for these standard procedures typically comes from:
- Expert Consensus/Manual Contours: For imaging-based measurements, manual contouring by expert clinicians is often the gold standard. The device itself requires a manually drawn contour as a prerequisite for its calculations.
- Pathology/Outcomes Data: While not directly mentioned for the device's validation, the "diagnostic purposes of patients with suspected heart disease" implies that, ultimately, the clinical utility of the measurements would relate to patient outcomes or confirmed pathology.
8. Sample Size for the Training Set
The document does not specify a sample size for any training set. Given that the core technology (2D feature tracking) is described as "already published," it's highly probable that such a method would have been developed and trained using various datasets. However, these details are not provided in this 510(k) summary.
9. How Ground Truth for the Training Set Was Established
Since no training set is described, the method for establishing its ground truth is also not provided in this document.
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Image /page/0/Picture/1 description: The image shows the logo for TOMTEC IMAGING SYSTEMS. The logo is in black and white. The word "TOMTEC" is in large, bold letters, with the "T" in "TOMTEC" being connected to the "M". Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller letters.
APR 1 3 2012
April 11th, 2012
Traditional 510(k) Summary
2D Cardiac Performance Analysis MR 1.0
Owner's Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
Contact Person
Inge Scheidt QM & RA Officer Phone Phone ++49-89-32175-515 ++49-89-32175-750 Fax
Common, Classification & Proprietary Names
Common Name: Various Image Analysis System Software Classification Name: Picture Archiving and Communications System Proprietary Name(s): 2D Cardiac Performance Analysis MR 1.0
Predicate Devices
| Predicate Device 1 | K090461 | Image-Arena 4.0 and Image-ArenaApplications 2D Cardiac PerformanceAnalysis, TomTec2D Cardiac Performance Analysiscomponent, only |
|---|---|---|
| Predicate Device 2 | K100352 | Diagnosoft HARP 2.06, Diagnosoft, Inc. |
The Subject Device "2D Cardiac Performance Analysis MR 1.0" is an adapted version of the Predicate Device 1 (K090461) 2D Cardiac Performance Analysis 1.0. It is adapted to the use with magnetic resonance images (MRI).
A central component of the Subject Device is the tracking which is also provided in Predicate Device 2 (K100352) Diagnosoft HARP 2.06 based on magnetic resonance images.
Image /page/0/Picture/16 description: The image shows a series of black, right-angle shapes arranged in a winding pattern. The shapes are closely packed together, creating a sense of movement or direction. The overall impression is abstract and geometric. The shapes are all the same size and orientation.
510(k) Summary
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Image /page/1/Picture/1 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features the word "Tomtec" in large, bold letters. Below the word "Tomtec" are the words "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
Device Description
2D Cardiac Performance Analysis MR (=2D CPA MR) is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 2D CPA MR is a software for the analysis, storage and retrieval of digitized magnetic resonance (MR) images.
The data can be acquired by cardiac MR machines. The digital 2D data can be used for comprehensive functional assessment of the myocardial function.
2D CPA MR is designed to run with a TomTec Data Management Platform (Image-Arena™, their derivatives or any other platform that provides and supports the Generic CAP Interface. The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.
The TomTec Data Management Platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities.
2D CPA MR is designed for the 2-dimensional functional analysis of myocardial deformation. Based on two dimensional datasets a feature tracking algorithm supports the calculation of a 2D contour model that represents the endocardial and epicardial border. From these contours the corresponding velocities, displacement and strain can be derived.
Intended Use
2D CPA MR software is intended for quantification of the myocardial deformation (strain) and movement (displacement / velocity) for digital magnetic resonance images. Possible quantification results are velocity, displacement, strain rate, time-to-peak and phase.
Prerequisite is to draw a contour (endocard or endocard and epicard) in a digital magnetic resonance image. Based on this manual drawn contour, the SW calculates with a tracking algorithm the borders' displacement.
Indication for Use
2D Cardiac Performance Analysis is intended for cardiac quantification based on magnetic resonance images. It provides measurements of myocardial function (displacement, velocity, strain, strain rate) that is used for diagnostic purposes of patients with suspected heart disease.
Technological Characteristics Comparison
The actual submission combines the advantages of the FDA cleared software products:
| Predicate Device 1 | K090461 | Image-Arena 4.0 and Image-ArenaApplications 2D Cardiac PerformanceAnalysis, TomTec2D Cardiac Performance Analysiscomponent, only |
|---|---|---|
| -------------------- | --------- | -------------------------------------------------------------------------------------------------------------------------------------------------- |
Image /page/1/Picture/16 description: The image shows a series of black, right-angled shapes arranged in a somewhat linear, curving pattern. The shapes are oriented in different directions, creating a dynamic and almost chaotic visual effect. The shapes are closely packed together, with some overlapping, which adds to the complexity of the overall composition.
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Image /page/2/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
| Predicate Device 2 | Commend Company Company Comments of Concessful Collection Company Controller Company Controlled Concession Comparison Comparison Comparison Comparis Comparis Comparis CompariK100352. | Diagnosoft HARP 2.06, Diagnosoft, Inc. | |
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A |
The Subject Device provides measurements to analyze the myocardial function on cardiac magnetic resonance images like Predicate Device 1 (K090461) and Predicate Device 2 (K100352).
The tracking technology of the Subject Device is sensitive enough to track the grey value patterns of regular MRI, thus eliminating the need of additional acquisition of tagged images, which are usually the basis for Predicate Device 2 (K100352). The tracking of the Subiect Device delivers contours of different regions of the myocardium like in Predicate Device 1 (K090461) and Predicate Device 2 (K100352).
Based on the tracking results regional measurements like strain can be derived like in Predicate Device 1 (K090461) and Predicate Device 2 (K100352).
The parameters can be expressed in their spatial directions (e.g. circumferential, radial) like in Predicate Device 1 (K090461) and Predicate Device 2 (K1003526).
An overlay of the tracked contours as well as graph displays for the measured parameters are available like in Predicate Device 1 (K090461) and Predicate Device 2 (K100352). The Subject Device is connected to the data management platform via the Generic Clinical Application Package Interface like Predicate Device 1 (K090461).
Discussion according non-clinical performance data testing
Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted.
The test procedure was performed according to the Project Quality Plan. Test results were reviewed by designated technical professionals before software proceeded to release.
The results are summarized in the test summary report. The conclusion states that:
- Verification strategies and test procedures used are appropriate ।
- Software system test procedures trace to software requirements -
- All software requirements are tested or otherwise verified -
- Test results meet the required pass/fail criteria -
Discussion according clinical performance data testing
The overall product concept was clinically accepted and the clinical test results support the conclusion that the Subject Device is as safe as effective, and performs as well as the Predicate Devices.
A clinical evaluation following the literature route based on the assessment of benefits, associated with the use of the device, was performed. The clinical evaluation shows that the published data are relevant and applicable to the relevant characteristics of the device under assessment and the medical procedure for which the device is intended.
120135
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Image /page/3/Picture/1 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" are the words "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used on the company's website and marketing materials.
Risk analysis aspects were treated in the risk management report. Based on this document the existing applied methods in the literature and the newly described techniques of the product (which are considered in the risk analysis) were evaluated.
No further risks were identified.
Conclusion from the analysis of the literature review
- The Risk-Benefit Assessment shows that the benefit is superior to the risk � (whereas the risk is low).
- The 2D feature tracking method based on 2D MR image data is already published. . The use is as accurate as standard procedures such as HARP (for MR) or 2D speckle tracking (for echo) and it is feasible for clinical practice.
- The quantitative results have been discussed controversial with existing methods. .
- The approach of drawing manual contour on standard MR images combined with . a 2D feature tracking doesn't change the clinical intention of the product. The workflow reduces time in contrast to dedicated MRI examination such as tagged imaging or late enhancement imaging.
- The data are sufficient to demonstrate compliance with the essential requirements t covering safety and performance of the device in question under normal conditions of use.
- The claims made in the device labelling are substantiated by the clinical data. .
Test Conclusions of non-clinical and clinical performance data
Test results support the conclusion, that the Subject Device is as safe as effective, and performs as well as or better than the Predicate Devices.
No reportable events or problems for the Predicate Devices exist. The overall product concept was clinically accepted and the test results support the conclusion that the Subject Device is as safe as effective and performs as well as the Predicate Devices.
Munich, April 11th, 2012
Inge Scheidt QM & RA Officer
510(k) Summary
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three birds in flight, arranged in a diagonal line.
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
APR 1 3 2012
Ms. Inge Scheidt OM & RA Officer TomTec Imaging Systems GmbH Edisonstrasse 6, Unterschleissheim Bavaria D-85716 GERMANY
Re: K120135
Trade/Device Name: 2D Cardiac Performance Analysis MR 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 13, 2012 Received: January 17, 2012
Dear Ms. Scheidt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your 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 and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
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
K120135 510(k) Number (if known):
Device Name:
2D Cardiac Performance Analysis MR 1.0
Indications for Use:
The clinical application package 2D Cardiac Performance Analysis MR is indicated for cardiac quantification based on digital magnetic resonance images. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagnosis purposes of patients with suspected heart disease.
Samu
(Division Sign-Off)
Division of Radiological Devices
of Radiological Devices Divisio Office of In nostic Device Evaluation and Safety Vitro D
510K K120135
Prescription Use X · (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 PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).