(36 days)
The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to: 1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images 2. Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc. The CAAS MRV has been designed to be used in everyday clinical practice, as well as for research purposes like clinical research trials.
The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.
The provided text describes the CAAS MRV software package, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, or performance metrics.
The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical validation study.
Based on the available information, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
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Acceptance Criteria: Not explicitly stated in the document as quantitative criteria with thresholds. The key "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a predicate device.
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Reported Device Performance: The document states that "CAAS MRV is substantially equivalent to the quantitative analysis software package MRI-Magnetic resonance Analytical Software System, K994283." It also mentions that the CAAS MRV "is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use."
Acceptance Criteria (Inferred from 510(k)) Reported Device Performance Substantial equivalence to predicate device (K994283) in technological characteristics and intended use CAAS MRV found substantially equivalent to predicate device Ability to delineate inner/outer ventricle walls and papillary muscles (auto/semi-auto) Device provides functionality to "determine" inner and outer wall and papillary muscles (auto/semi-auto/manual) Ability to derive global/regional functional parameters (EF, SV, Wall Movement) Device determines ventricular volume, ejection fraction, and other related parameters; quantifies wall motion Missing:
- Specific quantitative performance metrics (e.g., accuracy, precision, inter-observer variability, intra-observer variability) for measurements like Ejection Fraction, Stroke Volume, Wall Movement compared to a gold standard or the predicate device.
- Defined thresholds for these metrics (e.g., "Ejection Fraction measurement will be within X% of the true value").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing: The document does not provide any information about a specific test set, its sample size, or data provenance. This level of detail is typically part of a separate validation report, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: This information is not provided. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: This information is not provided.
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:
- No evidence: The document does not mention a multi-reader, multi-case comparative effectiveness study. The focus is on the device's inherent capabilities and its equivalence to a predicate, not on human-with-AI vs. human-without-AI performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied primary function: The device's description highlights its ability to "determine" ventricular parameters "either automatically, semi-automatically or manually." This suggests that a standalone (automatic algorithm only) performance would be a component of its functionality. However, specific standalone performance metrics from a study are not reported in this document. The 510(k) emphasizes its use by a user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Missing: This information is not provided. Given that the device analyzes MRI images, a likely ground truth would involve expert manual contouring and calculation, but this is speculative based on the document.
8. The sample size for the training set:
- Missing: This information is not provided. The document does not discuss training data for the algorithms.
9. How the ground truth for the training set was established:
- Missing: This information is not provided.
In summary:
This 510(k) submission primarily demonstrates that CAAS MRV is "substantially equivalent" to an already marketed device (MRI-Magnetic resonance Analytical Software System, K994283) in terms of its intended use and technological characteristics. It outlines the device's functions (automatic/semi-automatic/manual delineation, calculation of parameters like EF, SV, wall movement) but does not provide the detailed validation study results, specific acceptance criteria with quantitative thresholds, sample sizes for test/training sets, ground truth establishment methods, or expert qualifications that you requested. These details would typically be found in a more comprehensive technical report or validation study that underpins such a submission, but are not included in the provided 510(k) summary or FDA clearance letter.
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K041-682
This summary statement complies with 21CFR, section 807.92(c). Date summary prepared: 19 March 2004
This premarket notification has been submitted by Pie Medical Imaging BV and covers the CAAS MRV software package. Pie Medical Imaging is located at:
JUL 27 2004
| Pie Medical Imaging BV |
|---|
| Becanusstraat 13 D 01 |
| 6216 BX Maastricht |
| The Netherlands |
| Phone +31.43.3281328 |
| Fax +31.42.3281329 |
| Email: carla.devries@pie.nl |
| The contact person is: | Ms. Carla de Vries, Quality Assurance Officer |
|---|---|
| The trade name is: | CAAS MRV |
| The common name is: | Magnetic Resonance Ventricular analysis software |
| The classification name is: | Image Processing System (LLZ), CFR 892.2050. |
The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II.
The CAAS MRV software package is substantially equivalent to the quantitative analysis software package MRI-Magnetic resonance Analytical Software System, K994283.
The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.
The intended use of CAAS MRV is to enable the user to:
-
Delineate the inner and outer wall of the ventricles automatically or semi-automatically, as well as the papillary muscles, on MRI images
-
Derive from these contours the global and regional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc.
The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
The CAAS MRV is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use.
The CAAS MRV is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.
SoftSol Doc. 12556
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2004
Ms. Carla de Vries Quality Assurance Officer Pie Medical Imaging bv Becanusstraat 13D 6216 BX Maastricht THE NETHERLANDS
Re: K041682 Trade/Device Name: CAAS MRV Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 14, 2004 Received: June 21, 2004
Dear Ms. de Vries:
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. Ilsting 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 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.
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.
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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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brygdon
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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510(k) Notification - CAAS MRV
| INDICATION FOR USE STATEMENT | page 1 of 1 | |
|---|---|---|
| 510(k) number (if known): | K041682 | |
| Device Name: | CAAS MRV | |
| Indications For Use: |
The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to: 1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images
- Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc.
The CAAS MRV has been designed to be used in everyday clinical practice, as well as for research purposes like clinical research trials.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Sypm
(Division Sign-Off) Division of Reproductive, Abde and Radiological Devic 510(k) Number -
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
12552
§ 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).