(22 days)
The ImagenMD™ with ImagenQ™ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
ImagenMD™ with ImagenQ™ is a Windows software application which allows physicians and healthcare professionals to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The user can perform quality assessments, automatically and manually select myocardial boundaries and alignment, and visualize the results of quantitative perfusion calculations. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
This submission, K080770, describes the ImagenMD™ with ImagenQ™ system, a Windows software application designed to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, the provided text does not contain information regarding
acceptance criteria, a specific study proving the device meets said criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or details on how ground truth was established for training.
The submission primarily states that the device is "equivalent to the predicates" based on "testing and comparison of technological characteristics and intended uses." This implies that the device's functionality and output are comparable to existing, legally marketed devices, rather than establishing numerical performance metrics against pre-defined acceptance criteria.
Based on the provided text, the following information can be extracted/deduced:
-
A table of acceptance criteria and the reported device performance:
- Not provided. The submission asserts substantial equivalence to predicate devices without detailing specific performance metrics or acceptance criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The submission does not describe a clinical performance study with a defined test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment process is described in the provided document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is described.
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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:
- Not provided. No MRMC study is mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not provided. The device is described as assisting qualified healthcare providers, implying it's not a standalone diagnostic tool, and no standalone performance study is detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. No information on ground truth is available.
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The sample size for the training set:
- Not provided. No information on a training set is available.
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How the ground truth for the training set was established:
- Not provided. No information on a training set or its ground truth establishment is available.
In summary, this 510(k) submission focuses on demonstrating substantial equivalence by comparing technical characteristics and intended uses to existing predicate devices, rather than presenting a detailed performance study with quantifiable acceptance criteria.
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APR - 9 2008
5. 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
General Information:
| A. | Submitted By: | Cardiovascular Imaging Technologies4320 Wornall Road, Suite 55Kansas City, MO 64111Tel: 816-531-2842Fax: 816-531-0643 |
|---|---|---|
| Contact Person: | James A. Case | |
| Date Prepared: | March 17, 2008 | |
| B. | Device Trade Name: | ImagenMD™ with ImagenQ™ |
| Classification Name: | System, Emission Computed Tomography21 CFR 892.1200 (KPS)System, Image Processing, Radiological21 CFR 892.2050 (LLZ) | |
| C. | Predicate Devices: | ECAT LSO PET/CT 16EMORY Cardiac Toolbox |
Device Description: D.
ImagenMD™ with ImagenQ™ is a Windows software application which allows physicians and healthcare professionals to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The user can perform quality assessments, automatically and manually select myocardial boundaries and alignment, and visualize the results of quantitative perfusion calculations. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
- Indications for Use: E.
The ImagenMD™ with ImagenQ™ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
Page 13 of 95
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Comparison of Technical Characteristics to Predicate Device: F.
The ImagenMD™ with ImagenQ™ system and its predicates, the ECAT LSO PET/CT 16 and the Emory Cardiac Toolbox™ utilize the same type of data sets for analysis and calculation of data. -
H. Summary:
Testing and comparison of technological characteristics and intended uses found that all components of the ImagenMD™ with ImagenQ™ system are equivalent to the predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2008
Cardiovascular Imaging Technologies % Ms. Melanie Hasek Manager, Regulatory Affairs PRA International 9755 Ridge Drive LENEXA KS 66219
Re: K080770
Trade/Device Name: ImagenMD™ with ImagenQTM Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: LLZ Dated: March 17, 2008 Received: March 25, 2008
Dear Ms. Hasek:
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 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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4. Indications for Use:
Indications for Use
Page 1 of 1
2080770 510(k) Number (if known): _
Device Name: ImagenMDTM with ImagenQTM
Indications For Use:
The ImagenMD™ with ImagenQ™ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atmor M. Whing
(Division/Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 12 of 95
§ 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).