(31 days)
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.
ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. 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.
The provided text does not contain any information about acceptance criteria, device performance metrics, or any study design details.
The document is a 510(k) summary for the ImagenPRO™ system, which is a software application for viewing, reconstructing, and reorienting myocardial perfusion PET images. The focus of the provided text is on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
The key points from the provided text are:
- Device Description: ImagenPRO™ is a software application for inspecting, reconstructing, and reorienting myocardial perfusion PET images.
- Indications for Use: To visualize raw PET/CT data, reconstruct myocardial perfusion PET/CT images, and reorient PET/CT reconstructed tomograms.
- Predicate Devices: Siemens/CTI Accel (K002584) and GE Discovery LS (K023988).
- Substantial Equivalence: The document states that "Testing and comparison of technological characteristics and intended uses found that all resting and companison of won™ system are equivalent to the predicates." This is the primary "proof" presented, but it's a comparison of characteristics and intended uses, not a performance study against specific acceptance criteria.
- FDA Clearance: The letter confirms the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text.
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MAR 1 7 2005
VII. 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 | |
| B. | Device Trade Name: | ImagenPRO™™ |
| Classification Name: | System, Emission Computed Tomography | |
| C. | Predicate Devices: | Siemens/CTI Accel -- CPS Innovations - K002584GE Discovery LS - General Electric - K023988 |
D. Device Description:
ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. 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.
-
E. Indications for Use:
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT rcconstructed tomograms. -
F. Comparison of Technical Characteristics to Predicate Device:
The ImagenPRO™ system and its predicates, the Siemens e.cat and the GE Discovery LS utilize the same type of data sets for analysis and calculation of data.
Page 71 of 99
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Summary: H.
Testing and comparison of technological characteristics and intended uses found that all resting and companison of won™ system are equivalent to the predicates.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.
Public Health Service
MAR 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiovascular Imaging Technologies % Ms. Melanie Hasek Sr. Regulatory Affairs Specialist Regulatory/Clinical Consultants, Inc. 200 NE Mulberry LEE'S SUMMIT MO 64086
Re: K050366
Trade/Device Name: ImagenPROTM System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: KPS and LLZ Dated: February 14, 2005 Received: February 14, 2005
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 (Premarket Approval), 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 (Scctions 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) Fills letter with and in you've organ and cquivalence of your device of your device to a legally prematice nodicate 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 If you desire specific act 100 for your as 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 007. 77. " ou may obtain varers, 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/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
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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I. Indications for Use:
Indications for Use Form
Page 1 of 1
510(k) Number (if known): K150366
Device Name: ImagenPRO™
Indications For Use:
The ImagenPRO™ system is software that allows the user to visualize raw PET and/or The Indigent RO - System is beforeial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.
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)
Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0503(da
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.