(145 days)
Not Found
No
The description focuses on standard image processing techniques (reconstruction, reorientation, motion correction, filtering) and does not mention AI, ML, or related terms. The performance studies compare the device to predicates based on technological characteristics and image quality, not AI/ML performance metrics.
No
The device is a software application for processing and displaying cardiac SPECT images, which aids in determining the presence of cardiac diseases, but it does not directly treat or alleviate a medical condition.
Yes
The system's intended use explicitly states, "The results of this processing may be used in determining the presence of cardiac diseases," indicating its role in diagnosis.
Yes
The device is described as a "software application" that processes data from a separate hardware device (nuclear medicine gamma camera). It does not include or require any specific hardware components for its operation beyond a standard computer workstation.
Based on the provided information, the ImagenSPECT™ system is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the results of the processing "may be used in determining the presence of cardiac diseases." This indicates that the software is providing information that will be used in a diagnostic process.
- Input Data: The system processes data derived from a "nuclear medicine gamma camera," which is a medical imaging device used to acquire data from a patient.
- Processing and Analysis: The software performs processing and analysis of this data to create visualizations and potentially other outputs that aid in diagnosis.
While the system itself is software and doesn't directly interact with a biological sample in vitro, the data it processes originates from a diagnostic procedure performed on a patient. The software's function is to process and present this data in a way that assists a qualified healthcare provider in making a diagnosis. This aligns with the definition of an IVD, which includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes.
The fact that it processes data from a nuclear medicine gamma camera and the output is used to help determine the presence of cardiac diseases strongly points towards its classification as an IVD.
N/A
Intended Use / Indications for Use
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.
Product codes (comma separated list FDA assigned to the subject device)
KPS, LLZ
Device Description
ImagenSPECTTM is a Windows application which allows physicians and healthcare professionals to inspect. reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter setting, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. 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.
The ImagenSPECT™ system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine gamma camera (SPECT images)
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing and comparison of technological characteristics and intended uses found that all components of the ImagenSPECT™ system are equivalent to the predicates. In addition, half-count density (full-time scan, half dose/ half-time, full dose), reconstructed with ImagenSPECT using resolution recovery, iterative reconstruction was equivalent to the predicate with the same claim (AutoSPECT with Astonish, K090403).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ADAC JETStream (K061029), Siemens e.Cam Computer/e.Soft Workstation (K023190), Philips AutoSPECT with Astonish (K090403)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2016
Cardiovascular Imaging Technologies % Ms. Melanie Hasek Manager, Regulatory Publishing PRA Health Sciences 9755 Ridge Drive LENEXA KS 66219
Re: K152503
Trade/Device Name: ImagenSPECT™ Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, LLZ Dated: January 7, 2016 Received: January 8, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page_1_of_1_
SEE UPDATED PDF FORM
510(k) Number (if known): __K152503
Device Name: ImagenSPECT™
Indications For Use:
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.
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)
3
6. 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 Technologies
4320 Wornall Road, Suite 55
Kansas City, MO 64111
Tel: 816-531-2842
Fax: 816-531-0643 |
|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | James A. Case |
| | Date Prepared: | September 1, 2015 |
| B. | Device Trade Name: | ImagenSPECT™ |
| | Classification Name: | System, Emission Computed Tomography
21 CFR 892.1200 (KPS)
System, Image Processing, Radiological
21 CFR 892.2050 (LLZ) |
| C. | Predicate Devices: | ADAC JETStream (K061029)
Siemens e.Cam Computer/e.Soft Workstation
(K023190)
Philips AutoSPECT with Astonish (K090403) |
D. Device Description:
ImagenSPECTTM is a Windows application which allows physicians and healthcare professionals to inspect. reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter setting, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. 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.
The ImagenSPECT™ system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation.
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E. Indications for Use:
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. -
F. Comparison of Technical Characteristics to Predicate Device:
The ImagenSPECT™ system and its predicates, the e.Cam/e.Soft™ system, the JETStream™ and Astonish™ 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 ImagenSPECT™ system are equivalent to the predicates. In addition, half-count density (full-time scan, half dose/ half-time, full dose), reconstructed with ImagenSPECT using resolution recovery, iterative reconstruction was equivalent to the predicate with the same claim (AutoSPECT with Astonish, K090403).