ImagenSPECT

K152503 · Cardiovascular Imaging Technologies · KPS · Jan 25, 2016 · Radiology

Device Facts

• Record ID: K152503
• Device Name: ImagenSPECT
• Applicant: Cardiovascular Imaging Technologies
• Product Code: KPS · Radiology
• Decision Date: Jan 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

ImagenSPECT™ is a Windows-based software application for processing, reconstructing, and reorienting myocardial perfusion SPECT images. It accepts gated and ungated cardiac SPECT data from commercial gamma cameras. The system performs motion correction, applies filters, adjusts reconstruction settings, and models distance-dependent blur to create 3D tomographic data. Used by qualified healthcare providers (radiologists, nuclear cardiologists, nuclear medicine physicians) in clinical settings, the software outputs processed datasets for visualization on separate workstations. By enhancing image quality through resolution recovery and iterative reconstruction, the device assists clinicians in identifying cardiac disease, potentially improving diagnostic accuracy for patients.

Clinical Evidence

Bench testing only. Comparison of technological characteristics and intended use confirmed equivalence to predicates. Performance validation included testing of half-count density (full-time scan, half dose/half-time, full dose) reconstructed with resolution recovery and iterative reconstruction, demonstrating equivalence to the predicate AutoSPECT with Astonish (K090403).

Technological Characteristics

Windows-based software application. Processes nuclear medicine SPECT data. Features include motion correction, distance-dependent blur modeling, and iterative reconstruction with resolution recovery. Operates on standard PC hardware. Software-based image processing.

Indications for Use

Indicated for analysis and display of cardiac SPECT images to assist in determining the presence of cardiac diseases in patients undergoing nuclear medicine imaging.

Regulatory Classification

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.

Predicate Devices

• ADAC JETStream (K061029)
• Siemens e.Cam Computer/e.Soft Workstation (K023190)
• Philips AutoSPECT with Astonish (K090403)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 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<br>4320 Wornall Road, Suite 55<br>Kansas City, MO 64111<br>Tel: [phone]<br>Fax: [phone] |
|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | James A. Case |
| | Date Prepared: | September 1, 2015 |
| B. | Device Trade Name: | ImagenSPECT™ |
| | Classification Name: | System, Emission Computed Tomography<br>21 CFR 892.1200 (KPS)<br>System, Image Processing, Radiological<br>21 CFR 892.2050 (LLZ) |
| C. | Predicate Devices: | ADAC JETStream (k061029)<br>Siemens e.Cam Computer/e.Soft Workstation<br>(k023190)<br>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).