The ImagenUniversaJTM system is a software. application that allows the user to visualize raw PET and/or PET/CT data, to correct for transmission and emission, and to correct PET 3D data for photon scatter and prompt gamma photons. The resulting corrected tomograms can be exported to cardiac interpretive software for interpretation. The use of this system is limited to qualified, licensed healthcare providers (radiologists or nuclear med icine physicians) trained in the use of nuclear medicine imaging devices.

Device Description

ImagenUniversal™ is a Windows application which allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise. The system processes perfusion and gated PET reconstructed emission and transmission data to create corrected 3D tomographic data. The user can select correction parameters, filter settings, range of reconstruction, and registration setting. 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.

AI/ML Overview

The provided text describes the ImagenUniversal™ system, a software application designed to correct myocardial perfusion PET images. While the document is a 510(k) summary, it does not contain the detailed study information or acceptance criteria typically found in a clinical study report.

The document states:

"Testing and comparison of technological characteristics and intended uses found that all components of the ImagenUniversal™ system are equivalent to the predicates." This implies that the device was evaluated against existing, legally marketed predicate devices (Siemens Biograph 64 and 40 (K060631), Siemens Biograph mCT (K151486), and ImagenPRO (K050366)) to demonstrate substantial equivalence, a common pathway for 510(k) clearances. However, the specifics of this "testing and comparison" are not provided.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not explicitly present in the provided text.

Based on the information available, a summary can be constructed, but with significant gaps.

Summary of Acceptance Criteria and Study Information (Based on Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide detailed performance metrics for the ImagenUniversal™ system. The primary claim is substantial equivalence to predicate devices.

Acceptance Criterion	Reported Device Performance
Equivalence to Predicates	"Testing and comparison of technological characteristics and intended uses found that all components of the ImagenUniversal™ system are equivalent to the predicates."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text mentions the system processes "raw PET and/or PET/CT data," implying clinical data, but no further details are given.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not specified.
Qualifications: Not specified. The device's intended users are "qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices." It is plausible that such experts would be involved in any evaluation, but this is not stated.

4. Adjudication Method for the Test Set:

Not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

Not explicitly stated. The submission focuses on substantial equivalence to predicates, not a comparative effectiveness study demonstrating performance improvement with or without AI assistance. The device is described as a software application for correction, not necessarily an AI-assisted diagnostic tool in the sense of directly interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not explicitly stated in terms of a formal standalone performance study. The device's function is to "correct" raw data into tomograms that "can be exported to cardiac interpretive software for interpretation." This implies an upstream processing role rather than a direct interpretive role, so a standalone diagnostic performance evaluation in the traditional sense might not be directly applicable or detailed here. However, the "testing and comparison of technological characteristics" would inherently involve evaluating the algorithm's performance in generating corrected images.

7. The Type of Ground Truth Used:

Not specified. Given the nature of the device (correcting for transmission/emission misregistration, scatter, prompt gamma), ground truth would likely relate to the accuracy of these corrections compared to an ideal or gold standard measure, or the resultant image quality and diagnostic utility as assessed by experts. However, these specifics are not provided.

8. The Sample Size for the Training Set:

Not specified. The document does not mention a training set, which may or may not be relevant depending on the specific algorithms employed for corrections (e.g., if machine learning models are used).

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not specified. As no training set is mentioned, the method for establishing its ground truth is also not provided.

In conclusion, the provided FDA 510(k) summary focuses on establishing substantial equivalence to predicate devices based on "testing and comparison of technological characteristics and intended uses." It does not provide the detailed study design, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical study report to explicitly "prove" device performance against specific, quantifiable acceptance criteria.

Summary

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January 12, 2018

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Cardiovascular Imaging Technologies % Ms. Melanie Hasek Associate Director, Regulatory Publishing PRA Health Sciences 9755 Ridge Drive LENEXA KS 66219

Re: K173547

Trade/Device Name: ImagenUniversal™ Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, LLZ Dated: November 10, 2017 Received: November 16, 2017

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173547

Device Name ImagenUniversalTM

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

{ X } Prescription Use (Part 21 CFR 801 Subpart D)

{ } Over-The-Counter Use (21 CFR 801 Subpart C)

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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 114Kansas City, MO 64111Tel: 816-531-2842Fax: 816-531-0643
	Contact Person:	James A. Case
	Date Prepared:	November 13, 2017
B.	Device Trade Name:	ImagenUniversal™
	Classification Name:	System, Emission Computed Tomography21 CFR 892.1200 (KPS)System, Image Processing, Radiological21 CFR 892.2050 (LLZ)
C.	Predicate Devices:	Siemens Biograph 64 and 40 (K060631)Siemens Biograph mCT (K151486)ImagenPRO (K050366)

D. Device Description:

E. Indications for Use:
The ImagenUniversal™ system is a software application that allows the user to visualize raw PET and/or PET/CT data, to correct for transmission and emission misregistration, and to correct PET 3D data for photon scatter and prompt gamma photons. The resulting corrected tomograms can be exported to cardiac interpretive

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software for interpretation. 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.

F. Comparison of Technical Characteristics to Predicate Device:
The ImagenUniversal™ system and its predicates, the Biograph™ systems, and the ImagenPRO™ 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 ImagenUniversal™ system are equivalent to the predicates.

Regulation Number and Section

§ 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.