The ImagenSPECT™ 3.0 system is a software application that provides a processing environment for the analysis and display of cardiac SPECT and planar images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT 3.0 is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. This software can also be used for processing display and quantitation of multigated acquisition blood pool scans (MUGA) specifically the left ventricular ejection fraction (LVEF). ImagenSPECT™ 3.0 can also be used for quantitation of planar and SPECT, early and late 99mTc pyrophosphate images.

Device Description

ImagenSPECT™ 3.0 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 settings, 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. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECTT™ 3.0 is used to quantitate the uptake of 99™Tc pyrophosphate in early and late planar and SPECT studies. The ImagenSPECTTM 3.0 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. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (K152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for ImagenSPECT™ 3.0, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes comparative studies against predicate devices and statistical measures of agreement and difference. I will present the reported performance and infer the implicit acceptance criteria based on these comparisons.

Feature / Metric	Implicit Acceptance Criteria (Inferred)	Reported Device Performance and Statistical Significance
99mTc pyrophosphate heart contralateral ratios	High correlation and no significant statistical difference compared to predicate.	Pearson correlation coefficient (r) = 0.96 (between ImagenSPECT 3.0 and Siemens e.soft). P-value for student paired t-test = 0.15 (indicating no statistically significant difference).
MUGA derived LVEF measurements	High correlation and no significant statistical difference compared to predicate.	Pearson correlation coefficient (r) = 0.92 (between ImagenSPECT 3.0 and Siemens e.soft). P-value = 0.13 (indicating no statistically significant difference).
One-quarter time myocardial perfusion SPECT (phantom study)	Signal-to-noise ratio effectively preserved compared to full-time scans.	98.9% of the signal-to-noise using one-quarter time reconstructed with ImagenSPECT 3.0 when compared to full-time unfiltered reconstructed perfusion images.
One-quarter time myocardial perfusion SPECT (patient study - segmental difference)	Low average segmental difference and no significant statistical difference compared to conventional OSEM reconstructions.	Average segmental difference between full-time OSEM and one-quarter time ImagenSPECT 3.0 was 5.9%. P-value of the paired t-test = 0.76 (indicating no statistically significant difference).

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

The document does not specify the exact sample size for the test set for each study. It indicates that the studies involved:

"patient data" for 99mTc pyrophosphate and MUGA LVEF comparisons.
"patient studies" for the one-quarter time myocardial perfusion SPECT evaluation.
"phantom studies" for the one-quarter time myocardial perfusion SPECT signal-to-noise ratio.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the comparison to the Siemens e.soft system, it's likely the data was collected in a clinical setting in a country where such systems are used, but specific details are absent. The nature of the studies (comparison to existing methods) suggests they could be retrospective analyses of existing patient data, but this is not confirmed.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Instead, the ground truth appears to be established by the measurements obtained from the predicate Siemens e.soft system or conventional OSEM reconstructions, which are presumably considered the clinical standard.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The comparisons are statistical correlations and t-tests against established methods, not against expert consensus that would typically require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies described focus on the algorithm's performance in comparison to predicate systems, not on how human readers' performance improves with or without AI assistance.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are primarily standalone (algorithm only) performance evaluations. ImagenSPECT™ 3.0's calculations and reconstructions (e.g., heart contralateral ratios, LVEF, one-quarter time SPECT) are directly compared against the results from predicate systems (Siemens e.soft, conventional OSEM). There is no mention of human-in-the-loop performance evaluation in these specific studies.

7. The Type of Ground Truth Used

The ground truth used in these studies appears to be based on:

Measurements from legally marketed predicate devices: Siemens e.soft system for 99mTc pyrophosphate heart contralateral ratios and MUGA derived LVEF.
Conventional reconstruction methods: Full-time unfiltered reconstructed perfusion images and conventional ordered subsets expectation maximization (OSEM) reconstructions for one-quarter time myocardial perfusion SPECT.

This can be broadly categorized as "predicate device/method comparison" rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not specify the sample size for any training set. It focuses solely on the verification and validation studies (test sets) comparing ImagenSPECT™ 3.0 against predicate devices/methods.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a training set or its sample size, there is no information on how ground truth for a training set was established.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

August 11, 2020

Re: K201933

Trade/Device Name: ImagenSPECT™ 3.0 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, LLZ Dated: July 9, 2020 Received: July 13, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201933

Device Name ImagenSPECTTM 3.0

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 Technologies4320 Wornall Road, Suite 114Kansas City, MO 64111Tel: 816-531-2842Fax: 816-531-0643
	Contact Person:	James A. Case
	Date Prepared:	July 10, 2020
B.	Device Trade Name:	ImagenSPECT™ 3.0
	Classification Name:	System, Emission Computed Tomography21 CFR 892.1200 (KPS),Class IISystem, Image Processing, Radiological21 CFR 892.2050 (LLZ)Class II
C.	Predicate Devices:	Cardiovascular Imaging Technologies ImagenSPECT(K152503)Siemens e.Cam Computer/e.Soft Workstation(K023190)

D. Device Description:

This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECTT™ 3.0

{4}------------------------------------------------

is used to quantitate the uptake of 99™Tc pyrophosphate in early and late planar and SPECT studies.

The ImagenSPECTTM 3.0 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.

In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (K152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

Indications for Use: E.
The ImagenSPECT™ 3.0 system is a software application that provides a processing environment for the analysis and display of cardiac SPECT and planar images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT™ 3.0 is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. This software can also be used for processing display and quantitation of multigated acquisition blood pool scans (MUGA) specifically the left ventricular ejection fraction (LVEF). ImagenSPECT™ 3.0 can also be used for quantitation of planar and SPECT, early and late 99mTc pyrophosphate images.
F. Comparison of Technical Characteristics to Predicate Device:
The ImagenSPECT™ 3.0 system and its predicates, the ImagenSPECT™ (K152503) and the e.Cam/e.Soft™ system use the same type of data sets for analysis and calculation of data.
G. Device performance, verification and validation
ImagenSPECT™ 3.0 was tested in phantom and patient data to verify the successful performance of additional features. Specifically, this includes the quantitative assessment of LVEF on multigated acquisition blood pool scans (MUGA), quantitative uptake of 99mTc pyrophosphate and one quarter time myocardial perfusion SPECT testing.

99mTc pyrophosphate heart contralateral ratios from ImagenSPECT 3.0 was compared with heart contralateral ratios from the Siemens e.soft system. The Pearson rorrelation coefficient (r) between ImagenSPECT 3.0 and Siemens e.soft was 0.96 and the p value for student paired t-test was 0.15.

{5}------------------------------------------------

Ouantitative measurements of MUGA derived LVEF using ImagenSPECT 3.0 were correlated with LVEF measurements determined using the Siemens e.soft system (r=0.92) and were not statistically different (p=0.13).

One quarter time myocardial perfusion SPECT testing was examined in both phantom and patient studies. Phantom studies demonstrated that a change in signal-to-noise ratio 98.9% of the signal-to-noise using one quarter time reconstructed using ImagenSPECT 3.0 when compared to full-time unfiltered reconstructed perfusion images. One quarter time patient studies reconstructed using ImagenSPECT 3.0 were compared with conventional ordered subsets expectation maximization (OSEM) reconstructions. Myocardial perfusion SPECT images were analyzed using a 17 segment polar map of tracer uptake. The average segmental difference between full-time OSEM and one quarter time ImagenSPECT 3.0 was 5.9% and the P value of the paired t-test was 0.76.

In addition to testing ImagenSPECT 3.0 clinical performance, ImagenSPECT 3.0 was also successfully tested for the success of risk mitigation strategies.

H. Summary:
Testing and comparison of technological characteristics and intended uses found that all components of the ImagenSPECT™ 3.0 system are equivalent to the predicates. In addition, quarter-counts, e.g. half dose and/or half-time, reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction was equivalent to the predicate ImagenSPECT™ (K152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

Regulation Number and Section

N/A