Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

{0}------------------------------------------------ August 21st, 2023 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. McGovern Medical School % K. Lance Gould Professor of Cardiovascular Medicine 6431 Fannin Street, MSB 4.256 HOUSTON TX 77030 ## Re: K231731 Trade/Device Name: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: June 8, 2023 Received: June 13, 2023 ### Dear K. Lance Gould: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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, # Ningzhi for Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231731 #### Device Name Optional Screen Displays For HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 #### Indications for Use (Describe) HeartSee version 4 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity. HeartSee version 4 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The climician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data. X 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}------------------------------------------------ ## 510(k) Summary #### Owner/Contact: K. Lance Gould. M.D. Professor of Cardiovascular Medicine University of Texas Medical School at Houston 6431 Fannin St., Room MSB 4.256 Houston, TX 77030 Phone 713-500-6611 Fax 713-500-6615 Email K.Lance.Gould@uth.tmc.edu Date of preparation: June 8, 2023 Device trade name: Optional Screen Displays For HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 Common name: Cardiac Positron Emission Tomography (PET) Analysis Software Classification names: Regulation name: Emission computed tomography system. Regulation number: 21 CFR 892.1200. Regulatory code: Class II. Product Code: KPS. Devices claimed for equivalence: K202679 (HeartSee version 3) for coronary flow capacity and Emory Cardiac Toolbox version 4.1.7786.35544 (K123646) for left ventricular ejection fraction (EF) for PET-CT with Rb-82 Device description: HeartSee version 4 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee version 4 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. HeartSee version 4 contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the HeartSee version 4 software quantifies regional absolute rest and stress myocardial perfusion per unit tissue (ml/min/g), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio, and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values. HeartSee version 3 (K202679) and version 4 also display stress subendocardial to subepicardial ratio, subendocardial stress to rest ratio on relative activity tomograms and stress relative topogram maps expressed as a fraction of maximum ml/min/g, called relative stress flow (RSF). Archiving output data is supported for clinical diagnostics, quality control and research. In addition to these established measurements of perfusion in ml/min/g. CFR and CFC approved by FDA for K202679, HeartSee version 4 has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF by the precedent FDA approved Emory Cardiac Toolbox version V4.1.7786.35544. {4}------------------------------------------------ Indications for use: HeartSee version 4 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve, their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity. HeartSee version 4 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data. Summary of technological characteristics of the device compared to predicate device: HeartSee version 4 and its equivalent predicate HeartSee version 3 (K202679) are software tools using identical standard, industrial computing hardware and applications. The code in the software package HeartSee version 4 is identical to version 3 (K202679) including determination of quantitative myocardial perfusion in cc/min/g, Coronary Flow Reserve (CFR), the Coronary Flow Capacity (CFC) map and their displays. In addition to these established measurements of perfusion in ml/min/g. CFR and CFC approved by FDA for K202679, HeartSee version 4 has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82. | HeartSee version 3<br>K202679 | HeartSee version 4 | |------------------------------------------------------------------------------------------------------------------------------|---------------------| | Indications for use | | | Code base and libraries | | | DICOM inputs | | | Standard views recommended by the American College of Cardiology | | | Relative uptakes (% of maximum) – rest and stress | | | Absolute myocardial perfusion (cc/min/g) – rest and stress | | | Coronary Flow Reserve (CFR) map | | | Coronary Flow Capacity (CFC) map | | | Endo/epicardial display: extended view and analysis of transaxial view | | | Relative Stress Flow (RSF): based on absolute myocardial perfusion | | | Border zone on CFC map: based on CFC and RSF | | | Contour tracking of regional perfusion defects – for relative uptakes, absolute perfusion and coronary flow capacity (CFC) | | | Not available | Left ventricular EF | Comparison between HeartSee version 3 and HeartSee version 4 Comparison between Emory Cardiac Toolbox version 4 and HeartSee version 4 | Emory Cardiac Toolbox version 4<br>K123646 | HeartSee version 4 | |--------------------------------------------|--------------------| | Left ventricular EF | | Summary of performance data: By Cox multivariate analysis and Kaplan-Meier plots, CFR and separately stress perfusion derived by HeartSee version 3 (K202679) and version 4 associate significantly with mortality, major adverse coronary events (MACE) and their {5}------------------------------------------------ significant reduction after revascularization. By ROC analysis and paired t-tests, the stress subendo/subepicardial ratio, the subendocardial stress/rest ratio and the relative stress flow (RSF) associate with angina or ST depression ≥1mm during stress PET in patients with only mildly reduced CFC and no severely reduced CFC. Data also shows that HeartSee measurement of LVEF by PET-CT using Rb-82 provides an accurate, robust measure of LVEF that is comparable to Emory Toolbox for PET-CT EF approved by FDA. Conclusion: Data from the performance tests demonstrated that the device is as safe and effective and performs as well as or better than the predicate device. Therefore, the device is substantially equivalent to the predicate device.