(75 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on established quantitative analysis methods for PET images.
No
The device is a software tool used for interpreting PET images and quantifying myocardial perfusion, assisting in diagnosis, but it does not directly treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the software is used "to assist clinical interpretation of PET perfusion images and quantification of their severity," and the "Device Description" states it is "for facilitating the interpretation of PET perfusion images." Both phrases clearly indicate that the device assists in making a diagnosis.
Yes
The device description explicitly states "HeartSee is a software tool for cardiac positron emission tomography (PET)" and describes its functions as importing, processing, and quantifying data from PET images. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- HeartSee's Function: HeartSee is a software tool that processes and analyzes medical images (cardiac PET images) acquired from a patient. It does not interact with or analyze biological specimens taken from the body.
- Intended Use: The intended use clearly states that HeartSee is for "determining regional and global absolute rest and stress myocardial perfusion... in order to assist clinical interpretation of PET perfusion images and quantification of their severity." This is image analysis and quantification, not the analysis of biological samples.
Therefore, HeartSee falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HeartSee™ software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cclmin/q. 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™ 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.
Product codes
KPS
Device Description
HeartSee 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 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 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 software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/gm), 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 and the predicate K231731 also display stress subendocardial to subepicardial ratio and subendocardial stress to rest ratio on relative activity tomograms, and stress relative topogram maps expressed as a fraction of maximum cc/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 cc/min/g, CFR and CFC, HeartSee has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET
Anatomical Site
Cardiac / Myocardial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.
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)
No clinical testing was performed in support of this 510(k) Premarket Notification.
The nonclinical testing of the predicate device, combined with the system testing and cybersecurity testing of the proposed device, is sufficient to support substantial equivalence due to the nature of the modifications implemented in the proposed device. Since the overall design and functionality of the proposed and predicate devices is essentially identical, performance testing was targeted to verify and validate the new and updated features of the proposed device. No new types of testing were required.
Data from the nonclinical testing, system and cybersecurity testing, demonstrated that the proposed device meets established specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square.
March 3, 2025
Bracco Diagnostics Inc. Elyssa Murray Director of Global Regulatory Affairs, Medical Devices and Medical Device Combination Products 510 Carnegie Center Princeton, New Jersey 08540-0001
Re: K243881
Trade/Device Name: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: December 16, 2024 Received: December 18, 2024
Dear Elyssa Murray:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Daniel M. Krainak, Ph.D. Assistant Director 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
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Indications for Use
Submission Number (if known)
Device Name
HeartSee TM Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
Indications for Use (Describe)
HeartSee™ software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cclmin/q. 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™ 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.
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)
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510(K) SUMMARY
K243881
Bracco Diagnostics Inc. HeartSee Cardiac P.E.T. Processing Software
SUBMITTER/510(K) HOLDER 1.
Headquarters
Bracco Diagnostics Inc. 510 Carnegie Center Princeton, NJ 08540 USA
Elyssa Murray, Director ofGlobalRegulatory Affairs Contact: Phone: 609-524-2854 Contact Email: elyssa.murray@diag.bracco.com Date Prepared: December 9, 2024
DEVICE NAME 2.
| Proprietary Name: | HeartSee Cardiac P.E.T. Processing Software |
|---|---|
| Common name: | |
| Analysis Software | Cardiac Positron Emission Tomography (PET) |
| Classification Name: | Emission computed tomography system. |
| Classification Regulation: | 21 CFR 892.1200 (Class II) |
| Product Code: | KPS |
PREDICATE DEVICE 3.
- Optional Screen Displays For HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731)
4. DEVICE DESCRIPTION
HeartSee 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 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 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 software quantifies absolute rest and stress myocardial perfusion
5
per unit tissue (cc/min/gm), 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 and the predicate K231731 also display stress subendocardial to subepicardial ratio and subendocardial stress to rest ratio on relative activity tomograms, and stress relative topogram maps expressed as a fraction of maximum cc/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 cc/min/g, CFR and CFC, HeartSee has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF.
INDICATIONS FOR USE 5.
HeartSee™ software for cardiac positron emission tomography (PET) is indicated 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 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™ 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 COMPARED TO THE 6. PREDICATE DEVICE/S
The proposed device and K231731 have essentially the same overall design except for the software platform migration to the Windows operating system, a few minor software application updates, and the incorporation of cybersecurity enhancements. The code in the proposed software package is essentially the same as K231731 for the determination of quantitative myocardial perfusion in ml/min/g, Coronary Flow Reserve (CFR), the Coronary Flow Capacity (CFC) map, their displays, and determining left ventricular ejection fraction (EF) by PET-CT using Rb-82.
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR 7. SUBSTANTIAL EQUIVALENCE
The nonclinical testing of the predicate device, combined with the system testing and cybersecurity testing of the proposed device, is sufficient to support substantial equivalence due to the nature of the modifications implemented in the proposed device. Since the overall
6
design and functionality of the proposed and predicate devices is essentially identical, performance testing was targeted to verify and validate the new and updated features of the proposed device. No new types of testing were required.
SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8.
No clinical testing was performed in support of this 510(k) Premarket Notification.
SUMMARY OF OTHER INFORMATION 9.
No other information is available.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Data from the nonclinical testing, system and cybersecurity testing, demonstrated that the proposed device meets established specifications. Therefore, the device is substantially equivalent to the predicate device.