(22 days)
Not Found
No
The document describes image processing and quantification of perfusion data but does not mention AI, ML, or related terms.
No
HeartSee is a software tool for cardiac PET image processing and quantification to assist clinical interpretation, not a device that directly treats or provides therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is indicated "in order to assist clinical interpretation of PET perfusion images by quantification of their severity," and the "Device Description" section states it facilitates "the interpretation of PET perfusion images." Both of these functions are integral to the diagnostic process for coronary artery disease. Furthermore, it explicitly refers to "clinical diagnostics" in the Device Description.
Yes
The device description explicitly states "HeartSee is a software tool" and describes its functions as importing, reorienting, and quantifying data from existing PET images. There is no mention of any accompanying hardware component 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HeartSee's Function: HeartSee is a software tool that processes and quantifies data from imaging studies (PET scans) performed on the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "assisting clinical interpretation of PET perfusion images by quantification of their severity." This is image processing and analysis, not in vitro testing.
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 position tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in co'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 by quantification of their severity.
HeartSee is intended for use by trained professionals, such as nuclear technicians, 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.
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/q. 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 of 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. Archiving output data is supported for clinical diagnostics, quality control and research.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac PET images
Anatomical Site
cardiac / myocardial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, such as nuclear technicians, 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)
The verification and validation testing of the predicate device verification is deemed to be sufficient for the proposed device as the devices are identical with the exception of branding. No clinical testing was performed in support of this 510(k) premarket notification.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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.
June 12, 2018
Bracco Diagnostics Inc. % Ms. Patrice Marchildon Senior Director Regulatory Affairs 259 Prospect Plains Road, Building H MONROE TOWNSHIP NJ 08831
Re: K181343
Trade/Device Name: HeartSee Cardiac P.E.T. Processing Software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: May 18, 2018 Received: May 21, 2018
Dear Ms. Marchildon:
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 (QS) regulation (21 CFR Part 820);
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Page 2 - Ms. Patrice Marchildon
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Willin C. Jy 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 4.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known)
Device Name
HeartSee Cardiac P.E.T. Processing Software
Indications for Use (Describe)
HeartSee Software for cardiac position tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in co'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 by quantification of their severity.
HeartSee is intended for use by trained professionals, such as nuclear technicians, 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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information unless it displays a currently valid OMB number
FORM FDA 3881 (1/14)
Page of
Service (501) 441-6741
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510(k) Summary 5.
Bracco Diagnostics Inc. HeartSee Cardiac P.E.T. Processing Software (per 21CFR 807.92)
1. SUBMITTER/510(K) Holder
Headquarters
Bracco Diagnostics Inc. 259 Prospect Plains Road Monroe Township, NJ 08831 USA
Contact: Patrice Marchildon, Senior Director Regulatory Affairs Contact Phone: 609-514-2284 Contact Email: Patrice.Marchildon@diaq.bracco.com
Date Prepared: May 18, 2018
2. DEVICE NAME
| Proprietary Name: | HeartSee Cardiac P.E.T. Processing Software |
|---|---|
| Common name: | Cardiac Positron Emission Tomography (PET) |
| Analysis Software | |
| Classification Name: | Emission computed tomography system. |
| Classification Regulation: | 21 CFR 892.1200 (Class II) |
| Product Code: | KPS |
3. PREDICATE DEVICE
- HeartSee Cardiac P.E.T. Processing Software (K171303) ●
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/q. 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 of 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
4
basis for regional and global values. Archiving output data is supported for clinical diagnostics, quality control and research.
5. 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 cc/min/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 by 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.
6. Summary of Technological Characteristics Compared to the Predicate DEVICE/S
The proposed device and K171303 are software tools using identical standard, industrial computing hardware and applications. The code in the proposed software package is identical to K171303.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
The verification and validation testing of the predicate device verification is deemed to be sufficient for the proposed device as the devices are identical with the exception of branding.
8. Summary of Clinical Testing as Basis for Substantial Equivalence
No clinical testing was performed in support of this 510(k) premarket notification.
9. SUMMARY OF OTHER INFORMATION
No other information is available.
10. Conclusions Drawn From Non-clinical and Clinical Tests
Since the proposed HeartSee Cardiac P.E.T. Processing Software is identical to the K171303 version. Bracco Diagnostics Inc. has concluded that the proposed HeartSee Cardiac P.E.T. Processing Software is substantially equivalent to the predicate device K171303.