(112 days)
Not Found
No
The description focuses on standard image processing techniques, ROI analysis, and quantitative calculations based on user-defined inputs and correction factors. There is no mention of AI, ML, or related concepts like training sets, test sets, or performance metrics typically associated with AI/ML models.
No
The device is described as a software package for image analysis and quantification to facilitate interpretation of cardiac PET images, not as a device that directly treats, diagnoses, or prevents disease. It aids in diagnosis and assessment but does not perform therapeutic action.
Yes
The device is intended for processing, visual analysis, and quantification of medical images to assist physicians and technologists in interpreting diagnostic cardiac PET images in patients with suspected or known coronary artery disease. It explicitly states its use for "clinical diagnostics" and "quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images".
Yes
The device is explicitly described as a "software package" and states it uses "standard, industrial computing hardware and applications," indicating it does not include proprietary hardware.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that HeartSee is for "clinical diagnostics" and facilitates "image interpretation" for patients with suspected or known coronary artery disease. It also quantifies "absolute myocardial blood flow and CFR," which are diagnostic parameters.
- Device Description: The description details how the software processes images and quantifies physiological parameters (blood flow and CFR) using data derived from the patient (tracer uptake and arterial activity). This processing and quantification of patient-derived data for diagnostic purposes is a key characteristic of an IVD.
- Input Data: The software uses cardiac PET images, which are generated from the administration of a radiotracer to the patient. The software then analyzes the distribution and kinetics of this tracer within the patient's body to provide diagnostic information. This is a common workflow for IVDs that utilize imaging data.
- Predicate Devices: The listed predicate devices, K090178 (a PET scanner with cardiac software) and K113754 (cfrQuant), are also likely IVDs or components of IVD systems, further supporting the classification of HeartSee as an IVD.
While the software itself is not directly interacting with a biological sample in a test tube (the traditional definition of "in vitro"), the regulatory definition of an IVD is broader and includes devices that analyze data derived from the human body for diagnostic purposes. HeartSee fits this description by analyzing PET images, which represent the distribution of a substance within the patient's body, to provide diagnostic information about cardiac function.
N/A
Intended Use / Indications for Use
The cardiac position emission tomography (PET) analysis tool, HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.
HeartSee contain two fundaments. First, the software can import cardiac PET images in DICOM format from any PET camera from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.
Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).
HeartSee is intended for processing of DICOM images, visual analysis and quantification of relative myocardial tracer uptake, and quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images in patients with suspected or known coronary artery disease.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.
HeartSee contains two fundamental components. First, the software can import cardiac PET images in DICOM format from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.
Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).
To compute coronary flow reserve (CFR) - the ratio of increased blood flow (stress) to baseline blood flow (rest) – three inputs are required: integrated arterial activity in the early part after bolus injection, average myocardial activity in the late part after bolus injection, and correction factors for partial volume effects of the PET scanner. The first number comes from a region of interest (ROI) drawn in the thoracic aorta or left atrium on images taken soon after radionuclide bolus administration. The second number comes from the topographic maps of myocardial uptake acquired later after radiotracer injection. The third number varies by PET camera and will be initialized in a user preference file.
HeartSee is a software package that uses standard, industrial computing hardware and applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac PET images; cardiac PET images in DICOM format
Anatomical Site
cardiac; myocardial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nuclear medicine and nuclear cardiology physicians and technologists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
University of Texas Medical School at Houston % K. Lance Gould, M.D. Professor of Cardiovascular Medicine 6431 Fannin Street, Suite MSB 4.256 HOUSTON TX 77030
Re: K143664
Trade/Device Name: HeartSee Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: December 22, 2014 Received: January 15, 2015
Dear Dr. 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. 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
for
Robert Ochs, Ph.D. Acting 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
510(k) Number (if known)
Device Name
HeartSee
Indications for Use (Describe)
The cardiac position emission tomography (PET) analysis tool, HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.
HeartSee contain two fundaments. First, the software can import cardiac PET images in DICOM format from any PET camera from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.
Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5. 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: December 22, 2014
Device trade name: HeartSee
Common name: Cardiac Positron Emission Tomography (PET) Analysis Software
Classification names: emission computed tomography system (21 CFR 892.1200, Product Code KPS)
Devices claimed for equivalence:
General description: The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.
HeartSee contains two fundamental components. First, the software can import cardiac PET images in DICOM format from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.
Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).
To compute coronary flow reserve (CFR) - the ratio of increased blood flow (stress) to baseline blood flow (rest) – three inputs are required: integrated arterial activity in the early part after bolus injection, average myocardial activity
4
in the late part after bolus injection, and correction factors for partial volume effects of the PET scanner. The first number comes from a region of interest (ROI) drawn in the thoracic aorta or left atrium on images taken soon after radionuclide bolus administration. The second number comes from the topographic maps of myocardial uptake acquired later after radiotracer injection. The third number varies by PET camera and will be initialized in a user preference file.
Intended use: HeartSee is intended for processing of DICOM images, visual analysis and quantification of relative myocardial tracer uptake, and quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images in patients with suspected or known coronary artery disease.
Technological characteristics: HeartSee is a software package that uses standard, industrial computing hardware and applications.