(90 days)
Not Found
No
The summary describes standard image processing and analysis techniques for nuclear medicine images, with no mention of AI, ML, or related concepts.
No
The device is a renal analysis package that processes images and provides information to aid in interpretation, but it does not directly treat or alleviate a medical condition.
Yes
The device is described as a "renal analysis package" that aids the "physician in the performance and interpretation of Tc99m MAG3 renograms," which indicates its use in diagnosing renal conditions based on medical images.
No
The device is described as a "package" implemented on a specific hardware workstation (Apex XPert workstation of the Varicam gamma camera). While it performs software-based analysis of images, it is presented as part of a larger system that includes hardware.
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.
- Device Function: The QuantEM™ package processes and analyzes images obtained from a gamma camera after a radioactive tracer (Tc-99m MAG3) is administered to the patient. It does not analyze biological samples taken from the patient.
- Input: The input is "Tc-99m MAG3 renal images," which are medical images, not biological specimens.
- Purpose: The purpose is to aid in the "performance and interpretation of Tc99m MAG3 renograms," which are imaging studies, not laboratory tests on biological samples.
Therefore, the QuantEM™ package falls under the category of medical imaging software or analysis tools, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
QuantEM™ package is a renal analysis package for Tc-99m MAG3 renal images. It provides a comprehensive package consisting of processing and protocols to aid the technologist and physician in the performance and interpretation of Tc99m MAG3 renograms
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The QuantEM™ method was developed at Emory University, Atlanta, GA for calculating the clearance of Tc-99m MAG3. The QuantEM™ package is implemented on the Apex XPert workstation of the Varicam gamma camera (K953801).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Tc-99m MAG3 renal images
Anatomical Site
Renal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technologist and physician
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.
0
Summary of Safety and Effectiveness
QuantEM™ package is a renal analysis package for Tc-99m MAG3 renal images. The QuantEM™ method was developed at Emory University, Atlanta, GA for calculating the clearance of Tc-99m MAG3. It provides a comprehensive package consisting of processing and protocols to aid the technologist and physician in the performance and interpretation of Tc99m MAG3 renograms
The QuantEM™ package is implemented on the Apex XPert workstation of the Varicam gamma camera (K953801).
The effectiveness of the QuantEM"" package, implemented on the Apex XPert, is equivalent to the effectiveness of the QuantEM™ package implemented on GE Starcam computers (K932957).
The addition of the QuantEM1" package does not effect the safety and effectiveness of all other functions performed by the Apex XPert workstation.
Precautions to avoid erroneous processing results were taken and the necessary validation and tests were made to ensure correct processing results of the QuantEM™ package.
Based on the above, it is Elscint's opinion that the XPert QuantEM™ package usage is substantially equivalent in safety and effectiveness to QuantEMTM package on General Electric nuclear medicine computers (K932957), and that the Apex XPert workstation equipped with the QuantEM*** package is substantially equivalent in safety and effectiveness to the previously marketed version of the Varicam's Apex XPert workstation (K953801),