(30 days)
OUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
The QUANTIENT™ Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Pd/Pa, and data from ECG.
Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure to aortic pressure, measured during hyperemia. It provides the maximal blood flow in the presence of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation that the stenosis was not present. The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. This functionality is achieved when the QUANTIENT™ Measurement System is used in conjunction with the manufacturer's distal intracoronary pressure transducer and a proximal aortic pressure transducer.
Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure measured at resting conditions. The physician may use Pd/Pa at rest, along with knowledge of patient history, medical expertise and clinical judgment to determine if additional measurement of FFR during hyperemia or therapeutic intervention is indicated.
Information on screen can also be transferred to an external hemodynamic recording system (HRS) or to an external video monitor. Recorded procedures can be viewed on a PC for post-procedural review and analysis with application specific viewing software installed, such as RadiView™ software.
Additional functions let you import a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.
This document describes the QUANTIENT™ Measurement System, a diagnostic computer designed to record, compute, display, and store data from PressureWire™ guidewire and other external transducers for the diagnosis and treatment of coronary or peripheral artery disease.
This 510(k) pertains to a Special 510(k) submission, meaning it compares a modified version of a device to an already cleared predicate device (QUANTIENT™ Measurement System, K123984). The focus is on demonstrating substantial equivalence, meaning the modified device has the same intended use and technological characteristics as the predicate, and does not raise new questions of safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
Since this is a Special 510(k) submission for a substantially equivalent device, the performance acceptance criteria are implicitly those established for the original predicate device (K123984). The document explicitly states: "The intended use and technological characteristics of the QUANTIENT™ Measurement System that is subject to this Special 510(k) submission are the same as the predicate."
Therefore, the reported device performance for the subject device (K172182) is considered to be equivalent to the predicate device. The document does not provide a specific table of numerical acceptance criteria or performance metrics for the K172182 device itself, as the basis of this submission is equivalence to the predicate.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Subject Device K172182) |
|---|---|
| Ability to record, compute, display, and store data from PressureWire™ guidewire and other external transducers. | The device performs these functions, having the same technological characteristics as the predicate device. |
| Accurate display of systolic, diastolic, and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and Pd/Pa. | The device displays these parameters, which are considered equivalent to the predicate due to consistent technology. |
| Functional calculation and display of FFR. | The device calculates and displays FFR, used in conjunction with manufacturer's distal intracoronary pressure transducer and proximal aortic pressure transducer, equivalent to the predicate. |
| Functional calculation and display of Pd/Pa. | The device calculates and displays Pd/Pa, equivalent to the predicate. |
| Capability to transfer information to external hemodynamic recording systems or video monitors. | The device has this capability, equivalent to the predicate. |
| Capability to import patient work lists from hospital DICOM systems, export recorded measurement data to DICOM or external server, or save to USB. | The device has these capabilities, equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." and "No new clinical testing was completed in support of this Special 510(k) submission."
Therefore, no new test set was used for this particular submission. The data provenance and sample size would refer to the testing done for the predicate device (K123984), which is not detailed in this document.
The document does mention: "Physician use and data analysis was completed and published publicly. Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication." This indicates that previous clinical data support the use of the technology, but specific details on sample size, design, and provenance related to these publications are not provided within this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable to this Special 510(k) submission as no new testing was performed and no new ground truth was established for the subject device (K172182). The ground truth would have been established during the development and clearance of the predicate device (K123984), but details are absent here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new test set was used for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a diagnostic computer for physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar. The document does not mention any MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone system that computes and displays physiological parameters. It is "algorithm only" in the sense that it performs calculations based on transducer outputs without requiring direct human interpretation of raw signals for its primary function. However, the output (FFR, Pd/Pa values) is intended to be used by a physician "along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated." Therefore, it's a standalone measurement device providing data for human interpretation, rather than an "algorithm only" diagnostic system making a definitive diagnosis without human oversight.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device, the ground truth for physiological parameters (like blood pressure, FFR, Pd/Pa) would typically be established through comparison to established reference standards, often involving direct physical measurements or highly accurate invasive measurement techniques during clinical studies. The document states "Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication," implying that clinical outcomes and established clinical guidelines serve as the ultimate ground truth for the utility of these parameters. Specific details of the ground truth used for the predicate device's validation are not provided in this document.
8. The sample size for the training set
Not applicable. This is a Special 510(k) for a device that computes physiological parameters, not a machine learning or AI device that requires a distinct "training set" in the conventional sense. The device's algorithms are based on established physiological principles and measurement techniques, not on learning from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there isn't a training set in the context of this device's functionality. The "ground truth" for the device's calculations refers to the accuracy of its physiological measurements against accepted standards.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).