(33 days)
ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.
The ComboMap™ Pressure and Flow System is a computer-controlled (PCbased) instrument, which processes the information it receives from the transducer mounted in a Volcano Therapeutics SmartWire" Pressure Guide Wire, Volcano Therapeutics FloWire® Doppler Guide Wire, and/or external inputs, to produce real-time blood pressure and/or blood flow velocity. There are 4 modes available to operate from and switch between on the ComboMap™; System. Pressure, Flow, and Combo. Depending on the mode and setup selections made, the computer screen displays a combination of waveforms, measured values, and calculated parameters on the display screen. Additional controls also appear on the display screens.
In the Pressure Mode, the ComboMap™ provides digital and graphical readout of mean aortic pressure from a guide catheter, mean SmartWire® pressure, and a calculated parameter, such as gradient or fractional flow reserve (FR), and one of six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWire® pressure for display on a conventional physiologic monitoring svstem.
In the Flow Mode, there are two (2) operating modes to measure blood flow velocity in either coronary or peripheral vessels. This is because in coronary arteries, maximum blood flow velocity occurs predominantly during diastole and in peripheral arteries, maximum flow occurs during systole. The ComboMap™ displays the waveforms selected and provides digital readout of calculated parameters such as average peak velocity (APV) and flow reserve.
The ComboMap™ System offers the unique ability to simultaneously display pressure and velocity waveforms using the Combo Mode. Layout of the Pressure and Doppler display as well as selected waveforms is customized by the user allowing a combination of any of those described above in Pressure Mode and Flow Mode.
Depending on the clinicians' preference, the physician has the option of using a pressure guide wire (SmartWire®), a flow guide wire (FloWire®) or both. By using these guide wires from Volcano Therapeutics, the physician can measure pressure and/or flow velocity.
The provided document does not contain enough information to fully describe the acceptance criteria and the study that proves the device meets those criteria in the requested format.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Applicable testing was performed to evaluate the ComboMap™ Pressure and Flow System. The test results were found to be acceptable as required by the respective test plans and protocols."
This indicates that acceptance criteria and performance data exist, but they are not provided in this summary. The summary only confirms that the device passed its internal testing.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document. The device appears to be a measurement system, not one that requires human expert interpretation for ground truth, but the details of its validation are missing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable. The ComboMap™ Pressure and Flow System is a device for measuring physiological parameters (blood pressure and flow velocity), not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable in the context of "algorithm only." The ComboMap™ is a standalone system that performs measurements. Its performance would be evaluated on the accuracy and precision of its measurements against a reference standard, not against a "human-in-the-loop" scenario in the way an AI diagnostic tool would be. The document implies standalone performance testing was done, but no details are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth." For a measurement device like this, the ground truth would typically be established by highly accurate reference measurement methods (e.g., calibrated pressure transducers, flow meters) in a controlled environment. However, the details of these reference methods are not provided.
8. The sample size for the training set
This is not applicable. This device is a measurement system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
Summary of Available Information:
The document describes the ComboMap™ Pressure and Flow System as a multi-mode system combining the functionality of previous separate pressure and flow measurement devices (SmartMap®, WaveMap®, and FloMap®). It's intended to measure intravascular blood pressure and/or blood flow velocities.
The "Performance Data" section briefly states that "Applicable testing was performed to evaluate the ComboMap™ Pressure and Flow System. The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that internal testing was conducted against pre-defined acceptance criteria, and the device passed. However, the specifics of those criteria and the detailed performance results are not included in this 510(k) summary.
The 510(k) process in this case relies on demonstrating substantial equivalence to predicate devices (SmartMap® Pressure System, WaveMap® Pressure System, FloMap® Doppler Flow System). The key argument is that "Signal processing, measurement modalities and instrument connections are the same as the predecessor instruments. The intended use and the fundamental scientific technology of the SmartMap® WaveMap® and FloMap have not been altered but are combined together in the ComboMap™." This implies that the performance characteristics were expected to be similar due to the use of established technologies.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).