(30 days)
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system's intended use is for the assessment of a patient's haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood.
The Continuous Cardiac Output Pulmonary Artery Catheter, (catalogue # TruCATH), is a six-lumen, heparin-coated, polyvinyl chloride (PVC) flow-directed Pulmonary Artery Catheter. Once placed, the proximal extensions of the catheter are attached to the second part of the system, the Monitor. The Continuous Cardiac Output Monitor, (catalogue # TruCCOM), is a microprocessor-based computer which, when interfaced with the TruCATH, continuously calculates and displays cardiac output. The Monitor calculates cardiac output based on the thermodynamic principle of heat transfer using thermal power produced by the thermal coil area on the Catheter. Alternatively, the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.
The provided text describes a 510(k) submission for a modified continuous cardiac output pulmonary artery catheter and monitor system. The focus is on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing de novo acceptance criteria for a new device and proving its performance against those criteria. Therefore, several of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, number of experts for ground truth, MRMC studies) are not applicable or cannot be extracted from this type of regulatory document.
However, based on the information provided, here's a breakdown of what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format. Instead, the "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to "the same specifications as the predicate device".
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet same specifications as predicate device for: | Confirmed that the modified device met the same specifications as the predicate device for: |
| - Catheter functionality (e.g., heat transfer device (HTD) repositioning, material flexibility, luer lock bond strength) | - Functional Bench Testing results confirmed meeting specifications |
| - Catheter visual integrity | - Functional and visual testing results confirmed meeting specifications |
| - Catheter pull strength | - Pull test results confirmed meeting specifications |
| - Monitor electromagnetic compatibility (EMC) performance | - Electromagnetic compatibility testing results confirmed improved EMC performance and meeting specifications |
| - Monitor software validation | - Software validation results confirmed meeting specifications |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the "Functional Bench Testing," "Functional and visual testing," "Pull test," "Electromagnetic compatibility testing," or "Software validation." It also does not mention the data provenance (country of origin or retrospective/prospective nature). These tests appear to be laboratory/bench tests rather than clinical studies with patient data.
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. The ground truth for the "Substantial Equivalence" claim is based on engineering specifications and testing against the predicate device's performance, not expert clinical interpretation of results from a diagnostic test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing described is against engineering specifications and does not involve adjudication of clinical data.
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
No MRMC comparative effectiveness study was done. This regulatory submission is for a device modification of an existing medical device (Pulmonary Artery Catheter and Cardiac Output Monitor), not an AI-powered diagnostic tool requiring such studies. The stated modifications relate to physical design and software interface, not diagnostic interpretation enhancement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done in the sense that the device's components (catheter and monitor software) were tested independently against engineering specifications. The "algorithm" in this context refers to the monitor's microprocessor-based calculations for cardiac output, which were validated through "Software validation." The performance is inherent to the device's design and operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is the engineering specifications and established performance characteristics of the predicate device (Ami-MED Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor, 510(k) number K925444). The tests performed were designed to confirm that the modified device met these same specifications.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that involves a training set with labeled data. The "software validation" refers to verifying the correct operation of the monitor's embedded software.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).