(116 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.
The provided document describes a 510(k) premarket notification for the TruWave™ Disposable Pressure Transducer. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on comparing a new device to an existing one, rather than proving novel efficacy or conducting extensive clinical trials as would be required for a PMA.
Therefore, the information available pertains to the device's performance against a predicate and functional/safety testing, rather than a clinical study establishing diagnostic accuracy or effectiveness in a "predictive" sense, as would be typical for AI/ML devices. Many of the requested fields (such as multi-reader multi-case studies, expert adjudication for ground truth, or effect size of AI assistance) are not applicable to this type of device and submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Key Performance Specifications) | Reported Device Performance |
|---|---|
| Integral flush device flow rate | 3 mL/hr or 30 mL/hr (depending on the variant) |
| Operating Pressure Range | -50 to +300 mmHg |
| Nonlinearity and Hysteresis | ±1.5% of reading or ± 1 mmHg, whichever is greater |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical data for diagnostic accuracy. The testing performed was primarily performance testing to compare the device to a predicate. The document states:
- "Performance testing was conducted to compare the proposed device to the predicate device."
- "The TruWave disposable pressure transducer has successfully passed functional- performance post MRI exposure, the testing included pressure accuracy (nonlinearity and hysteresis)."
The details of the sample size (e.g., number of units tested, number of measurements) for these performance tests are not provided. Similarly, the "data provenance" in terms of subject demographics or clinical setting is not applicable as it's not a clinical study involving human patients to establish diagnostic performance. The tests are likely bench or laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As this is not a diagnostic AI/ML device, there is no "ground truth" established by experts in the context of interpreting medical images or clinical data. The performance criteria (e.g., pressure accuracy) are determined by quantitative laboratory measurements against set standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. There is no "adjudication method" described, as there are no expert interpretations or clinical diagnoses being made that would require adjudication.
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. This is not an AI-assisted device for human interpretation, therefore an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware device (a disposable pressure transducer) and does not involve AI algorithms operating in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the performance of this device is based on technical specifications and established measurement standards, rather than clinical outcomes or expert consensus on a diagnosis. For example, pressure accuracy (nonlinearity and hysteresis) would be measured against a highly accurate reference pressure measurement system.
8. The sample size for the training set
Not Applicable. This is a hardware medical device; it does not involve machine learning or a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not Applicable. There is no training set for this device.
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).