(98 days)
The disposable pressure transducer (DPT) is intended for direct measurement and monitoring of invasive blood pressure, intrauterine pressure, urine-dynamic pressure, compartmental (intramuscular) pressure and intracranial pressure.
The proposed device, disposable pressure transducer (DPT), is an extravascular pressure transducer interfaces between an intravascular catheter and monitor by converting changes in pressure into electrical currents that can be impute into a compatible patient monitor. It is for single use; DPT mainly consists of a transducer which converting the pressure changes to electrical currents, a luer connector which can be connected to an intravascular catheter, a transducer cable that can connect to a compatible patient monitor and a stopcock for altering direction fluid flow.
This document describes a 510(k) submission for a Disposable Pressure Transducer (DPT). The submission aims to establish substantial equivalence to a predicate device, the Transpac® Disposable Straight Pressure Transducer (DSPT) (K061573).
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text only states that "Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications and was substantially equivalent to the predicate device." It does not specify the actual acceptance criteria (e.g., specific accuracy ranges, drift limits, etc.) or the detailed reported performance results against those criteria. The focus of this 510(k) summary is on the conclusion of equivalence, not the granular performance data.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Met all design specifications (details not provided in the text) | Performance testing was conducted to validate and verify that the proposed device, Disposable Pressure Transducer (DPT) met all design specifications. |
| Substantial equivalence to predicate device (Transpac® Disposable Straight Pressure Transducer (DSPT), K061573) | Performance testing was conducted to validate and verify that the proposed device... was substantially equivalent to the predicate device. |
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 does not provide details on the sample size used for performance testing or the data provenance.
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 applicable and not provided. The device in question is a physical measurement transducer, not one requiring expert interpretation of data to establish ground truth for testing. Performance testing for such devices typically involves comparison against calibrated reference standards, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the testing does not involve human interpretation or 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 MRMC comparative effectiveness study was done. This type of study is not relevant for a disposable pressure transducer.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable to a disposable pressure transducer. The performance tests would have evaluated the device's ability to accurately convert pressure into electrical signals, without human intervention in the primary measurement process itself. The "standalone" performance here refers to the device's intrinsic accuracy and reliability. The text indicates "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," which implies standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for evaluating the performance of a pressure transducer would be established using calibrated reference pressure sources and possibly traceable measurement standards. For example, a precise pressure calibrator would be used to apply known pressures, and the DPT's output would be compared against these known values. This is not explicitly stated but is the standard practice for such devices.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. This device is not an AI/ML algorithm.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).