(112 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.
This document (K171996) is a 510(k) premarket notification for a medical device called the "TruWave™ Disposable Pressure Transducer." The key information is outlined in Section 5 – 510(k) Summary.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This document describes a device modification submission, not a submission for a completely novel device. Therefore, the "studies" focus on demonstrating that the changes made to the device (sterilization method and plasticizer) do not negatively impact its performance or safety compared to the predicate device. It is not an AI-powered device, so typical AI/ML study components (like expert consensus for image labeling, MRMC studies, or training set details) are not applicable.
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are essentially that the modified device performs "substantially equivalently" to the predicate device. The performance is reported as successful completion of various tests.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Change Impact | The change in plasticizer from DEHP to TOTM/DINCH® for different components should not alter the performance or safety. | "Testing was conducted to ensure that the change in sterilization method and change in materials did not alter the performance of the TruWave DPT kits." (Implies successful testing). The device "passed all biocompatibility testing." The device "successfully passed biocompatibility, functional testing, electrical performance and safety testing, and usability testing." |
| Sterilization Change Impact | The change in sterilization method from 100% Ethylene Oxide to E-beam radiation should not alter the performance or safety. | "Testing was conducted to ensure that the change in sterilization method and change in materials did not alter the performance of the TruWave DPT kits." (Implies successful testing). The device "passed all biocompatibility testing." The device "successfully passed biocompatibility, functional testing, electrical performance and safety testing, and usability testing." |
| Biocompatibility | The device must remain biocompatible after the material and sterilization changes. | The products "passed all biocompatibility testing." |
| Functional Performance | The device must continue to function as intended for intravascular, intracranial, or intrauterine pressure monitoring. | The TruWave disposable pressure transducer kits "successfully passed... functional testing." The design verification (electrical) test results were updated in the IFU to comply with AAMI/ANSI BP22:1994/(R)2016, implying successful compliance. |
| Electrical Performance | The electrical characteristics of the device must remain within specified limits, compliant with relevant standards (e.g., AAMI/ANSI BP22:1994/(R)2016). | The TruWave disposable pressure transducer kits "successfully passed... electrical performance and safety testing." Clarifying the design verification (electrical) test results in the Instructions for Use 'Performance Specifications' section to comply with AAMI/ANSI BP22: 1994/(R) 2016. |
| Safety Testing | The device must meet safety standards. | The TruWave disposable pressure transducer kits "successfully passed... safety testing." |
| Usability | The device should remain easy and safe to use. | The TruWave disposable pressure transducer kits "successfully passed... usability testing." |
| Substantial Equivalence | The modified device must be substantially equivalent to the predicate device in terms of intended use/indications for use, and technology, with no new questions of safety or effectiveness. | "The subject TruWave Disposable Pressure Transducer kits are substantially equivalent to the predicate TruWave Disposable Pressure Transducer Kits (K141495 and K142749)." "Testing was conducted to ensure that the change in sterilization method and change in materials did not alter the performance of the TruWave DPT kits." |
Regarding the details of the study:
Since this is a 510(k) for a modification to a physical medical device (a pressure transducer), the "study" is primarily a series of engineering, material, and biocompatibility tests rather than clinical trials or AI model validation studies. Therefore, many of the requested points are not applicable or explicitly stated in the provided summary.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the specific tests (e.g., how many units were tested for functional or electrical performance). This is typical for a 510(k) summary, as the detailed test protocols and sample sizes would be in the full submission, not the public summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were likely performed in a lab setting by the manufacturer (Edwards Lifesciences).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device submission. "Ground truth" in this context would refer to the established performance characteristics and safety profiles of the predicate device, against which the modified device is compared via defined test methods (e.g., accuracy of pressure readings, material integrity). It doesn't involve expert labeling or interpretation of complex data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as there's no human interpretation or labeling of data requiring adjudication. Performance is measured against engineering specifications and industry standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, this was not done. MRMC studies are specific to evaluating the impact of AI/ML systems on human reader performance, typically in diagnostic imaging. This device is a physical transducer, not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This question pertains to AI/ML algorithm performance. The device is a physical pressure transducer.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" implicitly used for this device comparison is the performance and safety data of the legally marketed predicate devices, as well as established engineering and medical device standards (e.g., AAMI/ANSI BP22:1994/(R)2016 for electrical performance, and general biocompatibility standards). The modified device must demonstrate that its performance remains within acceptable limits as defined by these standards and the predicate performance.
8. The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- This is not applicable. There is no "training set" for ground truth establishment.
§ 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).