(102 days)
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessel.
PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.
The provided 510(k) summary for the PressureWire® Aeris and PressureWire® Receiver describes its technical characteristics and claims substantial equivalence to predicate devices. However, the document does not describe the acceptance criteria and a study proving the device meets those criteria, as typically understood for sophisticated diagnostic or AI-powered devices.
Instead, this submission focuses on functional/safety testing to demonstrate that the new device (which incorporates wireless technology) is as safe and performs as well as previous wired versions. It does not present a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or effect size.
Here's an analysis based on the information provided, highlighting the absence of what was requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states "satisfies safety and performance requirements of the device specifications." This implies internal specifications, but the specific, measurable criteria are not disclosed. | "Electrical safety, EMC, radio, sterilization and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues." |
Explanation: The 510(k) summary does not define explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a particular diagnostic task). The "performance testing" mentioned is likely related to the device's functional integrity as a pressure guidewire, rather than its diagnostic efficacy in a clinical setting against a gold standard. The primary focus of this 510(k) is the change from a wired to a wireless signal transfer mechanism.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. The document does not describe a clinical performance study involving a test set of patient data.
- Data provenance: Not applicable.
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)
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable.
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
- MRMC study: No, this device is a medical instrument (pressure guidewire) for measuring physiological parameters, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. The device itself is the "standalone" instrument. It measures physiological parameters for clinicians to interpret. There is no "algorithm only" performance to evaluate in the context of interpretation, as this is not an AI-driven image analysis or diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not explicitly stated or applicable as no clinical performance study against a diagnostic ground truth is described. The "performance requirements" would likely be engineering specifications for pressure and temperature measurement accuracy and reliability, validated against calibrated standards or in-vitro models rather than clinical ground truth for diagnostic interpretation.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary of Device and 510(k) Filing:
The K080813 submission for the PressureWire® Aeris focuses on the technical modifications of an existing device (PressureWire®) by introducing a wireless signal transfer mechanism. The key argument for substantial equivalence is that the new wireless version performs its intended function (directing a catheter and measuring physiological parameters) and meets safety standards just like its predicate wired versions. The 510(k) summary explicitly states: "The guidewire part of subject device is identical to the predicate device (K062769)." The "Functional/Safety Testing" mentioned refers to electrical, EMC, radio, sterilization, and general performance testing to ensure the new wireless components do not introduce new safety concerns or functional degradation compared to the wired predicate. This is a common approach for 510(k) submissions where the changes are primarily technological rather than a new diagnostic claim or a new type of 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).