(262 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 vessels.
The PressureWire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire is available in two different lengths.
The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.
This FDA 510(k) summary for the PressureWire device (K140466) describes a modification to an already cleared device, not a new initial clearance study with acceptance criteria for clinical performance. Therefore, many of the requested categories related to clinical study design and performance metrics will not be fully addressed in this document.
The primary purpose of this 510(k) is to demonstrate substantial equivalence to a predicate device (PressureWire Certus and Aeris, K131452) after a minor design change. The "acceptance criteria" here are focused on demonstrating that the modified device maintains the safety and efficacy of the predicate, and performs comparably, rather than meeting specific performance thresholds against a clinical ground truth.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a modification, the "acceptance criteria" largely revolve around demonstrating that the modified device (PressureWire with new coating) performs equivalently or better than the predicate device in non-clinical tests. Clinical performance metrics like sensitivity, specificity, or reader improvement are not evaluated in this type of submission for this device.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 | "The PressureWire has been tested and is in compliance with ISO 10993-1:2009 with C1:2010), Biological evaluation of medical devices..." |
| Sterilization | Compliance with ISO TS 11135-2:2008 | "...ISO TS 11135-2:2008, Sterilization of health care products -Ethylene Oxide - Part 2 Guidance on the application of ISO 11135-1..." |
| Particulate Matter | Compliance with USP 33-NF 28 and USP 36 | "...USP 33-NF 28 General chapter Particulate matter in injections, and USP 36 Containers - Plastics." |
| Physical/Mechanical | Integrity for fractures, friction force, wire diameter & straightness (comparable to predicate) | "bench testing included physical, mechanical and coating integrity testing for fractures, friction force, and wire diameter and straightness." Results conclude it is "safe and effective and is substantially equivalent to the predicate device." |
| Coating Integrity | Maintained or improved after modification | "coating integrity testing." Results conclude it is "safe and effective and is substantially equivalent to the predicate device." |
Note: The document explicitly states: "The subject device, PressureWire™ (models Certus™ and Aeris™), meets the design inputs and raises no new safety or efficacy concerns. PressureWire™ is determined to be substantially equivalent to the presently marketed predicate device, K131452." This overall "acceptance" is based on the comprehensive testing summarized above.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" here refers to physical samples of the modified guidewire for bench testing. The document does not specify the number of individual guidewires tested for each category (e.g., how many wires were tested for friction, how many for fractures).
- Data Provenance: The testing was "performed design verification and validation ... in compliance with internal design control procedures which included bench testing." This implies internal testing by the manufacturer (St. Jude Medical Systems AB, Sweden). The data is retrospective in the sense that it's generated after the design modification but for internal verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For this type of device modification and 510(k) submission, there isn't a "ground truth" established by external experts in the same way one would for a diagnostic AI device requiring expert interpretation. The "ground truth" for the non-clinical tests is based on established engineering standards (ISO, USP) and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There's no human interpretation or subjective assessment of the test results that would require adjudication. Bench testing results are typically objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and would measure the impact of an AI algorithm on reader performance. The PressureWire is a medical instrument for direct physiological measurement, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable. The PressureWire is the standalone device; it's a sensor-equipped guidewire that measures physiological parameters. There isn't a separate "algorithm" in the sense of an AI model that could be evaluated standalone from the physical device. The device's performance is determined by its physical and electrical characteristics.
7. The Type of Ground Truth Used
For the non-clinical testing performed:
- Engineering Standards: Compliance with ISO 10993-1, ISO TS 11135-2, USP 33-NF 28 , and USP 36 .
- Predicate Device Performance: The underlying "ground truth" for the modification's impact is that the modified device's performance should be equivalent to or better than the original predicate device (K131452) across relevant physical and functional parameters, as established during the predicate's original clearance.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).