(24 days)
The SmartWire Pressure Guide Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The SmartWire II is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The SmartWire measures pressure when used with the SmartMap®, WaveMap®, and ComboMap® Instruments. The SmartWire II is available in a diameter of 0.014" (0.36 mm), lengths of 185 cm and 300 cm, and different tip flexibilities. The SmartWire II is packaged preconnected to the connector with a torque device to facilitate navigation through vasculature.
The provided text is a 510(k) summary for the Volcano Corporation's SmartWire Pressure Guide Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and a study proving those criteria are met for the device in question.
Here's an analysis based on the limited information provided, addressing your requested points:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific pressure measurement accuracy ranges) or report detailed numerical performance results for the SmartWire Pressure Guide Wire itself. Instead, it relies on a qualitative comparison to the predicate device.
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| Same fundamental scientific technology | The modified SmartWire® Pressure Guide Wire uses the same fundamental scientific technology. |
| Same intended use | Has the same intended use as that of the predicate device. |
| Biocompatibility according to ISO 10993-1 | The new material was tested for biocompatibility according to ISO 10993-1, and the results met the predetermined acceptance criteria. |
| Comparable performance to predicate device | The test results indicate the revised product is comparable to the predicate device. |
| No new questions regarding safety or efficacy | Modifications to the device do not raise any new questions regarding safety or efficacy. |
| Continuing substantial equivalence | The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of a clinical performance study. The "applicable testing" mentioned is part of design verification. The sample sizes for this testing are not provided, nor is the provenance of any data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This type of evaluation is typically associated with AI/software-based devices and not with a physical medical device like a guide wire, for which performance is assessed through engineering and biocompatibility testing.
4. Adjudication Method for the Test Set:
Not applicable, as no external expert-adjudicated test set is described.
5. MRMC Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study would be relevant for devices that assist human readers in interpreting medical images or data, which is not the primary function of a pressure guide wire.
6. Standalone (Algorithm Only) Performance:
Not applicable. The SmartWire Pressure Guide Wire is a physical medical device, not an algorithm. Its performance is intrinsically tied to its physical characteristics and interaction with the human body and other medical instruments (SmartMap®, WaveMap®, and ComboMap® Instruments).
7. Type of Ground Truth Used:
For the biocompatibility testing, the "ground truth" was established by the predetermined acceptance criteria for ISO 10993-1. For the overall device performance, the "ground truth" for comparison appears to be the performance of the predicate device, as the goal was to show comparability. This is an engineering and regulatory "ground truth" rather than a clinical outcome or expert consensus.
8. Sample Size for the Training Set:
Not applicable. The SmartWire Pressure Guide Wire is a physical medical device; there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
Summary of the Study (Based on the document):
The "study" or "performance data" referred to in the document is a Design Verification Plan that included a Risk Analysis. This testing aimed to demonstrate that the revised product (SmartWire Pressure Guide Wire with new material) is comparable to its predicate device (Volcano SmartWire® Pressure Guide Wire cleared under K021219) and that modifications did not introduce new safety or efficacy concerns.
Specifically, the document highlights:
- Testing for biocompatibility according to ISO 10993-1, with results meeting predetermined acceptance criteria.
- General statement that "test results indicate the revised product is comparable to the predicate device."
The nature of the modifications (changes to material) suggests that the focus of the performance data would have been on demonstrating that the new material did not negatively impact the established performance characteristics (e.g., pressure measurement accuracy, steerability, durability) already validated for the predicate device. However, the exact tests and their detailed results are not provided in this public summary.
Conclusion:
This 510(k) submission relies on a demonstration of substantial equivalence through rigorous design verification and compliance testing (e.g., biocompatibility) rather than a clinical trial with human-in-the-loop performance evaluation or AI algorithm validation. The acceptance criteria and "study" are framed around ensuring the modified device maintains the safety and efficacy profile of its predicate.
§ 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).