(43 days)
The SKIPPER and SKIPPER RACE guidewires are intended for use in the peripheral and coronary vasculature.
The SKIPPER and SKIPPER RACE are 0.014" diameter stainless steel guidewires in usable lengths of 175, 195, and 300cm. The guidewires are designed for use in interventional surgical iongallo or 170, 1999, it is introduced percutaneously into the blood vasculature and advanced to a diseased area. The SKIPPER and SKIPPER RACE guidewires contain a silicone or a hydrophilic coating.
The provided text is a 510(k) summary for the SKIPPER™ and SKIPPER™ RACE guidewires. This type of document is for medical device clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, the information requested in your prompt regarding acceptance criteria, study sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.
Summary of available information related to your prompt:
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Acceptance Criteria and Reported Device Performance: Not applicable/not explicitly stated in the context of specific quantitative criteria for device performance. The "performance data" section states that "Bench testing pertaining to performance characteristics was conducted on the SKIPPER and SKIPPER RACE guidewires and compared to the predicate device testing to demonstrate equivalency." This implies the acceptance criterion was "demonstration of equivalency" to the predicate device through bench tests, but no specific numerical criteria or results are provided.
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Sample Size Used for the Test Set and Data Provenance: Not applicable. Performance was assessed through "bench testing," not a clinical study with a test set of patient data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not applicable, as this was bench testing.
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Adjudication Method for the Test Set: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical medical device, not an AI/software device, and no MRMC study is mentioned.
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Standalone (Algorithm Only) Performance: Not applicable. This is a physical medical device.
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Type of Ground Truth Used: Not applicable. Performance was assessed via bench testing, likely against established engineering standards or the predicate device's performance, not against "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.
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Sample Size for the Training Set: Not applicable. This is a physical medical device, and there is no mention of a "training set" in the context of an AI/ML algorithm.
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How the Ground Truth for the Training Set Was Established: Not applicable.
Additional Information from the Document:
- Device Type: Guidewires (physical medical device).
- Intended Use: For use in peripheral and coronary vasculature.
- Predicate Device: ev3 Nitrex™ Nitinol Guidewire (K024021, K031864, K040345).
- Testing Done: Biocompatibility testing (in accordance with ISO 10993 Part 1 and FDA Memorandum #G95-1) and performance bench testing.
- Conclusion: The guidewires are substantially equivalent to the predicate device in intended use, materials, technological characteristics, and performance.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.