(30 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
The Asahi PTCA Guide Wire Fielder is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 180 cm and 300 cm length. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.
The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire Fielder. It states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices." However, it does not provide a table of acceptance criteria or specific reported device performance metrics. It also does not detail the methodology of the study or the provenance of data, only that testing was conducted.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a summary of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The text states that "bench and biocompatibility testing...met the acceptance criteria and performed equivalent to the predicate devices" but does not explicitly list the criteria or the specific device performance results.
2. Sample sized used for the test set and the data provenance
- Cannot be provided. The text mentions "bench and biocompatibility testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. There is no mention of expert involvement in establishing ground truth for any testing described.
4. Adjudication method for the test set
- Cannot be provided. There is no mention of an adjudication method.
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
- Cannot be provided. The device is a PTCA Guide Wire, not an AI or imaging device that would typically involve human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The device is a medical instrument, not an algorithm.
7. The type of ground truth used
- Cannot be explicitly stated based on the text. For "bench and biocompatibility testing," ground truth would typically be established through standardized methods, specifications, and laboratory measurements. However, the text does not detail how the acceptance criteria for these tests were set or what constitutes "ground truth" for them.
8. The sample size for the training set
- Not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for a physical device.
Summary of available information:
- Study Type: Bench and biocompatibility testing.
- Conclusion: The device "met the acceptance criteria and performed equivalent to the predicate devices." This implies the study aimed to demonstrate substantial equivalence through these tests.
- Predicate Devices: JoWire Neo's PTCA Guide Wire (K022762) and JoWire Asahi PTCA Guide Wire (K031277).
- No new safety or effectiveness issues were raised during the testing.
§ 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.