(96 days)
To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angloplasty (1 YOA) and poroculared in the cerebral blood vessel.
The Asani PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi PTCA Guide Wire:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria are not explicitly stated or defined. The submission focuses on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail metrics. | "All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature." |
| "functions as intended" | "Bench testing demonstrates that the device functions as intended." |
| "substantially equivalent to the specified specifications and the legally cleared predicate devices." | "The ASAHI Guide Wire characteristics are substantially equivalent to the specified specifications and the legally cleared predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission references "bench testing" but does not detail the sample sizes of devices or test conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes a medical device (guide wire), not an algorithm or diagnostic tool that requires expert-established ground truth on a test set (e.g., medical images). The testing appears to be physical or mechanical bench testing.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable. The device is a physical medical instrument (guide wire), not a diagnostic algorithm where human readers assess cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" would relate to its physical and functional properties meeting specifications. The document states:
- "Biocompatibility": Demonstrated by a "long history of use in medical devices" for its components. This implies a historical record of safe and successful use in similar applications.
- "Functioning as intended": Established through "bench testing." This likely involves engineering specifications and performance metrics for parameters like tensile strength, flexibility, lubricity, etc. However, the specific parameters are not detailed in the summary.
- "Substantial equivalence": Established by comparing its characteristics and materials to previously cleared predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
Summary of the Study and Acceptance:
The submission for the Asahi PTCA Guide Wire (K052339) is a 510(k) premarket notification, which aims to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.
The "study" described is primarily focused on bench testing to demonstrate:
- The device's materials are the same as existing predicate devices and have a long history of biocompatible use.
- The device functions as intended.
- The device's characteristics are substantially equivalent to the specified (presumably for the predicate devices) specifications.
The acceptance criteria, while not quantified with specific thresholds, are met by demonstrating this substantial equivalence and satisfactory performance in bench testing, allowing the FDA to conclude that the device is as safe and effective as its predicates. The FDA's acceptance is conveyed in the letter from November 30, 2005, stating that the device is "substantially equivalent."
§ 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.