(27 days)
This Hi-Torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The Hi-Torque Winn Guide Wire Family is a family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190 cm extendable and 300 cm exchange lengths. The distal core segment of the Winn is offered in 5 configurations: Winn 40. Winn 80. Winn 120, Winn 140T and Winn 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
This document describes a 510(k) summary for the Hi-Torque Winn Guide Wire Family. The submission leverages performance data from a predicate device, the HI-TORQUE PROGRESS Guide Wire Family, arguing substantial equivalence due to identical materials, design, and manufacturing processes. Therefore, no new performance testing was conducted specifically for the Hi-Torque Winn Guide Wire Family.
Here's an analysis based on the provided text, addressing your questions:
1. Table of acceptance criteria and the reported device performance
Since new performance testing was not conducted for the Hi-Torque Winn Guide Wire Family, the acceptance criteria and reported performance are implicitly those established for the predicate device, the HI-TORQUE PROGRESS Guide Wire Family. The document lists the types of performance characteristics that were tested on the predicate.
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance (Predicate) |
|---|---|
| Tensile Strength (Tip Pulls) | Successfully completed |
| Torque Strength (Turns to Separation) | Successfully completed |
| Torqueability (Rotational Accuracy) | Successfully completed |
| Tip Flexibility | Successfully completed |
| Friction/Lubricity Test (Pig Aorta) | Successfully completed |
| Coating Adhesion and Integrity Test (Particulate) | Successfully completed |
| Biocompatibility (Cytotoxicity ISO Elution Test, Hemolysis Test Direct Contact Method, Hemolysis Test Extraction Method, Complement Activation, Coagulation, Intracutaneous Reactivity Test, USP Systemic Injection Test, Sensitization Maximization Test, Material Mediated Rabbit Pyrogen Test, Bacterial Endotoxins (LAL)) | Successfully completed |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set of the predicate device. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for the tests conducted on the predicate device. The only noted data provenance is the "Pig Aorta" for the Friction/Lubricity Test, indicating an animal model was used for that specific test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The performance tests listed are mechanical, chemical, and biological characterization tests, not clinical studies requiring expert ground truth for interpretation.
4. Adjudication method for the test set
This information is not applicable and not provided. Performance tests like tensile strength or biocompatibility do not typically involve adjudication in the way clinical image interpretation studies do.
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
No such study was done. This device is a guide wire, a physical medical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was done. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the performance tests conducted on the predicate device, the "ground truth" would be established by the predefined acceptance criteria for each test (e.g., a specific tensile strength value, acceptable biocompatibility results according to ISO standards). It's based on engineering specifications, regulatory standards, and biological safety profiles.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
§ 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.