(168 days)
Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.
The Pre-Formed Guidewire Extra Support guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use.
The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The proximal end of the core wire is coated with grev polytetrafluoroethylene (PTFE) coating. The coil component is fitted over the distal end of the core and is a stainless-steel coiled with green PTFE coating. The coil and core components are secured together using a weld on the distal and a glue joint at the proximal end of the coil, forming the guidewire. The pre-shaped distal end of the guidewire is available in three sizes (extra-small, small and large).
The Pre-Formed Extra Support guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Extra Support guidewire.
The provided text is a 510(k) summary for a medical device (a guidewire) and not a summary of an AI/ML device study. Therefore, most of the requested information regarding AI/ML device acceptance criteria, study details, and data provenance cannot be extracted or inferred from this document.
The document discusses the substantial equivalence of a new guidewire to a predicate device based on bench testing and animal performance data, not AI/ML performance.
However, I can extract the acceptance criteria and the (non-AI/ML) "device performance" as reported for this specific guidewire:
1. Table of Acceptance Criteria and Reported Device Performance (for a Guidewire):
| Acceptance Criteria Category | Specific Test/Evaluation | Predetermined Acceptance Criteria Met? (Reported Device Performance) |
|---|---|---|
| Packaging & Sterilization | Thermal Conditioning and Packaging Distribution | Yes |
| Package Integrity: Visual Inspection | Yes | |
| Package Integrity: Pouch Peel Tear | Yes | |
| Package Integrity: Seal Integrity | Yes | |
| Package Integrity: Bubble Leak Testing | Yes | |
| Dimensional & Physical Properties | Dimensional Inspection: Length, Outer Diameter | Yes |
| Dimensional Inspection: Curve | Yes | |
| Lubricity | Yes | |
| Guidewire Distal Joint Pull Test | Yes | |
| 3 Point Bend | Yes | |
| Coating Adhesion | Yes | |
| Radiopacity | Yes | |
| ISO Corrosion Test | Yes | |
| Particulate Residue Test | Yes | |
| ISO Fracture Test | Yes | |
| ISO Flex Test | Yes | |
| Torque Fatigue | Yes | |
| Kink Resistance | Yes | |
| Biocompatibility | Cytotoxicity | Yes |
| Sensitization | Yes | |
| Irritation | Yes | |
| Systemic Toxicity | Yes | |
| Material Mediated Pyrogenicity | Yes | |
| Hemocompatibility | Yes | |
| Thrombogenicity | Yes | |
| Animal Performance | Performance in Porcine Model (GLP study) | Device performed equivalent to predicate, meeting all safety and performance objectives and Customer Requirement Specifications. |
Missing (as the document is not about an AI/ML device):
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The document refers to samples for bench testing and a porcine model but does not specify "test sets" in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is typically established by human experts or pathology, which is not relevant for this guidewire's non-clinical and animal testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is a study type for AI-assisted human performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI device. For this guidewire, "ground truth" equates to established engineering standards, material properties, and biological responses in animal models.
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
§ 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.