(175 days)
The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The Inno-Pathwire is a steerable guidewire available in a diameter of 0.014" (0.36 mm) and an effective length of 190 cm. The distal tip is shapeable. Before use, the tip can be shaped "J". The wire construction includes a stainless steel proximal shaft and a distal super-elastic nitinol shaft for flexibility and performance. The two shafts are connected by a super-elastic nitinol hypotube. The distal shaft is soldered with the tip coil or the tip coil and proximal coil both. For IW-14-190-EXS model, the distal shaft is soldered to the tip coil only but for IW-14-190-STS and IW-14-190-MDS, their distal shafts are soldered to the tip coil and proximal coil both. The tip coil is visible under Xray to assist the physician with the movement of the guidewire. The distal segment of the guidewire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guidewire movement within the catheter and arteries. The proximal end of the guidewire is coated with PTFE coating which reduces friction of the wire within a catheter.
The guidewire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire for twisting and controlling the guidewire. The guidewires are packaged within a cardboard box which contains five individual guidewires.
The provided text describes the acceptance criteria and study for the Inno-Pathwire, a medical device, in its 510(k) summary. However, this is a medical device submission for a guidewire, not a software or AI-based device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable (N/A) for this type of submission.
Here is the information that can be extracted from the provided text, modified to acknowledge the product type:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (Demonstrated) |
|---|---|
| Dimensional Verification | Achieved |
| Visual Inspection | Achieved |
| Torque Strength | Achieved |
| Coating Adherence/Integrity | Achieved |
| Lubricity | Achieved |
| Kink Resistance | Achieved |
| Radiopacity | Achieved |
| Tensile Strength/Tip Pull | Achieved |
| Torqueability | Achieved |
| Particulate Evaluation | Achieved |
| Resistance to corrosion | Achieved |
| Tip Flexibility | Achieved |
| Biocompatibility: | |
| Cytotoxicity | Acceptable (No safety risks) |
| Irritation and Skin Sensitization | Acceptable (No safety risks) |
| Acute Systemic Toxicity | Acceptable (No safety risks) |
| Pyrogenicity (Rabbit Pyrogen Test) | Acceptable (No pyrogenic response) |
| SC5b-9 Complement Activation | Acceptable (No safety risks) |
| Unactivated Partial Thromboplastin Time | Acceptable (No safety risks) |
| Rabbit Blood Hemolysis | Acceptable (No safety risks) |
| Hemocompatibility | Acceptable (No safety risks) |
| Thrombogenicity | Acceptable (No safety risks) |
| Sterilization: | |
| Sterility Assurance Level (SAL) | 10⁻⁶ (Validated to ISO 11135) |
| EO and ECH Residuals | Met requirements for limited exposure devices (ISO 10993-7) |
| Pyrogenicity (Bacterial Endotoxin Test) | Consistent with product release requirements |
The following fields are N/A because the Inno-Pathwire is a physical medical device (guidewire), not an AI or software device. The studies described are bench tests and biocompatibility tests, not evaluations of algorithmic performance.
2. Sample size used for the test set and the data provenance: N/A (Not an AI/software device; testing involved physical device samples and materials)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is based on engineering specifications, material science, and biological testing standards)
4. Adjudication method for the test set: N/A (Not an AI/software device evaluation)
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: N/A (Not an AI/software device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
7. The type of ground truth used: For physical performance tests, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO, ASTM) and the expected physical and chemical properties of the materials. For biocompatibility, it's the biological response measured against toxicity, irritation, and other harmful effects as defined by ISO 10993 standards.
8. The sample size for the training set: N/A (Not an AI/software device; no "training set" in the AI sense)
9. How the ground truth for the training set was established: N/A (Not an AI/software 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.