(15 days)
The IQ™ Hydrophilic Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature.
The IQ™ Hydrophilic Guide Wires with ICE® hydrophilic coating are steerable, spring-tipped guide wires. The IQ™ Hydrophilic is available in a nominal diameter of 0.014 inches, Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal three centimeters of all models are radiopaque spring coils and available in either a straight shapeable or a pre-formed J-Tip. The IQ™ Hydrophilic corewire consists of a PTFE coated SS corewire segment joined via a nickel-chromium alloy coupler to a tapered Nitinol corewire segment. The distal segment of this corewire is coated with an adhesive pre-coat that is jacketed with a Tungsten loaded polyurethane sleeve. This polymer sleeve is coated with ICE® Hydrophilic coating. A SS centering sleeve attaches a SS ribbon to the distal end of the corewire. The distal most portion of the corewire, the centering sleeve and the SS ribbon reside within the hollow center of the 3-cm spring-coil. The 185-centimeter version of the IQ™ Hydrophilic is designed with a proximal extension section that allows connection to the AddWire™ Extension Wire.
The document K032183 describes a Special 510(k) for a device modification to the BSC IQ Hydrophilic Guide Wire. This is a medical device, not an AI/ML algorithm, so many of the requested categories (like training set, test set, experts, MRMC studies) are not applicable. Nonetheless, I will provide the information relevant to the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.
Acceptance Criteria and Device Performance for BSC IQ Hydrophilic Guide Wire (K032183)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Functional Performance | Torque Response | Met minimum requirements |
| Tip Prolapse | Met minimum requirements | |
| Tip Shapeability | Met minimum requirements | |
| Marking (Brachial and Femoral) | Met minimum requirements (marker location verified) | |
| Material/Coating Integrity | Coating Adherence/Presence | Met minimum requirements |
| Tensile Strength | Met minimum requirements | |
| Combined Load (not specified if a materials test) | Met minimum requirements | |
| Polymer Peel | Met minimum requirements | |
| Safety & Compatibility | Visual Inspection (for defects) | Met minimum requirements |
| Device Compatibility (with other PTCA/PTA devices) | Met minimum requirements | |
| Biocompatibility | Met minimum requirements | |
| Shelf-Life | Product Shelf-Life | Met minimum requirements |
| Substantial Equivalence | Comparison to predicate devices (PT2™ Guide Wire, Luge™ Guide Wire) | Considered substantially equivalent based on intended use, design, and in vitro testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact number of guide wires or samples used for each test. It broadly states "Testing and evaluation of the IQ™ Hydrophilic Guide Wires included..."
- Data Provenance: The tests are "Non-Clinical Test Summary," implying laboratory/bench testing. The provenance of external data (e.g., country of origin, retrospective/prospective) is not applicable as this is not a study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device approval based on engineering and performance criteria tested in a laboratory setting, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human-interpreted data, not for direct device performance measurements.
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:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's functional integrity as tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by engineering specifications, material science standards, and predefined pass/fail criteria for each functional and material test (e.g., a specific tensile load must be withstood, coatings must adhere to a certain peel strength). The document states "Test results verified that the IQ™ Hydrophilic Guide Wires met all of the minimum requirements."
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML 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.