(63 days)
The HI-TORQUE PILOT Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The guide wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
The HI-TORQUE PILOT™ Guide Wire with Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in a 190 cm extendable length and a 300 cm exchange length.
There are three HI-TORQUE PILOT Guide Wire designs with varying tip stiffness, the HI-TORQUE PILOT 50, HI-TORQUE PILOT 150, and HI-TORQUE PILOT 200 Guide Wires.
The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter.
The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, polyurethane-covered area of the wire is covered with a hydrophilic coating.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
Acceptance Criteria and Device Performance Study
The information provided describes a 510(k) premarket notification for a medical device (HI-TORQUE PILOT™ Guide Wire Family with Hydrophilic Coating). As such, the "acceptance criteria" are not reported as specific numerical thresholds, but rather as showing that the device is "substantially equivalent" to a predicate device. The performance data is primarily focused on demonstrating this substantial equivalence through various in vitro and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Coating Performance | Coating Adherence | Met all acceptance criteria and performed similarly to predicate devices. |
| Coating Integrity (Particulate Testing) | Met all acceptance criteria and performed similarly to predicate devices. | |
| Friction Testing | Met all acceptance criteria and performed similarly to predicate devices. | |
| Mechanical Performance | Tensile Strength | Leveraged from predicate device (mechanical functionality unchanged). |
| Torqueability | Leveraged from predicate device (mechanical functionality unchanged). | |
| Torque Strength | Leveraged from predicate device (mechanical functionality unchanged). | |
| Tip Flex | Leveraged from predicate device (mechanical functionality unchanged). | |
| Biocompatibility | Cytotoxicity | Met all acceptance criteria and performed similarly to predicate devices. |
| Hemolysis | Met all acceptance criteria and performed similarly to predicate devices. | |
| Acute Systemic Toxicity | Met all acceptance criteria and performed similarly to predicate devices. | |
| Complement Activation | Met all acceptance criteria and performed similarly to predicate devices. | |
| Coagulation | Met all acceptance criteria and performed similarly to predicate devices. | |
| Intracutaneous (Intradermal) Reactivity Test | Met all acceptance criteria and performed similarly to predicate devices. | |
| USP Systemic Injection Test | Met all acceptance criteria and performed similarly to predicate devices. | |
| Sensitization | Met all acceptance criteria and performed similarly to predicate devices. | |
| Rabbit Pyrogen Test | Met all acceptance criteria and performed similarly to predicate devices. | |
| LAL Pyrogen | Met all acceptance criteria and performed similarly to predicate devices. | |
| Bacterial Endotoxins | Met all acceptance criteria and performed similarly to predicate devices. | |
| In vivo Thrombogenicity Tests | Met all acceptance criteria and performed similarly to predicate devices. | |
| Overall Conclusion | Substantial Equivalence | "The in vitro bench tests and the biocompatibility tests demonstrated that the HI-TORQUE PILOT Guide Wire met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each in vitro bench test or biocompatibility test. It generally states that "in vitro bench testing" and "biocompatibility testing" were conducted.
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. As these are bench and lab tests, the "provenance" would typically refer to the internal lab where the tests were performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the provided document describes testing of a physical medical device (guide wire) through in vitro bench tests and biocompatibility tests, not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" here is the physical performance and biological response measured in a controlled laboratory setting against predefined standards or predicate device performance.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image analysis or diagnostic studies with human interpretation, not for objective physical and chemical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for AI/software devices for diagnostic or interpretive tasks. The submitted device is a physical guide wire.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
This section is not applicable. The device is a physical guide wire, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance reported is inherently "standalone" in the sense that it's the device's intrinsic mechanical and biocompatible properties.
7. The Type of Ground Truth Used
The "ground truth" for the tests conducted includes:
- Predicate Device Performance: For mechanical and biocompatibility tests where new testing wasn't performed, the performance of the predicate device (HI-TORQUE PILOT Guide Wire, K030549) served as the reference.
- Defined Acceptance Criteria/Standards: For the new coating-related tests (adherence, integrity, friction) and the biocompatibility tests, the device was tested against established acceptance criteria, which would be based on recognized standards or internal specifications to ensure safety and effectiveness.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical guide wire; there is no "training set" as would be found in AI/machine learning development.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
§ 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.