(89 days)
This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within a vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
The Abbott Vascular 0.014" Hi-Torque Command (HT Command) Guide Wire with hydrophilic and hydrophobic coatings is a stainless steel and nitinol steerable guide wire with a maximum diameter of 0.0145", provided in 190 cm extendable, 250 cm, and 300 cm exchange lengths. The distal tip has a radiopaque length of 3.0 cm. The distal tip is straight and shapeable. The HT Command Guide Wire Family consists of two models with differing flexibility and performance; the HT Command and the HT Command ES. The proximal end of the 190 cm model is plunge ground and coined to fit into the hypotube portion of the DOC® Guide Wire Extension. The HT Command guide wire family is compatible with devices designed for use with 0.014" guide wires.
The provided text describes the Abbott Vascular Hi-Torque Command Guide Wire Family. The information focuses on the device's substantial equivalence to predicate devices based on in vitro bench testing. There is no information about a clinical study, AI/algorithm performance, ground truth establishment for a training set, or expert-based evaluations for this specific medical device submission. The submission relies solely on bench testing to demonstrate substantial equivalence.
Here's a breakdown based on the input requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter Compatibility | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
| Radiopacity | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
| Tensile Strength | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
| Torque Strength | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
| Torque Accuracy | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
| Coating Adherence and Integrity | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
| Friction Testing | Met all acceptance criteria. | Performed similarly to predicate devices; met all criteria. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as in vitro bench testing.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "in vitro bench testing" without specifying the number of test units.
- Data Provenance: Not applicable in the context of clinical data. These are laboratory bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The evaluation was based on objective physical and mechanical properties measured during bench testing, not on expert interpretations of data or images.
4. Adjudication method for the test set:
- Not applicable. There was no human interpretation or adjudication involved, as the tests were objective 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:
- No. This was not an MRMC study. There is no AI component or human reader evaluation described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device (guide wire); an algorithm-only performance study is not relevant.
7. The type of ground truth used:
- The "ground truth" for the in vitro bench testing would be the established scientific and engineering principles and standards for evaluating the physical and mechanical properties of guide wires (e.g., standard methods for measuring tensile strength, torque, etc.). The acceptance criteria are based on these predefined thresholds.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device and relies on bench testing, not machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
§ 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.