(113 days)
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA). 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 the 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 Jet (HT Jet) 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 Jet Guide Wire Family consists of two models with differing flexibility and performance: the HT Jet 15C and the HT Jet 25C. 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 Jet guide wire family is compatible with devices designed for use with 0.014" guide wires.
The Abbott Vascular Hi-Torque JET Guide Wire Family's acceptance criteria and performance are detailed in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the in vitro bench tests demonstrated that the Hi-Torque Jet Guide Wire met all acceptance criteria for the following performance aspects:
| Acceptance Criteria Aspect | Reported Device Performance |
|---|---|
| Catheter Compatibility | Met all acceptance criteria |
| Radiopacity | Met all acceptance criteria |
| Tensile Strength | Met all acceptance criteria |
| Torque Strength | Met all acceptance criteria |
| Torque Accuracy | Met all acceptance criteria |
| Coating Adherence & Integrity | Met all acceptance criteria (particulate testing) |
| Friction Testing | Met all acceptance criteria |
The overall conclusion is that the device performed similarly to the predicate devices and met all established acceptance criteria, indicating its substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the in vitro bench tests. It simply states that "in vitro bench testing" was conducted.
The data provenance is retrospective, as the tests were performed on the device after its design, and the results are presented as a summary of the outcomes of these tests. The country of origin of the data is not explicitly stated, but the submission is from Abbott Vascular Inc., located in Temecula, CA, USA, suggesting the testing was conducted or overseen in the USA.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the study described is an in vitro bench testing study, not an expert-based clinical or image-based diagnostic study. The "ground truth" for these performance tests is based on objective measurements against predefined engineering and performance specifications.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here. Adjudication methods are typically used in clinical trials or studies where subjective interpretations (e.g., by experts) need to be reconciled. For in vitro bench testing, acceptance is determined by direct measurement against pre-defined quantitative or qualitative criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, typically in medical image interpretation. The device in question is a guide wire, and the testing involved objective in vitro bench tests, not human interpretation tasks.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The study conducted was a standalone performance evaluation in the sense that the device's physical and mechanical properties were tested directly, without human intervention in the 'performance' of the device itself during testing. However, it's important to distinguish that this is not an "algorithm only" study, as the device is a physical medical instrument, not a software algorithm. The tests evaluate the intrinsic performance of the guide wire itself.
7. The Type of Ground Truth Used
The type of ground truth used for the in vitro bench testing is based on engineering specifications and predefined performance criteria. For example:
- Tensile strength: Measured against a minimum required breaking strength.
- Torque strength: Measured against torsional force limits.
- Radiopacity: Assessed against a standard for visibility under fluoroscopy.
- Friction: Measured against specified friction coefficients.
These are objective, quantifiable standards for the device's physical properties.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument (guide wire), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical medical 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.