(29 days)
The HI-TORQUE TurnTrac Guide Wire Family is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and /or reuse.
The HI-TORQUE (HT) TurnTrac Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip loads, hydrophilic coating lengths, tip shape and guide wire lengths.
The HT TurnTrac Guide Wire Family will be available with the features as listed below:
- 2 tip loads: 0.6g and 0.9g ●
- 2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES)
- 2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
- 1 tip shape: Straight ●
- 2 lengths: 190 cm, 300cm ●
The HI-TORQUE TurnTrac Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE TurnTrac Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.
The provided text describes a 510(k) submission for a medical device, the HI-TORQUE® TurnTrac Guide Wire Family. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials.
Therefore, the information you're asking for, which is typical for demonstrating safety and efficacy of new and complex medical devices, especially AI/ML-driven ones, is largely not present or not applicable in this 510(k) summary. This submission primarily relies on bench testing to show the device performs similarly to its predicate.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The text states: "The results from the in vitro bench tests demonstrated that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device."
However, the specific acceptance criteria values (e.g., minimum tensile strength in Newtons) and the actual reported performance values are not explicitly listed in a table within this document. The document only confirms that the criteria were met.
We can infer the categories of tests conducted:
| Acceptance Criteria Category | Reported Device Performance (as stated) |
|---|---|
| Tip Tensile Strength | Met all acceptance criteria |
| Torsional Wire Strength | Met all acceptance criteria |
| Torqueability | Met all acceptance criteria |
| Integrity (Particulate Testing) | Met all acceptance criteria |
| Friction Testing | Met all acceptance criteria |
| Biocompatibility | Considered substantially equivalent to the predicate device |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "in vitro bench testing" was conducted on the "modified device." It doesn't provide the number of units tested.
- Data Provenance: Not applicable in the context of patient data (e.g., country of origin, retrospective/prospective). These are entirely bench tests conducted in a lab setting, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a guide wire, "ground truth" for bench testing is established by engineering specifications and quantitative measurements (e.g., force transducers, microscopes, specialized test equipment), not by human expert opinion like radiologists for image interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or annotators, typically in clinical studies or image interpretation tasks. This is a bench test, and results are quantitative.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. An MRMC study is relevant for AI-assisted human performance in tasks like interpreting medical images. This 510(k) is for a physical medical device (a guide wire), and the testing described is purely in vitro bench testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm. It is a physical medical device.
7. The type of ground truth used
For the bench tests, the "ground truth" would be the engineering specifications and validated measurement techniques (e.g., calibration standards for tensile strength, precise measurements of torque, particulate counts verified against specific thresholds). It's not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a "training set" would be required.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
In summary:
This 510(k) submission, typical for Class II devices like guide wires, focuses on demonstrating substantial equivalence through in vitro bench testing rather than extensive clinical studies or AI/ML model performance validation. The criteria and studies requested in your prompt are largely geared towards software as a medical device (SaMD) or other complex clinical applications, which do not apply to this specific device submission.
§ 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.