(35 days)
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). 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 HI-TORQUE POWERTURN Guide Wire Family has a diameter of 0.014" with a 190 cm extendable length and a 300 cm exchange length. The POWERTURN Guide Wire Family is available in three tip support models and is constructed from a 304V stainless steel core. Over the proximal coined section of the 190 cm model is a Wire Identifier consisting of a black PTFE shrink tube which is removable and is used to help physicians distinguish between two Abbott Vascular wires while being used simultaneously. The distal tip of the guide wire is available 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 and the pre-shaped tip provides the physician the convenience of a "J" shape without manual shaping.
This K112957 document describes a 510(k) premarket notification for the HI-TORQUE® POWERTURN Guide Wire Family, a catheter guide wire, by Abbott Vascular. The submission aims to establish substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tip Tensile Strength | Not explicitly stated, implied to meet safety and performance benchmarks. | Met all acceptance criteria, performed similarly to predicate devices. |
| Torque Strength | Not explicitly stated, implied to meet safety and performance benchmarks. | Met all acceptance criteria, performed similarly to predicate devices. |
| Torqueability | Not explicitly stated, implied to meet safety and performance benchmarks. | Met all acceptance criteria, performed similarly to predicate devices. |
| Coating Adherence & Integrity (Particulate Testing) | Not explicitly stated, implied to prevent detachment and ensure patient safety. | Met all acceptance criteria, performed similarly to predicate devices. |
| Friction Testing | Not explicitly stated, implied to ensure smooth navigation within vessels. | Met all acceptance criteria, performed similarly to predicate devices. |
| Biocompatibility | No new biocompatibility issues (implied that material is well-established). | Biocompatibility testing was not repeated as prior testing on predicate devices was deemed applicable. No new safety or effectiveness issues were raised. |
Note: The document states that the device "met all acceptance criteria and performed similarly to the predicate devices." However, the specific quantitative acceptance criteria for each test are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for the in vitro bench testing. It only mentions that "in vitro bench testing" was conducted.
The data provenance is from in vitro bench testing, meaning it was conducted in a laboratory setting. There is no information regarding country of origin, retrospective, or prospective nature, as this applies to clinical study data, not bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings validate diagnoses or outcomes. For this device, the performance was assessed through in vitro bench testing against predefined engineering and material specifications, not against expert interpretation of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for resolving discrepancies among expert readers/evaluators of medical images or patient data. The evaluation of this guide wire involved direct measurement and observation of physical properties and performance characteristics in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. This submission concerns a physical medical device (a guide wire), not a diagnostic algorithm or AI system that assists human readers. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this device’s clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. As mentioned above, this device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on engineering specifications and established performance benchmarks derived from predicate devices and industry standards for guide wires. The in vitro bench tests measured physical properties and functional performance against these objective criteria.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant to machine learning algorithms, which are not involved in the evaluation of this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no training set involved in the evaluation of this physical 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.