(81 days)
Facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ACS HI-TORQUE EXTRA S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE IRON MAN™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.
The HI-TORQUE Guide Wires with HYDROCOAT™ Hydrophilic Coating are steerable guide wires with a nominal diameters of .010",014" and .018"and available in two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC Guide Wire Extension. The wires are constructed from a stainless steel core wire. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
Here's a summary of the acceptance criteria and the study details for the HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating, based on the provided text:
Acceptance Criteria and Device Performance Study Summary
The provided document describes a 510(k) submission for guide wires, focusing on demonstrating substantial equivalence to predicate devices, particularly regarding a new hydrophilic coating. The study primarily involves bench testing to compare the performance of the new device with its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accelerated Aging | Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate. | Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating. |
| Distal Tip Pull Test | Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate. | Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating. |
| Distal Tip Turns-to-Failure Test | Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate. | Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating. |
| Rotational Accuracy Test | Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate. | Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating. |
| Tip Flexibility Test | Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate. | Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating. |
| Coating Adherence/Integrity | Not explicitly stated what criteria were used for "acceptance," but implicitly, the new device with HYDROCOAT™ should perform similarly to the predicate and the ChoICE™ PT Plus Guide Wire. | Met acceptance criteria and performed similar to the predicate HI-TORQUE® Guide Wire with MICROGLIDE® Coating and substantially equivalent to the ChoICE™ PT Plus Guide Wire. |
Overall Conclusion: The results from the bench tests showed that the new ACS HI-TORQUE® Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE® Guide Wire with MICROGLIDE® Coating and the ChoICE™ PT Plus Guide Wire. No new safety or effectiveness issues were raised.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document states "Bench testing was performed," but does not give specific numbers of devices or tests conducted for each category.
- Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a controlled laboratory environment by the manufacturer. It is not clinical data (e.g., from specific countries, nor is it explicitly called retrospective or prospective patient data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the study described is bench testing of physical device properties, not a study involving interpretation of data by human experts (e.g., radiologists, pathologists) to establish a "ground truth" for diagnostic or clinical performance. The "ground truth" for these tests would be the measured physical properties of the devices themselves, compared against engineering specifications or predicate device performance.
4. Adjudication Method for the Test Set
- This information is not applicable for bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data that requires consensus or expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating medical images or data, which is not relevant to the described bench testing of guide wire physical characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable as the device is a physical guide wire, not a software algorithm or AI tool. Performance is evaluated directly through bench tests of its physical properties.
7. The Type of Ground Truth Used
- The "ground truth" for this study is based on the measured physical and mechanical properties of the guide wires during bench testing (e.g., pull strength, rotational accuracy, flexibility, coating adherence). These measurements are then compared against established engineering specifications or the performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- This information is not applicable as the described study is a bench testing and comparison of physical devices, not an AI/machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as above (no AI/ML training set).
§ 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.