(42 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
The HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW™ Universal Guide Wire is DOC® extendable in the 190 cm lengths.
The provided text describes a 510(k) summary for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family. This document focuses on demonstrating substantial equivalence to predicate devices through various bench tests and biocompatibility assessments, rather than presenting a clinical study on human diagnostic performance using an AI algorithm.
Therefore, many of the requested points related to AI, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes are not applicable to this submission.
Here's the information that can be extracted from the provided text:
1. Acceptance Criteria and Reported Device Performance
| Test Category | Specific Tests | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| In vitro Bench Testing | Tensile Strength | Not explicitly stated, implied to meet predicate device performance | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Strength | Not explicitly stated, implied to meet predicate device performance | Met all acceptance criteria and performed similarly to predicate devices. | |
| Torqueability | Not explicitly stated, implied to meet predicate device performance | Met all acceptance criteria and performed similarly to predicate devices. | |
| Coating Adherence and Integrity (Particulate Testing) | Not explicitly stated, implied to meet predicate device performance | Met all acceptance criteria and performed similarly to predicate devices. | |
| Friction Testing | Not explicitly stated, implied to meet predicate device performance | Met all acceptance criteria and performed similarly to predicate devices. | |
| Biocompatibility Testing | Cytotoxicity | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. |
| Hemolysis | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Acute Systemic Toxicity | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Complement Activation | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Coagulation | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Intracutaneous (Intradermal) Reactivity Test | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| USP Systemic Injection Test | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Sensitization | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Rabbit Pyrogen Test | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| LAL Pyrogen | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| Bacterial Endotoxins | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. | |
| In vivo Thrombogenicity Tests | Not explicitly stated, implied to meet predicate device performance | Demonstrated no new safety or effectiveness issues. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as a series of "In vitro bench testing" and "Biocompatibility testing." The submission states that these tests "demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program..." This indicates that the tests successfully showed the device's performance aligns with acceptable standards and is comparable to previously cleared devices.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "In vitro bench testing... were conducted on the subject device," implying a sample was used, but the specific number is not disclosed.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). These are lab-based bench tests and biocompatibility tests, not studies involving human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study assessing diagnostic performance where expert ground truth would be required. The tests are physical and chemical evaluations of the device's properties.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is typically done for diagnostic imaging devices involving human readers and AI. This submission is for a guide wire, and the testing involved bench and biocompatibility assessments, not MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This device does not involve an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would be the established engineering specifications and performance characteristics derived from validated test methods, and the performance of the predicate devices. For biocompatibility, it would be the pre-defined safety limits and established biological responses.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI algorithm or a training set in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve an AI algorithm or a 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.