(27 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a maximum diameter of 0.014" and available in: 175 cm and 190 cm extendable lengths 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 wire is constructed from a stainless steel core wire, with varying core lengths and diameters for each design. The distal end of the guide wire has a radiopaque tip that are available either as a straight 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.
The provided document describes the acceptance criteria and performance of the ACS HI-TORQUE CROSS-IT™ XT family of guide wires with HYDROCOAT™ Hydrophilic Coating.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Functional Tests) | Reported Device Performance |
|---|---|
| Distal Tip Pull Test | The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program. |
| Distal Tip Turns-to-Failure Test | The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program. |
| Rotational Accuracy Test | The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program. |
| Tip Flexibility Test | The results demonstrated that the new ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent to the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program. |
2. Sample Size for the Test Set and Data Provenance:
The document mentions "in vitro bench testing and in vivo performance evaluations" were performed for the test set. However, it does not specify the sample size used for these tests. It also does not specify the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The study described is a device performance study focusing on physical and functional characteristics, not an AI/imaging study requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided as the study is not an AI/imaging study requiring human adjudication for ground truth. The acceptance criteria were met through direct measurement and evaluation of device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed as this is a medical device performance study, not an AI assistance study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This concept is not applicable as the document describes the performance of a physical medical device (guide wire), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for this device performance study was established through in vitro bench testing and in vivo performance evaluations comparing the new devices against established predicate devices. This implies direct measurement of physical properties and observed performance in relevant settings. It is not expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools, but rather objective performance metrics against predefined criteria and predicate device performance.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The study describes the testing of a physical medical device, not a machine learning model, so there is no training set in the context of AI.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided as there is no training set mentioned.
§ 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.