(82 days)
The CXIM TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
The CXI™ TriForce is designed to facilitate wire guide exchange, infusion, and wire guide support. Each set contains the following sterile components:
- Outer 5.0 French Flexor® introducer .
- Inner 4.0 French CXI™ Support Catheter .
- Peel-Away® sheath .
The outer Flexor® introducer is manufactured with a stainless steel coil reinforced nylon construction which provides both flexibility and support to the sheath during use. The outer Flexor introducer is used to support the inner CXI™ Support Catheter during a procedure. The outer Flexor introducers are available in length measurements of 55 or 90 centimeters and can be manufactured with an angled or a straight tip. The inner CXI™ Support Catheter is manufactured with 4.0 French braided flexible kink resistant shaft materials with hydrophilic coating. The flexible shaft material is a laminated material consisting of a nylon layer, stainless steel braiding and an inner polyimide, polyurethane layer, and an innermost polytetrafluoroethylene layer. The inner CXI™ Support Catheters allow acceptance of a 0.035 inch diameter (0.89 millimeters) wire guide. The inner CXI™ Support Catheter will support a wire guide while performing percutaneous peripheral intervention. The CXI™ Support Catheters are available in length measurements of 65 or 100 centimeters and can be manufactured with an angled or a straight tip.
The tetrafluoroethylene Peel-Away® sheath is included in the set for assistance when inserting the inner CXI™ Support Catheter into the outer Flexor® introducer.
This document describes the acceptance criteria and study proving the device meets those criteria for the CXI™ TriForce Peripheral Crossing Set.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength Testing | Device should not fracture or rupture introducer or catheter during proper clinical use. Meets applicable sections of BS EN ISO 11070 and ISO 10555-1. | Predetermined acceptance criteria were met. |
| Liquid Leakage Testing | No liquid leakage from introducer, introducer valve, or catheter during proper clinical use. Meets applicable sections of ISO 11070 and ISO 10555-1. | Predetermined acceptance criteria were met. |
| Static Burst Testing | Pressures reached during proper clinical use (maximum pressure at maximum flow rate) are less than the static burst pressure of the catheter, and should not fracture or rupture the catheter. | Predetermined acceptance criteria were met. |
| Dynamic Burst Testing | Pressures reached during proper clinical use (maximum pressure at maximum flow rate) are less than the dynamic burst pressure of the catheter, and should not fracture or rupture the catheter. | Predetermined acceptance criteria were met. |
| Flow Rate Testing | Pressure exerted at maximum flow rate during proper clinical use should not fracture or rupture the catheter. | Predetermined acceptance criteria were met. |
| Biocompatibility Testing | Device is biocompatible. Meets applicable sections of ISO 10993-1. | Predetermined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each test conducted on the CXI™ TriForce Peripheral Crossing Set. The studies are described as "applicable testing to assure reliable design and performance" and "appropriate engineering tests." The data provenance is not specified, but the tests were performed by Cook Incorporated, a US-based company. These are likely prospective engineering and laboratory tests, not clinical studies on human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The tests performed are engineering and laboratory tests (e.g., tensile strength, burst pressure) on the device itself, not clinical studies requiring expert interpretation of patient data or establishment of ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for the direct physical and chemical property testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The studies conducted are focused on the device's physical and biological performance against established standards, not on human reader performance, with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device itself was subjected to various engineering and biocompatibility tests to ensure it met predetermined acceptance criteria. These tests were "algorithm only" in the context of device performance, as they measured the intrinsic characteristics of the product.
7. Type of Ground Truth Used
The "ground truth" for these tests consisted of predetermined physical and chemical specifications and standards as outlined in international and national standards (BS EN ISO 11070, ISO 10555-1, ISO 10993-1). The device's performance was measured against these established parameters. For example, the ground truth for tensile strength testing would be a specified maximum force the device must withstand without failure.
8. Sample Size for the Training Set
This information is not applicable. The listed studies are not AI/machine learning studies and therefore do not involve "training sets" in that context. The device performance was evaluated through direct testing against predetermined criteria.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no "training set." The performance criteria were established based on recognized engineering standards and regulatory requirements.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).