(266 days)
The Polyethylene Catheter is intended for use in angiographic procedures.
The Polyethylene Catheter, the subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Polyethylene Catheter is available in the 3.0 Fr size and is manufactured in lengths of 35, 40, 50, 55 and 65 centimeters. Each configuration includes a Luer lock adapter and a single lumen shaft.
This document is a 510(k) summary for the Cook Incorporated Polyethylene Catheter. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Conducted | Acceptance Criteria (Predetermined) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Conformance with applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013 | Met (demonstrated device is biocompatible for intended use) |
| Air Leakage Testing | No air leakage when tested according to BS EN ISO 10555-1:2013, Annex D | Met (no air leakage under proper clinical use) |
| Dimensional Verification Testing | Dimensional requirements within a specified tolerance | Met (dimensional requirements within specified tolerance) |
| Liquid Leakage Testing | No liquid leakage when tested according to BS EN ISO 10555-1:2013, Annex C | Met (no liquid leakage under proper clinical use) |
| Tensile Testing of the Catheter Shaft | Catheter meets requirements of BS EN ISO 10555-1, Annex B | Met (catheter meets requirements under proper clinical use) |
| Tensile Testing of the Hub-to-Shaft Bond | Peak load value of the hub-to-shaft connection in accordance with BS EN ISO 10555-1:2013, Annex B | Met (peak load value in accordance with standards under proper clinical use) |
| Tensile Testing of the Sideported Area | Peak load value of the sideported area of the shaft in accordance with BS EN ISO 10555-1:2013, Annex B | Met (peak load value in accordance with standards under proper clinical use) |
| Radiopacity Testing | Test articles visible when imaged under fluoroscopy | Met (test articles were visible under fluoroscopy) |
2. Sample size used for the test set and the data provenance:
The document mentions "test articles" and "sample size" for specific tests (e.g., biocompatibility) but does not provide exact numerical sample sizes for each test in the provided text. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, given that this is a 510(k) submission, the testing would typically be prospective and conducted at the manufacturer's facilities or accredited labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document is for a physical medical device (Polyethylene Catheter) and focuses on engineering and material performance testing rather than diagnostic accuracy involving human interpretation of clinical data. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the same way it would apply to an AI/imaging device is not relevant here. The "ground truth" for these tests is defined by the established international standards (e.g., ISO, BS EN ISO) and their specified methodologies and acceptance criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human readers or clinical interpretation requiring adjudication. Performance is assessed against predefined engineering and material standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests in this submission is defined by international and national standards (e.g., ANSI AAMI ISO 10993-1:2009(R)2013, BS EN ISO 10555-1:2013) that outline established methodologies, specifications, and acceptance criteria for measuring the physical, mechanical, and biological properties of medical catheters. For biocompatibility, it's about meeting the requirements of the cited ISO standard. For mechanical tests, it's about meeting the requirements and values specified in the BS EN ISO standard's annexes.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is a physical medical device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).