(214 days)
The High-Flo Silver Polyethylene Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.
The High-Flo Silver Polyethylene Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The High-Flo Silver Polyethylene Catheter is available in a 5.5 French size and is manufactured in lengths of 65 to 100 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen braided shaft.
The acceptance criteria and device performance for the High-Flo Silver Polyethylene Catheter are detailed in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Conformance with applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013, predetermined acceptance criteria met. | Device is biocompatible for the intended use, demonstrated by testing for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, in vivo thrombogenicity, and partial thromboplastin time. The predetermined acceptance criteria were met. |
| Tensile Testing of Hub-to-Shaft Bond | Peak load value of the hub-to-shaft connection in accordance with BS EN ISO 10555-1:2013, Annex B. | The predetermined acceptance criterion was met, verifying the peak load value of the hub-to-shaft connection under proper clinical use. |
| Tensile Testing of Tip-to-Shaft Bond | Peak load value of the tip-to-shaft connection in accordance with BS EN ISO 10555-1:2013, Annex B. | The predetermined acceptance criterion was met, verifying the peak load value of the tip-to-shaft connection under proper clinical use. |
| Liquid Leakage Testing | No liquid leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex C. | The predetermined acceptance criterion was met, verifying no liquid leakage under proper clinical use. |
| Air Leakage Testing | No air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D. | The predetermined acceptance criterion was met, verifying no air leakage under proper clinical use. |
| Static Burst Testing | Characterization of the catastrophic failure pressure for the catheter in accordance with BS EN ISO 10555-1:2013, Annex F. | Testing successfully characterized the catastrophic failure pressure for the catheter. The reported detail is that it was "successfully characterized," implying it met the objective of the test. |
| Dimensional Verification Testing | Dimensional requirements of the subject device are within a specified tolerance. | The predetermined acceptance criteria were met. |
| Hub Pressure Testing | Hub pressure, when tested at maximum flow rate, does not exceed the static burst pressure. | Testing successfully characterized the hub pressure and verified that it does not exceed the static burst pressure. The reported detail is that it was "successfully characterized" and "verified," implying it met the objective of the test. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each of the performance tests (e.g., number of catheters tested for tensile strength, burst pressure, etc.). It generally refers to "applicable testing" and that "the predetermined acceptance criteria were met."
The provenance of the data is internal to Cook Incorporated, as these are engineering and biocompatibility tests conducted directly on the device. It is not patient data, so concepts like "country of origin" or "retrospective/prospective" do not apply in the typical clinical study sense. These are laboratory-based, pre-market validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the reported tests. The ground truth for these tests is established by objective, standardized engineering and biocompatibility test methods (e.g., ISO standards) and measurable physical properties and biological responses, rather than expert consensus on a clinical diagnosis or image interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by multiple readers to establish a ground truth for diagnostic accuracy. The tests described are objective, quantitative laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No MRMC comparative effectiveness study was mentioned or performed. This device is a physical medical instrument (catheter), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance does not apply to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. As mentioned, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for these performance tests is based on objective, measurable criteria defined by international standards (e.g., BS EN ISO 10555-1:2013, ANSI AAMI ISO 10993-1:2009(R)2013) and the inherent physical and chemical properties of the device materials and design. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning context. The product development process involves design iterations and engineering testing, but not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this physical 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).