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The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature.

The Multi-Sideport Catheter Infusion Set is available in the 5.0 Fr size and is manufactured in lengths of 40, 65, 100 and 130 centimeters. The catheter is compatible with a 0.035 inch wire guide. The infusion segment lengths are 7, 15 or 20 centimeters and come with 14, 30 or 40 sideports. Each subject device set includes a catheter with a Luer lock adapter and a single lumen shaft, a tip occluder and Tuohy-Borst large bore clear plastic side adapter, and a dual check valve with a 1 ml syringe.

This document describes the performance testing and acceptance criteria for the Cook Incorporated Multi-Sideport Catheter Infusion Set (K182071), to support its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for the Test Set:

• The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "the test articles" were subjected to testing, implying a sufficient number of units were tested to demonstrate compliance with the acceptance criteria.
• The data provenance is from prospective testing conducted by Cook Incorporated, following applicable standards and FDA guidance documents. The country of origin of the data is not specified beyond indicating "Cook Incorporated" as the applicant.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

• This document describes performance and biocompatibility testing for a medical device (catheter) and does not involve clinical data or image analysis by human experts to establish ground truth. The ground truth for this type of device is established through documented, standardized test methods and pre-defined acceptance criteria based on engineering and material science principles.

4. Adjudication Method for the Test Set:

• This is not applicable as the study involves objective physical and biological performance testing against established standards, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, particularly those involving human interpretation of medical images, to assess the impact of AI assistance on human reader performance. This submission pertains to a catheter, which is a therapeutic/interventional device.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone performance study in the context of an algorithm or AI is not applicable here. This document describes the performance of a physical medical device (catheter), not a software algorithm.

7. Type of Ground Truth Used:

• The ground truth for this device is based on established engineering standards, material science properties, and biological safety criteria. Compliance is determined by objective measurements and observations during laboratory testing against predetermined acceptance criteria derived from these standards.

8. Sample Size for the Training Set:

• This is not applicable. The Multi-Sideport Catheter Infusion Set is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• This is not applicable for the reasons stated above.

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