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The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.

The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.

Acceptance Criteria and Device Performance Study for Pristine™ Long-Term Hemodialysis Catheter (K203767)

The information provided describes the substantial equivalence determination for the Pristine™ Long-Term Hemodialysis Catheter (K203767) by comparing it to a predicate device, the Pristine™ Hemodialysis Catheter (K182443). The regulatory submission focuses on demonstrating that the new device meets the same performance criteria as the previously cleared predicate device, with additional testing for specific design changes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the subject device met "all of the design verification and validation requirements previously reported for the predicate device. Pristine™ Hemodialysis Catheter (K182443, cleared May 31, 2019)."

For the specific design changes in the subject device, the verification testing was performed to the "exact same acceptance criteria as K182443."

The following table summarizes the acceptance criteria categories mentioned and the general reported performance. Specific numerical acceptance values are not provided in this document but are implied to be identical to those established for the predicate device.

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

The document states: "All samples used for final testing of each product attribute were representative of finished products." However, specific numerical sample sizes for each test are not provided.

The data provenance is implied to be from internal laboratory testing conducted by the manufacturer, C. R. Bard, Inc. The document does not specify country of origin for the data nor explicitly state if it was retrospective or prospective, but given the context of design verification and validation, it would be considered prospective testing of newly manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided in the document. The study described is a device performance verification and validation study against established engineering and performance criteria, not a study involving human interpretation of medical images or expert consensus for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. As this is a physical device performance study, there's no "adjudication" in the sense of reconciling multiple expert opinions. Test results are compared against pre-defined engineering acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document describes a design verification and validation study for a medical device against pre-defined engineering acceptance criteria, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This document pertains to a physical medical device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the pre-established engineering and performance specifications and acceptance criteria for the device's physical and functional attributes. These criteria are derived from applicable standards, guidance documents, test protocols, and customer inputs, which would have been established internally by the manufacturer and validated during the predicate device's clearance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is a device performance study, not a machine learning model development or validation study; therefore, there is no "training set."

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

This information is not applicable and not provided. As there is no training set, the establishment of ground truth for it is irrelevant to this document.

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