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The Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are indicated for use in hemodialysis, hemoperfusion and apheresis for short-term duration of less than 30 days via the subclavian, femoral or jugular vein.

The Joline D-Line Catheter ST family of catheters, consisting of the Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are a polyurethane radiopaque catheter which allows for hemodialysis, hemoperfusion and apheresis. A crosssectional view of the shaft of the Joline D-Line Catheter ST catheters reveals a double "D" configuration -one "D" for the arterial lumen and the other for the venous lumen. In the Extra Flow (EF) Short Term design the venous lumen extends beyond the arterial lumen and terminates in a round tip. The Dual Lumen Short Term catheter has both lumens exiting together and incorporates side-holes along the shaft of the catheter body in its design. Two color-coded safety clamps, red and blue, identify arterial and venous extensions. lmportant information such as priming volume and catheter length is printed on both sides of the clamp. A swiveling suture ring is available to secure the catheter after placement. Two extensions merge into a tapered bifurcation joint or hub molded to the catheter body. These extensions can be straight, curved or curved-to-one-side. The finished kit consists of either the Dual Lumen Short Term Hemodialysis or Extra Flow ITIc Timenta Kit of Childers packaged with various accessory components. These components include: guidewire, introducer needle, dilator, and luer lock caps.

This document describes the 510(k) summary for the Joline D-Line Catheter ST family of catheters. The submission focuses on demonstrating substantial equivalence to predicate devices through engineering bench testing, rather than clinical performance based on metrics like sensitivity, specificity, or AUC. Therefore, many of the requested criteria related to clinical study design (sample size, expert ground truth, adjudication) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The study was based on engineering bench testing, not clinical data with a "test set" of patients.
• Data Provenance: Not applicable. The data came from engineering laboratory tests, not patient data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The study did not involve expert review of clinical cases to establish ground truth. Compliance was based on engineering data and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" or clinical adjudication was performed.

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

• No. An MRMC comparative effectiveness study was not performed. The submission is for a medical device (catheter), not an AI/imaging diagnostic tool that would typically involve human reader performance.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission refers to established engineering standards (e.g., ISO 10555, ISO 10993) and the known performance characteristics of the legally marketed predicate devices. The new device's performance was compared against these established benchmarks.

8. Sample Size for the Training Set

• Not applicable. There was no "training set" as this was not an AI/machine learning study.

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

• Not applicable. See point 8.

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