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The HemoSplit™ long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.

HemoSplit Long-Term Dialysis Catheters are dual lumen catheters available in straight and precurved configurations with multiple insertion lengths. HemoSplit catheter bodies are made from a polyurethane material that is radiopaque. The dual lumen shaft has a double-D cross-sectional design with a venous lumen tip opening molded to facilitate over-the-guide wire placement. The arterial and venous lumens are separated a maximum of 8cm proximal to the distal tip of the venous lumen, and are able to float freely in the blood stream. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Each extension leg coming out of the bifurcation has an atraumatic acetal occlusion clamp, which closes to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue colorcoded luer connectors identify the arterial and venous lumens, respectively.

The provided document, K030020, AI Response HemoSplit, describes a 510(k) submission for the HemoSplit Catheter, a long-term hemodialysis catheter. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, not on proving effectiveness through clinical trials with human readers or AI.

Therefore, many of the requested categories related to AI performance, expert consensus, and multi-reader multi-case studies are not applicable to this document. The document details non-clinical performance data (bench testing) to show substantial equivalence.

Here's an analysis of the information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria and reported device performance in a direct "table" format as requested for AI performance metrics (e.g., sensitivity, specificity). Instead, it states that the device was tested against recognized standards and in-house protocols, and the results met the requirements and demonstrated equivalence.

• ISO 594-1:1986 (Luer Taper General Requirements)
• ISO 594-2:1986 (Luer Lock Fittings)
• FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term Intravascular Catheters, dated 3/16/95
• ISO 10555-1:1997 (Sterile, single-use, Part 1 General requirements)
• ISO 10555-3:1997 (Sterile, single-use, Part 3 Central venous catheters) | Bench testing was performed according to the referenced standards and in-house protocols. The test results met the requirements and were compared to the predicate devices. Conclusion: "All test results confirm the modified device to be substantially equivalent to the predicate devices." |
  | Biocompatibility | Conformance to:
• AAMI/ANSI/ISO-10993-1: 1997 (Biological evaluation of medical devices Part 1: Evaluation and testing)
• FDA Modified ISO 10993 Test Profile | "Results from biocompatibility testing met the requirements of ISO-10993, 'Biological Evaluation of Medical Devices Part-1: Evaluation and Testing' and the FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long term devices." Conclusion: "All test results confirm the modified device to be substantially equivalent to the predicate devices." |
  | Sterilization | Conformance to:
• AAMI/ANSI/ISO 11135:1994 (Medical devices - Validation and routine control of ethylene oxide sterilization) | (Implied by overall conclusion of substantial equivalence and adherence to standards.) The document states that the sterilization method is equivalent to predicate devices, and adherence to AAMI/ANSI/ISO 11135:1994 indicates validated routine control. Conclusion: "All test results confirm the modified device to be substantially equivalent to the predicate devices." |
  | Overall Substantial Equivalence | Demonstration of substantial equivalence to predicate devices (Opti-Flow/HemoGlide and Medcomp Ash Split-Cath II) based on safety and effectiveness. | "Performance data demonstrate that the HemoSplit Long-Term Hemodialysis Catheters are substantially equivalent to the predicate HemoGlide Long-Term Hemodialysis Catheters and Ash Split-Cath II Hemodialysis Catheters." And "The HemoSplit Long-Term Dialysis Catheter met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to the predicate..." |

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

• Sample Size: The document does not specify exact sample sizes for the bench tests. It broadly states "Bench testing was performed" and "design verification testing was conducted." Given this is a 510(k) for a physical medical device, not a diagnostic AI, the "test set" refers to the tested physical units.
• Data Provenance: The testing was non-clinical (bench testing) and conducted internally by Bard Access Systems, Inc. The location of the testing facility is not specified but would likely be within the United States where the company is based. It is prospective testing of manufactured units, not retrospective analysis of patient data.

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

Not applicable. The "ground truth" for this device's performance is established by metrological standards and physical measurements as part of bench testing, not by expert interpretation of images or patient data. The experts would be the engineers and quality control personnel performing the tests according to the cited standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or interpretations. The tests are based on objective physical measurements against established 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 (catheter), not an AI-powered diagnostic tool, and did not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

Not applicable. This is not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is derived from recognized international and national standards for medical devices (e.g., ISO, AAMI/ANSI, FDA guidances) and internal design specifications/requirements. This involves quantitative measurements and qualitative assessments (e.g., material compatibility, structural integrity) against predefined criteria.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no AI training set.

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

Not applicable. There is no AI training set.

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