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• The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.

• It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
• Alternate insertion sites include subclavian vein as required.
• Catheters greater than 40 cm are intended for femoral vein insertion.
• The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
• 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.

The provided FDA 510(k) clearance letter and associated documentation for the Hemodialysis Catheter (K241581) primarily detail the regulatory approval process, comparison to predicate devices, and non-clinical performance testing. It does not contain information about acceptance criteria for device performance based on clinical study data, nor does it describe a study that validates the device performance against such criteria in a clinical setting.

The document specifically states: "Clinical test: Clinical testing is not required." This indicates that the clearance was based on non-clinical performance data and substantial equivalence to legally marketed predicate devices, not on direct clinical evidence of the device's performance in patients.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample sizes used for the test set and data provenance from a clinical study.
• Number of experts used to establish ground truth and their qualifications from a clinical study.
• Adjudication method for a clinical study.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth used in a clinical study.
• Sample size for the training set from a clinical study.
• How ground truth for the training set was established in a clinical study.

The provided document focuses on the following types of performance data, which are non-clinical in nature:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

While not presented in a table with specific pass/fail metrics, the document implies that the device met the requirements of the following standards and guidance:

• FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016"
• ISO 10555-1:2013 (Sterile, single-use intravascular catheters - Part 1: General requirements)

The following non-clinical tests were performed to demonstrate compliance:

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

• Not Applicable for Clinical Data: The document explicitly states "Clinical testing is not required."
• For Non-Clinical Data: Specific sample sizes for each non-clinical test (e.g., tensile testing, leakage testing) are not detailed in this summary document. Data provenance is implied to be from internal lab testing conducted by Haolang Medical USA Corporation, in compliance with the cited ISO standards and FDA guidance.

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

• Not applicable as clinical testing with expert-established ground truth was not performed or required for this 510(k) clearance.

4. Adjudication Method for the Test Set

• Not applicable as clinical testing with an adjudication method was not performed or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not applicable. This type of study is typically for AI/imaging device performance evaluation, not for a physical device like a hemodialysis catheter, and certainly not for a clearance that states "Clinical testing is not required."

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

• Not applicable. This is not a software/AI device.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the non-clinical tests is adherence to the specified performance requirements as outlined in the referenced ISO standards (e.g., ISO 10555-1) and FDA guidance documents for hemodialysis catheters (e.g., "Implanted Blood Access Devices for Hemodialysis"). This involves objective, measurable physical, mechanical, and biological properties.

8. The Sample Size for the Training Set

• Not applicable. This refers to training data for AI/ML algorithms, which is not relevant to this device's clearance.

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

• Not applicable.

In summary, the FDA 510(k) clearance for the Hemodialysis Catheter (K241581) was granted based on a substantial equivalence determination supported by comprehensive non-clinical performance testing (physical, mechanical, biocompatibility, sterilization, and shelf-life) against recognized industry standards and FDA guidance, rather than a clinical study with patient data and expert-derived ground truth.

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