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For use with System 100.

Extension set male connector is specifically designed to secure the extension set to the Statock securement device. Connect luer extension fitting directly to the infusion catheter hub only.

The device has identical materials of construction, packaging and sterilization. It is provided sterile and the fluid pathway is nonpyrogenic. The intended use is to connect the System 100 circuit outflow line to the access catheter for filtered blood return into the patient. Two changes are reflected in this submission for an alternate catheter extension and do not change the intended use.

• 1. One of the two proprietary connectors was replaced with a standard male luer connector.
• 2. Labeling was updated to allow use of the alternate extension catheter on the outflow side of the System 100, UF 500 extracorporeal filter circuit.

Acceptance Criteria and Study for Infusion Catheter Extension, Model 1513

This document summarizes the acceptance criteria and the study performed for the Infusion Catheter Extension, Model 1513, based on the provided 510(k) summary (K023224).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document states that "Bench testing was performed on a variety of access catheters." It does not specify the exact number of different access catheters or the total number of tests performed.
• Data Provenance: The study was a prospective bench test conducted by the submitter (CHF Solutions, Inc.). The country of origin of the data is not explicitly stated but can be inferred to be within the United States, given the submitter's address in Minnesota and the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve human interpretation of data where expert consensus for ground truth would be required. The study is a bench test evaluating physical performance (flow rates) and material characteristics. Therefore, no experts were used to establish ground truth in the context of clinical interpretation or diagnosis.

4. Adjudication Method for Test Set

Not applicable. As this was a bench test evaluating physical and functional characteristics, there was no need for an adjudication method typically associated with human performance studies or clinical trials involving subjective assessments. The results would be objectively measured (e.g., flow rate values) against predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This device is a passive accessory (catheter extension) and its performance is evaluated through bench testing against functional and material specifications, not through human reading of medical images or diagnostic tasks.

6. Standalone (Algorithm Only without Human-in-the-loop Performance) Study

No, a standalone study in the context of an algorithm's performance was not done. This product is a physical medical device, not a software algorithm. Its performance is inherent to its physical design and materials, measured through bench testing.

7. Type of Ground Truth Used

The ground truth used was based on engineering specifications and functional requirements for flow rates that are "acceptable for use with the System 100." This includes objective measurements of flow through the device when connected to various access catheters of specified dimensions. Additionally, the ground truth for material composition, packaging, and sterilization was based on the established characteristics of the predicate device.

8. Sample Size for Training Set

Not applicable. This is a physical medical device submission, not an AI/ML algorithm requiring a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there was no training set for an algorithm.

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