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MiniCap Extended Life PD Transfer Sets: This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.

Locking Titanium Adapter for Peritoneal Dialysis Catheter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy.

Locking Cap for Peritoneal Dialysis Catheter Adapter: This device is indicated for use in the treatment of patients receiving peritoneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter between Baxter Transfer Set installations.

The MiniCap Extended Life PD Transfer Sets are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

The Locking Titanium Adapter for Peritoneal Dialysis Catheter (Titanium Adapter) and Locking Cap for Peritoneal Dialysis Catheter (Locking Cap) are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. The Titanium Adapter is a device that is secured to the end of a peritoneal dialysis catheter and is used to connect the peritoneal dialysis catheter to the Transfer Sets. The Locking Cap is used to cap the end of the Titanium Adapter between Transfer Set installations.

This document describes the premarket notification (510(k)) for two sets of medical devices from Baxter Healthcare Corporation:

1. MiniCap Extended Life PD Transfer Sets
2. Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter

The submission declares that these devices are substantially equivalent to legally marketed predicate devices. The majority of the information provided pertains to non-clinical performance testing and biocompatibility.

1. Acceptance Criteria and Reported Device Performance

The documents state that "All results meet their acceptance criteria, and support that the proposed device is appropriately designed for its intended use." However, specific numerical acceptance criteria and the detailed reported performance values (e.g., exact leak rates, torque values, flow rates) are not provided in the given text. Instead, the document lists the functional tests performed.

Table of Acceptance Criteria and Reported Performance (Based on provided text - specific values are not available):

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

The document does not explicitly state the sample sizes used for the functional and biocompatibility test sets. It generically mentions "nonclinical tests." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, but as these are non-clinical (laboratory/bench) tests, typical clinical study provenance details would not apply. The tests were presumably conducted by Baxter Healthcare Corporation.

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

This section is not applicable as the provided documentation describes non-clinical performance and biocompatibility testing of physical devices, not assessment of diagnostic accuracy or a similar task that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments.

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

This section is not applicable. The devices are physical medical instruments (transfer sets, adapters, caps) used in peritoneal dialysis, not AI-powered diagnostic or assistive technologies. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.

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

This section is not applicable as the devices are not algorithms or AI systems.

7. The Type of Ground Truth Used

For the functional tests, the "ground truth" is established by predefined engineering specifications and performance standards for the device's operation (e.g., no leaks, specific torque values, adequate flow rates). For biocompatibility, the ground truth is established by the biological responses observed in standardized tests performed according to ISO 10993 standards. These are objective measures rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This section is not applicable as the devices are physical medical instruments, not machine learning algorithms that require training data.

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

This section is not applicable for the same reasons as point 8.

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