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For the administration of fluids from a container into the patient's vascular system through a vascular access device. For use in adult populations only.

The proposed devices are patient controlled analgesia (PCA) syringe sets. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular access device. They are non-pyrogenic, sterile devices that can be directly attached to a syringe.

The PCA syringe sets consist of non-DEHP PVC tubing/bushing, female luer cap, antisiphon valve with female luer, on-off clamp(s), male luer lock, male luer cap, back check valve with female luer (2P3331 and 2P3332 only), and y-connector (2P3331 and 2P3332 only). They are used to administer analgesics from a syringe to the patient IV access device (2P3331 and 2P3332 only) or from a syringe to a primary administration set (2P3333 only); and are also used to administer fluids from a container at the y-type connector (2P3331 and 2P3332 only).

This document describes the acceptance criteria and the studies conducted to prove that Baxter Healthcare Corporation's PCA Syringe Sets meet these criteria, thereby demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the exact sample sizes used for each individual performance test (e.g., number of devices tested for leak, tensile strength, etc.). It generally states that "All tests met the acceptance criteria" and that "Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."

The data provenance is implied to be from internal laboratory testing conducted by Baxter Healthcare Corporation. No information is provided regarding the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench tests, biocompatibility, sterility, shelf life), they are typically prospective studies performed in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The studies described are primarily engineering performance tests, biocompatibility assessments, and sterility validations, which rely on industry standards (ISO, BS EN, USP) and predefined acceptance criteria rather than expert-established ground truth in the context of clinical interpretation or diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable. The tests performed are objective measurements and validations against specified standards, not subjective assessments requiring adjudication by multiple experts.

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 is not applicable. The device (PCA Syringe Sets) is a medical administration set, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to this device.

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

This is not applicable. The device is a physical medical administration set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance of the device is established by adherence to recognized national and international engineering and medical device standards, such as ISO 80369-7, BS EN ISO 8536-9, BS ISO 8536-12, BS EN ISO 8536-14, USP Chapters and , USP , ISO 10993 series, and ANSI/AAMI/ISO 11137 series. These standards define the acceptable range of performance for specific physical and biological characteristics of the device.

8. The sample size for the training set:

This is not applicable. The device is a physical product and not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable because there is no training set for this device.

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