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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The Clearlink System Non-DEHP Solution Set (2R8401) consists of a spike tip protector, non-vented spike, non-DEHP drip chamber, non-DEHP tubing, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), two-piece male Luer lock and male Luer cap. The Clearlink System Solution Set with Duo-Vent Spike (2R8875) consists of a spike tip protector, vented spike, non-DEHP drip chamber , non-DEHP tubing, tri-layer tubing, slide clamp, on-off roller clamp, Clearlink Luer activated valve (LAV), one-piece male Luer lock and male Luer cap.

The Clearlink System Non-DEHP Continu-Flo Solution Set (2R8519, 2R8546) consists of a spike tip protector, nonvented spike, non-DEHP drip chamber , non-DEHP tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), two-piece male Luer cap. Configurations of these sets differ in drip chamber flow rate (60 drops/mL or 10 drops/ mL).

This document describes the non-clinical testing performed on the Clearlink System Solution Sets to demonstrate their 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 specify the exact sample sizes used for each individual performance test. The data provenance is from Baxter Healthcare Corporation, indicating internal company testing. The document states "Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."

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

Not applicable. This is a medical device clearance based on non-clinical performance and biocompatibility testing, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" for these tests is defined by the established acceptance criteria in the relevant standards or internal test methods.

4. Adjudication method for the test set

Not applicable. This is a medical device clearance based on non-clinical performance and biocompatibility testing. The "ground truth" is determined by meeting pre-defined acceptance criteria set by standards or internal protocols.

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 device is an intravascular administration set, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is an intravascular administration set, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests described is based on:

• Standards and Regulations: ISO 594-1:1986, ISO 594-2:1998 for luer tests; ISO 10993 series and USP for biocompatibility; ANSI/AAMI/ISO 11137 series for sterility; FDA Guidance for microbial ingress.
• Internal Baxter Test Methods: "Per Baxter Test Method" as explicitly stated for almost all functional performance tests. These methods would be based on engineering specifications and risk assessments to ensure the device performs as intended and is safe.

8. The sample size for the training set

Not applicable. This device is an intravascular administration set, not an AI model requiring a training set.

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

Not applicable. This device is an intravascular administration set, not an AI model.

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