FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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).

AI/ML Overview

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

Test	Acceptance Criteria	Reported Device Performance
Male Luer Cap/Spike Tip Protector Removal Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Male Luer Cap/Spike Tip Protector Retention Test	Per Baxter Test Method	All tests met the acceptance criteria.
Continuous Bubble Test (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Accumulated Bubble Test (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Administration Set Integrity After Maximum Delivery (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Upstream Occlusion (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Downstream Occlusion (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Flow Rate Accuracy (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Solvent Bond Tensile Strength Test	Per Baxter Test Method	All tests met the acceptance criteria.
Solvent Bond Pressure Test	Per Baxter Test Method	All tests met the acceptance criteria.
Top End Tubing Assembly Clear Passage	Per Baxter Test Method	All tests met the acceptance criteria.
Spike Assembly Visual Inspection	Per Baxter Test Method	All tests met the acceptance criteria.
Drop Volume Accuracy, 10 drops/mL	Per Baxter Test Method	All tests met the acceptance criteria.
Drop Volume Accuracy, 60 drops/mL	Per Baxter Test Method	All tests met the acceptance criteria.
Cannula Pull Out Force	Per Baxter Test Method	All tests met the acceptance criteria.
Spike Assembly Insertion Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Spike Assembly Removal Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Shut Off Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Shut Off Test - Post 24 hours (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp 7 Day Subsystem and Tubing Damage Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Flow Stability Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Tug Stability Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Shut Off Test (plastic slide clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp 7 Day Subsystem and Tubing Damage Test (plastic slide clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Control Range Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Shut Off Test -Post 24 hours	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp 7 Day Subsystem and Tubing Damage Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Flow Stability Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Tug Stability Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Tubing Leak Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Shut-Off Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Check Valve Back Flow Test	Per Baxter Test Method	All tests met the acceptance criteria.
Check Valve High Pressure Test	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Valve Performance Post 100 Actuations	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Valve Performance Post 96 Hour Indwell	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Clear Air Passage	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Back Pressure Leak Test	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Luer Connection Leak Test	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Basic 10-Cycle Actuation Sequence	Per Baxter Test Method	All tests met the acceptance criteria.
ISO Luer Tests on Male Luer Connectors	ISO 594-1:1986 and 594-2:1998	All tests met the acceptance criteria.
ISO Luer Tests on Clearlink Connectors	ISO 594-2:1998	All tests met the acceptance criteria.
(Unscrewing Torque, Separation, Resistance to Overriding and Ease of Assembly Tests)	Per Baxter Test Method	All tests met the acceptance criteria.
Non-DEHP Claim Verification	Per Baxter Test Method	All tests met the acceptance criteria.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous (Irritation) Reactivity, Systemic Toxicity, Toxicological Assessment of Extractable Profile, Materials Mediated Pyrogen, Hemolysis, USP Physiochemical)	ISO 10993 series, USP , and FDA Guidance	All tests met the acceptance criteria, showing the device to be biocompatible.
Sterility	ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2	Established and validated a 10⁻⁶ Sterility Assurance Level (SAL).
Shelf-Life	Not explicitly stated (likely internal Baxter standard for aging tests leading to shelf-life claim)	Supported a shelf-life claim of 2 years.
Microbial Ingress Testing	FDA's Guidance for Industry and Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)] Section 8, Baxter's test method	All test results met acceptance criteria.

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.

Summary

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.