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Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device.

Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.

Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients.

The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (< 0.1% DEHP) tubing, blood chamber, 200 um Filter, Clearlink Luer Activated Valve (LAV), notch clamp, female Luer lock, dual anti-syphon valve, male Luer lock, and a filter vented cap for a male Luer lock. It can be used to administer solutions, blood, and blood products to the patient.

The blood set (2N3385) will be used for syringe-based infusion. The clinician attaches the blood set to a blood bag and manually draws blood into a syringe. The blood is then delivered into the patient's vascular system through a vascular access device.

The provided text describes a medical device, "Blood Administration Sets," and its substantial equivalence to a predicate device, but it does not contain information relevant to AI/ML device acceptance criteria or studies. The document is a 510(k) premarket notification for a traditional medical device (intravascular administration set), not an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device from this document.

The document focuses on:

• Device Description: Physical components, materials, and intended use as a blood administration set.
• Technological Characteristics Comparison: A detailed table comparing the proposed device (2N3385) with a predicate device (2N3383), highlighting differences like length, priming volume, and specific components (e.g., spike, blood chamber, dual anti-siphon valve, Clearlink LAV).
• Nonclinical Tests: Bench tests (e.g., Luer tests, tensile strength, leak tests, blood filter tests, spike tests, LAV tests, particulate matter, DEHP claim, blood compatibility, microbial ingress, shelf-life, shipping simulation) to evaluate functional performance and safety.
• Biocompatibility: Assessments per ISO 10993-1.
• Sterility: Validation of gamma radiation sterilization according to ISO 11137-2.
• Shelf-Life: 3-year claim supported by aging testing.
• Microbial Ingress Testing: Evaluations of potential entry points.

All these tests are standard for conventional medical devices and do not involve AI/ML performance evaluation.

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