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The All-In-One™ Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

The All-In-One™ Container is an empty, EVA container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient. The container will be marketed in sizes ranging from 150 mL to 4000 mL. The proposed container is similar to Baxter Healthcare Corporation's currently marketed All-In-One™ Container cleared on June 10, 1994 under K932477.

There is one solution contact material in the proposed All-In-One™ Container which is new to Baxter. It is an ethy ene vinyl acetate (EVA) film which is used to fabricate the container body. The other solution materials used in the proposed device were previously tested and used in other Baxter devices for similar IV container applications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Modified All-In-One™ Container:

No specific acceptance criteria or detailed study results are provided in the given 510(k) summary.

The document predominantly focuses on establishing substantial equivalence to a predicate device (K932477) by highlighting that the new device is nearly identical, with the only change being a new EVA film for the container body. The testing described is primarily for the new material's biological and physicochemical properties and the overall functional performance of the device.

However, based on the information provided, we can infer some general aspects of the testing and its outcomes.

Implied Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text)

1. Sample Size Used for Test Set and Data Provenance:

   • Sample Size: Not specified. The document states "Data regarding the functional performance... have been generated and submitted" and refers to "biological methods specified in ISO Standard 10993-1 and USP physicochemical tests described in General Chapter ". These standards typically outline testing methodologies which would involve a certain number of samples or replicates, but the exact sample sizes used in this specific submission are not detailed.
   • Data Provenance: Not explicitly stated, but given that Baxter Healthcare Corporation is a U.S. company submitting to the FDA, it is highly likely the studies were conducted in the U.S. and are retrospective analyses of internal testing.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Not applicable/Not specified. This device is a medical container, and the testing described is material and functional performance testing, not diagnostic performance where "ground truth" is established by human experts. The ground truth (or reference standard) would be defined by the specifications of the materials and the functional design, and evaluated by laboratory instruments and standardized protocols.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or diagnostic performance evaluations where human interpretation is involved. For material and functional testing, the results are objectively measured against pre-defined specifications.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The device described is a medical container, not a diagnostic tool requiring human readability or interpretation.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, this is not relevant for this device. "Standalone" performance refers to the capability of an algorithm without human intervention, which applies to AI/software as a medical device. This is a physical medical container.

6. Type of Ground Truth Used:

   • Material Testing: The ground truth for the biological and chemical reactivity testing would be the standards themselves (ISO 10993-1 and USP 23 General Chapter ) and the pass/fail criteria defined within those standards or Baxter's internal specifications derived from them.
   • Functional Testing: The ground truth for functional performance would be the engineering and design specifications for the container (e.g., leak integrity, tensile strength, clarity, sterility maintenance, compatibility with parenteral nutrition solutions over time).

7. Sample Size for the Training Set:

   • Not applicable/Not specified. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the device's development or validation.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, there is no training set for this type of device.

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