(15 days)
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 (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.
The provided text describes a traditional 510(k) premarket notification for an "All-In-One Container" manufactured by Baxter Healthcare Corporation. This submission focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies with specific statistical acceptance criteria that one might find for a more complex diagnostic or AI-driven device.
Based on the information provided, here's what can be inferred about acceptance criteria and the "study" (nonclinical tests) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, it makes a general statement:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is appropriately designed for its intended use and meets safety/functional requirements. | "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test set or the data provenance. It only refers to "risk analyses and design verification tests." These are typically internal tests, and details about sample size or origin are not usually disclosed in a 510(k) summary for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. The testing described for this device (an empty container for compounding and storage) would involve engineering and quality control assessments, not expert-adjudicated ground truth like in a medical image analysis study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials or diagnostic studies, not for the design verification of a medical container.
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 information is not applicable and not provided. An MRMC study is relevant for evaluating the performance of diagnostic tools (especially AI-powered ones) in conjunction with human readers. This device is a passive medical container, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. A standalone algorithm performance study is relevant for AI-powered devices. This device is an empty container and does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of this device. The "ground truth" for a medical container involves meeting established engineering specifications, material properties, sterility, and functional requirements. It would be determined through validated testing methods, not expert consensus or pathology.
8. The sample size for the training set
This information is not applicable and not provided. The "All-In-One Container" is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as above.
Summary of the "Study" (Nonclinical Tests) Mentioned:
The document states:
- "Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."
- "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."
This indicates that Baxter performed internal nonclinical testing to ensure the device met its design specifications and safety requirements. These tests are typically related to:
- Material properties: Ensuring the EVA material is suitable for parenteral nutrition solutions (e.g., chemical compatibility, extractables/leachables).
- Physical integrity: Testing the container for leaks, burst strength, and resistance to damage during storage and handling.
- Sterility: Verifying the container can be sterilized and maintains sterility until use.
- Functional aspects: Ensuring the transfer sets (single or three lead) function correctly with the container.
The "acceptance criteria" would be internally defined specifications for these tests (e.g., "no leaks when subjected to X pressure," "material compatible with Y solution for Z duration"). The "study" is the execution of these design verification tests, and the "proof" is that all results met the predetermined acceptance criteria. The 510(k) process in this instance relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K983294), implying that the established testing methods and acceptance criteria for the predicate device would also apply to the new device.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).