(69 days)
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA TPN container can be filled either by gravity or in conjunction with automated compounding equipment.
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA TPN container can be filled either by gravity or in conjunction with compounding equipment. The EVA TPN container is composed of Ethylene Vinyl Acetate copolymer (EVA). The containers will be available as a single chamber bag in two configurations. One configuration will be used for filling the container by gravity. The second configuration is for use with a B. Braun Medical Inc. compounder. The containers will range in volume capacity from 250mL - 4000mL. The gravity containers can be filled using standard admixture products (spikes, tubing), and clamped after filling. The container for use with the compounder will have an adapter unique to the compounder. The tubing is composed of a DEHP-free polyvinyl chloride material. Additional medications can be added to the gravity or compounder container using the medication port. After filling, the container can then be attached to an intravascular administration set via the set port.
The provided text is a 510(k) summary for the EVA TPN Container. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel device. As such, several of the requested categories of information are not present in the document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a table of performance metrics. It relies on the claim of "similar indications for use, materials of construction, labeling and sterilization methods as the predicate device" and that the "Mixing Container was tested in accordance with current international standards for containers for intravenous injections." No specific performance data or test results are provided.
2. Sample Size Used for the Test Set and Data Provenance:
Not specified. The document states "Mixing Container was tested in accordance with current international standards," but no details on sample size, test sets, or data provenance (country of origin, retrospective/prospective) are given for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a medical container, not an AI or diagnostic device that requires expert adjudication for ground truth.
4. Adjudication Method for the Test Set:
Not applicable for a medical container.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/diagnostic device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is not an AI/diagnostic device.
7. Type of Ground Truth Used:
Not applicable in the typical sense for a hardware device. The "ground truth" would be the performance against established international standards for containers for intravenous injections.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/model-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of available information related to acceptance and study:
The core of the submission for the EVA TPN Container is demonstrating substantial equivalence to a predicate device, the K983294 Baxter Healthcare Corporation; All-in-One Container. The "study" referenced is the testing of the "Mixing Container... in accordance with current international standards for containers for intravenous injections."
The acceptance criteria, in this context, are implicitly met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device and complies with relevant international standards. The document explicitly states: "There are no differences between the B. Braun Medical Inc. EVA TPN Mixing Container and the predicate device that raise new issues of safety and effectiveness." This statement serves as the primary "proof" that the device meets the implied acceptance criteria for safety and effectiveness through substantial equivalence.
§ 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).