(328 days)
The EVA TPN bag 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 bags are empty containers for use in compounding and storage of sterile medical solutions such as parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The empty bags are filled by connecting them to containers through standard spikes. A transfer set in different configurations, ranging from one-lead to three-lead sets, can be provided with the empty bag. The bags are clamped after filling by means of non-reopening clamps. Additional medications can be added to the container using a medication port. After filling, the containers can be attached to an intravascular administration set via the set port. The bags range in volume capacity from 150 mL to 5000 mL. The bag is discarded after use. The EVA TPN bags are made of a copolymer of ethylene and vinyl acetate. The tubings of the transfer set are made of a polyvinyl chloride material.
The provided text is a 510(k) summary for the EVA TPN bags. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed device performance results in the way clinical studies for diagnostic or AI-based devices would.
Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of medical device submission.
Here's an attempt to extract relevant information and explain why other parts are not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study (e.g., "sensitivity must be >X%"). Instead, the acceptance criteria are implicitly that the device performs functionally and safely, demonstrating substantial equivalence to the predicate devices, as per the international standard ISO 15747:2003.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Fulfill requirements of ISO 15747:2003 (Plastics containers for intravenous injection) | "Biological, chemical and physical testing performed on the final product demonstrate that the device fulfills the requirements set out in International Standard ISO 15747:2003 Plastics containers for intravenous injection." |
| Correct functional operation | "Functional testing showed correct operation of the device." |
| Safety and Effectiveness comparable to predicate devices | "Results of the non clinical and bench tests performed demonstrate safety and effectiveness of the devices. Based on the results of the testing performed, Valmed believes that the device is as safe and effective as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "testing performed" and "biological, chemical and physical testing" on the final product, but does not provide numbers for items tested.
- Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective). This refers to bench and non-clinical laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth for TPN bags (material safety, sterility, functional integrity) is established through standardized laboratory tests and adherence to international standards, not expert consensus on images or clinical cases.
- Qualifications of Experts: Not specified, but implied to be standard laboratory personnel qualified to perform the cited tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is for clinical interpretation discrepancies, which is not relevant for materials and functional testing of TPN bags.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a medical container, not a diagnostic imaging device or an AI algorithm that assists human readers.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This refers to an AI algorithm's performance, which is not relevant here. The device itself is standalone in terms of its function as a container.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on objective measurements and adherence to established international standards (ISO 15747:2003) for material properties (e.g., biocompatibility, specified materials like EVA, phthalate-free status), sterility (SAL 10-6), and functional performance (e.g., no leaks, proper connector function).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI model being trained for this device. The "training" for a physical device involves design, manufacturing, and quality control processes to meet specifications.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable as there is no training set in the AI sense. The manufacturing processes and material selection are validated against industry standards and regulatory requirements, which serve as the "ground truth" for ensuring the product meets its design intent.
§ 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).