(216 days)
The Empty EVA Bag is an empty container used for administration of TPN (Total Parenteral Nutrition) solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
The device is an empty flexible container (bag) in EVA material (Ethylene-vinyl acetate), that is to be filled up before use and intended for the administration of intravenous infusion solutions (TPN-Total Parenteral Nutrition). The bag is provided with three tubes necessary for the filling of the bag itself and the administration of the solution to the patient. The empty bag is filled by connecting it to containers (generally glass bottles) containing one or more solutions. The filling is done by the tube with the big bore connector where the non-re-opening clamp is located. After filling, the bag is clamped by means of non-re-opening clamp ad closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the access port (spike port). When the bag is already filled, other medications can be added using the second access port (injection port). The device will be available in multiple containment volumes ranging from 250mL to 5000mL.
This document describes the premarket notification (510(k)) for the "Empty EVA Bag" device. It is not an AI/ML medical device submission, so the questions regarding AI/ML-specific study design (training/test sets, expert adjudication, MRMC studies) are not applicable.
The submission focuses on demonstrating substantial equivalence to a predicate device ("Empty EVA Solution Container, Acta Medical, K121161") through non-clinical testing of the physical properties and biocompatibility of the device.
Here's an attempt to answer the questions based on the provided text, noting where AI/ML specific criteria do not apply:
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit numerical acceptance criteria values for each performance test. Instead, it states that "All the necessary safety and performance tests in support of substantial equivalence to the predicate device were conducted" and implies that the device met the requirements of the listed standards and internal specifications. The "Conclusion" for each "Feature" in the "TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE" table effectively serves as the "reported device performance" in relation to the predicate.
| Acceptance Criteria (Implied by standard compliance/internal spec) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility (ISO 10993-1, -4, -5, -10, -11) | Meet requirements for ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity, Haemolysis, Subacute/sub-chronic systemic toxicity, Pyrogenicity performed) |
| Bag Volume Capacity (per internal specification) | Tests conducted, implies met internal specification. |
| Resistance to hot printing removal (per internal specification) | Tests conducted, implies met internal specification. |
| Hangar Tensile Force (Internal Specification) | Tests conducted, implies met internal specification. |
| Hydraulic seal and mechanical resistance of the non-re-opening clamp (per internal specification) | Tests conducted, implies met internal specification. |
| Particulate matter (USP) | Tests conducted, implies met USP requirements. |
| Sterility (SAL 10-6, ISO 11137-1, 11137-2) | SAL 10-6 via radiation. Tests conducted, implies met ISO requirements. |
| Package integrity (ISO 11607-1) | Tests conducted, implies met ISO 11607-1 requirements. |
| Design Similarity to Predicate | Similar in design to predicate (single chamber, fill port, injection port, spike port, inviolable clamp). |
| Material Safety | Includes additional materials, but they are "largely used for other legally marketed devices under the same product code." Biocompatibility and performance testing "show that differences in materials of construction do not raise any questions of safety or effectiveness." |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of bags tested for volume capacity, tensile strength, etc.). It only indicates that "Nonclinical tests were conducted."
Data provenance: The testing was conducted to support an FDA 510(k) submission, suggesting it was performed by the manufacturer (Haemotronic S.p.a. in Italy) or a qualified testing lab. The data would be prospective, as it was generated specifically for this submission to demonstrate device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of medical device submission. Ground truth in this context refers to meeting engineering and biocompatibility standards, not clinical diagnostic accuracy assessed by experts.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication process for this type of non-clinical, physical, and biocompatibility testing. The "ground truth" is determined by established engineering and biological standards.
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
Not applicable. This is not an AI/ML driven diagnostic device, and no human reader studies were conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, ISO 15747 for plastic containers, ISO 11137 for sterilization, ISO 11607 for packaging).
- Compliance with internal specifications for various physical properties (Bag Volume Capacity, Resistance to hot printing removal, Hangar Tensile Force, Hydraulic seal and mechanical resistance of the non-re-opening clamp).
- Pharmacopeial standards (USP for Particulate Matter).
Essentially, the device meeting the specified quantitative and qualitative criteria defined by these standards and internal specifications constitutes the "ground truth" for its safety and performance.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no training set for an algorithm. Device manufacturing processes would involve quality control and validation using samples, but not like an AI training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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).