(160 days)
The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
The product is an empty flexible container (bag) in plastic material, that is to be filled before use, intended for the administration of intravenous infusion solutions), and provided sterile. It is provided in two different configurations, with three tubes or one tube:
- bag with 3 tubes: The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and 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 filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL.
- bag with 1 tube: the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and 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 line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.
The provided text is a 510(k) summary for the Haemotronic S.p.a. Empty EVA Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested elements for an acceptance criteria study report are not explicitly available in the provided document.
However, I can extract the information related to the non-clinical tests performed to support the substantial equivalence claim, which serves a similar purpose in demonstrating device safety and performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria with corresponding performance results in a table format. Instead, it lists standards the device meets or tests that were performed to confirm performance. The general acceptance criterion for all these tests is that the device meets the requirements of the specified standards, implying successful completion without adverse findings.
| Acceptance Criteria (Implied from Standards Met) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1 (covering Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Systemic Toxicity, Material-Mediated Pyrogenicity, Bacterial Endotoxin, Hemolysis) | The subject device meets requirements for ISO 10993-1. Specific tests performed: Cytotoxicity (ISO 10993-5), Sensitization and Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Subchronic Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (USP 43 ), Bacterial Endotoxin (USP 42 NF 37), Hemolysis (ISO 10993-4, ASTM F756-17). |
| Performance (per ISO 15747:2018): Resistance to temperature, pressure, leakage, dropping, transparency, cover, penetration ability of insertion port, adhesion strength, impermeability, tightness of injection point, tensile strength of hanger, identification legibility, resistance to hot printing removal, hydraulic seal, pneumatic seal, pinch clamp flow rate, UV transmission, mechanical resistance of bonding, impermeability for microorganisms. | Performed to confirm that differences in materials and technological characteristics do not affect safety or effectiveness. The document states "The performances of all models of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device." |
| Luer Connection: Meet requirements of ISO 80369-7 | Performed and results support substantial equivalence. |
| Filling Test: (No specific standard mentioned, but a required test) | Performed. |
| Visible Particulates in Injections: Meet requirements of USP | Performed. |
| Particulate Matter in Injections: Meet requirements of USP (Method 1) | Performed. |
| Package Integrity: Meet requirements of ISO 11607-1, ASTM D4332-01, ASTM D4169-16, ASTM F1980-02 | Tested according to these standards. |
| Chemical Testing (per ISO 15747:2018 & USP ): Requirements for raw container, test fluid, identification by FT-IR, Total Organic Carbon (TOC), DEHP analysis. | Performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the non-clinical tests. The data provenance is associated with laboratory testing to "demonstrate substantial equivalence," implying a prospective nature (testing performed specifically for this submission). The country of origin of the data is not specified, but the company is based in Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable as the study is a non-clinical, laboratory-based testing of a medical device, not an AI or diagnostic study requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
This is not applicable for non-clinical, laboratory-based testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the performance of diagnostic devices or AI algorithms where human interpretation is a factor.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is a purely physical medical device (an empty bag), not an algorithm or software-based device.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in documents like ISO 10993, ISO 15747, ISO 80369-7, and USP monographs. Compliance with these established scientific and regulatory benchmarks forms the basis of the "truth" for device performance.
8. The Sample Size for the Training Set:
This is not applicable. There is no training set as the device is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established:
This is not applicable. There is no training set.
§ 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).