(29 days)
The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.
The eZSURE™ Empty Fluid Container (EFC) is a sterile, nonpyrogenic, single-use intravenous (IV) bag constructed from flexible, non-PVC film. It is designed for the preparation and administration of IV fluids and is intended for disposal after a single use.
Two previously cleared subgroups include:
- eZSURE™ EFC with Needle-Free Valve (NFV) Additive Port (K223674)
- eZSURE™ EFC with ProSeal™ Injection Site Additive Port (K241442)
Both subgroups are currently available in 100 mL, 250 mL, and 500 mL capacities. This Submission introduces a new 1,000 mL capacity option for each subgroup.
Each EFC consists of a flexible plastic film bag with two (2) ports:
- Additive (filling) port – for introducing compatible fluids
- Spiking (administration/access) port – for accessing the infusate using a standard IV spike
The NFV model features a self-sealing needle-free valve additive port compatible with male Luer lock syringes. The Injection Site model incorporates a closed-system injection site with a double elastomeric membrane, compatible with the ProSeal™ Injector, which is also compatible with male Luer lock syringes. Both configurations support secure medication addition and maintain a sealed system after device removal.
The provided FDA 510(k) clearance letter describes a medical device, the eZSURE™ Empty Fluid Container, which is an IV bag. The submission primarily focuses on the device's technical characteristics and performance, particularly concerning the introduction of a new 1,000 mL capacity option.
Based on the provided document, the device in question (eZSURE™ Empty Fluid Container) is a Class II medical device (an I.V. container). The validation described heavily relies on bench testing and conformance to established international and national standards rather than clinical studies involving human patients or complex AI algorithms requiring extensive ground truth establishment and multi-reader studies.
Therefore, the acceptance criteria and study that proves the device meets them are focused on these engineering and biocompatibility aspects.
Here's the breakdown as requested, tailored to the information available in the 510(k) letter:
Acceptance Criteria and Device Performance for eZSURE™ Empty Fluid Container
The acceptance criteria for this device are primarily based on meeting the requirements of various recognized national and international standards related to IV containers, fluid transfer, and biocompatibility. The "study" proving acceptance consists of a series of bench tests and evaluations against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device (an IV container) with an extension of capacity, the performance criteria are primarily related to its physical and material properties, and its ability to safely contain and dispense fluids. The provided document details a comprehensive set of tests performed.
| Category | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| I. Functional Performance | ||
| Physical Integrity & Durability | - Resistance to temperature, pressure, and fluid leakage (ISO 15747:2018, Annex A.3) |
- Accelerated aging of above tests (ASTM F1980-21)
- Resistance to dropping (ISO 15747:2018, Annex A.4)
- Accelerated aging of above test (ASTM F1980-21)
- Hanger tensile strength (ISO 15747:2018, Annex A.11)
- Accelerated aging of above tests (ASTM F1980-21) | Conformant: All specified tests were performed on the Subject device (1000 mL capacity) and leveraged data from predicate devices. The Submitter's Comment indicates that functional testing was conducted and data summarized, concluding that performance results met intended use, and determined the difference in volume to be insignificant. |
| Additive Port (Common) | - Infusion container transparency (ISO 15747:2018) - Water vapor impermeability (ISO 15747:2018)
- Access port cover test (ISO 15747:2018)
- Access port penetration ability of insertion point (ISO 15747:2018)
- Access port adhesion strength of infusion device and impermeability of insertion point (ISO 15747:2018)
- Access port liquid tightness of insertion point (ISO 15747:2018)
- Identification test (ISO 15747:2018)
- Raw container and test fluids requirements (ISO 15747:2018)
- Impermeability to microorganism and migration (ISO 15747:2018)
- 7-day microbial ingress (FDA guidance and AAMI CN27:2021) | Conformant: These tests were performed with the NFV filling port version (under K223674) or demonstrated to be equivalent. Results implied conformance, as the submission states no substantial differences raised concerns and performance met intended use. |
| Additive Port (ProSeal™ Specific) | - Additive port air and liquid tightness (ISO 15747:2018) - Impermeability to microorganism (ISO 15747:2018)
- Additive port positive pressure fluid leakage (ISO 80369-7:2021)
- Sub-atmospheric pressure air leakage (ISO 80369-7:2021)
- Stress cracking (ISO 80369-7:2021)
- Resistance to separation from axial load (ISO 80369-7:2021)
- Resistance to unscrewing (ISO 80369-7:2021)
- Resistance to overriding (ISO 80369-7:2021)
- Device leakage integrity (ISO 8536-4:2019)
- Vapor containment test (NIOSH 2016 draft protocol)
- Microbial ingress (FDA guidance and AAMI CN27:2021) | Conformant: These tests were performed with the Injection Site filling port version (under K241442 and K240433) or demonstrated to be equivalent. Results implied conformance, as the submission states no substantial differences raised concerns and performance met intended use. |
| II. Biocompatibility | - Cytotoxicity (ISO 10993-5:2009) - Sensitization (ISO 10993-10:2010)
- Intracutaneous reactivity (ISO 10993-23:2021)
- Acute systemic toxicity (ISO 10993-11:2017)
- Subacute/subchronic systemic toxicity (ISO 10993-11:2017)
- In-vitro hemolysis (ISO 10993-4:2017)
- Material mediated pyrogenicity (ISO 10993-11:2017)
- Chemical characterization and toxicological risk assessment (ISO 10993-18:2020 & ISO 10993-17:2002)
- Particulate matter testing (ISO 15747:2018 & USP )
- EO residues limits (ISO 10993-7:2008, Amd.1:2019) | Acceptable Biological Risks Established: Testing was conducted under predicate devices (K223674/S001, K241442, K240433) and the Subject device. The Submitter's Comment explicitly states: "The biocompatibility testing and chemical characterization as well as risk analysis data on cleared device were evaluated for the Subject device... The difference was determined to be insignificant as results were determined to have met the device's biological safety specifications." Testing also confirmed compliance with EO residue limits for special patient populations. |
| III. Sterility, Shipping, and Shelf-Life | - Sterilization validation (ISO 11135:2014) - Simulated shipping testing (ASTM D 4169-16)
- Package integrity (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009)
- Pyrogen tests (ANSI/AAMI ST72/2019, USP 42-NF 37 , , )
- Shelf-life validation (3 years, ASTM 1980-21) | Conformant: The Subject device complies with ISO 11135:2014. Shipping and package integrity tests leveraged data from prior submissions (K151650/S004, K223674/S001, K151650). Pyrogen tests performed under K151650 will be conducted on every lot. A 3-year shelf-life was validated on the Subject device. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., "n=X units") for each specific test conducted on the 1000 mL subject device. It lists the types of tests performed and the standards they adhere to. For physical device testing, sample sizes are typically defined by the standards themselves (e.g., a certain number of units per lot, or a statistical sampling plan to achieve confidence). The statement "functional testing have been conducted and their data are summarized in section VII.A" implies sufficient samples were used to meet the standards' requirements.
- Data Provenance: The data provenance is primarily from bench testing conducted by the manufacturer or authorized test labs. The document mentions leveraging "relevant testing data from the Predicate devices and the existing device: K223674/S001, K241442 and K230343/S001" for many of the functional and biocompatibility tests, with specific tests performed "On Subject device" (the new 1000 mL version). The country of origin of the data is not specified beyond the company being in Singapore. All data is retrospective in the sense that it's historical data generated for the submission, but the tests themselves were designed to prospectively evaluate the device's performance against defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (an IV container) does not typically involve expert "ground truth" establishment in the way AI/radiology devices do. The "ground truth" is established by adherence to pre-defined, internationally recognized engineering and scientific standards (e.g., ISO, ASTM, USP) and their associated test methods. Experts involved would be engineers, material scientists, and quality assurance professionals responsible for designing, executing, and interpreting these standardized tests. Their qualifications would be in engineering, chemistry, biology, or related fields, with experience in medical device testing and regulatory compliance. The document does not specify the number or specific qualifications of these individuals.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" is based on established technical standards, not on subjective human interpretation requiring adjudication. Performance is measured against quantitative or qualitative acceptance criteria defined by these standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those involving image interpretation (e.g., AI in radiology), where human performance (with and without AI assistance) needs to be assessed. This device is a physical IV container and does not involve human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used is primarily based on:
- Engineering and Performance Standards: The device's ability to meet specified physical, mechanical, and chemical properties as defined by ISO, AAMI, ASTM, and USP standards.
- Biocompatibility Standards: The device's materials and their extracts demonstrating acceptable biological compatibility as per ISO 10993 series.
- Sterility Assurance: Validation of the sterilization process and maintenance of sterility as per ISO 11135.
This is fundamentally different from ground truth for AI algorithms which might use expert consensus or pathology results.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).