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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.

• 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.

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The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).

This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.

The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).

The provided FDA 510(k) summary (K243976) for the ZeroClear™ Bag Access details the device and its intended use as a component of a Closed System Drug Transfer Device (CSTD). However, it does not contain the specific information requested regarding acceptance criteria and the comprehensive study details as outlined in the prompt (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment, training set size).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (ProSeal™ Closed System Bag Access, K241988), primarily through functional performance, biocompatibility, and sterility testing against recognized standards. It highlights that no animal or clinical tests were deemed applicable for this submission.

Therefore, many of the requested fields cannot be directly populated from the provided text. Based on the document, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text for individual tests. The document mentions "testing data" but does not give specific numbers of devices or samples tested.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. The manufacturer is Singapore-based, but testing could occur elsewhere.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to the types of performance and safety tests conducted for this device (bench testing, biocompatibility, sterility). These tests do not involve expert interpretation or "ground truth" in the diagnostic or AI sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically used for studies involving human interpretation or subjective assessment, which is not the case for the physical and biological tests described.

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. The device is a physical medical device (component of a CSTD), not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The ZeroClear™ Bag Access is a physical component, not an algorithm or software. Its performance is inherent to its design and materials, not a standalone algorithmic output. The performance tests mentioned (e.g., airtightness, microbial ingress) evaluate the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the functional, biocompatibility, and sterility tests, the "ground truth" is defined by the pass/fail criteria of the referenced international and national standards (ISO, ANSI AAMI, ASTM, USP, NIOSH). For example, a device either leaks or it doesn't, based on predefined measurable thresholds in the standards.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. No training set is involved.

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days, when used as intended.

The ProSeal™ CSTD devices are single-use, sterile, non-pyrogenic CSTD component devices that are fitted to each other. They are used as sterile interfaces for the closed injections and withdrawals of liquids into and from the ProSeal™ CSTD component devices and external transfer devices. The ProSeal™ In Line Pump Set is a closed system in-line IV infusate/drug transfer adapter/ connector for providing closed system protection during hazardous drug administration when connected to a standard IV set at its distal end, with the proximal end attached to a mating ProSeal™ Injection Site (K240433) of a ProSeal™ CSTD component device such as the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442).

This document does not contain the information required to populate a table of acceptance criteria and reported device performance for a medical device that would involve AI or machine learning. The provided text is a 510(k) summary for a physical medical device (ProSeal™ In Line Pump Set), which is an intravascular administration set, and does not mention any AI components, software, or algorithms.

Therefore, questions related to:

1. Acceptance criteria and reported device performance (with AI metrics)
2. Sample size for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study and effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used (for AI)
8. Sample size for the training set
9. How ground truth was established for the training set

cannot be answered from the provided text.

The document focuses on the substantial equivalence of the ProSeal™ In Line Pump Set to a predicate device (ProSeal™ Injector Plus) based on:

• Intended use and indications for use
• Technological characteristics (materials, design, sterilization, shelf-life)
• Performance data from bench testing demonstrating compliance with ISO standards for mechanical, fluidic, and safety aspects.
• Biocompatibility testing (per ISO 10993)
• Sterility, shipping, and shelf-life testing.

The performance data listed pertains to physical device attributes such as leak integrity, flow rate, Luer lock connection tests, sharps injury protection, needle bonding strength, resistance to temperature/pressure/dropping, water vapor impermeability, spiking port ability and adhesion, particulate non-contamination, and impermeability to microorganisms. These are standard engineering and biomedical tests for physical medical devices, not performance metrics for AI algorithms.

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