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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 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) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC is made of non-PVC materials. The Nexcel Film for IV bag of the Subject EFC device is composed of a flexible plastic film bag and the device is provided in a two-port configuration with closures. A closed system inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle with the ProSeal™ Injector or ProSeal™ Injector Plus (cleared K240171) attached, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike in an IV therapy administration from the EFC. The transfer device with a male Luer lock attached with the ProSeal™ Injector (or ProSeal™ Injector Plus) is used to connect to the filling-/ additive- port for filling. The additive port incorporates a ProSeal™ Injection Site (cleared K240433) as its integrated subcomponent; hence no other injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.

The provided text describes the 510(k) summary for the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site. It details the device's modification from a predicate device, its indications for use, and a comparison of technological characteristics. The document primarily focuses on verifying the safety and effectiveness of the modified device by leveraging testing performed on existing cleared devices and conducting additional benchtop performance verifications.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which is what the requested questions (2, 3, 4, 5, 6, 7, 8, 9) are geared towards. These questions are typically relevant for AI/ML-based diagnostic devices where performance is measured against a ground truth and involves human experts. This device, being an "Empty Fluid Container with ProSeal™ Injection Site," is a physical medical device for fluid administration, not a diagnostic or AI-driven system.

Therefore, many of the requested fields cannot be answered from the provided input as they are not applicable to this type of device.

Here's what can be extracted and inferred based on the nature of the device:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are primarily based on conformance to recognized international and FDA standards, and successful performance in benchtop verification tests. The "reported device performance" is that it conforms to these standards and passed the tests.

For the remaining questions, they are not applicable or the information is not provided in the text for this medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The document describes benchtop performance verifications, which typically involve a specified number of units tested according to the method, rather than "test sets" of patient data. Details on the exact number of units tested for each benchmark are not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device does not involve expert interpretation or ground truth establishment in the diagnostic sense. Performance is assessed against engineering and biological standards.

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

• Not applicable. This relates to diagnostic interpretation, not physical device performance.

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 for AI-assisted diagnostic devices.

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

• Not applicable. This is for AI-driven algorithms.

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

• The "ground truth" for this medical device is adherence to established international and FDA recognized standards for medical devices (e.g., ISO, ASTM, USP standards for material safety, sterility, physical integrity, leakage, etc.). For biocompatibility, the ground truth is the biological response meeting safety thresholds according to ISO 10993.

8. The sample size for the training set

• Not applicable. This is for AI/ML models; this device is a physical product.

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

• Not applicable. This is for AI/ML models.

Ask a specific question about this device

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) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration. For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder. The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.

The provided text is a 510(k) Summary for a medical device called eZSURE™ Empty Fluid Container. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or the establishment of ground truth by experts.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a Class II medical device (an empty IV fluid container). The "acceptance criteria" and "study" described in the document relate to physical and biological performance testing of the container itself, not the performance of an AI algorithm in diagnostic imaging.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI test set.
• MRMC comparative effectiveness study details.
• Standalone AI performance details.
• Training set size or ground truth establishment for an AI.

The document describes the following types of acceptance criteria and studies for the physical medical device:

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

The document does not provide a single, consolidated table directly mapping acceptance criteria to quantitative performance results for each test. Instead, it lists the types of tests performed and states that the device "met their respective acceptance criteria" or "complies with" relevant standards.

Summary of Acceptance Criteria and Reported Performance (extracted from Section VII):

2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test listed. It mentions "testing done" and "test methods" but not the number of units tested. Data provenance is not applicable here as it refers to physical testing of a manufactured device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device's performance relates to physical and biological properties (e.g., whether it leaks, whether materials are biocompatible, whether it is sterile), which are established through standardized laboratory testing, not by expert human readers interpreting data.

4. Adjudication method for the test set:
Not applicable for physical/biological performance testing.

5. If a Multi-reader Multi-case (MRMC) comparative effectiveness study was done:
No, this type of study is for evaluating diagnostic performance of imaging devices or AI, which is irrelevant to an empty fluid container.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as there is no AI algorithm being evaluated for this physical device.

7. The type of ground truth used:
For the physical device, the "ground truth" is defined by the technical specifications and performance limits set by various ISO, ASTM, ANSI/AAMI, EN, and USP standards (e.g., a certain burst pressure, a specific level of particulate matter, absence of microbial growth).

8. The sample size for the training set:
Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as there is no AI model or training set.

In conclusion, the provided FDA 510(k) summary is for a standard medical device (an empty fluid container) and demonstrates its substantial equivalence based on physical, chemical, and biological performance testing, rather than the performance of an AI algorithm.

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