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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 is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting component device reduces the risk of microbial ingress for up to 168 hours or 7 days, when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

• A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector Plus housing perforates the double membranes for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination, when used as intended.

Based on the provided FDA 510(k) summary for the ProSeal™ Closed System Bag Access (K241988), here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary, which provides an overview of the substantial equivalence determination. It does not contain the full details of all the studies performed. Therefore, specific quantitative performance metrics beyond what is explicitly stated for acceptance and observed results are not available in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes functional performance, biocompatibility, sterility, shipping, and shelf-life testing. While specific quantitative acceptance criteria are not explicitly listed in a single table with corresponding numerical results, the document states conformance to various ISO and FDA recognized standards. The "Comment/Discussion" column in the comparison table indicates "Same" or "Similar" for many characteristics, implying that the acceptance criteria are met by demonstrating equivalence to the predicate device and adherence to standards.

For functional performance, the document lists the following tests and their corresponding standards, implying that meeting these standards constitutes the acceptance criteria. The performance data "supporting substantial equivalence" suggests that the device met these criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the functional performance, biocompatibility, or sterility tests. It refers to various ISO and ASTM standards, which typically prescribe minimum sample sizes for such tests.

• Data Provenance: The document states "Bench performance verifications and validations referred-to and performed" and "testing data on devices cleared under K222929." This indicates that the testing was primarily benchtop testing (laboratory-based) and retrospective, leveraging data from previously cleared devices within the ProSeal™ CSTD system (specifically K222929). There is no mention of data provenance by country of origin or specific patient data since the studies are physical/chemical rather than clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is Not Applicable to this 510(k) submission. The device is a physical medical device (intravascular administration set component), not an AI/ML diagnostic or image analysis device that requires expert human interpretation to establish ground truth from medical images or clinical data. Its performance is evaluated through physical, mechanical, and biological testing against established standards.

4. Adjudication Method for the Test Set

This section is Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving human interpretation or subjective assessments, especially for AI/ML devices where ground truth might be derived from multiple expert opinions. For a physical device undergoing performance and safety testing against objective engineering and biological standards, such adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of how much Human Readers Improve with AI vs. without AI Assistance

This section is Not Applicable. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices that evaluate human reader performance. The ProSeal™ Closed System Bag Access is a hardware component for drug transfer and does not involve human readers interpreting medical cases.

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

This section is Not Applicable. This concept applies to AI/ML software. The ProSeal™ Closed System Bag Access is a physical device component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to internationally recognized performance standards (e.g., ISO, ASTM, USP, ANSI/AAMI) for medical devices, specifically for intravascular administration sets and closed system transfer devices. This includes:

• Engineering/Physical Standards: Defining acceptable ranges for leak integrity, tensile strength, penetration force, package integrity, etc.
• Biological Standards: Defining acceptable levels for biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity) and sterility.
• Functional Claim Validation: Demonstration of preventing microbial ingress and vapor containment as defined by specific test protocols (e.g., microbial ingress test, vapor containment test).

8. The Sample Size for the Training Set

This section is Not Applicable. The product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The design and manufacturing processes are validated through engineering principles and compliance with quality systems (e.g., 21 CFR Part 820).

9. How the Ground Truth for the Training Set Was Established

This section is Not Applicable for the same reason as point 8.

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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.

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The ToxiSeal™ Vial Adaptor with External Flip Balloon 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

The ToxiSeal™ Vial Adaptor with External Flip Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials. In addition, the ToxiSeal™ Vial Adaptor with External Flip Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.

This is a 510(k) summary for a medical device called "ToxiSeal™ Vial Adaptor with External Flip Balloon". This submission seeks to demonstrate that the new device, which has some material and design changes compared to a previously cleared predicate device, is substantially equivalent and does not require a new premarket approval application.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a comparative format for each specific criterion. Instead, it lists the standards and types of tests performed, implying that the device met the requirements of these standards. The "Reported Device Performance" in this context refers to the affirmation that testing was conducted and demonstrated conformance with the cited standards and previously cleared devices' performance.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Sizes: The document does not explicitly state the specific number of units or samples used for each individual test. It mentions that testing was performed "on the Subject device" or "on test samples in their finished form aged to the intention i the Subject device validation lots."
• Data Provenance: The document does not specify the country of origin of the data. The studies are described as "bench performance verifications and validations" and refer to past clearances (K222929, K240433, K192075) for much of the leveraged data, implying these were laboratory-based tests. The submission originates from Singapore.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device submission. The device is a physical medical device (vial adaptor), not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth for a test set. The validation relies on technical performance standards and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. This is not an AI/ML-based diagnostic device where reader studies would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to recognized industry standards (ISO, ASTM, USP, ANSI/AAMI) for mechanical, chemical, biological, and sterility properties. For example:

• Mechanical Integrity: Conformance to ISO 22413, ISO 8536-4.
• Biocompatibility: Conformance to ISO 10993 series.
• Sterility: Conformance to ISO 11135.
• Particulate Matter: Conformance to USP .
• Shelf-life: Conformance to ASTM 1980-16.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML system that utilizes a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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