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Closed System Drug Transfer Device (CSTD) for safe preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs

The EQUASHIELD® Closed System Drug Transfer Device (CSTD) is intended for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs.

EQUASHIELD® CSTD is a sterile, single use system. The various system components are listed in the table below:

The above components are combined to create a system and are not intended to be used individually.

The variable sterile air chamber integrated into the encapsulated syringe provides selfcontained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane prevents the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days. The purpose of this submission is to obtain FDA clearance for new system components and material changes for previously cleared components and to revise the indication for use for clarity with respect to the functionality of the Syringe Unit.

Here's a breakdown of the acceptance criteria and the study information for the EQUASHIELD® Closed System Transfer Device (K221513) based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Non-Clinical Testing: No specific sample sizes are mentioned for the non-clinical tests (ISO standards, USP). However, these are typically bench-top tests performed on sufficient samples to demonstrate compliance.
• Biocompatibility: Not explicitly stated, but common for such tests to use a reasonable number of samples to ensure robust results.
• Sterility Shelf Life and Shipping Simulation: "Sterilized samples" were used for accelerated aging, and "final, packed, and sterile samples" were used for packaging integrity. The exact number is not specified but implicitly sufficient for the standards cited.
• Microbial Ingress: "Sterile and aged EQUASHIELD® CSTD samples" were used. The study explicitly states there were 10 repeated accesses for a period of 7 days, implying multiple devices were tested to draw a conclusion on "None of the tested samples showed growth." The exact number of CSTD samples is not specified.
• Drug Compatibility: Not explicitly stated, but "chemical analytic experiments and mechanical, functional and performance testing" would involve a sufficient number of devices.
• Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission, the data would have been generated to meet U.S. regulatory requirements. It is a prospective study as new testing was conducted specifically for this submission to support the device's performance.

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

This type of medical device submission (510(k) for a Closed System Transfer Device) does not typically involve expert review for establishing "ground truth" in the way an AI diagnostic device would. The "ground truth" for these tests is defined by established scientific standards (ISO, USP, ASTM) and benchmark compliance rather than expert consensus on diagnostic images or pathology. Therefore, there were no experts in the context of diagnostic interpretation establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data, and discrepancies need to be resolved to establish a consensus ground truth, typically for diagnostic 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 device is a Closed System Transfer Device, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the EQUASHIELD® CSTD is established by:

• Compliance with International and National Standards: ISO, USP, and ASTM standards define the acceptance criteria for various physical, chemical, and biological properties.
• Defined Performance Specifications: Each test verified that the device met its design specifications (e.g., preventing microbial ingress, maintaining sterility, drug compatibility).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model, and therefore does not have a training set.

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

Not applicable, as no training set was used.

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The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.

The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.

The provided text is a 510(k) summary for a medical device (Closed System Transfer Device, CSTD) and focuses on demonstrating substantial equivalence to a predicate device. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts. Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and the study proving an AI/ML device meets them.

The text discusses:

• Device Name: Closed System Transfer Device (CSTD)
• Indications for Use: Preparation, reconstitution, compounding, and administration of drugs (including antineoplastic and hazardous drugs), minimizing individual and environmental exposure to drug vapor, aerosols, and spills, and preventing microbial ingress.
• Predicate Device: Equashield Closed System Drug Transfer Device (CSTD) (K170706)
• Non-Clinical Testing: A series of tests conducted to verify compliance with various ISO standards (e.g., ISO 594-1, ISO 7886-1, ISO 22413) and biocompatibility testing (e.g., Acute Systemic Toxicity, Cytotoxicity, Hemolysis, Skin Sensitization).
• No Clinical Study: The document explicitly states "No clinical study is included in this submission."

Given this content, I am unable to provide information on:

1. A table of acceptance criteria and reported device performance for an AI/ML model.
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC study effects for AI assistance.
6. Standalone AI algorithm performance.
7. Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
8. Sample size for the AI/ML training set.
9. How ground truth for the AI/ML training set was established.

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The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.

The BD PhaSeal™ Optima Closed System Transfer Device (CSTD) is a sterile single-use closed system drug transfer device intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The system is comprised of four devices-Protector, Injector, Connector, and Infusion Adapter. The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. 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, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated up to 10 penetrations.

The BD PhaSeal™ Optima Closed System Transfer Device is an airtight and leakproof closed system drug transfer device (CSTD) designed to prevent environmental contaminants from entering the system and to prevent drug vapor concentrations from escaping, thus minimizing exposure to drug vapor, aerosols, and spills. It also prevents microbial ingress for up to 168 hours.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the specific sample sizes used for each performance test. It only indicates that "Performance testing was conducted" and that the "Results of these tests demonstrate that the subject device is substantially equivalent to the predicate device." The data provenance is not specified beyond being generated by the device manufacturer, Becton, Dickinson and Company. The studies appear to be retrospective in nature, performed by the manufacturer to demonstrate product performance for regulatory submission.

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

Not applicable. This device is a medical device (Closed System Transfer Device), not an AI-powered diagnostic or assistive tool that would require expert-established ground truth for its performance assessment. The tests conducted are laboratory-based and measure physical, chemical, and biological properties according to established standards.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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 not an AI-powered device.

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

Not applicable. This is not an AI-powered device. The "standalone" performance here refers to the device's inherent mechanical and material performance.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by the pre-defined acceptance criteria set by recognized international (ISO, ASTM) and national (FDA, USP) standards and guidance documents. For example, for microbial ingress, the ground truth is the absence of microbial contamination as defined by the FDA guidance. For airtight connections, the "ground truth" is the non-detection of vapor using the TiCl4 test. For biocompatibility, the ground truth is that the materials do not elicit adverse biological responses as defined by ISO 10993 standards.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. See point 8.

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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-use closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liguid. 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.

The PhaSeal Injector is one component of the PhaSeal system. It is a luer device adaptor that may be fitted to a syringe or IV tubing. It is used to gain dry and leak-proof access to a drug container or administration device which has been sealed with a PhaSeal Protector or Connector. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.

This document describes the performance and acceptance criteria for the BD PhaSeal Closed System Transfer Device - Injector, as summarized from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines design verification tests to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicit in the "Equivalent to Predicate" or "Per ISO 10993" results for each characteristic.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the "Dye Leak Test" or "Fragmentation Test." It mentions "Design Verification tests were performed based on the risk analysis performed," suggesting a controlled testing environment, but no specific sample numbers are given. The data provenance is internal to BD Medical - Medical Surgical Systems, likely conducted in a laboratory setting for device validation. It is a prospective study in the sense that the tests were performed specifically to verify the modified device's performance.

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

This information is not provided in the given text. The tests appear to be objective performance tests (dye leak, fragmentation) rather than expert-dependent assessments requiring ground truth establishment by human experts. Biocompatibility (ISO 10993) is likely assessed by trained laboratory personnel in accordance with the standard, not necessarily clinical "experts" in the sense of radiologists or similar.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests performed (Biocompatibility, Membrane Leakage, Membrane Fragmentation) are objective measurements or adherence to standards, not subjective assessments requiring adjudication by multiple readers.

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:

This information is not applicable. The device is a Closed System Transfer Device (CSTD), a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant to its purpose and performance evaluation.

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

This information is not applicable. The device is a physical product and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For the performance tests:

• Biocompatibility: The "ground truth" would be adherence to the established scientific and regulatory standards outlined in ISO 10993 for biological evaluation of medical devices.
• Membrane Leakage & Fragmentation: The "ground truth" or reference for performance is the predicate device (BD PhaSeal® Connector, Injector, Protector - K123213). The goal was to prove "equivalence," meaning the modified device should perform as well as the predicate device in these specific functional tests.

8. The Sample Size for the Training Set:

This information is not applicable. The described study is a design verification for a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above (no training set).

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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor contractions outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liguid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula 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.

The PhaSeal Protector is one component of the PhaSeal system. It is a drug vial adapter that is fitted to the drug vial and is used as a docking station between the drug vial and the BD PhaSeal Injector. In addition the Protector equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.

The provided 510(k) summary (K130197) does not contain information related to acceptance criteria, device performance, or any studies involving human readers or AI algorithms.

This document describes a medical device called the "BD PhaSeal Closed System Transfer Device - P55," which is a sterile, single-use closed system drug transfer device. The 510(k) summary focuses on the device's description, intended use, and substantial equivalence to a predicate device (BD PhaSeal® Connector, Injector, Protector - K123213).

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document describes the function of the device (airtight, leakproof, prevents transfer of contaminants, etc.) but does not quantify performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
4. Adjudication method for the test set: Not applicable as no such study is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone performance study was done: While there would undoubtedly be internal testing by the manufacturer for a device of this type (e.g., leak tests, microbial ingress tests), the provided 510(k) summary does not detail these studies' acceptance criteria, methodologies, or results. The summary focuses on the regulatory submission process.
7. The type of ground truth used: Not applicable as no ground truth for diagnostic or interpretative accuracy is relevant or discussed for this device.
8. The sample size for the training set: Not applicable as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable as this is not a machine learning device.

In summary, the provided text details a regulatory submission for a physical medical device and does not include the type of performance study data or acceptance criteria typically associated with AI/ML devices or diagnostic tools.

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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes fro 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.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Description of the Study Proving Acceptance Criteria

The study described is a series of non-clinical tests designed to demonstrate that the BD PhaSeal® Closed System Drug Transfer Device meets the specified performance criteria for leakproofness, airtightness, and microbial ingress. The summary states, "As there is no change to the subject device in comparison to the predicate devices, the performance data provided represent the performance of both the predicate and subject device of this 510(k)." The tests were conducted to substantiate its use as a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System (ONB product code).

Details on the Tests:

• Leakproof Connections: Tested using a Fluorescein Test.
• Airtight Connections: Tested using a TiCl4 Test (which detects vapor/smoke).
• Microbial Ingress: Tested to ensure no ingress at the Protector or Connector.

Additional Information Not Present in the Document:

The provided 510(k) summary focuses on demonstrating substantial equivalence through technological characteristics and a summary of performance tests. It does not contain the following information typically found in detailed study reports:

2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "additional tests referenced in the table" without detailing sample sizes or the origin (country, retrospective/prospective) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of physical performance tests (leak, airtight, microbial ingress). Ground truth is established by the test method itself, not expert consensus.
4. Adjudication method for the test set: Not applicable for these performance tests. The outcome is typically a pass/fail based on direct observation (e.g., presence/absence of leaks, smoke, or microbial growth).
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 device is a medical device for drug transfer, not an imaging or diagnostic AI product, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
7. The type of ground truth used: The ground truth for these tests is defined by the objective results of the specified testing methodologies (Fluorescein Test, TiCl4 Test, and microbial ingress testing). For example, "no leaks" is the ground truth from the fluorescein test.
8. The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established: Not applicable. This device does not use machine learning or require a training set.

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