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Closed System drug Transfer Device (CSTD) for 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 also prevents microbial ingress up to 7 days.

Equashield is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Equashield closed system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), an adaptor for the IV bag for withdrawal (Spike Adaptor-W), adaptors for injection into IV lines, syringes, or catheters (Luer Lock Adaptors). Nursing Pair connectors for standard IV tubing set ports (Female Luer Lock Connector and Male Luer Lock Connector), a Protective Plug, an adaptor for injection into an IV line with a Y-Site Tubing Set, or Secondary Tubing Accessory, and a Reconstitution Tubing Set for reconstituting powder drugs. The variable sterile air chamber integrated into the encapsulated syringe provides self-contained 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 seals off 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 add new components to the system including a thin size for components, introduce different material to the components and make labeling changes.

The Equashield Closed System Drug Transfer Device (CSTD) underwent a series of performance tests to demonstrate its substantial equivalence to predicate devices and ensure its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

| Test Category | Acceptance Criteria | Reported Device Performance |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Compliance with FDA Guidance and ISO 10993-1, -4, -5, -10, -11 for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility. | All testing passed. |
| Sterility | Compliance with ISO 11135 and ISO 11137-1 for sterilization, and ISO 10993-7, ISO 11737-1, and AAMI/ANSI ST72 for pyrogenicity, bioburden, and EO residuals. | All testing passed. |
| Package Integrity & Shelf Life | Compliance with ASTM F1140, ASTM F129, and ASTM F88 for internal pressurization failure, seal leaks, and seal strength. | All testing passed. |
| Bench Performance | Compliance with ISO 594-1, ISO 594-2, ISO 7886-1, ISO 8536-4, and ISO 22413 for visual inspection, detachment force, penetration force, and leak testing. | All testing passed. |
| Sharps Protection | Compliance with ISO 23908 for sharps injury protection features. | All testing passed. |
| Drug/DMA Compatibility | Full compatibility with antineoplastic drugs and DMA (N,N-dimethylacetamid). | Equashield was found to be compatible with antineoplastic drugs and DMA. |
| Extractables Screening | Identification of compounds and their estimated concentrations extracted under specified conditions (24 hours, 37°C and 50°C) in various solvents (50% ethanol, pH 3 0.9% saline, 33% aqueous DMA). | Results were obtained and submitted for review. The document does not explicitly state an "acceptance criteria" for extractables, but rather the process of determination for assessment. |
| Leachables Screening & Health Risk Assessment | Identification of compounds (and their estimated concentration) leached from CSTD assemblies at 25°C±2°C for 24 hours using four different hazardous drug carrier simulants. | Results were obtained and submitted for review. The document does not explicitly state an "acceptance criteria" for leachables, but rather the process of determination for assessment and compliance with ISO 10993-17. |
| Hazardous Vapors Containment | No escape of vapors from Equashield during use, determined by gas chromatography (GC) analysis using Flame Ionization (FID). | Testing met alcohol residual levels criteria. |
| Microbial Ingress Protection | Protection against microbial ingress for a period of up to 7 days after breaching the septum 10 times with a needle. | Testing results demonstrated Equashield was protected against microbial ingress for a period of 7 days after breaching the septum 10 times with the needle. |
| Particulates | Particulate levels in the device are low and meet USP 788 requirements. | Testing results demonstrated particulate levels in the Equashield are low and meet USP 788 requirements. |

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

The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., number of devices tested for leak testing, number of runs for microbial ingress). However, it implies that standard methodologies and sample sizes appropriate for the cited ISO and ASTM standards were employed.

The data provenance is not explicitly stated in terms of country of origin. The studies appear to be retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance for regulatory submission.

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

This type of information is generally not applicable to the performance testing described for the Equashield CSTD. The tests are laboratory-based and rely on established scientific and engineering standards (ISO, ASTM, USP) for objective measurement and evaluation, rather than human expert interpretation of subjective data (like in medical imaging for AI devices). Therefore, there is no "ground truth" to be established by experts in the context of this device's performance tests. The acceptance criteria are defined by industry standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective and based on established industry standards. There is no subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This kind of study is typically performed for AI-powered diagnostic or screening devices to assess how the AI impacts human reader performance. The Equashield CSTD is a medical device for drug transfer, and its performance is evaluated through objective physical, chemical, and biological tests, not by human reader interpretation of cases.

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

Yes, the performance tests described are essentially "standalone" evaluations of the device itself. They assess the device's intrinsic properties and functionality (e.g., leak-proof nature, vapor containment, microbial ingress protection) without requiring direct human interaction as part of the performance measurement beyond operating the test equipment. The device does not contain an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on established scientific and engineering principles and the specifications outlined in the referenced international standards (ISO, ASTM, USP). For example:

• Biocompatibility: Ground truth is defined by the absence of adverse biological reactions as per ISO 10993.
• Sterility: Ground truth is a sterility assurance level (SAL) of 10^-6 for sterilization, and specific limits for pyrogens and bioburden.
• Leak Testing: Ground truth is the absence of detectable leaks under specified pressure.
• Microbial Ingress: Ground truth is the prevention of microbial entry for 7 days after multiple penetrations.

These are objective, measurable outcomes defined by accepted standards.

8. The Sample Size for the Training Set

Not applicable. The Equashield CSTD is a physical medical device, not an AI model or software algorithm that requires a training set for machine learning. The studies described are for the physical properties and performance of the device itself.

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

Not applicable, as there is no training set for this device.

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Closed System drug Transfer Device (CSTD) for 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 also prevents microbial ingress up to 7 days.

Not Found

The provided text is an FDA 510(k) clearance letter for the Equashield Closed System Drug Transfer Device (CSTD). This document determines substantial equivalence to a predicate device and does not contain an acceptance criteria table, detailed device performance data from a specific study, information about study sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth sources, or training set details.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory information, the device name, and its intended use, rather than a detailed scientific study report with the specific performance metrics you are asking for.

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Closed System drug Transfer Device (CSTD) 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.

The Equashield system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the infusion bag for injection (Spike Adaptor 1), an adaptor for the infusion bag for withdrawal (Spike Adaptor W), an adaptor for female luer lock ports (Luer Lock Adaptor), nursing pair connectors for male and female luer lock ports (Female LL Connector and Male LL Connector), and a protective plug (Protective Plug). The Equashield closed system consists of 8 components that are dedicated to each other to create a system. The components are not intended to be used individually. Vial Adaptor is 48 x 31mm, 23mm at distal end. Plug is 51 x 17mm large. Female luer lock is 50 x 23 mm with a 5.2mm ID. Male luer lock is 42 x 21mm with a 15mm depth. Spike Adaptor is 75 x 42 mm and the height is 22mm.

The provided text is a 510(k) Summary for a medical device (Equashield Closed System Drug Transfer Device), which focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results. Therefore, much of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a numerical or categorical format with corresponding "reported device performance." Instead, it relies on demonstrating adherence to established consensus standards and substantial equivalence to predicate devices. The core performance claims are related to preventing microbial ingress and minimizing exposure to hazardous drugs.

Missing Information (Not available in the provided text):

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "performance data" in the context of substantial equivalence but does not provide details on specific studies, sample sizes, or data provenance.
2. 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 for this type of device and submission. There isn't "ground truth" established by experts in the sense of image interpretation or diagnosis. The "ground truth" here would be objective physical and chemical tests verifying the device's functionality.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there's no human adjudication of results in the traditional sense for this device. Performance is measured through empirical tests.
4. 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 a physical medical device, not an AI-powered diagnostic tool engaging human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" would be established through objective laboratory testing against specified standards (e.g., measuring microbial ingress, assessing leak-proof connections, verifying pressure equalization, physical integrity tests for sharps protection). The document refers to adherence to ISO standards (e.g., ISO 22413:2010 for transfer sets, ISO 10993 for biocompatibility).
7. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable. This is a physical medical device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states that the Equashield System Generation 2, its accessories, and components follow FDA recognized consensus standards. This implies that studies (tests) were conducted to demonstrate compliance with these standards. The specific standards listed are:

• ISO 594-1:1998, ISO 594-2:1998 (Luer fittings)
• ISO 7886-1:1993 (Sterile hypodermic syringes)
• ISO 8536-4:2010 (Infusion equipment, gravity feed)
• ISO 10993-1:2009, ISO 10993-4:2002, ISO 10993-5:2009 (Biological evaluation)
• ISO 14971:2007 (Risk management)
• ISO 22413:2010 (Transfer sets for pharmaceutical preparations)
• ISO 23908:2011 (Sharps injury protection)

The document explains that "Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects." This comparison, along with adherence to recognized standards, forms the basis of their claim for substantial equivalence and, by extension, meeting the necessary performance expectations for safety and effectiveness. However, detailed results of these performance studies or comparisons are not provided in this summary.

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