(117 days)
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 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| 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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.