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510(k) Data Aggregation
(207 days)
BD PhaSeal Optima Closed System Transfer Device
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:
| Performance Test | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Microbial ingress testing | Per FDA guidance document, "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" (presumably demonstrating no microbial ingress for up to 168 hours). | PASS |
| Airtight connections | Utilizing TiCl4 vapor test (specific acceptance criteria for vapor leakage not detailed, but likely related to no detectable vapor escape). | PASS |
| Leakproof connections | Utilizing Fluorescein test (specific acceptance criteria for liquid leakage not detailed, but likely related to no detectable liquid escape). | PASS |
| Protector assembly force and removal force testing | Not explicitly stated, but implies forces within acceptable ranges for proper device function and user interaction. | PASS |
| Protector expansion chamber burst testing | Not explicitly stated, but implies the chamber can withstand internal pressure without bursting. | PASS |
| Packaging integrity and shelf life testing | Per ASTM D4169-16 (Performance Testing of Shipping Containers), ASTM F88/F88M-15 (Seal Strength), ASTM F2096-11 (Gross Leak Detection). Acceptance criteria would involve maintaining package integrity and sterility over the shelf life. | PASS |
| Hazardous vapor containment | Using alcohol residuals level criterion (specific residual level not detailed, but implies levels below a hazardous threshold). | PASS |
| Ethylene Oxide (EO) residuals testing | Per ISO 10993-7 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals). Acceptance criteria would be below specified limits. | PASS |
| EO sterilization validation | Per ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process). Acceptance criterion: Sterility Assurance Level (SAL) of 10-6. | PASS |
| Pyrogenicity - bacterial endotoxin test (LAL) | Acceptance criteria not explicitly stated, but implies endotoxin levels below a specified threshold. | PASS |
| Biocompatibility: Cytotoxicity | Per ISO 10993-5. Acceptance criteria: non-cytotoxic. | All materials are biocompatible. |
| Biocompatibility: Sensitization | Per ASTM F2148 and ISO 10993-10. Acceptance criteria: non-sensitizing. | All materials are biocompatible. |
| Biocompatibility: Intracutaneous Reactivity | Per ISO 10993-10 and USP 39-NF 34 . Acceptance criteria: no significant irritation or reactivity. | All materials are biocompatible. |
| Biocompatibility: Acute Systemic Toxicity | Per ISO 10993-11. Acceptance criteria: no systemic toxicity. | All materials are biocompatible. |
| Biocompatibility: Pyrogenicity (material-mediated rabbit pyrogen) | Per USP and ISO 10993-11. Acceptance criteria: no pyrogenic response. | All materials are biocompatible. |
| Biocompatibility: Hemolysis | Per ISO 10993-4. Acceptance criteria: non-hemolytic. | All materials are biocompatible. |
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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