(110 days)
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.
BD PhaSeal™ Optima Closed System Drug Transfer Devices (CSTD) are sterile, single use closed system drug transfer devices intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The BD PhaSeal™ Optima 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.
Device labeling includes the following statement: "The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer's labeling recommendations for the storage and expiration dating of the drug vial. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information."
The provided text describes the regulatory clearance for the BD PhaSeal™ Optima Closed System Drug Transfer Device-Injector (N40-O). It does not describe an AI/ML powered medical device. Therefore, many of the requested fields are not applicable.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Attachment/detachment force | PASS |
| Fragmentation | PASS |
| System flow rate | PASS |
The text states: "all predetermined acceptance criteria were met."
2. Sample sized used for the test set and the data provenance
The sample sizes for the performance tests are not specified in the provided document.
The data provenance is not specified beyond the tests being conducted by the manufacturer, Becton, Dickinson and Company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a mechanical Closed System Drug Transfer Device, not an AI/ML system requiring expert ground truth for interpretation.
4. Adjudication method for the test set
This is not applicable as the device is a mechanical Closed System Drug Transfer Device, not an AI/ML system or a diagnostic device requiring adjudication of interpretations. The performance tests appear to be quantitative measurements against defined criteria.
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 is not applicable. The device is a mechanical Closed System Drug Transfer Device and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical Closed System Drug Transfer Device and does not have an algorithm component.
7. The type of ground truth used
For the performance tests (Attachment/detachment force, Fragmentation, System flow rate), the ground truth would be established by objective physical measurements against predefined engineering or regulatory specifications.
8. The sample size for the training set
This is not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a mechanical 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.