(218 days)
The PhaSeal system is a 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 Protector 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 technique 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 and 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 and spills. The PhaSeal® Protector also prevents microbial ingress.
Here's a breakdown of the acceptance criteria and the study details for the PhaSeal Closed System Drug Transfer Device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated Goal) | Device Performance (Metric/Result) |
|---|---|
| Maintain Sterility (Study 1) | At 16-hour mark: 98.2% probability that vials will not be contaminated. |
| At 168-hour mark: 98.2% probability that vials will not be contaminated (derived from 1.8% failure rate across 168 hours). | |
| Solutions are expected to remain sterile for up to 168 hours. (Visual, microscopic, and microbiologic subculture analyses) | |
| Maintain Sterility (Study 2) | At 168-hour mark: 99.7% probability that the vial would remain sterile (0.3% probability of failure). (Monitored for contamination by independent microbiology laboratory after controlled incubation for 14 days) |
| Prevent Microbial Ingress | Microbial ingress was NOT observed on any of the samples with the PhaSeal Protector. (Testing in accordance with "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]") |
| Minimize exposure to drug vapor, aerosols, and spills | The device is a "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." This is stated as a functional characteristic and indication for use, not a metric directly measured by the studies. |
Study Details
1. "Utility of the PhaSeal Closed System Drug Transfer Device" (Study 1)
- Sample Size (Test Set): 1328 syringes produced.
- Data Provenance: Not explicitly stated, but generated at "4 different institutions," suggesting a multi-center internal or collaborative study. The study appears prospective, as samples were removed and tested at specific time points.
- Number of Experts for Ground Truth: Not applicable, as ground truth was established through objective microbiological and visual/microscopic analysis.
- Qualifications of Experts: N/A
- Adjudication Method: N/A
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This was a standalone performance study of the device.
- Standalone Performance: Yes, the study focused solely on the device's ability to maintain sterility.
- Type of Ground Truth Used: Objective microbiological analysis (evidence of contamination by an independent microbiology laboratory), visual, and microscopic analyses.
- Sample Size (Training Set): Not applicable, as this is a non-AI device performance study.
- How Ground Truth for Training Set Established: N/A
2. "Second Look at the Utilization of Closed-System Transfer Devices (PhaSeal)" (Study 2)
- Sample Size (Test Set): Not explicitly stated how many aliquots or IV bags were tested, but it's referred to as "aliquots... transferred... to intravenous bags."
- Data Provenance: Not explicitly stated, but confirms and refines results of the first study. Appears prospective.
- Number of Experts for Ground Truth: Not applicable, as ground truth was established through objective microbiological analysis.
- Qualifications of Experts: N/A
- Adjudication Method: N/A
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This was a standalone performance study.
- Standalone Performance: Yes, the study focused solely on the device's ability to maintain sterility.
- Type of Ground Truth Used: Objective microbiological analysis (evidence of contamination by an independent microbiology laboratory).
- Sample Size (Training Set): Not applicable, as this is a non-AI device performance study.
- How Ground Truth for Training Set Established: N/A
3. Microbial Ingress Testing
- Sample Size (Test Set): Not explicitly stated, but "any of the samples with the PhaSeal Protector" suggests multiple samples were tested.
- Data Provenance: Performed in accordance with "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]". Appears prospective.
- Number of Experts for Ground Truth: Not applicable.
- Qualifications of Experts: N/A
- Adjudication Method: N/A
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No.
- Standalone Performance: Yes, this was a standalone performance test.
- Type of Ground Truth Used: Objective observation of microbial ingress.
- Sample Size (Training Set): Not applicable.
- How Ground Truth for Training Set Established: N/A
§ 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.