(86 days)
The PhaSeal 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 or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.
The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes fro the transfer of liquid. 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 and spills and also minimizing the risk of microbial contamination.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Item# | Performance Specification: Acceptance Criteria | Status of BD PhaSeal® System (Reported Performance) |
|---|---|---|
| 1 | Leakproof Connections | No Leaks (Fluorescein Test) |
| 2 | Airtight Connections | No Visible Smoke (TiCl4 Test) |
| 3 | Microbial Ingress | No Ingress at the Protector or Connector |
Description of the Study Proving Acceptance Criteria
The study described is a series of non-clinical tests designed to demonstrate that the BD PhaSeal® Closed System Drug Transfer Device meets the specified performance criteria for leakproofness, airtightness, and microbial ingress. The summary states, "As there is no change to the subject device in comparison to the predicate devices, the performance data provided represent the performance of both the predicate and subject device of this 510(k)." The tests were conducted to substantiate its use as a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System (ONB product code).
Details on the Tests:
- Leakproof Connections: Tested using a Fluorescein Test.
- Airtight Connections: Tested using a TiCl4 Test (which detects vapor/smoke).
- Microbial Ingress: Tested to ensure no ingress at the Protector or Connector.
Additional Information Not Present in the Document:
The provided 510(k) summary focuses on demonstrating substantial equivalence through technological characteristics and a summary of performance tests. It does not contain the following information typically found in detailed study reports:
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "additional tests referenced in the table" without detailing sample sizes or the origin (country, retrospective/prospective) of the data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of physical performance tests (leak, airtight, microbial ingress). Ground truth is established by the test method itself, not expert consensus.
- Adjudication method for the test set: Not applicable for these performance tests. The outcome is typically a pass/fail based on direct observation (e.g., presence/absence of leaks, smoke, or microbial growth).
- 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 device is a medical device for drug transfer, not an imaging or diagnostic AI product, so MRMC studies are not relevant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
- The type of ground truth used: The ground truth for these tests is defined by the objective results of the specified testing methodologies (Fluorescein Test, TiCl4 Test, and microbial ingress testing). For example, "no leaks" is the ground truth from the fluorescein test.
- The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
- How the ground truth for the training set was established: Not applicable. This device does not use machine learning or require a training set.
§ 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.