(307 days)
The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
This FDA Submission is to include an authorization to legally market the ProSeal" Vented Universal Vial Adaptor to the existing ProSeal™ CSTD devices system of eleven (11) devices that were cleared for sales in the US, the most recent being the ToxiSeal™ Vial Adaptor (K241823).
The ProSeal™ Vented Universal Vial Adaptor is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard vials and ProSeal™ CSTD component devices for close system fluid transfer. When connected to a standard vial and engaged with a ProSeal™ Injector (Syringe Adaptor), fluid can be transferred to and from the connecting component device in a closed system. The ProSeal™ Vented Universal Vial Adaptor and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours (or 7 days). when used as intended.
The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:
- A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector housing perforates the double membrane for 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 also minimizing the risk of microbial contamination.
The provided text is a 510(k) summary for the ProSeal™ Vented Universal Vial Adaptor. It outlines the device description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence. However, it does not describe acceptance criteria for an AI/ML-enabled medical device performance study, nor does it provide details on the specific study that would prove such a device meets acceptance criteria.
The document pertains to a physical medical device (a vial adaptor) and its mechanical, material, and sterility performance, not a software-based AI/ML device for which metrics like sensitivity, specificity, or AUC would be relevant. Therefore, most of the requested information (sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission.
The closest analogous information in this document relates to functional performance testing and biocompatibility testing for the physical device.
Here's how to interpret the available information in the context of the prompt, acknowledging the mismatch:
The document effectively describes the "acceptance criteria" and "study" for a physical medical device based on regulatory standards and comparison to a predicate, not an AI/ML device.
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of quantitative acceptance criteria in the typical AI/ML sense (e.g., target AUC, sensitivity). Instead, it states that the device was tested and demonstrated to be in conformance with recognized ISO and FDA standards, and that "Performance testing demonstrates that this difference [in air-vent size] does not raise new questions regarding safety and effectiveness." The acceptance criteria for this physical device are the successful completion and conformance to these standards and the demonstration of substantial equivalence to the predicate.
Here's a reinterpretation of their "acceptance criteria" based on the provided text, focusing on the functional performance tests listed:
| Acceptance Criteria (Reinterpreted from Standards) | Reported Device Performance (Implied "Meets Criteria") |
|---|---|
| Conformance to ISO 8536-4:2019 (Positive/Negative pressure leakage) | Tested and demonstrated conformance |
| Conformance to ISO 8536-4:2019 (Positive pressure water leak integrity) | Tested and demonstrated conformance |
| Conformance to ISO 22413:2021 & ISO 8871-5:2016 (Penetration force) | Tested and demonstrated conformance |
| Conformance to ISO 22413:2021 & ISO 8871-5:2016 (Fragmentation) | Tested and demonstrated conformance |
| Conformance to NIOSH CSTD 2016 draft protocol (Vapor containment) | Tested and demonstrated conformance (from K241823 data) |
| Conformance to FDA guidance, ANSI AAMI CN27:2021 & ISO 80369-7:2021 (Microbial ingress) | Tested and demonstrated conformance (from K222929 data) |
| Conformance to ISO 8536-4:2019 Ann. A.2 & USP (Particulate matter) | Tested and demonstrated conformance |
| Conformance to ISO 11135:2014 & various ASTM/EN standards (Sterility, Package Integrity, Shelf-Life) | Tested and demonstrated conformance |
| Conformance to ISO 10993 series (Biocompatibility) | Tested and demonstrated conformance (referenced from predicate devices) |
| Non-pyrogenic per ANSI/AAMI ST72/2019, USP methods | Tested and demonstrated conformance |
| Shelf-life of 3 years validated per ASTM 1980-16 | Validated for 36 months |
| Residual fluid |
§ 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.