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510(k) Data Aggregation
(97 days)
ProSeal Injection Site Extended Male Luer Lock (422140)
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 the system, 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.
The ProSeal™ Injection Site Extended Male Luer Lock (ProSeal™ Injection Site) is a new component device for the ProSeal™ Closed System (drug) Transfer Device (CSTD) system. It is intended for connection with interface membranes between any standard female Luer lock port and ProSeal™ CSTD component devices for closed system fluid transfer. It is a variant of the cleared ProSeal™ Connector, a component of the ProSeal™ CSTD system. When connected to a female Luer lock port and engaged with a ProSeal™ Injector or a ProSeal™ Injector Plus (K240171) (Syringe Adaptor), fluid can be transferred to the connecting device in a closed system. The ProSeal™ Injection Site 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 of 7 days, when use as intended. The closed transfer of liquid utilizes a double membrane septum design with self-sealing elastomeric membranes. Modifications from the existing ProSeal™ Connector include a geometric design change and a material change of the membrane from TPE to polyisoprene.
This is a 510(k) premarket notification for a medical device, specifically the ProSeal™ Injection Site Extended Male Luer Lock (model 422140). The document asserts "substantial equivalence" of this device to a previously cleared predicate device, the ProSeal™ CSTD's Connector (K240171).
The provided text does not contain any information about a study proving the device meets acceptance criteria related to AI/algorithm performance (e.g., sensitivity, specificity, or human reader improvement with AI assistance). This document concerns a physical medical device (an intravascular administration set component) and its functional, biocompatibility, and sterility performance, comparing it to an already cleared similar device.
Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm device meets these criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to the type of device and submission described in this FDA clearance letter.
The document discusses "functional performance acceptance criteria" for the physical device, which are met through conformance to various ISO and FDA recognized standards.
Here's an interpretation of the document's content relevant to "acceptance criteria" for this physical device:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Acceptance Criteria (Met by Conformance to Standards) | Reported Device Performance (Demonstrated Conformance) |
|---|---|
| Functional Performance: | Bench Performance Verification and Validation conducted: |
| - Conformance to AAMI CN27: 2021 (General requirements for Luer activated valves) | - Positive pressure fluid leakage test |
| - Conformance to ISO 8536-4: 2019 (Infusion equipment for medical use) | - Sub-atmospheric pressure air leakage test |
| - Conformance to ISO 80369-7: 2021 (Small-bore connectors for intravascular/hypodermic applications) | - Stress cracking test |
| - Conformance to US FDA Guidance for Intravascular Administration Sets Premarket Notification Submissions | - Resistance to separation from axial load test |
| - Mechanical prohibition of environmental contaminants entering system | - Resistance to separation from unscrewing test |
| - Prohibition of drug or vapor escape | - Resistance to overriding |
| - Prevention of microbial contaminations into drug/fluid path for up to 7 days | - Device leakage integrity test |
| - Vapor containment test per NIOSH 2016 draft protocol | |
| - Microbial ingress test per FDA guidance and AAMI CN27: 2021 | |
| Biocompatibility: | Testing referenced from existing/referred-to device: |
| - Conformance to ISO 10993-1: 2018 (Biological evaluation of medical devices - Part 1) | - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, 14-day Subacute/Subchronic Acute Systemic Toxicity, In-vitro Hemolysis Assessment, Material Mediated Pyrogenicity, Chemical characterization and Toxicological Risk Assessment. |
| - Particulate matter testing conducted on Subject device in accordance with ISO 8536-4: 2019 and USP . | |
| Sterility & Shelf-Life: | Compliance/Testing: |
| - Conformance to ISO 11135: 2014 (Ethylene Oxide Sterilization) | - Device complies with sterilization requirements, supported by evaluations including AAMI TIR 28: 2016, USP (Bacterial endotoxin), ASTM F1980-16 (Accelerated aging), ASTM F88/ F88M-21 (Seal strength), and ISO 10993-7: 2008/ Amd 1: 2019 (Ethylene oxide sterilization residuals). |
| - Validated shelf life of 3 years (36 months) | - Shelf-life validated as 3 years (36 months). |
Regarding the other requested points (not applicable to this document's content):
- Sample size used for the test set and data provenance: Not applicable. This document refers to bench testing of a physical device, not a performance study on an ML model's test set.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for an AI model is not relevant to the evaluation of this physical medical device.
- Adjudication method for the test set: Not applicable.
- 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/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML model for this device. For the physical device, "ground truth" would be the objective measurement against established ISO/FDA standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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