(35 days)
The Dual Luer Lock Cap is indicated for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female Luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing Dual Luer Lock Cap and will be sold as a cap to cover an open Luer port after the Luer port has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male Luer lock connection on one end and a female Luer lock connection on the other end.
Below is the requested information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.
Acceptance Criteria and Device Performance Study
This device, the Dual Luer Lock Cap, is an IV Administration Set component. The performance testing focused on meeting recognized international standards for Luer fittings.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Standard | Reported Device Performance |
|---|---|---|
| Air leakage | ISO 594-1:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Separation Force | ISO 594-2:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Unscrewing torque | ISO 594-2:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Ease of assembly | ISO 594-1:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Stress cracking | ISO 594-1:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Liquid leakage test | ISO 594-1:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Luer gauging | ISO 594-1:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Resistance to overriding | ISO 594-2:1986 | Met (implied by "All test results meet the acceptance criteria") |
| Biocompatibility | ISO 10993-1 | Shown to be biocompatible and appropriate for intended use (prolonged duration, external communicating, indirect blood path testing) |
Note: The document states that "All test results meet the acceptance criteria," indicating successful performance without providing specific quantitative results for each test.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests (e.g., how many Dual Luer Lock Caps were tested for each criterion). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective, beyond stating that "Baxter Healthcare Corporation conducts risk analyses and design verification tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable. The device is a physical medical component, not an AI/diagnostic software. Ground truth for its performance is established by objective engineering tests against international standards (ISO 594-1 and ISO 594-2), not expert consensus on interpretations.
4. Adjudication Method
This section is not applicable, as there is no expert interpretation or consensus-based ground truth for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable. The device is a physical medical component, not an AI system intended to assist human readers in interpreting cases. Therefore, a MRMC study comparing human readers with and without AI assistance was not performed.
6. Standalone Performance Study
This section is applicable in the sense that the device's performance was evaluated in a standalone manner (i.e., the physical device itself was subjected to engineering tests without human intervention in the performance of the device's function). The "Performance Data" section directly addresses the results of these standalone tests against ISO standards.
7. Type of Ground Truth Used
The ground truth used for performance validation was based on objective engineering standards ("Bench performance testing requirement according to ISO 594-1:1986" and "ISO 594-2:1986") and biocompatibility standards ("ISO 10993-1").
8. Sample Size for the Training Set
This section is not applicable. The device is a physical medical component and does not utilize a training set in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for this type of 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.