(252 days)
The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.
The Female Luer Lock Cap is an individually packaged, sterile, single use disposable product used to cover male Luer fittings. Luer fittings are commonly used on IV administration products and accessories to provide universal compatibility and are well established in the market. Luer lock fittings are securely joined by means of a tabbed hub on the female fitting which screws into threads in a sleeve on the male fitting. The Female Luer Lock Cap is an injection molded, polyethylene component. Polyethylene material is durable, biologically inert, gamma stable, and used extensively in the medical device industry. The product is terminally gamma sterilized to a Sterility Assurance Level (SAL) of 10-6.
The provided text describes the regulatory filing for a medical device called the "Female Luer Lock Cap" and details its equivalence to a predicate device. It is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a new clinical trial for effectiveness. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, effect sizes, specific expert qualifications, or training set sizes) is not applicable or present in this document.
However, I can extract the acceptance criteria and a summary of the performance testing as requested for the substantial equivalence determination for this non-AI/ML medical device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the international standards that the Female Luer Lock Cap is tested against. The document states that "Performance bench testing results meet acceptance criteria and verified the Female Luer Lock Cap meets applicable Industry Standard requirements for the design and functional performance, biocompatibility, sterilization and packaging, and demonstrates substantial equivalently to the predicate device."
Here's a table summarizing the tests, the standards they adhere to (which define the acceptance criteria), and the general reported outcome:
| Performance Test Category | Testing Standard(s) / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Luer Connector Standard | ISO 594 Part 1 & Part 2 (FDA FR 6-129): | Meets standard requirements |
| - Ease of assembly | ||
| ISO 80369-7 (FDA FR 5-115): | Meets standard requirements | |
| - Positive Pressure Liquid Leakage | ||
| - Sub-atmospheric Pressure Air Leakage | ||
| - Stress Cracking | ||
| - Resistance to Separation from Axial Load | ||
| - Resistance to Separation from Unscrewing | ||
| - Resistance to Overriding | ||
| Biocompatibility | ISO 10993-1 (FDA FR 2-258): | Meets standard requirements |
| - Cytotoxicity | ||
| - Sensitization | ||
| - Intracutaneous Reactivity / Irritation | ||
| - Systemic Toxicity | ||
| - Hemocompatibility | ||
| - Material-Mediated Pyrogen | ||
| - Bacterial Endotoxins Test | ||
| - Subacute Toxicity | ||
| - Subchronic Toxicity | ||
| Sterilization | ANSI/AAMI/ISO 11137-1 & 11137-2 (FDA FR 14-528 & 14-409): | Meets standard requirements |
| - VDmax15 | ||
| - Sterility Assurance Level (SAL) of 10-6 | Achieved SAL of 10-6 | |
| Package Integrity | ASTM F1929-15 (FDA FR 14-484): | Meets standard requirements |
| - Detecting Seal Leaks by Dye Penetration | ||
| ASTM F88/F88M-15 (FDA FR 14-482): | Meets standard requirements | |
| - Seal Strength of Flexible Barrier Materials | ||
| Shelf Life | No specific standard listed, but tests for "package integrity and product performance" at "multiple time points" for "three years" are mentioned. | Three-year shelf life supported |
Additional Information (Not Applicable for this type of device/submission)
The following information is typically relevant for AI/ML device studies involving human interpretation and clinical data, which is not the case for this 510(k) submission of a physical luer lock cap.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device and packaging used for bench testing. The provenance of these physical samples (e.g., from which manufacturing batch) is not specified, nor is it typically required for this type of summary. Data provenance like "country of origin of data" or "retrospective/prospective" refers to clinical data, which was not used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (like leakage, strength, or sterility) is established by adherence to physical test standards and instrumentation, not human expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no human interpretation or subjective assessment that would require adjudication.
- 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, as this is a physical medical device, not an AI-powered diagnostic/assistance tool.
- 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): The ground truth for this device's performance is objective measurement based on established international and ASTM standards (e.g., ISO 594, ISO 80369-7, ISO 10993-1, ISO 11137, ASTM F1929, ASTM F88/F88M) for physical and biological properties.
- The sample size for the training set: Not applicable. There is no AI/ML model being trained.
- How the ground truth for the training set was established: Not applicable.
§ 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.