(27 days)
When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
The dark blue DualCap™ for male luers is designed to fit securely on IV administration male luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile. This device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.
The provided text is a 510(k) Premarket Notification Submission for the "Catheter Connections' Dark Blue DualCap™ for Male Luers". It describes the device, its intended use, and compares it to a previously cleared device (Sponsor's Cleared Device - K093229). The core of this submission is to demonstrate substantial equivalence to the predicate device, primarily focusing on a change in packaging configuration.
Here's an analysis of the acceptance criteria and study information based on the provided text:
- This document does not describe a study in the traditional sense of a clinical trial or performance study with specific metrics like sensitivity, specificity, or reader performance. Instead, it's a regulatory submission demonstrating substantial equivalence to a predicate device, largely based on a change in packaging. The "studies" mentioned are comparisons of specifications, risk analysis, and standard engineering tests (peel strength, sterility, biocompatibility).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|
| Identical Indications for Use | Identical: "...disinfect and protect male luer connectors..." |
| Substantially Equivalent Intended Use | Identical: "...disinfect and decontaminate... and act as a barrier to contamination..." |
| Same Technological Characteristics (design, material, sterilization method, operation) | Substantially equivalent: Retains hermetic foil/polymer seal, identical structure and components. Verified by specification comparisons. |
| Safety and Effectiveness not altered | Verified by Risk Analysis; testing showed substantial equivalence. |
| No new safety/effectiveness questions | Verified by Risk Analysis; no new questions identified. |
| Accepted scientific methods exist for assessing new characteristics | Yes: ISO 11137:2006 (Sterilization), ISO 10993 (Biocompatibility). |
| Performance data available to assess new characteristics | Yes: Standard Peel strength tests. |
| Performance data demonstrate equivalence | Yes: Peel strength tests showed substantial equivalence. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of devices or units tested for each characteristic. The "comparison of specifications" implies reviewing documentation rather than physical testing on a large sample. "Standard Peel strength tests" were performed, but the sample size for these tests is not specified.
- Data Provenance: The document describes a comparison between a "Modified Device" and a "Sponsor's Cleared Device". The data would likely be from internal testing and specifications of the manufacturer for both devices. There is no mention of country of origin of data in a broad sense, nor if the data is retrospective or prospective, as it pertains to specific engineering tests and comparisons rather than patient data.
3. Number of Experts and Qualifications for Ground Truth:
- Not Applicable. This submission is not based on expert consensus for ground truth on clinical outcomes or diagnostic accuracy. It relies on engineering specifications, regulatory standards (like ISO), and internal testing to demonstrate substantial equivalence for a device designed for disinfection and physical barrier functions.
4. Adjudication Method:
- Not Applicable. This is not a study requiring adjudication of expert opinions or clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not a diagnostic device involving human readers or interpretation. Therefore, an MRMC study and effects of AI assistance are not relevant.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. This is a physical medical device (disinfectant cap), not an AI algorithm. Its performance is evaluated through material science, microbiology (implied by disinfection claim, though not detailed in this section), and structural integrity, not algorithmic output.
7. Type of Ground Truth Used:
- The "ground truth" here is established through:
- Regulatory Standards: Adherence to ISO standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility).
- Engineering Specifications: Comparisons of design, materials, manufacturing processes, and performance characteristics (e.g., peel strength) against the predicate device.
- Risk Analysis: To determine if changes introduce new safety or effectiveness concerns.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a "training set".
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set is involved.
§ 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.