(235 days)
When left in place for 30 seconds the Light Blue DualCap® disinfects needleless luer access valves and the Dark Blue DualCap® disinfects the IV administration line male luer connections; the caps provide a physical barrier to contamination up to 7 days, under normal conditions if not removed.
The DualCap® Disinfectant Cap is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The Subject device is not made with natural rubber latex, is non-pyrogenic, non-preservative and is not made with DEHP. The product consists of a Light Blue DualCap® for use on Luer access valves and a Dark Blue DualCap® for use on IV administration line male Luer connections. The Light Blue DualCaps® and Dark Blue DualCaps® are available in a number of packaging combinations such as two Light Blue DualCaps®, a Light Blue DualCap® and Dark Blue DualCap® combination, and as singles.
Additionally, DualCap® Disinfectant Caps will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk to the kitting manufacturer.
The provided text describes a 510(k) summary for the DualCap® Disinfectant Caps, which is a medical device intended to disinfect needleless luer access valves and IV administration line male luer connections. The document outlines acceptance criteria related to disinfection efficacy and physical barrier integrity, along with the performance data supporting these claims.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Disinfection Efficacy: ≥ 4-log reduction in specified test organisms (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans) with a 30-second exposure time. | In vitro antimicrobial efficacy studies completed on DualCap® Disinfectant Caps under worst-case conditions show a ≥ 4 log reduction in each test organism (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans). This supports the 30-second disinfection time. |
| Physical Barrier to Contamination: Maintain an air-tight seal for up to 7 days, preventing contamination. | Testing was performed to show that there was an air-tight seal between the LAV and light blue DualCap® Disinfecting Cap and an air-tight seal between the male luer connector and the dark blue DualCap® Disinfecting Cap after 7 days. This supports the 7-day use-of-life claim. |
| Material Biocompatibility: Conformance to FDA Blue Book Memorandum #G95-1 and ISO 10993. | Biocompatibility testing (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility) was conducted and the device met the requirements. |
| Luer Compatibility & Integrity: Conformance to ISO 594 (various clauses: gauging, liquid leakage under pressure, separation force, ease of assembly, resistance to overriding, securement threads). | All applicable Physical tests (ISO 594-1 and ISO 594-2) were completed and the DualCap® Disinfectant Caps passed all tests. This includes ensuring compatibility with standard male Luer IV connectors, accessible injection valves, and demonstrating the securement threads. |
| Prevention of Disinfectant Entry into Fluid Path: Ensure disinfectant does not enter the intraluminal space of male luers. | Testing was completed to demonstrate that the DualCap® Disinfectant Caps for Male Luers did not allow disinfectant to enter into the fluid path of the male luers. This was verified for the Dark Blue component. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the "test set" in the traditional sense of a clinical trial. The performance data is primarily based on in vitro studies and bench testing.
- In vitro antimicrobial efficacy studies: "worst case conditions" were used, but no specific number of samples (e.g., number of caps tested, number of replicates per organism) or test runs are detailed.
- Air-tight seal study: No specific number of caps or connections tested is provided.
- Biocompatibility testing: Standard battery of tests was performed in accordance with ISO 10993. The number of samples for each test (e.g., cytotoxicity, sensitization) is not specified.
- Physical tests (ISO 594): No specific number of caps or connections tested is provided.
- Prevention of disinfectant entry: Not specified.
Data Provenance: All studies described appear to be in vitro laboratory studies or bench testing. The document does not indicate any human clinical trials, patient data, or geographical origin of data (e.g., country).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device's performance is established by the results of standardized laboratory tests and engineering benchmarks (e.g., ISO 594, microbial log reduction). It does not involve human interpretation of images or clinical data that would require experts to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As the ground truth is established by objective laboratory measurements and standardized test results rather than expert consensus on subjective data, an adjudication method is not relevant.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. No MRMC comparative effectiveness study was conducted. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the effect of AI on their performance is measured. The DualCap® Disinfectant Caps are a physical device with a disinfection and barrier function, not a diagnostic AI tool.
6. Standalone (Algorithm Only) Performance Study
Yes, in essence. The performance studies described (microbiological efficacy, physical tests, biocompatibility) represent the "standalone" performance of the device itself (the cap with its integrated alcohol) without human intervention influencing the core disinfection or barrier function during the test. While users apply the cap, the efficacy tests are assessing the inherent properties of the device system.
7. Type of Ground Truth Used
The ground truth used is primarily objective laboratory measurements and international standard compliance:
- Microbiological performance: Measured log reduction of specific microorganisms.
- Physical performance: Conformance to engineering standards (ISO 594) through metrics like leakage, separation force, and thread compatibility.
- Biocompatibility: Results of standardized in vitro and in vivo biological tests as per ISO 10993.
- Barrier function: Demonstrated air-tight seal.
- Prevention of fluid path contamination: Direct measurement of alcohol presence in the fluid path.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data for development. The design and validation are based on engineering principles, material science, and microbiological efficacy, not machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8)
§ 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.