(84 days)
When left in place for five (5) minutes, the Dark Blue DualCap disinfects 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" is designed to Internet on all ISO standard mater and man and newides effective disintection of the male luer fromector after five minutes of applicat sterite. This device is not made with natural rubber latex, is non-pyrogenic, preservative free and is not made with DEHP, Additionally Datk Blue DualCap® will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterite to the kitting manufacturer for incorporation into the procedure Kits,
The provided document describes the Catheter Connections' Dark Blue DualCap® for Male Luers (K142399), a device intended to disinfect and protect male luer connectors. Here's an analysis of the acceptance criteria and supporting studies based on the provided text, using the requested format:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Disinfect male luer connectors within five (5) minutes after application. | The Dark Blue DualCap disinfected male luer connectors within five (5) minutes. |
| Act as a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed. | The Dark Blue DualCap provided a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed. | |
| Biocompatibility | Compliant with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1 Evaluation and Testing, "May 1, 1995. This includes tests for Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility, and Pyrogen. | The biocompatibility evaluation for the dark blue cap was conducted in accordance with the specified standard and included all listed tests. The submission device and predicate devices are stated to be identical in this regard. (Implied successful completion). |
| Microbiological Efficacy | Achieve a specific log reduction in antimicrobial activity against selected organisms (Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pyogenes, MRSA, VRE, Candida albicans, Candida krusei) using ASTM E 2315-03, 2008. | Time Kill Studies showed a ≥ 4 log reduction in all cases for various microorganisms, including Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pyogenes, antibiotic-resistant bacteria (MRSA, VRE), and yeasts (Candida albicans, Candida krusei). |
| Achieve a specific log reduction in antimicrobial efficacy on the DualCap for Male Luers under worst-case conditions against Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Escherichia coli. | Additional in vitro antimicrobial efficacy studies completed under worst-case conditions showed a ≥ 4 log reduction for each test organism (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Escherichia coli). | |
| Physical Compatibility | Compatible with typical male luer devices adhering to ISO594-1 and ISO 594-2 standards. | Testing using ISO594-1 and ISO 594-2 was completed for the Dark Blue DualCap® for Male Luers, and the device "passed all tests." |
| Disinfectant Containment | The device should not allow disinfectant to enter into the fluid path of the male luers. | "Testing was also completed to demonstrate that the Dark Blue DualCap® for Male Luers did not allow disinfectant to enter into the fluid path of the male luers." (Implied successful demonstration). |
Study Details
The document refers to a 510(k) Premarket Notification Submission (K142399) for the Catheter Connections' Dark Blue DualCap® for Male Luers. The submission device is explicitly stated to be physically identical to the predicate device (DualCap™ for Male Luers, K123967) in terms of "intended use, design, materials, operation, function, and sterilization method." Therefore, the performance data provided supports the substantial equivalence by demonstrating the new device performs identically to the predicate.
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test in the performance data section. It mentions "Time Kill Studies" and "Additional in vitro antimicrobial efficacy studies" without giving the number of samples per test. For physical testing, it states "Applicable testing using ISO594-1 and ISO 594-2 was completed" and "passed all tests," again without specific sample counts.
- Data Provenance: Not explicitly stated, but the testing appears to be laboratory-based ("in vitro antimicrobial efficacy studies") rather than from human clinical studies. The origin country of the data is not mentioned, but the submission is to the U.S. FDA. The studies are prospective in nature, designed to assess specific performance characteristics.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information (experts establishing ground truth) is typically relevant for studies involving human interpretation (e.g., image analysis, diagnosis) or clinical endpoints where expert consensus is needed. For the performance data presented (biocompatibility, microbiological efficacy, physical compatibility, disinfectant containment), the "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, FDA guidelines) and objective laboratory measurements, rather than expert consensus on a test set. Therefore, this information is not applicable in the context of the provided performance data.
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Adjudication method for the test set:
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies where multiple readers or experts assess cases, and their disagreements need resolution. Since the described tests are objective laboratory measurements against defined standards, an adjudication method is not applicable.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool or one that involves human readers for interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is typically relevant for software or AI medical devices. The Dark Blue DualCap is a physical device (disinfectant cap). Therefore, the concept of "standalone algorithm performance" is not applicable. The performance tests assessed the device's inherent physical and functional properties.
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The type of ground truth used:
- Biocompatibility: Adherence to established FDA guidelines and international standards (ISO 10993) for biological evaluation.
- Microbiological Efficacy: Objective measurement of log reduction against specified microorganisms, following industry standard protocols (ASTM E 2315-03, 2008). The ground truth is the quantitative antimicrobial activity observed in the laboratory.
- Physical Compatibility: Compliance with international standards for luer connectors (ISO594-1 and ISO 594-2). Ground truth is successful meeting of the physical specifications.
- Disinfectant Containment: Objective measurement or observation of the absence of disinfectant ingress into the fluid path.
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The sample size for the training set:
- This pertains to machine learning models (AI). As this is a physical medical device, there is no "training set" in the context of an algorithm.
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How the ground truth for the training set was established:
- As there is no training set for an algorithm, this question is not applicable to the device described.
§ 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.