Search Results

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

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)

Ask a specific question about this device

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

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Ask a specific question about this device