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The Curos Tips ™ are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Tips may be used in the home or healthcare facility.

The Curos Tips™ are intended for use on IV administration lines Male luer as a disinfecting cleaner, which contains 70% IPA, prior to line connection and to act as a physical barrier to contamination between line accesses. The Curos Tips have a highly visible green color that may allow improved compliance by easy visual verification. The Curos Tips may be used in the home or healthcare facility.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Curos Tips™ (K121171)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states "The efficacy testing was completed using a total of 6 bacteria." This refers to the six specific microorganisms listed in the table. The method described is in vitro testing.

• Sample Size for Test Set: The sample size for each microorganism is not explicitly detailed beyond "a total of 6 bacteria" indicating six distinct species were tested. The actual number of replicates or individual tests per species is not provided.
• Data Provenance: The study was an in vitro study. The country of origin is not explicitly stated, but the company (Ivera Medical Corporation) is based in San Diego, California, USA, suggesting the study was likely conducted in the USA. It is a prospective study in the sense that the testing was performed to evaluate the specific device for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described study is an in vitro microbiological efficacy test, not a study requiring human expert assessment of images or clinical outcomes. The "ground truth" is defined by the objective measurement of microbial reduction.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is an in vitro microbiological efficacy test. Adjudication typically applies to studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study detailed is an in vitro efficacy test, not a clinical study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) study was not done. This device is a physical disinfectant, not an algorithm or AI system. The study assessed the standalone efficacy of the physical device and its disinfectant properties.

7. The Type of Ground Truth Used

The ground truth used was microbiological reduction data. Specifically, it was the measured "bacterial count reduction (Δ Log)" after a 3-minute exposure to the Curos Tips™.

8. The Sample Size for the Training Set

This information is not applicable. The Curos Tips™ is a physical medical device, not a machine learning or AI model, and therefore does not have a "training set" in that context.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is not an AI/ML model and does not have a training set.

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