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The Curos Red is intended for use on dialysis catheter female Luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, the Curos Red will disinfect the female Luer and act as a cover until removed. The Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red in the home or healthcare facility.

The Curos Red Port Protector contains 70% Isopropyl alcohol and is intended for use on dialysis catheter open female luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. The Curos Red has a highly visible red color that may allow improved compliance monitoring by easy visual verification to ensure that all open female luers are disinfected and covered. The Curos Red may be used in the home or healthcare facility.

Here's a breakdown of the acceptance criteria and study information for the Curos Red Port Protector, extracted from the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Beyond the bacterial count reduction, the device also met the following acceptance criteria (details on specific thresholds are not provided in the summary but are implied by meeting the requirements of the standards):

• ISO 594-2 testing: for ease of assembly, rotational force to remove (un-torque evaluation), and leakage using water under pressure and leakage using vacuum with air.
• Simulated Clinical Condition Evaluation testing: to demonstrate that the device seals and acts as a cover for the port.
• Sterilization: Validated Gamma sterilization process complying with ISO11137-1:2006, ISO11137-2:2006, and ISO11137-3:2006/(R) 2010.
• Biocompatibility: Materials of construction meet FDA recognized standard ISO10993.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for the efficacy studies. However, efficacy testing typically involves multiple replicates per organism and condition.
• Data Provenance: The studies were conducted by Ivera Medical and are in vitro (laboratory-based) tests. The country of origin is not specified but is implicitly the location of Ivera Medical (Carlsbad, California, and San Diego, California, based on the contact information). The studies are prospective in the sense that they were conducted to specifically test the Curos Red device's performance against predefined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the summary. Efficacy testing (like pathogen reduction) relies on standardized laboratory protocols, and the "ground truth" is typically defined by the experimental results themselves against the known inoculation concentrations, rather than expert consensus on interpretation.

4. Adjudication method for the test set

• This information is not applicable for the in vitro efficacy testing described. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations where human interpretation is involved.

5. 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, a MRMC comparative effectiveness study was not done. This device is a medical accessory for disinfection and port coverage, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, the primary performance studies were standalone. The efficacy tests (bacterial count reduction) were performed directly on the device and its disinfectant properties, without human interpretation in the loop influencing the disinfection process or its outcome. The leakage and sealing tests were also evaluating the mechanical properties of the device independently.

7. The type of ground truth used

• For the efficacy studies (bacterial count reduction), the ground truth was established through microbiological testing against known concentrations of target microorganisms. The reduction in viable organisms after exposure to the device's disinfectant determined the effectiveness.
• For mechanical tests (ISO 594-2, Simulated Clinical Condition Evaluation), the ground truth would be based on engineering and performance specifications defined by the relevant standards and the manufacturer's internal protocols.

8. The sample size for the training set

• This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI models. The device's performance is determined by its physical and chemical properties.

9. How the ground truth for the training set was established

• This information is not applicable as there is no training set for this type of medical device.

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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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The Curos is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. Curos ™ will disinfect the valve three (3) minutes after application and act as a physical barrier to contamination for up to seven (7) days (168 hours) if not removed. The effectiveness of Curos Protectors were tested in vitro against Staphylococcus aureus. Staphylococcus epidermidis, Escherichia coli and Pseudomonas aeruginosa, Candida glibrata, Candida albicans and was found to have >4 log reduction. The Curos Port Protector may be used in the home or healthcare facility.

The Curos™ Port Protector device is a single use, sterile device that contains 70% lsopropyl Alcohol and is intended to be used as a disinfectant for needleless luer activated valves

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The entire population was killed, the reduction in bacteria count was limited to the population quantified by the positive controls used in the testing.

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

The document does not explicitly state the specific sample size (number of times each test was run or number of devices tested) for the efficacy test set. It mentions "a total of 4 bacteria, 2-gram negative and 2 gram positive" and "two selected fungus/yeast micro-organisms." This implies a set of 6 distinct microorganisms were tested.

The data provenance is a non-clinical performance test data and appears to be retrospective in the context of this 510(k) submission, as it was conducted to support the updated indications for use. The country of origin of the data is not specified, but the submission is to the US FDA by a company based in San Diego, California, suggesting the studies were likely conducted in the US or under US regulatory guidelines.

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

This information is not provided in the document. The ground truth for this type of disinfectant efficacy study is typically established by laboratory testing using standardized microbiological methods to quantify bacterial reduction, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable to this type of study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are making subjective assessments that need to be reconciled. For a quantitative microbiology test, laboratory standards and controls dictate the results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance, often with and without AI assistance, which is not relevant to the Curos Port Protector's disinfectant efficacy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was done. The efficacy testing quantifies the disinfectant capability of the "Curos Port Protector" device itself, without human intervention being a variable in the outcome of the log reduction, beyond proper application in the test setup. This is a direct measure of the device's inherent antimicrobial properties.

7. Type of Ground Truth Used

The ground truth used is based on quantitative microbiological laboratory results (bacterial count reduction, Δ Log) against specific microorganisms. This is a direct measurement of the device's ability to disinfect.

8. Sample Size for the Training Set

This information is not provided and is not applicable. The Curos Port Protector is a medical device that uses chemical and physical barriers for disinfection, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development. The data presented is performance data for the physical product.

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

This information is not applicable for the reasons stated above (no AI/machine learning involved, thus no training set).

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