(265 days)
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
| Organism | Acceptance Criteria (bacterial count reduction (ΔLog)) | 3 minute exposure (bacterial count reduction (ΔLog)) |
|---|---|---|
| Staphylococcus aureus | ≥4 Log | 6.7 Log |
| Staphylococcus epidermidis | ≥4 Log | 6.9 Log |
| Escherichia coli | ≥4 Log | 6.7 Log |
| Pseudomonas aeruginosa | ≥4 Log | 6.9 Log |
| Candida Albicans | ≥4 Log | 6.5 Log |
| Candida Glabrata | ≥4 Log | 6.8 Log |
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.
§ 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.