(183 days)
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
| Organism | Acceptance Criteria (bacterial count reduction (Δ Log)) | 3 minute exposure (bacterial count reduction (Δ Log)) | 7 day (168 hours) exposure (bacterial count reduction (Δ Log)) |
|---|---|---|---|
| Staphylococcus aureus | ≥ 4.0 | 6.0 | 6.9 |
| Staphylococcus epidermidis | ≥ 4.0 | 6.8 | 7.3 |
| Escherichia coli | ≥ 4.0 | 5.2 | 5.2 |
| Pseudomonas aeruginosa | ≥ 4.0 | 5.1 | 5.1 |
| Candida Albicans | ≥ 4.0 | 5.6 | >4.8* |
| Candida Glabrata | ≥ 4.0 | 5.4 | >5.3* |
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).
§ 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.