(91 days)
The Curos™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the intended use.
The Curos™ Port Protector device is a single use, sterile device that contains 70% Isopropyl Alcohol and is intended to be used as a disinfectant for needleless luer activated valves.
I will describe the acceptance criteria and the study that proves the device meets them based on the provided text.
The device in question is the Curos Port Protector, a single-use, sterile device containing 70% Isopropyl Alcohol, intended for disinfecting needleless luer activated valves.
1. Table of Acceptance Criteria and Reported Device Performance
| Organism | Acceptance Criteria (bacterial count reduction (ΔLog)) | 3-minute exposure (bacterial count reduction (ΔLog)) | 7-day (168 hours) exposure (bacterial count reduction (ΔLog)) |
|---|---|---|---|
| Staphylococcus aureus | > 4.0 | 6.0 | 6.9 |
| Staphylococcus epidermis | > 4.0 | 6.8 | 7.3 |
| Escherichia coli | > 4.0 | 5.2 | 5.2 |
| Pseudomonas aeruginosa | > 4.0 | 5.1 | 5.1 |
2. Sample Size Used for the Test Set and Data Provenance
The text indicates that the efficacy testing was performed using "a total of 4 bacteria, 2-gram negative and 2 gram positive." It does not specify the number of replicates or individual samples tested for each bacterium condition (e.g., how many Curos Port Protectors were tested per organism, per time point).
The data provenance is not explicitly stated in terms of country of origin. The study appears to be a prospective laboratory-based test (efficacy testing) designed to demonstrate the device's antimicrobial properties.
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 efficacy study is based on quantitative microbial reduction, which is an objective measurement rather than an expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. This was a laboratory efficacy study with quantitative, objective measurements of bacterial count reduction, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was a standalone laboratory study evaluating the disinfectant efficacy of the device itself, not a study involving human readers or AI assistance in a clinical setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The efficacy testing assessed the performance of the device (Curos Port Protector) in reducing bacterial counts independently, without human intervention in the disinfection process beyond applying the device.
7. The Type of Ground Truth Used
The ground truth used was objective quantitative microbial reduction data. This means the number of viable bacteria was measured before and after exposure to the Curos Port Protector, and the reduction in count was calculated.
8. The Sample Size for the Training Set
Not applicable. This device is a physical disinfectant, not an AI/ML algorithm that requires a training set. The study described is a performance validation for the device's inherent properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.