(243 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, non-sterile device that contains 70% Isopropyl Alcohol and is intended to be used to decontaminate needleless luer activated valves.
This is a 510(k) premarket notification for the Curos™ Port Protector, a device containing 70% Isopropyl alcohol intended to decontaminate needleless luer activated valves. The submission aims to demonstrate substantial equivalence to a predicate device, the APLICARE Alcohol Prep Pad (K833182).
This document doesn't provide specific acceptance criteria or an explicit study that proves the device meets those criteria in the typical format of an AI/ML device study. Instead, it focuses on demonstrating substantial equivalence through performance test data for decontamination and comparison data to a predicate device.
Here's an attempt to extract and format the information based on the provided text, recognizing that it's not a direct fit for an AI/ML device study format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction of bacterial count for selected gram-positive bacteria | "reducing the bacterial count two (2) selected gram positive bacteria" |
| Reduction of bacterial count for selected gram-negative bacteria | "reducing the bacterial count... 2 selected gram negative bacteria" |
| Equivalence to predicate device | "demonstrated equivalence to the predicate device with comparison test data." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). It only states "performance test data."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The "ground truth" here relates to microbial reduction, which would be measured in a lab setting, not through expert consensus on images or similar data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Performance tests for decontamination typically involve laboratory measurements and not human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. The Curos™ Port Protector is a physical medical device for decontamination, not an AI/ML diagnostic or assistive tool for human readers.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable in the context of an AI/ML algorithm. However, the performance tests on bacterial reduction and comparison to the predicate device can be considered a standalone evaluation of the device's efficacy without direct human interaction beyond its application.
7. Type of Ground Truth Used
The ground truth for the performance tests would be the measured bacterial counts before and after decontamination by the device, as determined by standard microbiological laboratory techniques. This is effectively a laboratory measurement/outcome data.
8. Sample Size for the Training Set
This information is not applicable and not provided, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as this is not an AI/ML device.
Summary of Device and Evidence:
The Curos™ Port Protector is a single-use, non-sterile device containing 70% Isopropyl Alcohol, designed to decontaminate needleless luer activated valves by reducing bacterial counts. It also provides a physical barrier.
The evidence for its effectiveness and substantial equivalence relies on:
- Performance test data demonstrating the reduction of bacterial counts for two selected gram-positive and two selected gram-negative bacteria.
- Comparison test data demonstrating equivalence to the predicate device, APLICARE Alcohol Prep Pad (K833182).
The details of these studies, such as specific bacterial strains, methodology, statistical analysis, and exact performance metrics (e.g., percentage reduction, log reduction), are not included in this summary document but would have been part of the full 510(k) submission.
§ 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.