(34 days)
When left in place for five (5) minutes, DualCap Duo™ disinfects needleless Luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
The DualCap Duo™ is designed to fit securely on Luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.
The provided text describes a medical device called "Catheter Connections' DualCap Duo™" and its substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics. Instead, it generally states that performance data demonstrate equivalence and that the device "will meet all established acceptance criteria for performance testing."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other specific study details since they are not present in the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
* Not Available. The document states, "The Catheter Connections' DualCap Duo™ will meet all established acceptance criteria for performance testing," but does not list specific criteria or the quantitative performance results against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not Available. No details about sample size or data provenance (country of origin, retrospective/prospective) are mentioned for any testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not Applicable / Not Available. This device is a disinfectant cap, not an AI/imaging device requiring expert ground truth for a test set in the same manner. No information about experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable / Not Available.
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:
* Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not Applicable. This is not an algorithm. The device's performance is standalone in the sense that its disinfection capabilities are intrinsic to the product. The document states, "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols," and "Performance data gathered demonstrated that the Catheter Connections' DualCap Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not Applicable / Not Available. For a device that disinfects, performance would likely be measured through microbiological testing against certain pathogen reductions or barrier efficacy, but the specific "ground truth" methodology is not detailed.
8. The sample size for the training set:
* Not Applicable / Not Available. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
* Not Applicable / Not Available. This is not an AI/machine learning device.
Information that is available about the device and its testing:
- Device Name: Catheter Connections' DualCap Duo™
- Intended Use/Indications For Use: When left in place for five (5) minutes, it disinfects needleless Luer access valves. Thereafter, the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
- Key Technological Characteristic/Mechanism: Contains 70% isopropyl alcohol to disinfect. Provides a physical barrier.
- Standards Used for Evaluation (referenced, not detailed):
- ISO 11137: 2006, Sterilization of health care products - Radiation.
- ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
- Other unspecified "additional standards and protocols."
- Conclusion of Performance Data: "Performance data gathered demonstrated that the Catheter Connections' DualCap Duo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)." This indicates that the new device's performance was found to be comparable to that of an already cleared device (K093229 - DualCap™) based on the testing performed according to the referenced standards. The device is deemed "safe and effective for its intended use."
To summarize, the document asserts that testing was performed and demonstrated substantial equivalence to a predicate device, and that the device meets acceptance criteria. However, it does not provide the specific acceptance criteria, quantitative performance results, or detailed study methodology that would be required to complete the requested table and answer many of the questions.
§ 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.