(30 days)
When left in place for five (5) minutes, DualCap Solo™ 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 Solo™ 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, this device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.
This document is a 510(k) Premarket Notification Summary for the Catheter Connections' DualCap Solo™. It does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. Instead, it makes a general claim of substantial equivalence to a predicate device (DualCap™ K093229) based on performance testing.
Therefore, I cannot fulfill most of your request directly from the provided text. I can, however, extract the claimed Indications For Use and the general statement about performance data.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided specifically. The document states, "The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing," but does not list these criteria or the numerical results from the performance testing.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The document states "Verification testing was performed according to protocols," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be provided. This type of information is usually relevant for studies involving subjective assessments, such as imaging or diagnostic AI. The DualCap Solo is a physical device for disinfecting and acting as a barrier, so "ground truth" would be established through microbiology and engineering testing, not expert interpretation of outputs.
4. Adjudication method for the test set:
- Not applicable/Cannot be provided. For the same reason as point 3, adjudication methods like 2+1 or 3+1 are not relevant for this type of device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Cannot be provided. This is an AI-specific study type, and the DualCap Solo is not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Cannot be provided. The device is not an algorithm.
7. The type of ground truth used:
- Inferred based on device type: For a disinfectant and barrier cap, the "ground truth" would likely involve microbiological assays (to confirm disinfection efficacy) and physical barrier integrity tests (to confirm it prevents contamination). The document mentions "Biocompatibility requirements according to ISO-10993" and "Sterilization requirements of ISO 11137" which are examples of standards guiding such ground truth establishment.
8. The sample size for the training set:
- Not applicable/Cannot be provided. This device is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Cannot be provided. This device is not an AI model requiring a training set.
Summary of available information:
Indications For Use (as per K113842):
"When left in place for five (5) minutes, DualCap Solo™ 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."
General Statement on Performance:
"Performance data gathered demonstrated that the Catheter Connections' DualCap Solo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."
"The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing."
Type of Ground Truth (Inferred):
Microbiological efficacy (disinfection), physical barrier effectiveness, biocompatibility, and sterility testing, based on standards like ISO 11137 and ISO 10993.
The document is a regulatory submission for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as an already cleared predicate device, rather than providing a detailed scientific study report with all raw data and acceptance criteria specifics.
§ 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.