(176 days)
When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
The DualCap™ is designed to fit securely on Luer access valves and IV administration line male Luer connections. 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.
Additionally DualCap™, the device will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterile to the kitting manufacturer (DualCap™ will be packaged in metalized unit container and will be impervious to ETO). The Catheter Connections' DualCap™ will be incorporated into the procedure kit.
The provided text does not describe an acceptance criteria study for a medical device that makes use of AI/ML. The document is a 510(k) premarket notification for a device called "Catheter Connections DualCap," which is an alcohol-impregnated cap designed to disinfect Luer access valves and IV administration line male Luer connections.
Therefore, I cannot provide information for the following points as they are not applicable to the provided document:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and existing scientific methods for assessing safety and effectiveness (e.g., sterilization, biocompatibility, and performance testing), not through clinical studies involving human readers or AI/ML algorithms.
The document indicates that "The Catheter Connections' DualCap™ will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Catheter Connections' DualCap™ is substantially equivalent to the noted predicate devices." However, it does not explicitly list these acceptance criteria or the detailed results of the performance testing. It mentions that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." The standards referenced are ISO 11137:2006 for sterilization and ISO-10993 for biocompatibility.
In summary, the provided text describes a traditional medical device (not an AI/ML device) and confirms that performance testing was conducted to demonstrate substantial equivalence, but it does not provide the specific details of acceptance criteria or study outcomes.
§ 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.