(42 days)
The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.
The DECap™ is a non-vented cap.
The provided document is a 510(k) clearance letter for a medical device called "DECap™". It primarily focuses on the regulatory approval for marketing the device based on its substantial equivalence to a legally marketed predicate device.
Unfortunately, this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.
The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".
This means the device was cleared because it was shown to be substantially equivalent to an existing device, not necessarily through a new study with explicit acceptance criteria for its performance. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a predicate device, which can involve performance data but doesn't always require a comprehensive study against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, I cannot provide the requested information from this document. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.