(76 days)
SUB-Q Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.
The EMED SUB-Q Subcutaneous Tissue Infusion Set (SUB-Q Set) device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. Each infusion set has a luer lock at one end and a 90 degree 24g or 27g needle mounted to a standard or closing wing-stabilizer at the distal end of one or more lumens. Each lumen is connected by lengths of tubing and a number connectors, depending on configuration. The luer lock is used to connect to the infusion source. The needles are treated with medical grade silicone for ease of insertion into the skin. The device is for single use.
My apologies, but this document does not contain the specific information required to answer your request in the format provided. The document is a 510(k) summary for a medical device (SUB-Q Subcutaneous Tissue Infusion Set) seeking clearance based on substantial equivalence to a predicate device.
Here's why the requested information cannot be extracted from this document:
- Type of Device: This is an infusion set, which is a physical medical device. The requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is typically relevant for AI-based or diagnostic software devices that involve analyzing data (e.g., images, patient records) to make a determination or assist in diagnosis.
- Nature of the Submission: This 510(k) emphasizes substantial equivalence to a predicate device (K020530). This means the manufacturer is demonstrating that the new device has the same intended use, fundamental scientific technology, and similar performance characteristics to an already cleared device, rather than proving novel clinical effectiveness through extensive new studies.
- Performance Testing: The document states, "Non-clinical testing of the EMED SUB-Q Set included leakage, occlusion, and jointstrength which demonstrated the device meets the requirements for its intended use." This refers to engineering and physical durability tests for the infusion set, not clinical performance metrics like sensitivity, specificity, accuracy, or expert agreement that would be associated with AI/diagnostic systems.
- Lack of AI/Diagnostic Context: There is no mention of algorithms, machine learning, image analysis, expert readers, ground truth establishment for a diagnostic outcome, or any other elements that would necessitate the type of detailed study information you've requested.
Therefore, since the device is a physical infusion set and the submission is based on substantial equivalence to a predicate, the document does not contain details about:
- A table of acceptance criteria and reported device performance in the context of diagnostic accuracy.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for diagnostic performance.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance studies.
- Type of ground truth (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy.
- Sample size for a training set (as this is not an AI/ML device).
- How ground truth for a training set was established.
This document focuses on demonstrating that the modified infusion set is as safe and effective as its predicate device through physical and material characteristic comparisons, and basic non-clinical performance tests (leakage, occlusion, joint strength).
§ 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.