(77 days)
The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body.
Intravascular administration sets are described in 21 CFR 5880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a maie luer-lock conector (without injection site) and NNC-3CL has the male luer lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site). The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.
This document, a 510(k) summary for the Nipro® Disposable Solution Infusion Set, does not contain the detailed information required to answer your request.
Here's why and what information is missing:
Missing Information:
- Acceptance Criteria and Device Performance Table: The document describes the device and its intended use, but it does not provide any specific performance metrics (e.g., flow rate accuracy, drip chamber clarity, material degradation) or corresponding acceptance criteria. There is no table detailing these.
- Study That Proves the Device Meets Acceptance Criteria: The document explicitly states: "As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets." This indicates that no formal study, as you've described, was performed or presented in this document to prove the device meets specific acceptance criteria. Instead, reliance is placed on historical clinical use and the substantial equivalence to a predicate device.
- Sample Size (Test Set, Training Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, How Ground Truth was Established: All of these data points are related to a formal performance study (e.g., clinical trial, bench test with predefined metrics). Since no such study is detailed in this 510(k) summary, none of this information is present.
In summary, the provided text is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing a specific performance study with acceptance criteria. The claim of safety and effectiveness is based on historical market use, not a novel study with measurable outcomes against specific criteria.
§ 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.