(236 days)
The Nipro Coreless Needle and the Nipro Coreless Needle Set, for which coring is prevented, are intended to be used to inject a drug solution into a reservoir implanted in the body.
Nipro Coreless Needles and Nipro Coreless Needle Sets are described in Hypodermic single lumen needle (21 CFR 8880.5570) or Intravascular administration set (21 CFR §880.5440). The Nipro Coreless Needle and Nipro Coreless Needle Set, for which coring is prevented, are intended to be used to inject a drug solution into a reservoir implanted in the body.
The Nipro Coreless Needles and Nipro Coreless Needle Sets that we intend to market include 2 different types: the straight type (7 sizes) and the 90° angle type (7 sizes). The Nipro Coreless Needle consists of a luer hub, a cannula, and a protector over the cannula. The needle base and the needle protector are composed of polypropylene (PP) and the cannula is made of stainless steel (Type 304).
The Nipro Coreless Needle Sets consist of a needle connected to a length (100 mm or 450 mm) of soft polyvinylchloride (PVC) tubing with a clamp roller along it and a luer connector and luer cap at the other end. Models in which there is a Yshaped tube for mixture injection include a second length of PVC tubing connected at the first luer connector with a clamp roller along it which is then connected to another luer connector and cap.
The materials used for the components include stainless steel (Type 304), polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), polycarbonate (PC), natural rubber (NR), and polyoxymethylene (POM).
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria.
The key information provided relates to:
- Device Description: Nipro® Coreless Needle and Nipro Coreless Needle Set, designed to prevent coring when injecting drug solutions into implanted reservoirs.
- Intended Use: To inject a drug solution into a reservoir implanted in the body, with coring prevented.
- Predicate Device: Huber Needle and Huber Needle Set, Exel International, Inc. (K895769 and K895770).
- Comparison of Technical Characteristics: States that Nipro Medical Corporation and Exel International, Inc. devices are "exactly the same devices, therefore, all technical characteristics are identical." This is the basis for claiming substantial equivalence.
Without further documentation, it's not possible to provide the requested detailed information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert reviews. This document primarily serves as notification and declaration of substantial equivalence based on a comparison to an existing device rather than a report of a new performance study.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.