(254 days)
This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.
The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection. The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath. The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a hypodermic needle and syringe. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an Artificial Intelligence (AI) or software-based medical device.
The document primarily focuses on demonstrating "substantial equivalence" of a new physical device (Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe) to a previously cleared predicate device. The performance data mentioned (biocompatibility, sterilization, shelf-life, non-clinical bench testing) refers to the physical properties and safety of the needle and syringe, not the performance of an AI algorithm.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document. The provided text does not describe an AI medical device or its performance studies.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).