(266 days)
Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Disposable Syringe consists of barrel, plunger and piston. The proposed device is available in luer slip or luer lock connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Syringe with Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The proposed device is also available with fixed needle 25-26 gauge and 1/2 – 1 inch length. The Sterile Disposable Syringe with Safety Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The safety cap will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. All subject device are operated manually.
This document is a 510(k) Premarket Notification summary for a Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, and Sterile Disposable Syringe with Safety Needle. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information related to the acceptance criteria and study proving device performance in the context of an AI/ML device. This is a clearance for a traditional medical device (syringes), and the evaluation is primarily based on equivalence to existing devices and adherence to relevant ISO standards and ASTM tests.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and regulatory submission described in the provided text.
The "studies" mentioned are non-clinical (bench) tests to verify compliance with standards like ISO 7886-1 for syringes, ISO 7864 for needles, and ISO 10993 for biocompatibility. These are standard engineering and materials tests, not AI model evaluations.
§ 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).