(181 days)
The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes.
The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.
The provided submission is for a medical device (Disposable Insulin Syringe), not an AI/ML powered device. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The information requested (multi reader multi case study, standalone performance, ground truth establishment, training set sample size, etc.) pertains to AI/ML device evaluations and cannot be extracted from this document, which describes the testing and comparison of a traditional medical device against a predicate device.
The document discusses various performance data, including biocompatibility, sterilization, shelf life, and physical performance testing according to ISO and ASTM standards. These tests demonstrate the device's safety and effectiveness as a disposable insulin syringe, but not as an AI/ML system.
§ 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).