(365 days)
The BD U-500 Insulin Syringe is intended for the subcutaneous injection of U-500 insulin for patients requiring more than 200 units per day.
The U-500 Insulin Syringe is a standard single use 0.5mL plastic syringe intended for the injection of U-500 insulin into the subcutaneous tissue. It features a 31G needle and 6 mm needle length with unique U-500 scale markings on the syringe barrel. The U-500 syringe also features a green needle shield and a green U-500 symbol. It is a single use, sterile, nontoxic syringe. The fluid path of the syringe is sterile and non-pyrogenic.
This document pertains to a 510(k) premarket notification for a medical device, specifically the BD U-500 Insulin Syringe. The information provided describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO 8537, Volumetric Accuracy) | Reported Device Performance |
|---|---|
| **At volumes |
§ 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).