(64 days)
The device is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The proposed device consists of a sterile syringe, labeled for either U-100 Insulin or Tuberculin, with a permanently attached single lumen needle, and an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip or thumb operation or by pressing the shield. Once activated, the safety shield is securely and permanently locked.
The provided text is a 510(k) summary for the Kendall Monoject® Safety Syringe. It describes the device, its intended use, and its substantial equivalence to a previously marketed device. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria for performance, such as diagnostic accuracy or clinical outcomes.
The nonclinical testing mentioned (Biocompatibility testing) only states that the device meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. This is a general safety standard, not a performance study.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document focuses on regulatory approval through substantial equivalence, primarily by comparing the new device's design and intended use to a predicate device and confirming biocompatibility, rather than providing detailed performance data against specific acceptance criteria.
§ 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).