(179 days)
The U&U Insulin Syringe with Safety Retractable Device is a sterile, single use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The U&U Insulin Syringe is a sterile, single use, disposable, insulin syringe intended for injection of U-100 insulin into the body.
The U&U Insulin Syringe with/without Safety Retractable Devices are similarl devices except one has a safety feature and the other is a standard insulin syringe.
The U&U Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharps container.
The subject devices are sterile, single use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The U&U Insulin Syringe with/without Safety Retractable Device will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )
The provided document is a 510(k) premarket notification for a medical device (U&U Insulin Syringe with/without Safety Ret retractable Device). It outlines the device's technical characteristics, intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.
However, the document does not contain the specific information required to answer the prompt's request for acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML medical device.
The information requested, such as a table of acceptance criteria and reported device performance (in statistical metrics like sensitivity, specificity, AUC, etc.), sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, and how ground truth was established, are specifically relevant to the evaluation of AI/ML-driven devices.
This document describes a traditional mechanical medical device (insulin syringe), and its evaluation focuses on physical performance standards (e.g., ISO standards for syringes and needles, biocompatibility). Therefore, the concepts of "acceptance criteria" and "study proving it meets acceptance criteria" as laid out in the prompt's questions are not applicable in the context of this specific document.
To summarize, with respect to the questions asked, the document does not provide the information because it pertains to a mechanical device, not an AI/ML device, and thus the requested metrics and study types are not relevant to its regulatory submission.
§ 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).