(1007 days)
This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.
The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacitivs fabricated of polypropylene. It has a locking device made of the same polypropylene material. The "umbrella" describes the locking mechanism which emulates the shape and functioning of an umbrella.
Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the foward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.
This document describes a medical device, the UNIVEC Model 884 Umbrella Nonreusable Syringe, and its intended use. However, it does not contain any information about acceptance criteria, device performance, or any studies conducted on the device's performance in relation to acceptance criteria.
Therefore, I cannot provide the requested information in a table or answer the specific questions about studies, sample sizes, ground truth, or expert qualifications. The provided text is solely a device description and a statement of intended use, likely part of a regulatory submission (e.g., 510(k)).
To answer your questions, I would need a document that includes:
- Specific performance metrics and their target values (acceptance criteria).
- Details of a study conducted to evaluate the device against these criteria. This would include methodology, results, statistical analysis, and information regarding ground truth and expert involvement.
§ 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).