(208 days)
The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
The Manual Safety Syringe is a single-use safety hypodermic syringe, which is very similar to a traditional syringe, with the exception that it possesses an integral needle retracting mechanism. The device comes in two variations:
- 3. Manual Safety Syringe (2-parts) 5ml
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- Manual Safety Syringe (3-parts) 5ml
The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back.
The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated.
The Manual Safety Syringe is only available in one size (5ml).
- Manual Safety Syringe (3-parts) 5ml
This document is a 510(k) summary for the Manual Safety Syringe, indicating it is not a study reporting acceptance criteria and device performance. The summary claims substantial equivalence to a predicate device and states that a "clinical evaluation has volunary standards, and the results show that the Manual Safety Syringe 5ml is clinically acceptable." However, it does not provide specific details about the clinical evaluation or clearly define acceptance criteria. It mentions "biocompatibility testing, compliance with production and comparison to the predicate device" as contributing to the conclusion of substantial equivalence.
Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed device rather than providing a detailed report of acceptance criteria and a study proving those criteria were met for this specific device.
§ 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).