(161 days)
Sterile Syringe with Safety needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Sterile Syringe with needle for Single Use is intended for use in the aspiration of fluids for medical purpose.
Sterile Syringe for Single Use is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Safety Needle for Single Use is intended to be used with a luer slip syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Sterile Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.
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I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is an FDA 510(k) clearance letter for various types of syringes and needles. It confirms that the devices are substantially equivalent to legally marketed predicate devices and mentions the indications for use.
It does not include any details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their provenance.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) study or effect sizes of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
This type of information would typically be found in the 510(k) submission itself (which is not provided here) or a more detailed performance study report, not in the clearance letter summarizing the FDA's decision.
§ 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).