(141 days)
To inject fluids into or withdraw fluids from the body.
The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-27G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years.
The provided text is a 510(k) summary for a medical device, specifically a Nipro Syringe. It describes a conventional medical device, not an AI/ML-driven device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.
The document discusses:
- Device Description: A piston syringe with varied sizes, gauges, and tips.
- Indications for Use: To inject or withdraw fluids from the body.
- Technological Characteristics: Materials, design, sterilization, expiry dating, and dimensions.
- Non-Clinical Performance Testing: A comprehensive list of biocompatibility, visual inspection, dimensional, mechanical, chemical, sterilization, transportation, pyrogen, and shelf-life tests performed to demonstrate substantial equivalence to a predicate device.
- Clinical Study Conclusion: Explicitly states "No clinical Study is included in this submission."
Since the prompt is specifically about the acceptance criteria and study that proves the device meets the acceptance criteria (implying an AI/ML device context), and the document describes a physical medical device (syringe), it does not contain the information necessary to answer the questions about AI/ML device performance, ground truth, expert consensus, or MRMC studies.
§ 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).