(156 days)
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the body.
The Sterile Hypodermic Syringe for Single Use is intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.
The provided text is a 510(k) summary for a medical device (Sterile Hypodermic Syringe for Single Use) and does not contain information about acceptance criteria and study details as typically found for AI/ML-based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance, material comparisons, and adherence to recognized standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these are not discussed in the provided text.
The document primarily outlines:
- Device Description: Sterile Hypodermic Syringe for Single Use, consisting of a barrel, plunger, and piston, available in various volumes and luer slip/luer lock connector types.
- Indication for Use: Intended for medical purposes on adult and pediatric populations to inject fluids into or withdraw fluids from the body.
- Predicate Device: K210227, Sterile syringe for single use with/without needle.
- Comparison to Predicate: Differences noted include volume specifications, piston material (Polyisoprene Rubber vs. Silicone Rubber), patient population explicit mention, and shelf-life (5 years vs. 3 years). These differences are argued not to affect safety and effectiveness.
- Non-Clinical Test Performance Testing: The device was tested for conformance with:
- ISO 7886-1:2017 (Sterile hypodermic syringes for single use)
- ISO 80369-7: 2016 (Small-bore connectors for liquids and gases in healthcare applications)
- Biocompatibility Testing (ISO 10993-1): Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity.
- Particulate Matter Testing: USP .
- Sterile Barrier Packaging Test: Visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15), and dye penetration test (ASTM F1929-15).
- Sterilization and Shelf Life Test: Validated per ISO 11135, including EO residue, ECH residue (ISO 10993-7:2008), Bacteria Endotoxin Limit (USP ), and Shelf Life Evaluation (physical, mechanical, chemical, package tests on aging samples).
The document declares that the device is substantially equivalent to the predicate based on these non-clinical tests and comparisons. It does not involve AI/ML components or the types of studies typically associated with such technologies.
§ 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).