(156 days)
Single use, Sterilized, Intended use for the subcutaneous injection of Botox®Cosmetic into parts of body below the surface of skin.
UniTox® Syringe are sterile, single use, disposable hypodermic syringes with a permanently affixed lumen needle to the tip of syringe. The syringe consists of a barrel, a plunger rod with Synthetic Rubber Gasket, and yellow colored end-cap over the needle to prescrve sterility of the fluid path.
In addition the UniTox ® Syringe are pyrogen free, and available , 0.5cc (20units), 30G X 5/16"needle length and conformed following standard (graduate drawing attached)
ISO 7864 Sterile, Hypodermic Needles for single use
ISO 8537: second edition,: 2007 Sterile, Single use Syringe with/without needle
The provided document for KIZ3710 (UniTox® Syringe) is a 510(k) premarket notification summary. This type of submission is for medical devices that are substantially equivalent to already legally marketed devices. As such, the required testing and documentation focuses on demonstrating this equivalence rather than de novo performance studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning device. The UniTox® Syringe is a physical, disposable hypodermic syringe, and its safety and effectiveness are established through comparison to predicate devices, material biocompatibility, and adherence to relevant ISO standards (e.g., for sterile hypodermic needles and syringes).
The document specifically states:
- "The UniTox @ Syringe are substantially equivalent in Design, Function, Performing and all used material to already cleared DMJECT Uni-body Insulin Syringe by K993017, and other several needle permanently attached Insulin Syringe, but different graduate to use Botox®Cosmetic."
- "there are no difference in technological characteristic between the UniTox® Syringe and cited predicate device, only has different graduate (mark ) to use Botox®Cosmetic. accordingly, no any new issues of safety or effectiveness raised."
- "UniTox® Syringe using exact same raw material, which has been previously tested and accepted Biocompatibility, and also manufactured with same process as alteady cleared Predicate Device DM JECT, SUREJECT uni-body insulin syringe K993017, so additional Biocompatibility testing to ISO10993 standard is not required."
In summary, none of the requested information regarding AI device acceptance criteria, study data, sample sizes, expert ground truth establishment, or clinical performance studies is relevant or present in this document, as it describes a conventional medical device whose approval is based on substantial equivalence to predicate devices.
§ 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).