(195 days)
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 18-34 gauge and 2-40 mm lengths.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and are supplied in a sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The provided text describes the 510(k) summary for hypodermic needles and does not contain information about an AI/ML-enabled medical device. Therefore, I cannot address the specific points regarding acceptance criteria and study details for such a device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing for physical, mechanical, chemical, biocompatibility, and sterilization properties of the needles.
- No AI/ML device: The document pertains to "Sterile Safety Hypodermic Needles for Single Use" and "Sterile Hypodermic Needles for Single Use-Disposable Needles," and "Sterile Hypodermic Needles for Single Use-Self-sealing Hypodermic Needles." These are physical medical devices, not AI/ML-enabled software.
- No AI/ML performance data: Consequently, there are no acceptance criteria or study details related to the performance of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) or its impact on human reader performance.
- Non-clinical tests: The document lists numerous non-clinical tests conducted to prove the device meets standards like ISO 7864, ISO 9626, and ISO 80369-7, as well as biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogen). It also mentions a "Simulated Clinical Study" and "Safety Feature Test" for the sharps injury prevention feature, though details on the study design or sample size are not provided beyond stating that pre-established criteria were met.
Therefore, I cannot generate the table or information requested as it is not present in the provided text.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).