(295 days)
The Safety Hypodermic Needle With/Without Syringe device is intended for use in the aspiration of fluids for medical purposes. The Safety Hypodernic Needle With/Without Syringe is compatible for use with standard her lock syringes. Additionally, after withdraval of the needle from the body, the attached can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
The Safety Hypodermic Needle With/Without Syringe consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation. The locking mechanisms are positioned within the center and proximal end of the Sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use.
The provided text is a 510(k) summary for "Safety Hypodermic Needles With/Without Syringe" and primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It does not describe a study that uses acceptance criteria to prove the device's performance.
Instead, the submission states:
- "Performances: Conforms to ISO7864" for the Safety Hypodermic Needle (compared to predicate K113422).
- "Performances: Conforms to ISO7886-1" for the Safety Hypodermic Needle With Syringe (compared to predicate K110771).
- "Biocompatibility: Conforms to ISO10993" for both.
- "Labeling: Meet the requirements of 21 CFR Part 801" for both.
These statements indicate that the device was evaluated against existing international standards (ISO) and FDA labeling regulations, but the document does not provide details of specific acceptance criteria or the study data that demonstrates conformance to these standards. It rather asserts conformance.
Therefore, for the specific questions requested, the information regarding a detailed performance study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not available in the provided text. The document focuses on a comparative analysis of characteristics with predicate devices to demonstrate substantial equivalence, rather than a standalone performance study with defined acceptance criteria and results.
§ 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).