(89 days)
The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The DuoProSS Needle device is a sterile, single use, standard hypodermic needle. The device is available in various Gauges and lengths. Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle shield. The device is packaged in a peal-back pouch and sterilized by ethylene oxide. The DuoProSS Needle device consists of 4 parts or materials: a stainless steel cannula, a polypropylene hub, epoxy glue and a polypropylene needle guard.
The provided text describes a hypodermic needle (DuoProSS Needle) and its 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating similarity to existing devices rather than extensive clinical efficacy studies typically associated with novel or high-risk devices.
Therefore, the information you're requesting regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment (as typically applied to AI/ML or diagnostic devices) is not applicable to this particular 510(k) submission for a standard hypodermic needle.
The "study" that proves the device meets acceptance criteria in this context is the submission itself, which primarily focuses on:
- Substantial Equivalence: Demonstrating that the DuoProSS Needle has the same intended use, technological characteristics, and safety/effectiveness profiles as a predicate device (Terumo Disposable Hypodermic Needle K771203 and others).
- Design and Materials: Providing details on the components and materials used, which are standard for hypodermic needles.
- Sterilization: Stating that the device is sterilized by ethylene oxide.
- Compliance with General Controls: Acknowledging adherence to general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, etc.).
There is no mention of a clinical trial, performance study with acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy), or any data requiring expert adjudication, multi-reader multi-case studies, or standalone algorithm performance for this device.
In summary, the provided document does not contain the information requested in your numbered points because it pertains to a traditional medical device submission (510(k) for a hypodermic needle) that does not require such performance data for market clearance.
§ 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).