(115 days)
The PureWay® Sharps Collector container is a disposable infectious waste container in 1.2 gallon, 2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector container will be ultimately destroyed through incineration.
There are three indications for use statements corresponding to three sizes of container. These are reproduced below:
Indications for Use Statement: 1.2 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75″ x 6″ x 7.27″ and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, sinqle use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for Use Statement: 2 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75″ x 6″ x 11.15″ and weighs 11b 1oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for Use Statement: 3 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75" x 15.73" and weighs 2 Ibs. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic and is available in 1.2 Gallon and 3 Gallon sizes. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal.
Each container is non-sterile, single use, disposable infectious waste container).
The containers are designed to contain and hold sharps such as anqio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture.
In summary, all PureWay® Sharps Collector containers are blow molded usinq High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure.
The provided text is a 510(k) premarket notification for the PureWay® Sharps Collector Container. It describes the device, its intended use, and a comparison to a predicate device. However, it does not describe an AI/ML-driven medical device, and therefore the information requested about acceptance criteria, study design, ground truth, and human reader performance for AI/ML systems is not applicable and cannot be extracted from this document.
The document focuses on the physical and mechanical properties of a medical sharps container and its compliance with relevant performance standards (ISO 23907, CSA Z316.6-07, ASTM F2132-01).
Therefore, I cannot provide the specific details requested in your prompt regarding AI/ML device performance and testing.
§ 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).