(577 days)
BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used in settings where venous blood specimens are collected by trained healthcare professionals for the collection, transportation, and processing of blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are used for trace element testing (e.g., Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc).
The BD Vacutainer® Trace Element K2EDTA Tube is an evacuated plastic blood collection tube. It consists of closure assembly, a plastic tube, and EDTA coating (dipotassium) and is available in two draw sizes, 6 mL (13 x 100 mm) and 3 mL (13 x 75 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic, which enhances user safety and disposal because of the reduced risk of tube breakage and the use of incineration as a method of disposal compared to glass. The EDTA anticoagulant coating is spray-dried on the walls of the tube in the dipotassium (K2) form.
The BD Vacutainer® Trace Element Serum Tube is also an evacuated plastic blood collection tube consisting of a closure assembly, a plastic tube and contains a silica clot activator additive which is spray-dried on the interior walls of the tube. It is available in one draw size, 6 mL (13 x 100 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic.
All of these plastic tubes are closed with a BD Hemogard™ Closure, which consists of a rubber stopper and protective plastic shield to help reduce user exposure to blood. The stopper/closures are color coded to reflect the intended use (Royal Blue for trace element tubes).
The provided text describes a 510(k) premarket notification for new blood collection tubes, asserting their substantial equivalence to previously cleared predicate devices. It focuses on the device's characteristics and performance testing. However, the information does not describe an AI/ML-based device, nor does it involve the use of experts for ground truth establishment, MRMC studies, or training/test sets in the context of an AI/ML model for clinical diagnosis or prediction.
Therefore, I cannot fulfill your request for information related to Acceptance Criteria and Proof of Device Performance for an AI/ML device based on the provided text. The document is about a physical medical device (blood collection tubes) and its performance related to functionality, sterility, and suitability for trace element testing, not an AI/ML algorithm.
If you have a document describing an AI/ML medical device, please provide it, and I will do my best to extract the requested information.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.