(337 days)
The Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Eclipse Blood Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needle stick injury if manually activated after the blood draw. For blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials
The provided text is a U.S. FDA 510(k) summary for the Eclipse Blood Collection Set. It describes the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain the detailed information requested regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a diagnostic AI device.
The document states: "The Eclipse Blood Collection Set was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria." However, it does not specify what those predetermined acceptance criteria were or present a table comparing them to reported device performance.
It also mentions various types of performance testing, such as biocompatibility, performance data (per ISO 80369-7:2016 and ISO 80369-20:2015), and sterilization/shelf-life testing against relevant ISO and ASTM standards. While these indicate tests were performed to ensure the device meets safety and functionality standards relevant to its type, they are largely about manufacturing and material safety, not diagnostic performance or AI model validation.
Crucially, the document explicitly states: "Clinical Study: Not applicable". This indicates that a clinical study, which would typically involve human subjects and the kind of performance data (e.g., sensitivity, specificity) relevant to AI diagnostic devices, was not performed or deemed necessary for this type of medical device clearance.
Therefore, the requested information, which is more applicable to diagnostic AI devices, cannot be extracted from this document, as the Eclipse Blood Collection Set is a physical blood collection device and not an AI-powered diagnostic tool.
§ 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.