(35 days)
The Sol-Guard™ XtraThin Wall Safety Pull button blood collection set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male Luer adaptor, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and should remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.
The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.
While the provided FDA 510(k) clearance letter and summary meticulously detail the substantial equivalence of the "Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set" to its predicate device, it does not contain information related to software, artificial intelligence (AI), diagnostic accuracy, or human reader performance.
The document describes a physical medical device (a blood collection set) and its mechanical and material properties. The term "acceptance criteria" in this context refers to the bench and performance testing standards (e.g., ISO and ASTM standards) the device must meet to demonstrate its safety and effectiveness, particularly concerning the change in needle inner diameter.
Therefore, I cannot provide an answer that includes:
- A table of acceptance criteria for diagnostic performance or AI.
- Sample sizes for a "test set" in an AI/diagnostic context.
- Data provenance, expert qualifications, or adjudication methods for ground truth.
- MRMC comparative effectiveness studies or effect sizes for human readers with AI assistance.
- Standalone algorithm performance.
- Ground truth types like expert consensus, pathology, or outcomes data.
- Training set sample size or how its ground truth was established.
The document is entirely focused on the physical characteristics and performance of a blood collection device, not on any kind of diagnostic or AI-driven system.
If you are looking for information regarding acceptance criteria and studies for AI-powered medical devices, you would need a 510(k) submission or clearance letter for such a device. This document is for a conventional, non-AI medical device.
§ 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.