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The RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are intended to enable withdrawal of blood samples from a patient.

The RELI® Safety Blood Collection Tube Holder is designed to prevent accidental needle stick injuries.

The RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder are intended to be used in combination with conventional multiple sample blood collection needles (up to 1 ½" in length) and vacutainers for safe handling and disposal immediately following routine venipuncture procedures.

The Safety Blood Collection Tube Holder is designed with a user activated safety shield to cover the needle immediately following venipuncture procedure to help prevent needle stick injuries and safely dispose of the device in compliance with OSHA requirements.

The safety shield can be activated by gently pressing the shield toward the needle in one of two ways without the need for user to approach the sharp end:

1. Press shield toward exposed needle on a stable surface or
2. With thumb behind the shield, press shield onto exposed needle.

An audible click is heard when the safety shield has been properly activated and the Safety Blood Collection Tube Holder with enclosed needle is safe to discard.

The Safety Blood Collection Tube Holder is clear with safety shield available in clear, blue, or orange color options. The Blood Collection Tube Holder is clear. The devices can be used with conventional multi-sample needles up to 1 ½ inches in length.

The provided text describes a 510(k) premarket notification for a medical device (blood collection tube holders) and provides a summary of its characteristics and limited performance testing. However, it does not include the detailed type of information you've requested about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The document is for a Class II medical device (Hypodermic Single Lumen Needle accessory) – a physical blood collection tube holder – not an AI/software as a medical device (SaMD) or a device that directly leverages AI for diagnostic or treatment purposes. Therefore, the concepts of "ground truth," "expert consensus," "MRMC studies," "training set," or "AI assistance" are not applicable to this particular FDA submission.

The "Performance Testing - Non-Clinical" section details physical performance tests relevant to a blood collection tube holder, such as:

• ISO 80369-7: Mating with bidirectional blood collection needle.
• ASTM F 1980-2007: Accelerated aging for sterility (though the device itself is non-sterile, the packaging would need to maintain sterility if it were a sterile product).
• Simulated Use Testing: 500 samples with 100% successful use, no device failures, and no incomplete enclosures of the sharp. This appears to be a functional test rather than a clinical study.

Therefore, it is not possible to fill out the requested table or answer the questions based on the provided document because the document describes a physical medical device and its mechanical/functional testing, not an AI-powered device or a study involving human readers or AI performance metrics.

The document's purpose is to demonstrate substantial equivalence to a predicate device based on similar indications, technology, and performance, primarily concerning the physical characteristics and safety mechanism of the blood collection tube holder.

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