(81 days)
The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a non-sterile single-use plastic tube holder. It is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® QUICKSHIELD with SNAPPY Tube Holder helps secure VACUETTE® tubes in place during collection. Note: Always follow tube manufacturer's specimen collection instructions for holding tube in place to ensure a complete vacuum draw. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
The provided text is a 510(k) summary for a medical device (VACUETTE® QUICKSHIELD with SNAPPY Tube Holder) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and performance of an AI/algorithm-based device. Therefore, most of the requested information cannot be extracted from this document.
However, I can extract the general acceptance criteria for showing substantial equivalence and the "device performance" in terms of its characteristics compared to the predicate.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device K102774. This means the device must be shown to have the same intended use, fundamental scientific technology, and materials, and any differences do not raise new questions of safety or effectiveness.
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Reported Device Performance: The document doesn't present a quantitative performance metric in the way you might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, it compares the characteristics of the modified device to the predicate.
Acceptance Criteria / Characteristic Reported Device Performance (Subject Device) Predicate Device (K102774) Performance/Characteristics Substantial Equivalence The device is deemed substantially equivalent to the predicate. This is the overarching "acceptance criterion" of the 510(k) process. N/A (The predicate device itself was cleared as substantially equivalent previously). Intended Use To be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures by properly trained healthcare professionals. To be used together only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures by properly trained healthcare professionals. (Note: The change in intended use to broadened needle type is the subject of this 510(k), but the fundamental use is the same) Holder SNAPPY Tube Holder (21CFR880.5570, Product Code FMI) Same Holder Material Polypropylene, with tabs Same Sharp Safety Feature Polypropylene holder with polypropylene needle locking shield Same Safety Feature Activation Stable surface or thumb Same Sterilization Non-sterile Same Needle Recommendation VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483) and VACUETTE® Multi-Sample Needles (K973620) VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483) Technological Characteristics The device is "substantially equivalent to the predicate device in fundamental scientific technology and materials." The modification is specifically to include an additional recommended needle type (VACUETTE® Multi-Sample Needles). The overall design and safety mechanism (QUICKSHIELD with SNAPPY Tube Holder) are maintained from the predicate. The predicate device shares the same fundamental scientific technology and materials for the holder and safety features. The difference is the original predicate was only cleared with VACUETTE® VISIO PLUS Blood Collection Needle.
Missing Information (Not applicable to this document as it's not an AI/algorithm study):
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
Reason for Missing Information:
This document is a 510(k) summary for a physical medical device (blood collection tube holder), not an AI or algorithm-based device. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies" as they relate to AI performance are not applicable and are not discussed in this type of submission. The "study" here is primarily a comparison of device specifications and intended use against a legally marketed predicate device to demonstrate substantial equivalence, rather than a performance study with clinical outcomes or accuracy metrics.
§ 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).