(21 days)
Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window 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.
Here's a summary of the acceptance criteria and the study details for the Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No failures during simulated blood drawing with thumb activation option. | No failures occurred (0 failures out of 500 tests). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 500 devices were tested.
- Data Provenance: The text does not specify the country of origin. It indicates it was a "simulated blood drawing" test, which implies a prospective, internal validation study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The text states "multiple users employing the thumb activation option." It does not specify the exact number of users or their qualifications (e.g., healthcare professionals, engineers, etc.). The "ground truth" here is the functionality of the device during simulated use.
4. Adjudication Method for the Test Set:
- The text does not explicitly detail an adjudication method. It simply states "No failures occurred," implying a direct observation of device function rather than a need for multiple expert opinions to resolve discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- This device is a medical instrument (blood collection tube holder), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI or human readers is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- The ground truth was based on direct observation of device functionality (absence of failure) during simulated venipuncture procedures.
8. The Sample Size for the Training Set:
- The document describes a modification to an existing device (predicate device K033478) and a test of the modified device. There is no mention of a separate "training set" in the context of machine learning or algorithm development, as this device's performance is not based on such models. The 500 devices tested were for verification of the modification.
9. How the Ground Truth for the Training Set Was Established:
- As this is not an AI-based device, the concept of a "training set" and its associated ground truth establishment is not applicable. The study described is a performance verification test.
§ 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).