(56 days)
The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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.
The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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.
The provided text describes a 510(k) summary for the VACUETTE® QUICKSHIELD Safety Tube Holder. It focuses on demonstrating substantial equivalence to a predicate device and includes a very limited study.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Assumed) | Reported Device Performance |
|---|---|
| No failures of the safety shield during simulated venipuncture | 0 failures in 500 uses |
| Substantial equivalence to predicate device in intended use, materials, and overall performance characteristics | Reported as substantially equivalent |
Note: The document implies "no failures" as the acceptance criterion for the safety shield's functionality. The "substantial equivalence" is a regulatory finding rather than a quantifiable performance metric in the same way.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 500 VACUETTE® QUICKSHIELD Safety Tube Holders.
- Data Provenance: The document states "In a study of 50 users, 500 VACUETTE® QUICKSHIELD Safety Tube Holders were used in simulated venipuncture." This indicates a prospective study involving human users. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study described is a performance test of a mechanical safety feature, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the safety shield was its physical activation and function.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the task involved observing a simple pass/fail outcome of the safety shield activation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is typically for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VACUETTE® QUICKSHIELD Safety Tube Holder is a medical device for blood collection with a safety mechanism.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The described study evaluates the device's inherent mechanical function (safety shield activation) without human interpretation affecting its performance outcome. While "users" were involved, their role was to operate the device, not to make a diagnostic judgment. The device's performance was measured directly.
7. The Type of Ground Truth Used
The ground truth was essentially the physical functionality of the safety shield – whether it successfully activated and covered the needle. This is an objective observation of the device's mechanical design.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical safety device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this device does not involve a training set.
§ 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).