(214 days)
The VACUETTE® QUICKSHIELD Complete is intended to be used only with 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. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with 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. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
This document is an FDA 510(k) Premarket Notification summary for a medical device, not a study describing AI algorithm performance. Therefore, most of the requested information regarding acceptance criteria for AI algorithms, sample size, ground truth expert establishment, MRMC studies, and training set details are not applicable.
However, I can extract the acceptance criteria and performance data for this physical medical device based on the provided text.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Requirement" and "Outcome" columns in the "PERFORMANCE DATA" section. The document states that performance testing was conducted to demonstrate substantial equivalency and that the device performs as intended. All listed requirements passed.
| Requirement | Outcome (Pass or fail) |
|---|---|
| Force to remove shield | Pass |
| Torque to rotate shield | Pass |
| Torque to screw out needle | Pass |
| Spin out | Pass |
| Force to activate safety mechanism | Pass |
| Force necessary to bend safety shield with needle by 90° | Pass |
| Puncture force | Pass |
| Friction force | Pass |
| Leakage | Pass |
Additionally, the following were met:
- Sterility: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ via e-beam irradiation, in accordance with ISO 11137-1 and ISO 11737-1.
- Biocompatibility: Demonstrated compliance with ISO 10993 series standards and FDA guidance for:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation (ISO 10993-23)
- Hemocompatibility (ISO 10993-4)
- Material mediated pyrogenicity (ISO 10993-11)
- Acute Systemic Toxicity (ISO 10993-11)
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were tested for "Force to remove shield"). It refers to "Simulated use tests" and "Performance testing" in general.
Data provenance is not specified in terms of country of origin for the testing, and the testing described is prospective for demonstrating compliance with standards for the device being submitted.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The document describes the testing of a physical medical device (blood collection system) against engineering and biological performance standards, not an AI algorithm requiring expert ground truth for classification or detection.
4. Adjudication Method for the Test Set
This information is not applicable as the device performance is measured against objective engineering and biological standards, not requiring human adjudication of subjective data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This information is not applicable. MRMC studies are typically performed for imaging diagnostics or AI-assisted diagnostic tools to assess the impact on human reader performance. This document is for a physical blood collection device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device is a physical product, not an algorithm. The performance tests ("Torque to rotate shield," "Puncture force," etc.) are inherent to the device's design and function in a standalone manner.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by recognized consensus standards (e.g., ISO 23908, ISO 7864, ISO 9626, ISO 11137-1, ISO 11737-1, ISO 10993 series) and internal specifications. This means that the device was tested to meet predefined physical, mechanical, and biological properties, not a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of an AI study.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI algorithm; there is no training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
§ 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.