(26 days)
The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
The VACUTAINER® Brand Safety Blood Collection Assembly is a configuration of the commercially available BDD SafetyGlide™ Needle preattached to a VACUTAINER® Direct Draw Adapter (Blood Collection Holder assembly). The VACUTAINER® Brand Safety Blood Collection Assembly is intended to be marketed as a sterile, multi-sample, single use device.
Acceptance Criteria and Device Performance Study for the VACUTAINER® Brand Safety Blood Collection Assembly
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a "Simulated Use Study" designed to evaluate the safety features of the VACUTAINER® Brand Safety Blood Collection Assembly, specifically the successful activation of its protective shield.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High rate of successful shield activation | 100% successful shield activation for all 500 devices tested. |
| Acceptable confidence limits for successful shield activation | 0.7% Upper 95% Confidence Limit; 1.1% Upper 99% Confidence Limit. |
| Acceptable "Ease of Activation" | Over 90% of investigators reported "As Expected" Ease of Use; remaining equally divided between "Easier Than Expected" or "Harder Than Expected." |
| Manageable blood splatter | Blood splatter was observed in some instances; package labeling includes handling recommendations to reduce risk. |
| No significant modification to venipuncture technique required | Evaluated by investigators; no specific metrics provided but implied to be acceptable. |
| Accommodates left/right-handed and single-handed use | Evaluated by investigators; no specific metrics provided but implied to be acceptable. |
| Inability to deactivate the safety mechanism post-activation* | The original SafetyGlide™ Needle, which is pre-attached, "could not be deactivated." |
Note: While the "inability to deactivate" was a specific finding from the original SafetyGlide™ Needle 510(k) and not re-tested in the Simulated Use Study, it's a critical safety feature of the component pre-attached to this device.
2. Sample Size and Data Provenance
- Test Set Sample Size: 500 VACUTAINER Safety Blood Collection Assembly devices.
- Data Provenance: The document does not explicitly state the country of origin where the Simulated Use Study was conducted, nor does it specify if the data was retrospective or prospective. Given the nature of a "Simulated Use Study," it would highly likely be prospective data collection. The study was conducted by "VACUTAINER Systems" which is a division of Becton Dickinson, a US-based company, suggesting the study likely took place in the US or under their oversight.
3. Number of Experts and Qualifications
- The document refers to "investigators" who participated in the Simulated Use Study. It does not specify the number of investigators or their individual qualifications (e.g., specific medical titles, years of experience). It can be inferred that these investigators are healthcare professionals who perform venipuncture, as the study was designed to evaluate the device "in a blood drawing environment."
4. Adjudication Method
- The document does not describe an explicit adjudication method for establishing ground truth within the Simulated Use Study. The study relies on direct observation and reporting by the "investigators" regarding shield activation, blood splatter, ease of activation, and technique modification. This suggests a direct assessment without a separate adjudication process for discrepant opinions. The 100% success rate for shield activation implies a clear (binary) outcome easily observable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done as described in the provided text. The study mentioned is a "Simulated Use Study" which focuses on assessing the device's functional performance and safety features directly, rather than comparing human reader performance with and without AI assistance. The device is a physical medical device (blood collection assembly), not an AI-powered diagnostic tool.
6. Standalone Performance Study
- Yes, a standalone study was done, in the sense that the "Simulated Use Study" evaluates the device directly without human intervention to interpret results from an algorithm. The study directly assessed the operational success of the device's safety mechanism (shield activation). It's a study of the device's physical performance, not its algorithmic output.
7. Type of Ground Truth Used
- The ground truth for the Simulated Use Study was based on direct observation and subjective reporting by trained investigators during simulated venipuncture. For successful shield activation, it was a clear, objective outcome (did it activate or not). For ease of activation, it was subjective ("As Expected," "Easier Than Expected," "Harder Than Expected"). Blood splatter was also based on observation.
8. Sample Size for the Training Set
- The document does not mention a training set as this device is a physical medical device and not an AI/machine learning model that requires a training set. The 500 devices were part of the test set for the "Simulated Use Study."
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there was no training set for an AI/machine learning model. The study focused on evaluating the physical device's performance directly.
§ 864.2240 Cell and tissue culture supplies and equipment.
(a)
Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.(b)
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.