(46 days)
A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.
A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.
Here's an analysis of the provided text regarding the acceptance criteria and the study conducted for the Becton Dickinson VACUTAINER® Brand Safety-Lok™ Blood Collection Set:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each tested parameter. Instead, it focuses on demonstrating equivalence to the predicate device. The general acceptance criterion implied is that the modified device's performance is equivalent to, or improved compared to, the current (predicate) device, and that any identified differences do not affect overall product performance.
| Parameter Tested | Reported Device Performance (Modified vs. Current) | Implicit Acceptance Criteria / Goal |
|---|---|---|
| Flow Rates | Demonstrated equivalent performance | Equivalent to current product |
| Shield Activation Force | Demonstrated equivalent performance | Equivalent to current product |
| Shield Sustaining Force | Demonstrated equivalent performance | Equivalent to current product |
| Shield Override Force | Demonstrated equivalent performance | Equivalent to current product |
| Heat Stake Break Force | Demonstrated equivalent performance | Equivalent to current product |
| Pressure Testing | Demonstrated equivalent performance | Equivalent to current product |
| I.V. Penetration | Demonstrated equivalent performance | Equivalent to current product |
| Drag Forces | Demonstrated equivalent performance | Equivalent to current product |
| Ease of Package Opening | Equivalent or improved | Equivalent to or better than current product |
| Ease of Safety Shield Activation | Equivalent or improved | Equivalent to or better than current product |
| Ease of Disposal | Demonstrated equivalent performance (implied by "equivalent or improved" for other "ease of" metrics) | Equivalent to or better than current product |
| Successful Safety Shield Activation (Simulated & Actual Use) | Successful activation for both principal and predicate devices | 100% successful activation or equivalent to current product |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "a study" and "studies" but provides no numerical sample sizes for any of the performance tests (flow rates, forces, pressure, penetration, drag, or simulated/actual use).
- Data Provenance: The study was conducted by Becton Dickinson VACUTAINER Systems (BDVS) comparing their principal device to the predicate device manufactured by Nissho. This implies the data is proprietary and likely originated from internal testing within BDVS or their contracted labs. The document does not specify the country of origin of the data beyond "Becton Dickinson VACUTAINER Systems, Franklin Lakes, New Jersey." It is retrospective in the sense that the study was completed and reported on December 19, 1996, to support a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this study. The study involves functional and simulated/actual use performance comparisons of medical devices, not diagnostic or image-based evaluations requiring expert interpretation for ground truth establishment. The "ground truth" here is the objective functional performance of the devices.
4. Adjudication Method for the Test Set
This information is not applicable. The nature of the tests (quantitative measurements of flow rates, forces, pressure, etc., and observations of "ease of" attributes and "successful activation") does not lend itself to an adjudication method typically used for subjective diagnostic assessments in clinical studies. The "adjudication" was likely an internal process of data collection, analysis, and comparison by the Becton Dickinson engineering and quality teams.
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 information is not applicable. This study is about the functional performance of a blood collection device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a study of a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used in this study is based on objective functional performance measurements of the physical device and simulated/actual use observations. For example:
- For flow rates, the ground truth would be the measured flow rate.
- For shield activation forces, the ground truth would be the measured force.
- For successful safety shield activation, the ground truth would be the direct observation of whether the shield successfully activated or not.
- For "ease of" metrics, the ground truth would be based on user feedback or objective criteria established for those assessments.
8. The Sample Size for the Training Set
This information is not applicable. This study does not involve machine learning algorithms or a "training set" in that context. The "training" for such a device would be the design and manufacturing process, optimized through engineering principles and iterative testing, not algorithmic training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.