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THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS A WINGED BLOOD COLLECTION NEEDLE AND FLEXIBLE TUBING FOR VENIPUNCTURE TO COLLECT BLOOD SPECIMENS FROM PATIENTS OR MONITORING BLOOD PRESSURE. THE SAFETY-LOK™ BLOOD COLLECTION SET ALSO CONTAINS A NEEDLE SAFETY SHIELD WHICH MINIMIZES THE POSSIBILITY OF NEEDLESTICKS IF MANUALLY ACTIVATED FOLLOWING BLOOD COLLECTION. THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS ALSO RECOMMENDED FOR USE IN PATIENTS WITH SMALL VEINS.

THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS ALSO INDICATED FOR THE INTRAVENOUS ADMINISTRATION OF FLUIDS AND MAY BE USED FOR ANY PATIENT POPULATION WITH CONSIDERATION GIVEN TO PATIENT SIZE, APPROPRIATENESS FOR THE SOLUTION BEING INFUSED AND DURATION OF THERAPY.

The VACUTAINER® Brand Blood Collection Sets and Safety-Lok™ Blood Collection Set is a sterile winged blood collection needles with flexible tubing and a female luer adapter manufactured by Becton Dickinson VACUTAINER Systems, Sumter, South Carolina. The Safety-Lok™ Blood Collection Set is provided with a safety shield for covering the used needle prior to disposal. A male fuer adapter is provided on specific reorder numbers. The male luer adapter contains a non-patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter.

The provided document is a 510(k) Premarket Notification for the Becton Dickinson VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's intended use and general characteristics.

Based on the available information, the document does not contain details about acceptance criteria, specific performance studies with quantifiable results against those criteria, or information on AI-related aspects.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance:

   • N/A. The document states: "Biocompatibility of the VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set has been demonstrated in testing which was performed in accordance with the ISO 10993 Biological Testing requirements." and "Further, functional performance of the Safety-Lok™ Blood Collection Set has previously been demonstrated in 510(k) Premarket Notifications to the FDA."
   • This indicates that performance testing was conducted, but the specific acceptance criteria and the quantitative or qualitative results against them are not included in this summary.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • N/A. This information is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • N/A. This information is not provided. The study is described as biocompatibility and functional performance testing, not a study requiring expert readers to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. This information is not provided.

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:

   • N/A. This document predates widespread AI in medical devices (dated January 30, 1998). No MRMC or AI-assisted studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • N/A. This document is for a physical medical device (blood collection set), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A. The document mentions "Biocompatibility... in accordance with the ISO 10993 Biological Testing requirements" and "functional performance." For a physical device like a blood collection set, ground truth would typically be established by standardized physical/chemical tests, biological assays, and possibly direct observation of function (e.g., successful blood draw, secure safety mechanism activation). Specific details are not given.

8. The sample size for the training set:

   • N/A. No training set for an algorithm is mentioned or relevant to this device.

9. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for an algorithm.

Summary of what the document does provide regarding studies:

• Type of Study: Biocompatibility testing (in accordance with ISO 10993) and functional performance testing.
• Purpose: To demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices for regulatory approval.
• Results Mentioned: Biocompatibility "demonstrated," and functional performance "previously demonstrated" in earlier 510(k) notifications. No specific data or acceptance criteria are detailed in this particular summary.

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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.

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.

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