Search Results

The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intradermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intradermal, intra-muscular or subcutaneous).

The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Single-use syringe with needle protection system. Syringes sizes: .3, .5, & 1 ml.

Function: Syringes are used for aspiration/injection of fluids. The device contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used need as syringe combination.

This document describes the safety and effectiveness of the Becton Dickinson SafetyGlide™ Syringe, comparing it to predicate devices. The syringe includes a needle protection system designed to prevent accidental needle sticks after use.

Here's an analysis of the provided text based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the "sharps injury prevention feature was compared to the predicate devices."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparison appears to be based on physical performance parameters rather than expert clinical assessment.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The comparison appears to be based on direct testing of performance parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a syringe, and the study focuses on physical performance characteristics, not on the interpretation of medical images or data by multiple readers. The prompt mentions "human readers improve with AI vs without AI assistance," which is not applicable to a device like a syringe.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device is a physical syringe, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used:

The ground truth used for this study appears to be performance metrics against established engineering standards or the performance of legally marketed predicate devices. The criteria (activation forces, security of assembly, safety barrier resistance, impact resistance) are measurable physical properties, not clinical outcomes, pathology, or expert consensus in a diagnostic sense.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is a physical medical device and not an AI or machine learning model. Therefore, no training set size is mentioned.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set for a physical device.

Ask a specific question about this device

The general use syringes are intended for the aspiration and injection of fluids. Insulin syringes are intended for the injection of insulin.

This change in syringe plunger tip formulation is for the Becton Dickinson syringe. Products include: General purpose and insulin syringes. Sterile and non-sterile syringes. Syringes with and without needles attached. No design changes are being made.

The Becton Dickinson Single Use Hypodermic and Insulin Syringes, with an alternate latex-free rubber formulation for the plunger tip, were assessed for functional equivalence to the predicate device.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. However, it indicates these were conducted for the alternate plunger tip formulation to demonstrate equivalence to the current plunger tip formulation (predicate device).
The data provenance is not specified in terms of country of origin, but it is a retrospective evaluation aiming to demonstrate equivalence to an existing product.

3. Number of Experts and Qualifications

This information is not provided. The study involves laboratory and performance testing of a medical device, not a diagnostic assessment typically requiring expert interpretation of clinical images or data.

4. Adjudication Method

Not applicable. This was a technical performance study on a physical device, not an assessment requiring adjudication of diagnostic interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission concerns a material change in a syringe plunger tip and its functional equivalence, not a comparative effectiveness study involving human readers or AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This submission is for a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the equivalence study was established by comparing the performance indicators of the alternate plunger tip formulation against the established functional performance and specifications of the predicate device's (current plunger tip formulation) performance and relevant international standards (ISO, USP). Essentially, the predicate device's measured performance served as the "ground truth" for comparison for each test.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection.

Single use sterile and non-sterile disposable hypodermic syringes manufactured by Becton Dickinson.

This document describes changes to the Becton Dickinson Single Use Hypodermic Syringes, specifically a change in the plunger tip material from natural rubber to synthetic rubber. The submission aims to demonstrate that the modified device is substantially equivalent to the predicate device.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in a quantitative format with specific thresholds. Instead, it describes "equivalence" to the predicate device in various functional and safety aspects.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for testing. It refers to "syringes manufactured using the new synthetic 'latex/natural rubber free' stopper material" having "demonstrated equivalence" in various tests. There's no information about the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document describes technical and functional testing of a medical device, not a diagnostic or observational study requiring expert interpretation of results to establish ground truth. Therefore, the concept of "experts establishing ground truth" as typically applied in AI/diagnostic studies is not applicable here. The ground truth would be established by objective measurements and specifications.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements of mechanical and biological properties, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating human interpretation of medical images or data. This submission focuses on the mechanical and biological performance of a syringe plunger tip, which does not involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth is based on:

• Predicate Device Performance: The established, safe, and effective performance of the existing natural rubber plunger tip is the benchmark.
• Objective Functional Specifications: Requirements for leak-proof seals, actuation forces, performance under sterilization, and specific pump application parameters serve as the objective ground truth against which the new device's performance is measured.
• ISO Biocompatibility Guidelines: These provide the standard for biological and chemical safety, serving as the ground truth for biocompatibility claims.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment process.

Ask a specific question about this device