(49 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Activation Forces | Performed in a similar manner to the predicate device. |
| Security of Assembly | Performed in a similar manner to the predicate device. |
| Safety Barrier Resistance | Performed in a similar manner to the predicate device. |
| Impact Resistance | Performed in a similar manner to the predicate device. |
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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).