(86 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Function/Efficacy | |
| Ability to maintain a leak-proof seal. | Demonstrated equivalence to syringes with natural rubber stoppers. |
| Perform after exposure to all expected sterilization conditions (radiation, ethylene oxide, autoclave). | Demonstrated equivalence to syringes with natural rubber stoppers. |
| Exhibit actuation forces equivalent to current natural rubber containing syringes. | Demonstrated equivalence to syringes with natural rubber stoppers. |
| Meet stringent requirements for use in syringe pump applications, including low flow rate (0.01 ml/hr) neonatal administration of fast-acting drugs. | Demonstrated equivalence through syringe pump application testing covering the range of use, including low flow rate use. |
| Safety | |
| Functional Safety: Consistency of plunger movement for low flow rate neonatal administration (e.1 ml/hr to 1.0 ml/hr). | The proposed synthetic "latex/natural rubber free" plunger tip meets this requirement, demonstrating functional equivalence to the predicate device. |
| Biocompatibility: Pass all biological and chemical evaluations recommended in ISO biocompatibility guidance. | Proven to be safe over specified manufacturing process and formulation variables; passes all biological and chemical evaluations. |
| Functional Safety (overall): Functional equivalence in all applications, including neonatal syringe pump use. | Demonstrated functional equivalence to the predicate device. |
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.
§ 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).