(128 days)
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
| Acceptance Criteria (Test) | Reported Device Performance (Alternate Plunger Tip) |
|---|---|
| Leak Test (ISO 7886 and ISO 8537) | Passed; demonstrated equivalence to current plunger tip formulation. |
| Autoclavibility | Satisfactorily passed (autoclaved at 270°F, 15 minutes, then passed ISO leak testing). |
| Syringe Infusion Pump Performance | Demonstrated equivalent performance to natural rubber plunger tip samples. |
| Chemical Testing | Acceptable per ISO and USP requirements. |
| Biocompatibility | Satisfactorily completed. |
| Plunger Actuation Forces | Equivalent or superior to the current plunger tip. |
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.
§ 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).