(81 days)
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and 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 the body. Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.
The provided document describes a 510(k) premarket notification for an Automatically Retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance in the way typically seen for diagnostic algorithms.
Therefore, the requested information elements related to specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and ground truth types are not applicable to this document's content.
However, I can extract the acceptance criteria and a summary of how the device meets them based on the equivalence testing performed to satisfy the 510(k) submission.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the comparison to the predicate device and relevant industry standards. The reported device performance is that it meets these criteria, demonstrating equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance: | |
| Delivery Accuracy (per ISO 7886-1:1993/Corrigendum 1:1995) | Conforms to ISO 7886-1:1993/Corrigendum 1:1995 |
| Needle Cover Strength ( |
§ 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).