(83 days)
The Duploject® is intended for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with a syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.
The Duploject® is a single-use, disposable syringe, which is used in the application of two nonhomogenous fluids or solutions onto a surgical site. The Duploject® consists of two disposable syringes and withdrawal needles for reconstitution of the solutions. It also contains the following components for use in the simultaneous application of the two solutions: a clip, with a common plunger, is used to join the two identical disposable syringes together and ensures that equal volumes of the two components are fed through a common joining piece and mixed prior to dispensing. Three extra application needles and one extra joining piece are included in the package to use as replacements, if needed. The Duploject® is sterile and non-pyrogenic.
This looks like a 510(k) premarket notification for a medical device called Duploject®. However, it does not contain the specific information you requested regarding acceptance criteria or the study proving the device meets those criteria.
The provided text focuses on:
- Device Description: What the Duploject® is and how it works.
- Intended Use: The purpose of the device.
- Comparison to Predicate Devices: How the Duploject® is similar to other legally marketed devices (Duoflo Dispenser, RMI Dual Fluid Irrigating Syringe, Surgical Sealant Dispenser). This comparison table is a key part of establishing substantial equivalence, which is the basis for 510(k) clearance.
- FDA Clearance Letter: Official communication from the FDA stating that the device is substantially equivalent and can be marketed.
While the table labeled "Comparison of device characteristics to predicate" does list "Delivery Accuracy," it only states "The slide bar on the syringe holder ensures delivery of equal amounts of the contents of the syringes." This is a feature description, not a quantitative acceptance criterion or a report of measured performance. There is no study data presented to "prove" this beyond the assertion.
Therefore, I cannot provide the requested information from the given text alone. The document is a regulatory submission for substantial equivalence based on comparison to predicate devices, not a detailed performance study report.
§ 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).