(73 days)
The MicroMyst Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
The MicroMyst Applicator will be configured using the following components: Applicator (14cm long, multi-lumen shaft that provides separate channels for the flow of two fluids and filtered air) Air line with filter (a poly (vinyl chloride) tubing with an integral 0.2 µL filter; the free end of this tubing connects to a flow source or flow-regulator)
The provided text is related to a 510(k) submission for a medical device called the "MicroMyst Applicator." However, it focuses primarily on regulatory approval and equivalence to a predicate device, and does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as outlined in your prompt.
The document highlights:
- Device: MicroMyst Applicator
- Indication for Use: Simultaneous delivery of two non-homogenous solutions onto a surgical site.
- Safety and Effectiveness: Stated to be demonstrated through biocompatibility and in vitro bench testing, supporting substantial equivalence to a predicate device.
- Conclusion: The device is substantially equivalent to a predicate device based on safety and effectiveness data, same indications for use, and same operating principle.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets specific performance criteria from the provided text. The document describes a regulatory submission for a device, not a performance study with detailed methodology, results, or ground truth establishment.
To answer your questions accurately, I would need a document that describes:
- Specific performance metrics for the device (e.g., flow rate accuracy, mist uniformity, delivery precision).
- Quantifiable acceptance criteria for those metrics.
- Details of a study (e.g., bench testing, clinical trial) that measured these metrics.
- The results of that study compared to the acceptance criteria.
- Information on sample sizes, ground truth establishment, expert involvement, and statistical methods.
§ 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).