(230 days)
The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.
The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a sealed chamber during ablation, ensuring continuous liquid supply and suction.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the DRG Reaction Chamber/Safety Tip, primarily focusing on its substantial equivalence to a predicate device for market clearance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).