(78 days)
The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
The PLUS 30 PRIORITY PACKTM:
INDEFLATOR PLUS 30TM Inflation Device- See description above.
PLUS 30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)
INDEFLATOR PLUS 30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.
The PLUS 30 PRIORITY PACK™ is comprised of the INDEFLATOR PLUS 30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.
This 510(k) summary is for a medical device (Inflation Device) and does not contain information related to an AI/ML powered device. Therefore, it is not possible to extract the requested information about acceptance criteria, study design, and ground truth as these concepts are not applicable to the provided text.
The document describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not present any performance studies or acceptance criteria in the context of an AI/ML algorithm.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.