(21 days)
INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter.
20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catherectomy devices, stent delivery systems, intravascular ultrasound devices.)
The INDEFLATOR 20/30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge.
The 20/30 PRIORITY PACK™ is comprised of the INDEFLATOR 20/30™ 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 device submission, K961471, for the INDEFLATOR 20/30™ Inflation Device and 20/30 PRIORITY PACK™ does not contain information typically found in studies designed to establish acceptance criteria for AI/ML-based medical devices.
The document is a 510(k) Summary for a medical device that appears to be a manually operated mechanical inflation device for use in cardiovascular procedures. The submission focuses on demonstrating substantial equivalence to predicate devices (ACS INDEFLATOR 20/20™ and Baxter Inflation Pro™ II) based on similar indications, methods of use, design, and manufacturing processes.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria because the provided text describes a traditional medical device, not an AI/ML system. The concepts of "acceptance criteria" and "study" in the context of AI/ML performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets) are not relevant to this type of device submission.
§ 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.