(29 days)
The Encore™ 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
Individual Device Intended Use:
- Encore™ 26 Inflation Device: Inflation device are indicated for use with balloon . dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
- GateWay™ Plus Y-Adapter: Used for providing hemostasis around quidewires, . balloon dilatation catheters, and other therapeutic devices
- Torque Device: Used for guidewire manipulation during general intravascular . procedures.
- Guidewire Insertion Tool: Used for percutaneous introduction and placement of . guidewires in vascular procedures.
The Encore™ Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
The provided text describes a 510(k) premarket notification for the Encore™ 26 Advantage Kit. This submission details the device's intended use and claims substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or a study proving that the device meets such criteria. The "Summary of Non-Clinical Testing" mentions that design verification was performed, and "No additional testing was required for kit inclusion. Sterility testing was performed to verify the overall substantial equivalence to the predicates. No additional biocompatibility testing was required." The "Summary of Clinical Testing" explicitly states, "Clinical Evaluation was not required for this device."
Therefore, I cannot provide the requested information in a table or respond to the specific questions because the provided text does not contain any data related to acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either test or training sets. This device was cleared based on substantial equivalence to an existing predicate device, not through a performance study against specific acceptance criteria.
§ 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.