(69 days)
The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating luer lock. The manometer is graduated between vacuum and 30 atm.
The provided text is a 510(k) premarket notification for a medical device called the "Fluent Inflation Device." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving those criteria are met in the format of a clinical or AI-based diagnostic study.
Here's an analysis of what can be extracted and what information is missing based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Specified acceptance criteria for bench tests | Results of verification tests met the specified acceptance criteria |
Missing Specifics: The document states that "results of the verification tests met the specified acceptance criteria," but it does not provide the specific quantitative acceptance criteria (e.g., "pressure retention for X minutes with
§ 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.