(76 days)
The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments.
The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments. The Injecto Flush was also designed to have no effect on on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit.
I apologize, but the provided text "DEC 30 1996 SUMMARY The Injecto Flush was designed to give a more practical and consistent way of flushing out reusable biopsy forceps and cannulated instruments... 9" is a product description for a medical device called "Injecto Flush" and doesn't contain any information about a study, acceptance criteria, device performance, sample sizes, expert qualifications, or any of the other specific details requested in your prompt.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
To answer your request, I would need a text that describes a study evaluating the Injecto Flush device, including details about its performance, the methodology of the study, and the criteria used to deem it successful.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.