(181 days)
The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.
The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv. The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction. The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity. The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function. The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.
The provided text is a 510(k) summary for the device ENDOFLOW II – Irrigation, Warming and Suction System. It outlines the device's intended use and compares its technological characteristics and functions to predicate devices to establish substantial equivalence.
However, the document does not contain specific details about acceptance criteria, reported device performance figures, sample sizes, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.
The "H. Performance Data" section merely states: "Performance testing have been executed to validate the performance and safety of the devices. Verification and validation activities were conducted to establish the performance and safety characteristics of the ENDOFLOW® II. The results of these activities demonstrate that the ENDOFLOW® II is safe and effective when used in accordance with its intended use and labeling." This is a general statement and does not provide the requested detailed information about the study or its outcomes.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, and data provenance based on the provided text. The document confirms that performance testing was performed and that the device was found safe and effective, but it doesn't offer the detailed evidence of that testing.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.