(42 days)
The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger.
The Endoscopic Applicator device is a sterile single use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. The Endoscopic Applicator consists of two components; (1) a minimally reflective stainless steel cannula and (2) a plastic stylet (obturator). The Endoscopic Applicator is designed with a luer connector, for connection to a syringe containing the hemostatic agent. The packaging used for the Endoscopic Applicator is a pouch that consists of a see-through laminated film and TYVEK. Alternatively, a second pouch may be used. Either package configuration is placed within a paperboard carton.
The provided text does not contain information about acceptance criteria or a study proving that an Endoscopic Applicator device meets acceptance criteria.
Instead, the document is a 510(k) summary for a medical device (Endoscopic Applicator) seeking substantial equivalence to a predicate device. It explicitly states that "performance testing was considered unnecessary" and "clinical data was deemed unnecessary to demonstrate equivalence of the new device to the predicate device for its intended purpose."
Therefore, I cannot provide the requested information based on the given text.
§ 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.