(59 days)
The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and /or creation of anastomoses, has application in multiple open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) #970720.
This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary simply states that:
- "All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) #970720."
- "The technological characteristics of the ENDOPATH® EZ45 Endoscopic Linear Cutter are identical to those described in 510(k) #970720."
- "The ENDOPATH® EZ45 Endoscopic Linear Cutter performance is identical to that described in 510(k) #970720."
This means that the current device (ENDOPATH® EZ45 Endoscopic Linear Cutter) is being claimed as substantially equivalent to a previously cleared device (referenced by 510(k) #970720). Therefore, the detailed performance data and acceptance criteria would be found in the original 510(k) submission (#970720), not in this summary.
Based on the provided text, I cannot extract the requested information regarding acceptance criteria or a study. All answers to your questions would be "Not provided in this document" or "Information refers to a predicate device's submission."
§ 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.