(59 days)
The device is intended for the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.
The device consists of a polyurethane specimen container used in conjunction with a stainless steel cone retractor. The excised gallbladder, or other similar tissue specimen, is placed within the specimen bag. The bag is then brought within the confines of the cone retractor. The cone retractor is then used to shield the specimen during trans-abdominal extraction. The device can operate through a variety of trocar port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.
The provided text describes a 510(k) submission for the DeGall II Laparoscopic Gallbladder Extractor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document states: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to withdraw and contain specimens under conditions in excess of those encountered during normal clinical use." This is a general statement about testing without detailing specific acceptance criteria, method, or results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 as the necessary information is not present in the provided 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.