(70 days)
The AEON™ Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.
The AEON™ Retrieval Bag, is a sterile, disposable, single-use, individually-packaged polymeric sack with laparoscopic introducer system that is designed to facilitate the removal of tissues or organs in the process of laparoscopic surgery.
The system consists of a sack connected to a laparoscopic introducer system. The introducer system comprises an elongated rod for laparoscopic insertion, flexible arms to allow deployment of the sack in the surgical cavity, and a drawstring to facilitate sack closure and extraction.
The provided text describes the AEON Retrieval Bag, a medical device for laparoscopic surgery, and its 510(k) submission to the FDA. However, the document does not contain information about the acceptance criteria and the study that proves the device meets specific performance criteria.
Instead, it states:
- "Nonclinical tests were conducted with the AEON™ Retrieval Bag to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications. Devices are tested for bag material/seal strength, bag material/seal leak integrity, and bag resistance to breakage in simulated removal testing. Real time shelf life testing was also performed."
- "This submission does not include data from Clinical Studies."
Therefore, I cannot provide the requested table, sample sizes, expert details, or other study-specific information because it is not present in the given text. The document focuses on regulatory approval based on substantial equivalence to a predicate device and non-clinical testing without detailing specific acceptance criteria or study results for those tests.
§ 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.