(30 days)
The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.
Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery. gynecology, and urology. The trocars are made from biocompatible materials. They are available as reusable in 3.5, 5, 10 or 12mm diameter with lengths of 60, 110, and 150mm. The trocars are offered with or without a stopcock, and threaded or smooth. The devices are color coded for easy identification.
This 510(k) submission (K101937) for the Aesculap Hybrid Trocar System does not include any data from a clinical study or performance data to prove the device meets acceptance criteria.
The document explicitly states:
"No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices."
This indicates that clinical acceptance criteria and subsequent studies demonstrating their fulfillment were not a requirement for this particular submission. The substantial equivalence was established by comparing the device's technological characteristics to existing predicate devices (K942053, K982623, and K071976).
Therefore, I cannot provide the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, etc., as it is not present in the provided document.
§ 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.