(12 days)
The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.
The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.
The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Domier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).
The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).
The provided text is a 510(k) summary for the Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-DO5 and Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P. It describes the devices and their intended use but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting detailed clinical study results. It is likely that such study details would be found in other accompanying documents that are not included here, if they were required for this type of device.
Therefore, I cannot provide the requested table and 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.