(67 days)
THE MEDICAL ENGINEERING LABORATORIES, INC, TRI TALON RETRIEVAL FORCEPS (TRIPOD) IS INTENDED TO FOR USE IN THE FOLLOWING APPLICATIONS:
GASTROSCOPE, SIGMOIDOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOOD IMPACTION OR FOREIGN OBJECTS FROM THE ESOPHAGUS OR STOMACH.
COLONOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENTS CHANNEL FOR REMOVAL OF FOREIGN OBJECTS OR POLYPS FROM THE COLON.
BRONCHOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOREIGN OBJECTS FROM THE LUNG.
URETEROSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR THE REMOVAL OF STONES AND FOREIGN OBJECTS FROM THE URETER AND BLADDER.
Not Found
The provided text is related to a 510(k) clearance letter for a medical device called "TRI TALON RETRIEVAL FORCEPS". This document indicates FDA clearance for marketing based on substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance metrics, study design, sample size, ground truth establishment, or expert involvement typically found in a clinical performance study report.
Therefore, I cannot fulfill your request for the detailed information as the provided text does not contain it. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on new clinical performance data with specific acceptance criteria in the way you've described for AI/diagnostic devices.
To provide the requested information, I would need a clinical study report or a different type of regulatory submission that details the performance evaluation of the device against specific criteria.
§ 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.