(127 days)
The Pathfinder Endoscope Overtube with Balloon is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
The Pathfinder Endoscope Overtube with Balloon device consists of a hollow tube with a balloon at the distal end for use over a flexible gastrointestinal endoscope. The purpose of the balloon is to contact the lumen walls to provide stabilization to the distal end of the overtube within the GI tract. The endoscope is inserted through the proximal end of the device and comes out the distal end. The free space between the overtube and the endoscope is lubricated with water through the irrigation line by connecting to the irrigation/water Luer (female Luer lock fitting) and injecting water. The vacuum line is connected to free space within the device and is completely contained. A source of vacuum must be connected to the barb fitting per the diagram below for the overtube to transition between the flexible and rigid conditions. The balloon line is connected to an extrusion within the device that creates an air pathway from handle to the balloon. An inflation device must be connected to the Luer (male Luer lock fitting) to inflate and/or deflate the balloon. The handle rotator has two positions. The first position connects the device to atmosphere (vent) to stay in the flexible condition. The second position connects the device to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. Balloon inflation and deflation are actuated and controlled by an existing balloon controller unit within the endoscopy suite. The device must be connected to the balloon controller to transition into the inflated and deflated condition.
The provided text does not contain information about a study that proves a device meets acceptance criteria related to AI/algorithm performance.
The document is a 510(k) Premarket Notification from the FDA to Neptune Medical, Inc. for their "Pathfinder Endoscope Overtube with Balloon Device." It describes the device, its intended use, comparison to predicate devices, and summaries of functional and performance bench testing, and biocompatibility testing. It explicitly states:
- "No clinical testing was applicable to this submission."
- The entire submission focuses on a physical medical device, not an AI or algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI-powered device's performance, as the provided text pertains to a traditional medical device not involving AI.
§ 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.