(60 days)
The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.
The FemRx 100°SR™ System is a refined urologic resectoscope. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs).
The system is designed to cut and coagulate prostate tissue by sliding the loop assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.
This document describes a medical device, the FemRx TURPSR™ System, which is a urological resectoscope. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and does not contain information related to acceptance criteria, a study proving performance against such criteria, or any of the detailed aspects requested in your prompt regarding AI/algorithm performance.
Therefore, I cannot extract the requested information from the provided text. The document describes a traditional surgical instrument and not a device incorporating AI or requiring performance validation against specific algorithmic metrics.
§ 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.