(81 days)
The FemRx "00"STARTM System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection, morcellation and aspiration of tissue in the urethra, prostate and bladder.
The FemRx 700 STARTM System is a refined urologic resectoscope. The device consists of: 1) an electrode/tissue morcellator assembly including drive cable, 2) a sheath and; 3) a motor drive unit. 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/morcellator 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 is a 510(k) summary for the FemRx "00"STARTM System, a urological transurethral resection device. It describes the device's intended use, its components, and how it operates. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other details requested in questions 1 through 9.
The document states that "The system is identical (substantially equivalent) to the FemRx "EPSTARTM System used in gynecological applications." This implies that the device is being cleared based on its substantial equivalence to a previously cleared device, rather than through new performance studies specifically for the "00"STARTM System as a urological device.
Therefore, I cannot provide the requested information based on the input text. All of the requested information, such as acceptance criteria, study details, sample sizes, and ground truth methodologies, are entirely absent from the provided 510(k) summary.
§ 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.