Search Results

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.

Ask a specific question about this device