FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)

K964892 · Gynecare Innovation Center · FJL · Feb 4, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964892
• Device Name: FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
• Applicant: Gynecare Innovation Center
• Product Code: FJL · Gastroenterology, Urology
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Refined urologic resectoscope; used for transurethral resection of prostate, bladder, and urethral tissue. Input: standard telescope coupled to operative video camera; electro-surgery unit (ESU) for energy. Operation: surgeon inserts telescope; squeezes finger rings to move loop assembly distally; applies electrocautery current; spring-loaded mechanism returns device proximally to cut/coagulate tissue under visual control. Features separate inflow/outflow channels for continuous irrigation/visibility. Used in hospital environments by urologists. Output: resected tissue; visual feedback via video monitor. Benefit: enables controlled tissue resection and coagulation during urological procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical resectoscope; manual spring-loaded axial loop assembly; compatible with standard ESUs; includes irrigation channels for fluid circulation; requires external telescope and video camera system.

Indications for Use

Indicated for urological transurethral resection of tissue in the urethra, prostate, and bladder by trained professional urologists in hospital environments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FemRx TURPSTAR™ System
• Circon/ACMI USA Elite™
• Olympus A2757 Resectoscope

Submission Summary (Full Text)

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K964892

FEB - 4 1997

# 510(K) SUMMARY

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 TURPSR™ 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.

The system as described in the preceding 3 paragraphs is identical (substantially equivalent) in all design and component aspects, except one, to the FemRx TURPSTAR™ System which is also used in urological applications. The TURPSTAR™ system has an additional component, a morcellator, which uses an arthroscopic shaver to reduce the size of the resected tissue prior to the tissue being carried out the fluid path. Neither of the other referenced predicate devices (the Circon/ACMI USA Elite™ and the Olympus A2757 Resectoscope) nor the TURPSR™ have a morcellator.

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