[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]

K962506 · Gynecare Innovation Center · FJL · Sep 16, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962506
• Device Name: [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
• Applicant: Gynecare Innovation Center
• Product Code: FJL · Gastroenterology, Urology
• Decision Date: Sep 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FemRx TURPSTAR™ 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.

Device Story

System consists of electrode/tissue morcellator assembly, sheath, and motor drive unit; used with standard telescope and video camera system. Operates by sliding loop/morcellator assembly axially; cutting/coagulation achieved via electrocautery current from compatible ESU. Surgeon controls movement via finger rings; cutting occurs during proximal return stroke. Continuous fluid circulation provided via separate inflow/outflow channels for visualization. Used in hospital environments by urologists. Provides visual control via video monitor; facilitates tissue removal; benefits patient through efficient resection/morcellation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrode/tissue morcellator assembly, sheath, motor drive unit. Compatible with standard telescopes, video camera systems, and electro-surgery units (ESUs). Features separate channels for irrigant inflow/outflow. Mechanical axial sliding mechanism for tissue resection.

Indications for Use

Indicated for urological transurethral resection, morcellation, and aspiration of tissue in the urethra, prostate, and bladder in patients requiring such procedures, performed by trained urologists.

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 OPERASTAR™ System

Submission Summary (Full Text)

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09/11/96 18:49 FEM RX → 13015942339 NO.307 D02
SEP 16 1996
510(K) SUMMARY K 962506

The FemRx $\text{^TURPSTAR™}$ 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 $\text{^TURPSTAR™}$ 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.

The system is identical (substantially equivalent) to the FemRx $\text{^OPERASTAR™}$ System used in gynecological applications.

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