KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE

K960323 · KARL STORZ Endoscopy-America, Inc. · FGB · Apr 22, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960323
• Device Name: KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Apr 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA ‘Gelet’ uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.

Device Story

Semi-rigid ureteroscopes with graduated shafts and remote eyepiece; Alken motion control device attaches to irrigation/instrument channel. Manually operated, reusable surgical instruments. Used by physicians in clinical/surgical settings for ureteral visualization and guidance of laser fibers, electrodes, or small instruments. Provides precise mechanical control for accessory introduction; facilitates diagnostic and therapeutic ureteral procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Semi-rigid endoscopes; chromium plated Monel 400 body contact materials; manual operation; reusable.

Indications for Use

Indicated for visualization of the ureter and performance of diagnostic and therapeutic procedures in patients requiring ureteroscopic intervention.

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.

Submission Summary (Full Text)

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Karl Storz
Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 387
Fax [phone]
K960323
APR 22 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA’s knowledge.

**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]

**Contact:**
Betty M. Johnson
Manager, Regulatory Affairs

**Device Identification:**
**Common Name**
Semi-rigid ureteroscope and accessory

**Trade Name**
Karl Storz ‘Gelet’ Uretero-Renoscopes
Karl Storz Alken motion control device

**Indication:** The KSEA ‘Gelet’ uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.

**Device Description:** The KSEA ‘Gelet’ uretero-renoscopes are semi-rigid endoscopes with graduated shafts and a remote eyepiece. The Alken motion control device is an attachment to the irrigation/instrument channel to control the introduction and movement of accessories. Both devices are manually operated, reusable surgical devices. The body contact materials are chromium plated Monel 400®.

**Substantial Equivalence:** The KSEA ‘Gelet’ uretero-renoscopes and the Alken motion control device are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same or similar. The minor differences in dimensions between the KSEA ‘Gelet’ uretero-renoscopes, the Alken motion control device and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed: Betty M. Johnson
Manager, Regulatory Affairs

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