12 URETEROSCOPES/URETERO-RENOSCOPES

K963855 · Richard Wolf Medical Instruments Corp. · FGB · Apr 3, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963855
• Device Name: 12 URETEROSCOPES/URETERO-RENOSCOPES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.

Device Story

Compact Operating Fiber Uretero-Renoscopes and Ureteroscopes are thin, fiber-optic endoscopes designed for visualization of the ureter and kidney. Devices feature an oval channel for irrigation and the simultaneous use of one or two auxiliary instruments; an additional guide is used for lithoclast applications. Available in various lengths, shorter models are used for ureteral procedures, while longer models (uretero-renoscopes) reach the kidney. The devices are operated by physicians in a clinical setting. The physician views the anatomy directly through an eyepiece. The device facilitates diagnostic and therapeutic interventions, such as stone disintegration, biopsy, and foreign body removal, providing clinical benefit through minimally invasive access to the upper urinary tract.

Clinical Evidence

No clinical tests performed. Evidence is limited to bench testing, specifically mechanical load (bending) tests to ensure shaft integrity and validation of optical quality following fractional steam sterilization cycles.

Technological Characteristics

Fiber-optic endoscopes with high-resolution image bundles (up to 30,000 pixels). Features include an atraumatic tip, wide-angle telescope, and an oval irrigation/instrument channel. Designed for steam sterilization (autoclavable).

Indications for Use

Indicated for patients requiring examination of the ureter and kidney, including diagnostic and therapeutic procedures such as lithotripsy, biopsy, or foreign body removal.

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

• Cysto-Urethroscope 4616 (pre-enact.)
• Cysto-Urethroscope 8616.10 (pre-enact.)
• Slender Uretero-Renoscope 27023AS (K940464)
• Ureteroscopes Micro-6 / Micro-6 long (pre-enact.)
• Operating Uretero-Renoscope 27024KE/KB (K940464)
• Operating Ureteroscopes MR-7 Series (pre-enact.)

Submission Summary (Full Text)

{0}

108

Richard Wolf Medical Instruments Corporation

510(k) Summary of Safety and Effectiveness

APR - 3 1997

353 Corporate Woods Parkway

Vernon Hills, Illinois 60061

Telephone: [phone]

Fax: [phone]

K963855

| Submitter: | | | Date of Preparation: August 23, 1996 | |
| --- | --- | --- | --- | --- |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | | | Phone number (include area code): [phone] | |
| Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: Compact Operating Fiber Uretero-Renoscopes and Ureteroscopes | | Model number: 8712.402, 8702.402, 8703.402, 8707.402, 8705.402, 8719.401, 8708.401, 8718.401, 8708 403, 8718.403, 8714.401, 8704.401 and accessories: 8952.313, 8954.765, 8954.766, 8708.253 | | |
| Common name: Ureteroscopes | | Classification name: Endoscope and accessories | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 pre-enact. | 1 Cysto-Urethroscope 4616 | | 1 Richard Wolf M.I.C. | |
| 2 pre-enact. | 2 Cysto-Urethroscope 8616.10 | | 2 Richard Wolf M.I.C. | |
| 3 K 94 04 64 | 3 Slender Uretero-Renoscope 27023AS | | 3 Storz | |
| 4 | 4 Ureteroscopes Micro-6 / Micro-6 long | | 4 Circon | |
| 5 K 94 04 64 | 5 Operating Uretero-Renoscope 27024KE/KB | | 5 Storz | |
| 6 | 6 Operating Ureteroscopes MR-7 Series | | 6 Circon | |

# 1.0 Description

The submitted devices are thin endoscopes with fiber image bundle and an oval channel for irrigation and for use of one or two instruments simultaneously.

The devices have a direct view, an oblique or an offset eyepiece.

A single or double instrument port is needed for the insertion of the auxiliary instruments. For lithoclast application an additional guide is used.

The longer endoscopes are called uretero-renoscopes and are used for procedures in ureter and kidney. The shorter ones are called ureteroscopes and are used for procedures in ureter (and for procedures in kidney, if the urinary tract is short enough).

RICHARD WOLF

{1}

Richard Wolf Medical Instruments Corporation
K963855
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

## 2.0 Intended Use

The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.

## 3.0 Technological Characteristics

- autoclavable (steam sterilization) for high hygiene demands
- high resolution image bundle with reduced pixel size, down to 30,000 pixels for realistic reproduction of the operation site (8702.402 and 8712.402 14,000 pixels)
- atraumatic tip for problem free introduction into the uteric ostium
- bright wide angle telescope and high flow rate for optimal visualization

## 4.0 Substantial Equivalence

These devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Storz and Circon.

## 5.0 Performance Data

Mechanical load test (bending test) shows, that there is no fracture of the shaft if normally used. The steam sterilization in the clinical use and the tests performed by Richard Wolf shows, that the steam sterilization has no influence to the optical quality of the Uretero-Renoscopes, when using the fractional method.

## 6.0 Clinical Tests

No clinical tests performed.

## 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Jan 17, 97

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RICHARD WOLF