URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042

K990050 · Richard Wolf Medical Instruments Corp. · FGB · Mar 26, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990050
• Device Name: URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Mar 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories. transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology. tumor diagnostics and / or biopsy removal of foreign bodies . The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.

Device Story

Compact Operating Uretero-Renoscope 8706.402 is a thin, rigid endoscope featuring a rod lens system and an integrated channel for irrigation and surgical instruments. Used in conjunction with an introduction sheath (8706.042) to access the renal pelvis; the sheath remains stationary while the scope is used or replaced by a flexible uretero-renoscope for upper calyx access. Operated by physicians in clinical settings for diagnostic and therapeutic procedures, including stone lithotripsy (electrohydraulic, laser, pneumatic, or ultrasonic) and biopsy. Provides direct visualization of the ureter and kidney to guide clinical decision-making and surgical intervention.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rigid endoscope with rod lens system; includes irrigation/instrument channel and introduction sheath. Features atraumatic tip. Autoclavable (steam sterilization at 134°C).

Indications for Use

Indicated for examination of the ureter and kidney, including transurethral extraction and lithotripsy of stones, tumor diagnostics/biopsy, and foreign body removal. Contraindicated in patients with acute hypertrophy of the prostate or stenosis of the ureter.

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

• Uretero-renoscope (K963855)

Submission Summary (Full Text)

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3/26/99

1

990050

Pg 1 of 2

353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: [phone] Fax: [phone]

**RICHARD WOLF**
MEDICAL INSTRUMENTS CORPORATION

# 510(k) Summary of Safety and Effectiveness

| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | Date of Preparation: | January 5, 1999 | | |
|--------------------------------|----------------------------------------|----------------------------------------|-----------------|---------------------------------|----------------|
| Division name (if applicable): | N.A. | FDA establishment registration number: | 14 184 79 | | |
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code): | [phone] | | |
| City: | Vernon Hills | State/Province: | Illinois | FAX number (include area code): | [phone] |
| Country: | USA | ZIP / Postal Code: | 60061 | | |
| Contact name: | Mr. Robert L. Casarsa | | | | |
| Contact title: | Quality Assurance Manager | | | | |

**Product Information:**

| Trade name: | Model number: |
|------------------------------------------------|----------------------|
| Compact Operating Uretero-Renoscope by Gautier | 8706.402 / .042 |
| Common name: | Classification name: |
| Uretero-Renoscopes | Ureteroscopes |

**Information on devices to which substantial equivalence is claimed:**

| | 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---------------|------------------------------------|--------------|
| 1 | K963855 | Uretero-renoscope | Richard Wolf |
| 2 | 2 | 2 | 2 |

#### 1.0 Description

Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system, a channel for irrigation and for the simultaneous use of an instrument.

The uretero-renoscope may be inserted with the introduction sheath, 8706.042 to view the renal pelvis. The introduction sheath remains stationary while the ureterorenoscope may be removed and replaced by a flexible uretero-renoscope when reaching the upper calyx group.

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K990050 pg 2 of r

### 2.0 Intended Use

The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible uretero-renoscope and for evacuation of irrigation solution.

#### 3.0 Technological Characteristics

- atraumatic tip for problem free introduction into the uteri ostium .
- sharp, brilliant quality over the entire image .
- . autoclavable / steam sterilization 134°C / 273°C

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf.

#### 5.0 Performance Data

No performance standards are known.

#### 6.0 Clinical Tests

Clinical tests performed were not performed.

#### 7.0 Conclusions Drawn

These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.

By: Robert J. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Jan 4, 99

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 1999

Mr. Robert L. Casarsa Quality Assurance Manager RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60061

Re: K990050

Compact Operating Uretero-Renoscope with Insertion Sleeve Dated: January 5, 1999 Received: January 7, 1999 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FGB

Dear Mr. Casarsa:

We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Device Name: _ Compact Operating Uretero-Renoscope with Insertion Sleeve

### Intended Use:

- The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.
- · transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology.
- . tumor diagnostics and / or biopsy
- removal of foreign bodies .

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.

# Contraindications:

For all submitted ureteroscopes and ureter-renoscopes:

Comply with contraindications for the patient which result findings and are described in relevant literature, for example:

- · acute hypertrophy of the prostate
- · stenosis of the ureter

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

David C. Seggern

Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

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