FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066

K051176 · Richard Wolf Medical Instruments Corp. · FAJ · Oct 5, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051176
• Device Name: FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Oct 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Flexible Video Cystoscope is used for visualizing body cavities and organs via natural and surgically generated passages. For examination, diagnosis and/or therapy in conjunction with endoscopic accessories/auxiliary instruments through the scope's working channel. The scope is used in the medical disciplines of Urology ( urogential tract, cystoscopy, nephroscopy) and Surgery (choiedochoscopy).

Device Story

Flexible video cystoscope/choledochoscope (models 7308.061, 7308.066) utilizes CCD video image sensor at distal tip to capture images; replaces traditional fiber-optic light guide. Device connects to Richard Wolf 5520 camera system for image processing and display. Operated by physicians in clinical settings for urological and surgical procedures. Features include ergonomic handle with remote control buttons for camera functions, removable adapter with instrument port, irrigation/drain stopcocks, and biopsy valve. Control lever allows tip deflection (up/down) to facilitate insertion. Output provides real-time visualization of body cavities to assist in diagnosis and therapeutic interventions.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against IEC601-1/UL2601-1 and IEC601-1-2 safety standards.

Technological Characteristics

Flexible endoscope with distal CCD video sensor; control lever for tip deflection; ergonomic handle with remote camera control buttons; removable adapter with instrument port, irrigation/drain stopcocks, and biopsy valve. Connectivity via cable to external camera controller (5520 system). Designed to meet IEC601-1/UL2601-1 and IEC601-1-2 standards.

Indications for Use

Indicated for visualization of body cavities and organs via natural passages for examination, diagnosis, and therapy in urology (urogenital tract, cystoscopy, nephroscopy) and surgery (choledochoscopy) using endoscopic accessories.

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

• Flexible Fiberscopes and Accessories (K980401)
• Cysto-Videoscope VISERA CYF-V, CYF-VA (K021074)
• Digital Flexible Cysto-Videoscope DCN (K30960)
• 1 CCD Endocam 5520 System (K023659)
• 1 CCD Multi Endocam 5502 with Electronic CCD Endoscope 4934.551 (K983279)

Submission Summary (Full Text)

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K051176
Pg 1 of 2

OCT 5 - 2005

353 Corporate Woods Parkway Vernon Hills, IL 60061-3110 Phone: [phone] Customer Service: 800-323-WOLF (9653) www.richardwolfusa.com

# 12.0 510(k) Summary of Safety and Effectiveness

| Submitter: | |
|---------------------------------------------------------------------|----------------------------------------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | May 4, 2005 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | ( 847 ) 913 1113 |
| FAX number (include area code): | ( 847 ) 913 0924 |
| Product Information: | |
| Trade name: | Flexible Video-Endoscope |
| Model number: | 7308.061, 7308.066 |
| Common name: | Flexible Video Cystoscope /<br>Choledochoscope |
| Classification name: | Cystoscope / Nephroscope<br>/Choledochoscope |
| Information on devices to which substantial equivalence is claimed: | |
| 510(k) Number | Trade or proprietary or model name |
| | Manufacturer |
| 1 K980401 | 1 Flexible Fiberscopes and Accessories |
| | 1 Richard Wolf |
| 2 K 021074 | 2 Cysto-Videoscope VISERA CYF-V,<br>CYF-VA |
| | 2 Olympus |
| 3 K30960 | 3 Digital Flexible Cysto-Videoscope DCN |
| | 3 ACMI |
| 4 K023659 | 4 1 CCD Endocam 5520 System |
| | 4 Richard Wolf |
| 5 K983279 | 5 1 CCD Multi Endocam 5502 with<br>Electronic CCD Endoscope 4934.551 |
| | 5 Richard Wolf |

Medical Instruments Corporation

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K o51176-P2 %

## 1.0 Description

RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION

Image /page/1/Picture/3 description: The image contains text describing flexible video cystoscopes and choledochoscopes. The submitted flexible video cystoscopes and choledochoscopes are a modification of the Richard Wolf flexible fiber-cystoscopes. The flexible video cystoscopes have a CCD video image sensor for generating a video image with a camera controller instead of an image fiber light guide. The video cystoscopes connect to the Richard Wolf camera system 5520.

#### Intended Use 2.0

The Flexible Video Cystoscope is used for visualizing body cavities and organs via natural and surgically generated passages. For examination, diagnosis and/or therapy in conjunction with endoscopic accessories/auxiliary instruments through the scope's working channel. The scope is used in the medical disciplines of Urology ( urogential tract, cystoscopy, nephroscopy) and Surgery (choiedochoscopy).

### Technological Characteristics 3.0

The videoscopes have similar dimensions, working channels and design as the Richard Wolf flexible fiber-cystoscopes. Both cystoscopes are designed with a control lever for locking the tip in any angled position. Two different control directions are available, is . the endoscope is deflected either upward or downward upon activating the control lever proximally or distally. The tips are angled approximately 45° and angled. This makes the insertion into the urethra easier and more comfortable for male patients. The adapter with instrument port, irrigation and drain stopcocks and optional biopsy valve is removable. The new style ergonomic handle is equipped with two remote control buttons that control the camera function.

### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as existing devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf, Olympus and ACMI.

#### 5.0 Performance Data

The flexible videoscopes 7301.061 / 7301.066 are designed to meet the standards IEC601-1/ UL2601-1 and IEC601-1-2.

#### 6.0 Clinical Tests

By:

No special clinical tests performed.

#### 7.0 Conclusions Drawn

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

Robert L. Casare

Robert L. Casarsa Quality Assurance Manager

Date: May 4, 2005

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rublic Health Service

Image /page/2/Picture/1 description: The image shows a logo with a stylized depiction of three figures in motion, possibly dancing or running. The figures are rendered in black and have a fluid, dynamic appearance. To the left of the figures, there is some text arranged in a semi-circular fashion, also in black. The text appears to be part of the logo, possibly the name of an organization or brand.

OCT 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MI) 20050

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporations 353 Corporate Woods Parkway VERNON HILLS IL 60061-3110

Re: K051176

Trade/Device Name: Flexible Video Cystoscope / Choledochoscope (Models 7308.061 and 7308.066) Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FBN and FAJ Dated: September 7, 2005 Received: September 9, 2005

Dear Mr. Casarsa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially of the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to reclassified in accordence with the 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) that do not require approval of a premarks approval application (PMA). 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, abbeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal sounces. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 5.0 Indications for Use

# 4 05 1176 510(k) Number:

Device Name:

Flexible Video Cystoscope / Choledochoscope

Indications For Use: The Flexible Video Cystoscope is used for visualizing body cavities and organs via natural passages. For examination, diagnosis and/or therapy in conjunction with endoscopic accessories/ auxiliary instruments through in
scone's working should co scope's working channel. The scope is used in the medical disciplines of

· Urology (urogenital tract, cystoscopy, nephroscopy),

· Surgery (choledochoscopy)

Prescription Use (Part 21 CFR 801 Subpart D)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

AND/OR

Over-The Counter

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

David A. Logemann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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