WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES

K980302 · Richard Wolf Medical Instruments Corp. · HIH · Jul 20, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980302
• Device Name: WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology

Device Story

Resectoscopes consist of working elements, sheaths (standard/continuous-irrigation), electrodes (cutting/coagulation), obturators, and endoscopes. Device enables endoscopic visualization and tissue ablation via high-frequency (HF) energy. Physician inserts sheath into body opening using obturator; endoscope provides visualization; working element carries electrodes to target site. Electrodes perform mechanical/electrosurgical cutting and coagulation of soft tissue (e.g., prostate, myoma). Used in OR/clinic settings by urologists, gynecologists, and surgeons. Design improvements include reduced spring force for ergonomic operation, ceramic insulation for wear resistance, titanium construction for weight reduction, and Hytrel insulation for sealing accuracy. Output is visual feedback for the clinician to guide tissue resection, facilitating minimally invasive surgical intervention and patient recovery.

Clinical Evidence

No clinical tests were performed. Safety and effectiveness were established through bench testing, including endurance tests and steam sterilization validation. HF components were tested for conformity to ANSI/AAMI HF 18, IEC 601-2-2, and IEC 601-2-18 standards.

Technological Characteristics

Resectoscope system comprising working elements, sheaths, electrodes, and obturators. Materials: Titanium (housing), Ceramic (insulation), Hytrel (electrode insulation), Radel (temperature-resistant components). Sensing/Actuation: Mechanical working element with spring-loaded electrode movement. Energy: High-frequency (HF) electrosurgical energy. Connectivity: None. Sterilization: Steam sterilization. Standards: ANSI/AAMI HF 18, IEC 601-2-2, IEC 601-2-18, 93/42/EEC.

Indications for Use

Indicated for endoscopic examination, diagnosis, and therapy of tissue in urology, gynecology, and surgery, including TURP, TURB, adenoma/myoma resection, soft tissue tumor removal, endometrium ablation, bladder neck slitting, and prostate incision.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• Continuous Irrigation Resectoscope System, Model 8655 (K895857/A)
• EVAP Electrodes Model 8423, 8410, 8413 (K953983)
• USA Elite System Resectoscopes (Circon ACMI)
• Resectoscopes 27040-27050, 27143 (Karl Storz)

Submission Summary (Full Text)

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JUL 201998 K980302

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P 1 9 3

353 Corporate Woods Parkway Vernon Hills, Illinois 60064 Phone: [phone] Fax: [phone]

RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION

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| 510(k) Summary of Safety and Effectiveness | | | | |
|-----------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------|---------------------------|
| Submitter: | | Date of Preparation:<br>January 23, 1998 | | |
| Company / Institution Name:<br>Richard Wolf Medical Instruments Corporation | | FDA establishment registration number:<br>1418479 | | |
| Division Name (if applicable):<br>N.A. | | Phone number (include area code):<br>[phone] | | |
| Street Address:<br>353 Corporate Woods Parkway | | FAX number (include area code):<br>[phone] | | |
| City:<br>Vernon Hills | State/Province:<br>Illinois | Country:<br>USA | | ZIP/Postal Code:<br>60061 |
| Contact Name:<br>Mr. Robert Casarsa | | | | |
| Contact Title:<br>Quality Assurance Manager | | | | |
| Product Information | | | | |
| Trade Name:<br>Resectoscopes E-Line | | Model Number:<br>8654, 8655, 8656, 8657, 8658, 8661,<br>8663, 8666, 8668, 8407 to 8439 | | |
| Common Name:<br>Resectoscope | | Classification Name:<br>Resectoscope,<br>Resectoscope, Working Element | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 K895857/A | 1 Continuous Irrigation Resectoscope<br>System, Model 8655 | | 1 Richard Wolf | |
| 2 K953983 | 2 EVAP Electrodes Model 8423,<br>8427, 8410, 8413 | | 2 Richard Wolf | |
| 3 | 3 USA Elite System Resectoscopes | | 3 Circon ACMI | |
| 4 | 4 Resectoscopes 27040-27050, 27143 | | 4 Karl Storz | |

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981307

#### 1.0 Description

The resectoscopes consist of working elements, standard and continuous-irrigation resectoscope sheaths, coagulation and cutting electrodes, standard, timerlake (deflecting) and visual obturators, and endoscopes. The working element is the carrier of the endoscope and guide element to the electrodes.

The standard resectoscope sheath is inserted together with obturators in to the body opening to enable an atraumatic passage. After removal of the obturators, the shaft provides a guidance for the working element and rinsing charge, while the distal sheath simultaneously serves as a cutting-edge.

The obturator fills the hollow sheaths. The visual obturator in combination with the endoscope is used to insert the sheath under vision. The standard electrodes are used for combined cutting and coagulation of soft tissue, e.g. prostate or myoma.

The inside of the patient is visualized when the endoscope is inserted into the body through natural or surgically generated access.

#### 2.0 Intended Use

Resectoscopes are used for endoscopically controlled ablation of tissue.

Indication: For the examination, diagnosis and/ or therapy in combination with endoscopic accessories in the various medical disciplines, such as, urology, gynecology, and surgery.

Field of Application: TURP (Transurethral Resection of Prostate), TURB (Transurethral Resection of Bladder Tumors), adenomas, myoma resection, soft tissue tumor, endometrium ablation, as well as slitting of the neck of the bladder and incision of the prostate.

Long sheath resectoscopes are used with long urethras.

### 3.0 Technological Characteristics

The resectoscopes improved design and material achieves a more efficient operation.

The new E-Line working elements have a spring forced reduced by 55% from the earlier generation, while the sliding ability is improved. The resulting operation shows less signs of fatigue.

- The material used for the new E-Line resectoscope sheath insulation at the cut-off edge is ceramic rather than GFK which results in higher wear resistance. The submitted sheaths are made from Titan rather than brass / new silver which produces a housing approximately 20% lighter than its predecessor. Some of the continuous irrigation sheaths are oval which improve the flow-off rate.
- The submitted E-Line electrode insulation is made from Hytrel instead of Teflon which produces size accuracy and improves sealing.

Improved temperature resistance and processing is achieved by replacing Maranyl with Radel.

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P3093

#### Substantial Equivalence 4.0

The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. 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, Circon, and Karl Storz.

#### Performance Data 5.0

No performance standards are known.

The devices conform to the relevant provisions of European Device Directive 93/42/EEC.

Endurance tests and steam sterilization tests were performed to guarantee that the devices are safe and effective.

The HF devices were tested for conformity with the specified standards ANSI/AAMI HF 18, IEC 601-2-2 / IEC 601-2-18.

#### 6.0 Clinical Tests

No clinical tests were performed.

#### 7.0 Conclusions Drawn

The devices were designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.

By: Robert J. Casale

Robert L. Casarsa Quality Assurance Manager

Date: Jon 23, 98

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

# JUL 20 1998

Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K980302

Resectoscopes, Instruments and Accessories E-Line (working elements, standard and continuous irrigation resectoscope sheaths, coagulation and cutting electrodes, and obturators) Dated: April 21, 1998 Received: April 22, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH 21 CFR 876.1500/Procodes: 78 FJL 78 FDC 78 FAS

Dear Mr. Casarsa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we bave determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the ensciment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cometic 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 Regulations, 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 (OS) for Medical Devices: General regulation (2) 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 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/cdrl/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti 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): K980302

Device Name:

Resectospes, Instruments and Accessories E-Line, consisting of

working channels, standard and continuous irrigation, resectoscope sheaths,

coagulation and cutting electrodes, standard, timberlake (deflecting) and

visual obturators, and endoscopes

Indications for Use: Intended Use:

Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology

Revised 7/15/98

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Peter Satling/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K980302 510(k) Number _

Prescription Use
Per CRF 21 CFR 801.109

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Over-The Counter Use

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