S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES

K062720 · Richard Wolf Medical Instruments Corp. · FJL · Mar 22, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K062720
• Device Name: S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FJL · Gastroenterology, Urology
• Decision Date: Mar 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. For Urology: Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract. For Gynecology: Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

Device Story

Bipolar resectoscope system for endoscopic tissue ablation; utilizes 0.9% NaCl (saline) irrigation. Design features additional neutral pin at working element; HF current flows from active electrode through saline to neutral pin on resectoscope sheath/optic/electrode forks; avoids current path through patient body. Used in urology and gynecology clinics/ORs by physicians. Benefits include reduced risk of TUR-syndrome (compared to glycine/purisole) and minimized intra-operative muscle tremor (nerve obturatorius stimulation).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar electrosurgical resectoscope; includes active electrode and neutral pin connection. Materials conductive to HF current (sheath, optic, electrode forks). Energy source: HF bipolar generator. Connectivity: standard resectoscope connector and neutral pin for bipolar generator interface. Irrigation medium: 0.9% NaCl saline.

Indications for Use

Indicated for patients requiring urological or gynecological surgical procedures involving soft tissue ablation, removal, or coagulation. Urology: TURP, bladder neck resection, TURBT, transurethral incision of prostate, and coagulation of lower urinary tract bleeding. Gynecology: Treatment of intrauterine myomas, polyps, adhesions, septa, and endometrial ablation.

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

• Resectoscopes E-line (K980302)
• Resection Pump and Resectoscope for Chip Aspiration (Resection Master) (K042523)
• Bipolar resectoscope (Olympus)
• ACMI Vista CTR Bipolar Loop Electrode (K031001)
• ACMI Disposable Bipolar Cord (K022480)
• Plasma Kinetic Tissue Management System (Gyrus)

Submission Summary (Full Text)

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Ko62720

MAR 2 2 2007

# 5.0 510(k) Summary of Safety and Effec

| 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: | 06. February 2007 | |
| FDA establishment registration number: | 14 184 79 | |
| Phone number (include area code): | [phone] | |
| FAX number (include area code): | [phone] | |
| Product Information: | | |
| Trade name: | "S-line" S(a)line Bipolar Resectoscope, Electrode and Cable | |
| Model number: | 8680.xxx / 46XX.xxx / 8108.2xx | |
| Common name: | Bipolar resectoscope | |
| Classification name: | Resectoscope | |
| Information on devices to which substantial equivalence is claimed: | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K980302 | 1 Resectoscopes E-line | 1 Richard Wolf |
| 2 K042523 | 2 Resection Pump and Resectoscope for Chip Aspiration (Resection Master) | 2 Richard Wolf |
| 3. Not known | 3. Bipolar resectoscope | 3. Olympus |
| 4 K031001 | 4 ACMI Vista CTR Bipolar Loop Electrode | 4 ACMI |
| 5 K022480 | 5 ACMI Disposable Bipolar Cord | 5 ACMI |
| 6 Not known | 6 Plasma Kinetic Tissue Management System | 6 Gyrus |

### 1.0 Description

The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.

#### 2.0 Intended Use

S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

### For Urology:

1

Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.

2/5/07
1/07

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Transurethral resection of the prostate (TURP) and bladder neck. 0 Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.

For Gynecology:

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.

Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

#### 3.0 Technological Characteristics

Besides the standard HF connection at the working element, which is connected to the active area of the electrode, there is an additional pin for the neutral HF-connection. The neutral pin is connected to the working element that has a conductive connection to the resectoscope sheath, optic and finally to the forks of the electrode.

The saline used in bipolar resectoscope applications can minimize adverse effects. The Purisole or Glycine that is used in monopolar resectoscope applications can cause adverse effects, such as TUR-Syndrome, if the solution enters the blood stream. In addition, intra-operative muscle tremor (stimulation of nerve obturatorius) is largely avoided, because the applied HF current is directed from the active area through the conductive fluid to the forks of the electrode, optic, sheath and working element, without running through the body of the patient to the neutral electrode as in monopolar applications.

#### 4.0 Substantial Equivalence

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

#### 5.0 Performance Data

No performance standards are known.

#### 6.0 Clinical Tests

By:

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 instructions manual,

Robert Hanson

Robert L. Casarsa Quality Assurance Manager

Date: Feb 12, 2007

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## MAR 2 2 2007

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

Re: K062720

> Trade/Device Name: S-Line Bipolar resectoscopes and bipolar electrodes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FJL, FDC, FAS and HIH Dated: February 28, 2007 Received: March 2, 2007

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 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) that do not require approval of a premarket 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, labeling, 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.

Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are three stars below the word "Centennial". The seal is surrounded by a border of text and stars.

noting Public Hoalth

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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 agencies. 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.

This letter will allow you to begin marketing your device as described in your Section 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), 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 vours.

Nancy C. Brogdon

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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4.0 Indications for Use

**510(k) Number (if known):** K062720

S-Line Bipolar resectoscopes and bipolar electrodes Device Name:

S(a)line Resectoscopes are used for endoscopically controlled Intended use: removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:

Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.

Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coaqulation of bleeding in the lower urinary tract.

For Gynecology:

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.

Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

510(k) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________ > AND/OR

Over-The Counter Use

(Part 21CFR 801 Subpart D)

(Part 21CFR 801 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. Symons

ivision Sion-Of Division of Reproductive. Abdomin and Radiological Device

2/5/07 4-1
2/5/00 QL17