SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY

K050161 · Conmed Electrosurgery · GEI · Feb 3, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050161
• Device Name: SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY
• Applicant: Conmed Electrosurgery
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFlex™ Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.

Device Story

System 7500-B is an electrosurgical generator with Argon Beam Coagulation (ABC) capability. ABCFlex Probe connects to generator to deliver argon gas and high-frequency (HF) electrosurgical current to a tungsten electrode tip. Ceramic tip insulates thermal plastic tubing from heat; prevents electrode contact with patient tissue. Surgeon controls gas flow and current via switching element on generator. Used in endoscopic procedures (gastroenterology, bronchoscopy) for superficial ablation and hemostasis. Operates via contact (desiccation) or non-contact (fulguration) modes. Provides therapeutic tissue destruction; benefits include controlled coagulation and hemostasis in endoscopic settings.

Clinical Evidence

Bench testing only. Compliance with recognized consensus standards for electrosurgical devices (IEC 60601-1, 60601-2-2), sterilization (ISO 11135), and biocompatibility (ISO 10993) was demonstrated.

Technological Characteristics

Electrosurgical generator with argon beam coagulation. Materials: tungsten electrode, ceramic tip, thermal plastic tubing. Energy: HF electrosurgical current. Standards: ANSI/AAMI HF-18, IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-2, ISO 11135, ISO 10993. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for destruction of human tissue in surgical procedures and non-contact superficial ablation and hemostasis via flexible endoscope in gastroenterology and bronchoscopy.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• System 7500® Electrosurgical Unit (K981220)
• ABC® Probe for Flexible Endoscopes (K990586)

Submission Summary (Full Text)

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| Submitted by: | CONMED Electrosurgery Division<br>14603 East Fremont Avenue<br>Centennial, CO 80112 USA<br>Telephone: [phone]<br>Facsimile: 303-699-9854 |
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| Contact Person: | Pamela L. Vetter |
| Date Prepared: | January 24, 2005 |
| Proprietary Name: | System 7500 ^® -B ESU and ABCFlex ^™ Probe |
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories (21 CFR 878.4400)<br>79 GEI |
| Predicate Device: | System 7500 ^® Electrosurgical Unit, K981220, cleared 27-April-1998<br>ABC ^® Probe for Flexible Endoscopes, K990586, cleared 17-May-1999 |

K 050161

Summary of Safety and Effectiveness

Device Description: The System 7500 -B is an electrosurgical generator with Argon Beam Coagulation (ABC) capability. The basic modes of operation are conventional electrosurgical cutting, coagulation plus argon beam coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode or argon beam may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result. The ABCFlex™ Probe has applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas. The device consists of a connector for delivering argon gas to the operative site as well as an internal cable to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during the coagulation procedure. Current and gas flow is controlled by the surgeon activating and deactivating a switching element part of the System 7500 -B ESU.

Intended Use of Device: The System 7500 -B is used for the destruction of human tissue in surgical mended OSE of Device. The Oystem 7000 - B is about the BBCFlex™ Probe is intended for use with the System 7500 -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.

Technological Characteristics: The proposed devices are equivalent to the identified predicate devices with respect to technological characteristics and function. The devices have been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-2, Sterilization of health care products -Requirements for validation and routine control of Ethylene Oxide Sterilization, ISO 11135 and Biocompatibility, ISO 10993.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

FEB - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela Vetter Manager of Regulatory Affairs Conmed Electrosurgery 14603 E. Fremont Avenue Centennial, Colorado 80112

Re: K050161

K050161
Trade/Device Name: System 7500® -B Electrosurgical Unit and ABCFlex™ Probe Regulation Number: 21 CFR 878.4400 Regulation Number. 21 CFX 876. 1788
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 24, 2005 Received: January 25, 2005

Dear Ms. Vetter:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications
referenced above and have determined the device merketed in interstate referenced above and have decembiled the arrested predicate devices marketed in interstate for use stated in the enclosure) to regary manced promoted in the Federal Food. Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Dr commerce prior to May 28, 1970, the enactions of the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMA devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the device, sucject to the general stars and segistration, listing of general controls provisions of the free necesses of the same of the misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it class III (PMA). it if your device is classified (sec above) nils existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controls. Extrong may - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of Pederal Regarations)
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination costs of the Atl Please be advised that FDA s issuation of a bacewice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a determination that Jour are Federal agencies. You must or any Federal statutes and regulations and intel to: registration and listing (21 l comply with an the Act s requirements, mercesses, " CFR Part 807), labeling (21 CFR Part 800), god and fapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Pamela Vetter

This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle witi anow you to begin mailing of substantial equivalence of your device to a legally premarket notineation: The PDF intembers on 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 If you desire specific acrice for your as [phone]. Also, please note the regulation entitled, Contact the Office of Compilancemarket notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainters within the Act from the Division of Small other general information on your response 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,

Marke A. Mellers

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K050161 |
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Device Name:

Indications for Use:

The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFlex™ Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

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

—

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millmann

for

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and Neurologi

K050161