BEAMER ARGON SNARE PROBE

K081580 · Conmed Corporation · GEI · Jun 19, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081580
• Device Name: BEAMER ARGON SNARE PROBE
• Applicant: Conmed Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.

Device Story

Beamer Argon Snare Probe delivers argon gas and high-frequency electrosurgical current to operative site via flexible endoscope; used with Beamer system generator. Device consists of catheter tubing, internal stainless steel wire, and distal snare loop (braided or monofilament). Distal end features ceramic tip providing thermal insulation; tungsten electrode remains recessed within tip to prevent tissue contact during argon beam coagulation. Physician operates device through flexible endoscope (bronchoscope, gastroscope, colonoscope, duodenoscope). Snare can be retracted into catheter. Single-use, sterile device. Enables argon beam coagulation and electrosurgical snare procedures; ceramic tip protects tubing from heat degradation.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Stainless steel wire, tungsten electrode, ceramic tip. Catheter tubing for gas delivery. Lengths: 160 cm and 230 cm. Snare sizes: 15 mm and 30 mm. Sterilized via ethylene oxide. Single-use. Electrosurgical accessory.

Indications for Use

Indicated for use with the Beamer system generator to deliver argon gas and electrosurgical current via flexible endoscope (bronchoscope, gastroscope, colonoscope, or duodenoscope) to an electrode wire snare at the operative site.

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

• ConMed Optimizer Snare (K820430)
• Olympus SD Electrosurgical Snare (K902735)
• ConMed ABC Probes for Flexible Endoscopes (K990586)
• ERBE Argon Plasma Coagulator (K013348)

Submission Summary (Full Text)

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ConMed Endoscopic Technologies Beamer™ Argon Snare Probe

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8000 8 I Nin

## 510(k) Summary of Safety and Effectiveness

- ConMed Endoscopic Technologies, Inc. Sponsor Name: 1. 129 Concord Road Billerica, MA 01821 Telephone: [phone] Contact Individual: Karen Provencher Sr. Regulatory Affairs Specialist
- ConMed Beamer™ Argon Snare Probe 2. Device Name:

#### Identification of Predicate or Legally Marketed Device: 3.

ConMed Optimizer Snare cleared under K820430 on April 8, 1982 Olympus SD Electrosurgical Snare cleared under K902735 on August 2, 1990

ConMed ABC Probes for Flexible Endoscopes cleared in K990586 on May 17, 1999

ERBE Argon Plasma Coagulator cleared in K013348 on October 26, 2001

#### 4. Device Description:

The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.

The Beamer Snare Probe consists of connectors for attachment to the output of an Argon Beam Coagulation Unit. The device also consists of catheter tubing for delivering argon gas to the operative site within the patient, as well as an internal wire to carry high frequency (HF) electrosurgical current to the electrosurgical snare. The snare probe device is provided in two lengths 160 cm and 230 cm for use in flexible bronchoscopes, gastroscopes, colonoscopes and duodenoscopes.

The electrosurgical snare is provided in a symmetrical loop (braided or monofilament oval) in sizes of 15mm and 30mm and can be positioned back into the catheter tube, such that it does not contact the patient's tissue during the argon beam coagulation procedure.

The Beamer Argon Snare Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The

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ConMed Endoscopic Technologies Beamer™ Argon Snare Probe

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proximal end of the stainless steel wire is locked into the connector be The distal end of the wire is soldered to a snare shaped wire located at the distal end of the probe. In its retracted position the snare wire is in electric contact to a tungsten electrode. The distal end of the Beamer Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The tungsten electrode remains recessed in the ceramic tip such that there is no tissue contact during the argon beam coagulation procedure.

There are five configurations of the Beamer Argon Snare Probe. The probes vary in length and loop configuration to accommodate the procedure performed by the physician. The Beamer Argon Snare Probes are provided sterile by ethylene oxide and are single use only.

#### 5. Intended Use:

The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.

#### Comparison of Technological Characteristics: 6.

The Beamer Snare Probes are substantially equivalent to the predicate devices both in intended use, technological characteristics and materials.

#### 7. Performance Testing:

Biocompatibility and bench testing have been performed to demonstrate equivalence of the Beamer Argon Snare Probes to their predicate devices. All testing passed the predetermined performance specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the image. The text is in a circular format around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 9 2008

ConMed Corporation % Intertek Testing Services Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K081580

Trade/Device Name: Beamer™ Argon Snare Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 03, 2008 Received: June 05, 2008

Dear Mr. Lehtonen:

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 (PMA), 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 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.

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Page 2 - Mr. Daniel W. Lehtonen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark on Mil

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/1 description: The image shows the logo for Conmed Endoscopic Technologies. The logo features a stylized graphic to the left of the word "CONMED" in large, bold letters. Below "CONMED" are the words "ENDOSCOPIC TECHNOLOGIES" in a smaller font. The letters are all in black.

### C. INDICATION FOR USE

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510(k) Number (if known)_KO81580

Device Name: Beamer™ Argon Snare Probe

## Indication for Use:

The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.

| Prescription Use<br>(Per 21 CFR 801 Subpart D) | X | AND/OR | Over the Counter Use<br>(Per 21 CFR 801 Subpart C) |
|------------------------------------------------|---|--------|----------------------------------------------------|
|------------------------------------------------|---|--------|----------------------------------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

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