BEAMER ARGON PROBE

• K Number: K081644
• Device Name: BEAMER ARGON PROBE
• Manufacturer: CONMED CORPORATION
• Date Cleared: 2008-09-10 ( 90 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

The Beamer™ Argon Probes are indicated for argon enhanced coagulation of tissue.

Device Description

The Beamer Argon Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The proximal end of the stainless steel wire is soldered into the connector body. The distal end of the wire is crimped to an electrode located at the distal end of the probe. The distal end of the Beamer Argon Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The electrode remains recessed in the ceramic tip such that there is no tissue contact during the procedure. There are several configurations of the Beamer Argon Probe. The probes vary in length and outside diameter to accommodate the procedure performed by the physician. The Beamer Argon Probes are provided sterile by ethylene oxide and are single use only.

Predicate Devices

K990586, K013348, K052035

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and basic functionality of an argon probe for coagulation, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for argon-enhanced coagulation of tissue, which is a therapeutic intervention.

Diagnostic

No
The device is indicated for argon enhanced coagulation of tissue, which is a therapeutic procedure rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like a stainless steel wire, connector body, electrode, and ceramic tip, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "argon enhanced coagulation of tissue." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
• Device Description: The description details a probe designed for delivering argon gas and electrical energy for coagulation. This is a surgical or procedural tool, not a device for analyzing biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.

In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Beamer Argon Probes are used for a therapeutic intervention (coagulation) directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Beamer™ Argon Probes are indicated for argon enhanced coagulation of tissue.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

The Beamer Argon Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The proximal end of the stainless steel wire is soldered into the connector body. The distal end of the wire is crimped to an electrode located at the distal end of the probe. The distal end of the Beamer Argon Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The electrode remains recessed in the ceramic tip such that there is no tissue contact during the procedure.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990586, K013348, K052035

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

Summary

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Ko 81644

ConMed Endoscopic Technologies Beamer™ Argon Probe

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Image /page/0/Picture/3 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" is the phrase "ENDOSCOPIC TECHNOLOGIES" in smaller letters. The logo appears to be for a company that specializes in endoscopic technologies.

SEP 1 0 2008

510(k) Summary of Safety and Effectiveness

• 1. Sponsor Name: ConMed Endoscopic Technologies, Inc. 129 Concord Road Billerica, MA 01821 Telephone: [phone] FAX: [phone] Contact Individual: Karen Provencher Sr. Regulatory Affairs Specialist
     Preparation Date: March 10, 2008
• 2. Device Name: ConMed Beamer™ Argon Probe
• 3. Identification of Predicate or Legally Marketed Device: ConMed ABC Probes for Flexible Endoscopes cleared under K990586 on May 17, 1999 ERBE Straight Fire & Side Fire Probes cleared under K013348 on October 26, 2001 Canady Plasma Probes for Flexible Endoscopy cleared under K052035 on August 31, 2005

4. Device Description:

The Beamer Argon Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The proximal end of the stainless steel wire is soldered into the connector body. The distal end of the wire is crimped to an electrode located at the distal end of the probe. The distal end of the Beamer Argon Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The electrode remains recessed in the ceramic tip such that there is no tissue contact during the procedure.

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

5. Intended Use:

The Beamer™ Argon Probes are indicated for argon enhanced coagulation of tissue.

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sib44

ConMed Endoscopic Technologies Beamer™ Argon Probe

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6. Comparison of Technological Characteristics: The Beamer Argon 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 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 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 an abstract design that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The design is composed of three curved lines that intersect and form a shape similar to a staff with snakes entwined around it.

SEP 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConMed Corporation % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K081644

Trade/Device Name: Beamer" Argon Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 28, 2008 Received: August 29, 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) promarket 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 the reporting 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 M. Millican

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

Enclosure

4

ConMed Endoscopic Technologies Beamer™ Argon Probe

81644

Image /page/4/Picture/2 description: The image shows the logo for CONMED Endoscopic Technologies. The logo features a stylized graphic to the left of the word "CONMED" in all caps. Below the word "CONMED" is the phrase "ENDOSCOPIC TECHNOLOGIES" in a smaller font size.

C. INDICATION FOR USE

510(k) Number (if known)

Device Name: Beamer™ Argon Probe

Indication for Use:

The Beamer™ Argon Probes are indicated for argon enhanced coagulation of tissue.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (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)

.....

Mark A. Melkeren

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

31644

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