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.

AI/ML Overview

The provided text describes a 510(k) summary for the ConMed Beamer™ Argon Probe. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than novel clinical performance studies with specific statistical acceptance criteria.

Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets specific acceptance criteria for performance, especially in the context of AI or diagnostic systems.

However, based on the available information, here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Assessment
Technological Characteristics	Substantially equivalent to predicate devices (ConMed ABC Probes, ERBE Straight Fire & Side Fire Probes, Canady Plasma Probes for Flexible Endoscopy)	Met (stated as "substantially equivalent")
Intended Use	Substantially equivalent to predicate devices (argon enhanced coagulation of tissue)	Met (stated as "substantially equivalent")
Biocompatibility	All testing passed the predetermined performance specifications.	Met
Bench Testing	All testing passed the predetermined performance specifications.	Met

2. Sample size used for the test set and the data provenance

Not applicable for a clinical study. The document refers to "bench testing" and "biocompatibility testing" but does not provide details on the sample sizes or data provenance for these engineering-focused tests. It's a 510(k) submission, so the "test set" in the context of clinical performance (like for an AI device) is not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information is for clinical studies, especially those involving human interpretation or diagnostic ground truth. The submission focuses on device equivalence through engineering/bench testing.

4. Adjudication method for the test set

Not applicable. This is relevant for clinical studies involving multiple reviewers or ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI device, and no MRMC study was performed or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an AI device.

7. The type of ground truth used

For biocompatibility and bench testing, the "ground truth" would be established by engineering specifications, regulatory standards (e.g., ISO for biocompatibility), and internal product requirements. The document states "predetermined performance specifications" were used.

8. The sample size for the training set

Not applicable. This is not an AI device, therefore no training set was used.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device.

Summary of what the document focuses on:

The ConMed Beamer™ Argon Probe's 510(k) submission primarily relies on demonstrating substantial equivalence to existing predicate devices (ConMed ABC Probes, ERBE Straight Fire & Side Fire Probes, Canady Plasma Probes for Flexible Endoscopy) in terms of:

Intended use: Argon enhanced coagulation of tissue.
Technological characteristics: Described as having a stainless steel wire, electrode, ceramic tip, and varying configurations (length/diameter).
Materials: Implied to be equivalent through the substantial equivalence claim.

The "Performance Testing" section states that biocompatibility and bench testing were performed, and all testing "passed the predetermined performance specifications." However, the specific details of these tests, methodologies, and the exact specifications are not provided in this summary. The FDA's acceptance of the 510(k) indicates that they found sufficient evidence of substantial equivalence based on these tests and comparisons to predicates.

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: 978-964-4232 FAX: 978-964-4230 Contact Individual: Karen Provencher Sr. Regulatory Affairs Specialist
  Preparation Date: March 10, 2008
1. Device Name: ConMed Beamer™ Argon Probe
1. 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:

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.

Page 75 of 159

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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.

Page 76 of 159

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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

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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

Page 1 of 1

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.