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The ConMed Beamer System CE600 with Accessories is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation on tissue when used in conjunction with compatible applicators or probes.

The Conmed Beamer System CE600 with Accessories is an electrosurgical system that uses high frequency (HF) electrical current waveforms to cut and/or coagulate tissue whereby coagulation can be assisted by Argon gas. The system comprises of the following components: Electrosurgical unit (ESU) Beamer Mate CE200, Argon gas supply unit Beamer Plus CB200, Pressure reducer, Cart CC200, Footswitches, Reusable Cable for Neutral Electrodes (CE200-A04), Connecting Cable for flexible argon probes.

This 510(k) summary describes a substantial equivalence claim for the Conmed Beamer System CE600. The submission relies solely on comparing the new device's technical specifications and intended use to legally marketed predicate devices to establish substantial equivalence, rather than providing a study with specific acceptance criteria and performance data.

Therefore, the following information is not available in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, number of experts for ground truth, or adjudication methods for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI assistance.
• Results of a standalone algorithm performance study.
• Type of ground truth used for performance evaluation (as no performance study is detailed).
• Sample size for a training set or how ground truth for a training set was established (as no machine learning or AI component requiring training data is mentioned).

The document's primary argument for substantial equivalence is based on:

1. Device Description and Comparison to Predicate Devices:

The submission meticulously details the new device (Conmed Beamer System CE600 and its components: Electrosurgical unit (ESU) Beamer Mate CE200, Argon gas supply unit Beamer Plus CB200, Pressure reducer, Cart CC200, Reusable Cable for Neutral Electrodes, Connecting Cable for flexible argon probes) and directly compares their features, functionality, and intended use to several predicate devices, primarily the Erbe VIO 300D and Erbe APC2 systems.

Key Similarities highlighted include:

• Intended Use: Both the new ESU and predicate devices are for electrosurgical cutting and coagulation, with similar operational principles (program-based, color TFT display, channel selection, finger/foot switches, return electrode monitoring).
• Output Characteristics: The Conmed Beamer System CE600 ESU's output characteristics (Power, Impedance Matching, Voltages, and Frequencies) are stated to be "equivalent and same effective" to the predicate devices for various cutting and coagulation modes (monopolar, bipolar, soft coagulation, non-contact coagulation).
• Argon Unit Functionality: Both the new and predicate argon units generate controlled argon gas flow activated by the ESU, operate with their dedicated ESU, and feature a "Purge" key.
• Pressure Reducer: The pressure reducer is identified as the "same model (same technology, same materials, same characteristics) from the same manufacturer (Linde company)" as the predicate.
• Cart Functionality: Both the new and predicate carts serve the same functional purpose for carrying the system.
• Connecting Cables: Both new and predicate connecting cables for argon probes have the same intended use, principles of operation, and technological characteristics (non-sterile, reusable, compatible with Conmed CET Argon Probes, no patient contact, same dimensions).

Key Differences are acknowledged but asserted not to affect safety or effectiveness:

• ESU Connector Sockets: Differences are noted in the type and configuration of monopolar and bipolar connector sockets.
• Channel Selection and User Interface: Differences in the method of selecting channels and interacting with the display (rotary switch vs. pushbuttons, simultaneous display of all channels vs. single channel display).
• Argon Unit Connection: The new system connects the ESU and Argon unit via a cable and feeds HF power directly from the ESU, whereas the predicate uses case-to-case connectors and feeds HF power through the argon unit.
• Argon Probe Connection: The new system uses a standard 3-pin plug at the ESU and a male Luer-Lock gas outlet at the CB200, while the predicate uses a special multifunctional plug and a female Luer-Lock gas outlet at the argon unit.
• Cart Mains Cord: The new cart has a mains cord detachable only by tool, while the predicate has a detachable cord and outlet sockets.

2. Conclusion on Substantial Equivalence:

The submission concludes that:

• "The Conmed Beamer System with its component CE200 shows same performance of the current modes in comparison with the Predicate Device and thus represents good substantial equivalence to the Predicate Device."
• "The fact that the HF power is not fed through the CB200 Argon Unit as it is the case with the Predicate Device does not affect the clinical properties at all. Since all other technical details are the same, the CB200 with accessories represents also substantial equivalence to its predicate Device."
• "The CC200 cart shows same properties as its Predicate Device. Minor differences do not affect the clinical properties of the system."
• "Thus, the system CE600 with accessories raises no new issues of safety or effectiveness."

In essence, the "study" proving the device meets acceptance criteria (implicitly, the criteria for substantial equivalence to predicates) is the structured comparison of the device's design, functional specifications, and intended use against the known characteristics of legally marketed predicate devices, coupled with the manufacturer's assertion that any identified differences do not impact safety or effectiveness. No independent clinical or performance study with defined acceptance metrics is presented in this 510(k) summary.

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