General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory hand piece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.

Device Description

The CONMED® Sabre Genesis™ and CONMED® HyfreSurg™OP Electrosurgical Generators are electrosurgical generators with the basic modes of operational electrosurgical cutting and coagulation. The devices consist of a single electrosurgical generator unit for each model to supply high frequency (HF) electrosurgical current to accessory hand pieces to produce the clinical effect. When cutting, the subject device provides the energy to the active electrode which is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the subject device provides the energy to the active electrode which 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 subject devices (Sabre Genesis and HyfreSurg OP) are of the same construction in components and assembly. The difference is the HyfreSurg OP does not have the Pulse Cut functionality and the control panel is altered accordingly.

Use of these products for unintended applications could lead to an unsafe condition.

The device utilizes previously cleared/marketed and required accessories.

AI/ML Overview

The provided text describes a 510(k) summary for the CONMED® Sabre Genesis™ and CONMED® HyfreSurg OPTM Electrosurgical Units. However, it does not include specific acceptance criteria for the device performance in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI/software devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device standards.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence cannot be fully answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device operates safely, provides alarms for risks, and complies with safety standards (e.g., IEC 60601-1, IEC 60601-2-2).	"The device provides alarms for conditions that could pose a risk to the patient." "Specific testing performed was in conformance with the requirements of [listed IEC standards]."
Effectiveness/Functionality: Delivers RF electrosurgical current for cutting and coagulation as intended. Performance characteristics are equivalent to predicate devices.	"Performance characteristics of the subject devices are equivalent to the subject devices and have been verified to meet the requirements above as well as performance requirements defined in design inputs." "Design verification and validation activities demonstrated the subject devices to be equivalent where applicable to the predicate devices."
Electromagnetic Compatibility: Meets EMC standards (IEC 60601-1-2).	"IEC 60601-1-2: 2005, Medical Electrical Equipment -- Part 1-2 General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests." (Implies compliance)
Usability: Complies with usability standards (IEC60601-1-6).	"IEC60601-1-6: 2004, Medical electrical equipment - Part 1-6: General requirements for safety -Collateral standard: Usability." (Implies compliance)
Biocompatibility: No direct patient contact, thus no biocompatibility concern.	"The subject devices do not have direct patient contact."
Substantial Equivalence: Demonstrated to be substantially equivalent to predicate devices (CONMED® System 2450™, CONMED® System 5000™).	The entire 510(k) submission and FDA clearance letter confirm substantial equivalence.

Missing Information/Not Applicable (N/A) from the Text:

Quantitative Performance Metrics: The document does not provide specific numerical targets (e.g., accuracy > 90%, sensitivity > 85%) for clinical or analytical performance. This is typical for electrosurgical units, which are hardware devices, not AI/software.
Study Design for "Proving Device Meets Acceptance Criteria": The document refers to "Performance Testing" and "Design verification and validation activities" but does not detail a specific clinical or analytical study designed to prove these criteria in a statistical sense, as would be expected for an AI/software device. Instead, it relies on adherence to established standards and comparison to predicate devices.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable/Not mentioned. The testing described is primarily focused on engineering and electrical safety standards for a hardware device, not a performance test on a specific dataset like an AI model.
Data Provenance: Not applicable/Not mentioned. There is no "data" in the sense of patient records or images being used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. There is no ground truth establishment in the context of an AI/software device for an electrosurgical unit.
Qualifications of Experts: Not applicable.

4. Adjudication Method

Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This document describes an electrosurgical unit (a hardware device), not an AI-assisted diagnostic or clinical support tool where human reader performance would be a relevant metric.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: No. This is a hardware device; there is no "algorithm only" performance separate from the device's function.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. For this type of device, "ground truth" generally refers to adherence to engineering specifications and safety standards, as verified through physical testing, rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. This is a manufactured hardware device, not an AI model that undergoes a "training" phase with a dataset.

9. How Ground Truth for Training Set Was Established

How Ground Truth Was Established: Not applicable.

In summary: The provided 510(k) summary is for a traditional electrosurgical unit, not an AI/software device. Therefore, the concepts of "acceptance criteria," "study," "test set," "ground truth," "experts," and "training set" as they relate to AI/software performance evaluation are not applicable or described in this document. The device's "performance" is demonstrated through compliance with recognized medical device standards and substantial equivalence to previously cleared predicate devices, focusing on safety and basic functional effectiveness.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ConMed Electrosurgery. The logo consists of a stylized "C" shape in a square to the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "ELECTROSURGERY" in smaller letters. The logo is simple and professional, and it is likely used to represent a company that manufactures or sells electrosurgical equipment.

510k Summary of Safety and Effectiveness

CONMED® Sabre Genesis™ Electrosurgical Unit CONMED® HyfreSurg OPTM Electrosurgical Unit

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Electrosurgery is hereby submitting the 510(s) Summary of Safety and Effectiveness for the 510(k) Number __________________________________________________________________________________________________________________________________________

A. Submitter

ConMed Electrosurgery 14603 E. Fremont Ave. Centennial, Colorado 80112

B. Company Contact

Shawn Riedel Vice President, Quality Assurance and Regulatory Affairs 14603 E. Fremont Ave. Centennial, Colorado 80112

Phone: 303-269-8224 Fax: 303-699-9854 e-mail: shawn riedel@es.conmed.com

C. Device Name

Trade Name:	CONMED® Sabre Genesis™ Electrosurgical UnitCONMED® HyfreSurg OPTM Electrosurgical Unit
Common Name:	Electrosurgical unit and accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device and accessories
Regulation Number:	21 CFR 878.4400	Class II 79 GEI
Panel:	General and Plastic Surgery

D. Predicate Device Name

CONMED® System 2450™ Electrosurgical Unit ConMed Electrosurgery 510(k) K052009 CONMED® System 5000™ Electrosurgical Unit ConMed Electrosurgery

510(k) K020186

Sabre Genesis l-lyfreSurg OP 03665

FEB 1 6 201

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E. Device Description

Use of these products for unintended applications could lead to an unsafe condition.

The device utilizes previously cleared/marketed and required accessories.

F. Intended Use

The CONMED® Sabre Genesis™ and CONMED® HyfreSurg OP™ Electrosurgical Generators are intended for use in open and laparoscopic surgery and in office based surgical procedures.

G. Indications for use

H. Technological Characteristics

The technological characteristics of the proposed device are identical to the predicate devices. Any differences represent limitations of previously cleared technology. The device has been designed to comply with numerous applicable standards.

I. Safety Information

Questions of safety and effectiveness are the same for this device as they are for the predicated devices and other electrosurgical generators on the market. There are no new technologies incorporated into the device. The device provides alarms for conditions that could pose a risk to the patient. The operator sets the appropriate mode and output settings for the device.

J. Biocompatibility

The subject devices do not have direct patient contact.

K. Performance Testing

Where applicable, specific testing performed was in conformance with the requirements of the following standards:

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사 IEC 60601-1:1998, Medical electrical equipment -- 2nd Ed. plus amendments 1 and 2 - also representing UL60601-1, EN60601-1, CSA C22.2 No. 60601-1 except for national deviations.
IEC 60601-1-1: 2000, Medical Electrical Equipment Part 1-1 General Requirements faor Safety . - Collateral Standard: Safety Requirements for Medical Electrical Systems.
IEC 60601-1-2: 2005, Medical Electrical Equipment -- Part 1-2 General Requirements for Safety 포 - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-4: 2000, Medical Electrical Equipment Part 1-4 Medical electrical equipment -. Part 1-4: General requirements for safety - Collateral Standard: Programmable electively systems.
트 IEC60601-1-6: 2004, Medical electrical equipment - Part 1-6: General requirements for safety -Collateral standard: Usability.
IEC60601-1-8: 2005, Medical electrical equipment Part 1-8: General requirements for safety - 미 Collateral standard: General requirements, tests and guidance for salam systems in medical electrical equipment and medical electrical systems.
IEC 60601-2-2: 2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.

L. Subject vs. Predicate Device

The subject device(s) are of the same inherent technology and construction as the predicate devices. The chasis and the bezel for the devices are essentially the same dimensionally and are fabricated from the same materials. The subject devices have a universal power supply not found in the predicate devices.

Performance characteristics of the subject devices are equivalent to the subject devices and have been verified to meet the requirements above as well as performance requirements defined in design inputs. Design verification and validation activities demonstrated the subject devices to be equivalent where applicable to the predicate devices.

Specific differences between the subject and predicate devices are found in the substantial equivalence table.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

ConMed Electrosurgery % Mr. Shawn Riedel Vice President of Quality Assurance and Regulatory Affairs 14603 East Fremont Avenue Centennial, Colorado 80112

FEB 1 6 201

Re: KI03665

Trade Name: CONMED® Sabre Genesis™ Electrosurgical Generator CONMED® HyfreSurg™ OP Electrosurgical Genertaor Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 1, 2010 Received: December 16, 2010

Dear Mr. Riedel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Shawn Riedel

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

A. B. R
for

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: CONMED® Sabre Genesis™ Electrosurgical Generator CONMED® HyfreSurg™OP Electrosurgical Generator

Indications for Use:

... ...

General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

12n-C Division of Surgical, Orthopedic, and Restorative Devices

Page of of

510(k) Number K103665

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.