The Arthroscopic Energy™ System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.

Device Description

The ConMed Arthroscopic Energy System consists of a radiofrequency (RF) generator, probes or electrodes, a dispersive pad (as needed), and wired or wireless foot controls. The probes or electrodes are single-use devices used with the Arthroscopic Energy System for the purpose of wet field arthroscopic and orthopedic soft tissue resection (dissection), ablation (removal) and coagulation (hemostasis).

The generator is compatible with ConMed monopolar and bipolar probes or electrodes. The generator outputs are delivered to the probes or electrode handpieces within the specification ranges currently cleared and marketed by generators that have equivalent indications. The generator has a liquid crystal display (LCD) touch screen user interface. Power levels are assigned numeric values and are adjustable via the user interface. Control is accomplished via probe or electrode hand-piece controls, wired foot control or wireless foot control.

AI/ML Overview

The ConMed Arthroscopic Energy System is an electrosurgical device. The descriptive text does not contain specific acceptance criteria, corresponding performance metrics, or details of a study that would provide such information. However, based on the provided text, the device underwent testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific device performance numerically (e.g., a specific ablation rate in mm/min, or a defined temperature accuracy range). Instead, it states that testing was completed to "confirm that the Arthroscopic Energy System provides equivalent results in resection, ablation, coagulation and hemostasis in comparison to the predicate device, ArthroCare® System 12000 (K082666)."

The types of testing performed are listed, which indirectly relate to performance attributes:

Test Category	Specific Tests Performed
Probe Testing	Functional testing
System Testing	Suction rate, Ablation rate, Temperature accuracy, Decibel level, Short detection testing, Comparative testing for dissection, ablation, and hemostasis
Standards Testing	Biocompatibility (ISO 10993-1), Packaging (ISO 11607-1), Sterilization (ISO 11135-1), Shelf-life (ISO 10993-7), Electromagnetic compatibility (IEC 60601-1-2; IEC 60601-2-2), Electrical safety (IEC 60601-1)

Reported Device Performance:
The document broadly indicates that the device "provides equivalent results" and "is as safe, as effective, and performs as well as" the predicate devices for their respective functionalities. No specific numerical performance results are provided in this summary.

2. Sample Size for Test Set and Data Provenance:

The document does not provide details on the sample sizes used for any of the tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench or in-vitro testing based on the descriptions ("probe testing," "system testing," "standards testing"). There is no mention of human subject data or clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable as the document does not describe a study involving expert assessment of images or clinical outcomes to establish a "ground truth." The evaluation focuses on the engineering and functional performance of the device against predicate devices and relevant standards.

4. Adjudication Method:

Not applicable, as there is no expert assessment or "ground truth" to adjudicate.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and functional comparisons, not through human reader performance analysis.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This concept is not relevant to the described device. The device is a medical instrument (electrosurgical system) that requires human operation; it is not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on achieving performance metrics comparable to legally marketed predicate devices and compliance with established industry standards (e.g., ISO, IEC). It's essentially a "performance equivalence" ground truth rather than an "expert diagnostic" or "pathology" ground truth.

8. Sample Size for Training Set:

Not applicable. The device is hardware (an electrosurgical system) and does not involve a "training set" in the context of machine learning or AI.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized "C" in a black square on the left, followed by the word "CONMED" in large, bold letters. Below "CONMED" is the word "CORPORATION" in smaller letters. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.

510(k) SUMMARY

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K140578 .

Date Prepared: April 10, 2014

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration Number: 1320894

B. Company Contact

Dionne Sanders, RAC Regulatory Affairs Specialist Tel: (727) 399-5564 Fax: (727) 399-5264

C. Device Name

Trade Name:	Arthroscopic Energy System
Common Name:	Electrosurgical Device and Accessories
Classification Names:	Electrosurgical Cutting and Coagulation Device andAccessories
Proposed Class/Device:	Class II
Product Codes:	GEI
Regulation:	21 CFR Part 878.4400

D. Predicate/Legally Marketed Devices

Device Name:	ArthroCare® System 12000
Company Name:	ArthroCare Corporation
510(k) #:	K082666
Device Name:	ConMed Sabre Genesis Electrosurgical Generator
Company Name:	ConMed Electrosurgery
510(k) #:	K103665

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Image /page/1/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized black square with a white curved shape inside, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is a horizontal line, and below that is the word "CORPORATION" in a smaller, sans-serif font.

Device Description II.

F. Intended Use / Indications

The Arthroscopic Energy System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.

G. Summary of Technological Characteristics

The following table represents a summary of the technological characteristics of the ConMed Arthroscopic Energy System, ConMed Electrosurgery Sabre Genesis, and the ArthroCare System 12000.

	PROPOSED DEVICEConMed Corporation	PREDICATE DEVICEArthroCare System 12000	REFERENCE DEVICESabre Genesis
	Arthroscopic Energy System(AES-1)	(Quantum)K082666	K103665
BriefDescription	A radiofrequency generatorthat is intended to be usedwith a selection of bipolar ormonopolar probes andelectrodes, a dispersive pad(as needed), and wired orwireless foot controls.	A bipolar, high frequency,electrosurgical generatorcalled the Controller that isintended to be used with afamily of disposable, bipolar,single use Wands.	An electrosurgical generatorwith the basic modes ofoperation being conventionalelectrosurgical cutting andcoagulation.
IntendedUse/Indicationsfor Use	Indicated for resection,ablation, and coagulation ofsoft tissue and hemostasis ofblood vessels in arthroscopicand orthopedic surgicalprocedures.	Indicated for resection,ablation, and coagulation ofsoft tissue and hemostasis ofblood vessels in arthroscopicand orthopedic procedures.	Intended for use in open andlaparoscopic surgery and inoffice based surgicalprocedures.
Functionality	Bipolar and Monopolarradiofrequency	Bipolarradiofrequency	Bipolar and Monopolarradiofrequency
Operatingmodes	Cut and Coagulation	Cut and Coagulation	Cut and Coagulation
Probes	Single-use, disposable bipolarand monopolar probes	Single-use, disposablebipolar wands	Single-use, disposable bipolarand monopolar probes

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Image /page/2/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized, curved shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. A horizontal line underlines the word "CONMED".

Testing was completed to confirm that the Arthroscopic Energy System provides equivalent results in resection, ablation, coagulation and hemostasis in comparison to the predicate device, ArthroCare ® System 12000 (K082666). Testing completed included -

Probe testing
- o Functional testing
A System testing
- O Suction rate
- o Ablation rate
- Temperature accuracy O
- Decibel level 0
- Short detection testing o
- Comparative testing for dissection, ablation, and hemostatis o
Standards testing
- Biocompatibility (ISO 10993-1) 0
- Packaging (ISO 11607-1) 0
- Sterilization (ISO 11135-1) ಂ
- Shelf-life (ISO 10993-7) 0
- Electromagnetic compatibility (IEC 60601-1-2; IEC 60601-2-2) 0
- Electrical safety (IEC 60601-1) o

H. Substantial Equivalence

The Arthroscopic Energy System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, technological characteristics to the ArthroCare® System 12000 (K082666) with the exception of the absence of a monopolar functionality. The subject device and predicate device systems provides bipolar functionality for cutting and coagulation using hand and foot controls which provide the ability to change power settings and measure joint fluid temperature. The Arthroscopic Energy System also provides monopolar functionality and is substantially equivalent in design, principles of operation, technological characteristics, and modes of operation to the ConMed Sabre Genesis (K103665).

I. Conclusion

Based upon the testing and analysis performed, the Arthroscopic Energy is as safe, as effective, and performs as well as the ArthroCare® System 12000 (K082666) for bipolar functionality and the ConMed Sabre Genesis (K103665) for monopolar functionality.

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wave-like lines extending from its body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 23, 2014

ConMed Corporation Ms. Dionne Sanders, RAC Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K140578

Trade/Device Name: Arthroscopic Energy" System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 10, 2014 Received: April 11, 2014

Dear Ms. Sanders:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Dionne Sanders, RAC

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): _K140578

Device Name: Arthroscopic Energy™ System

Intended Use / Indications for Use:

The Arthroscopic Energy™ System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Module A- Page 4

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.