ARTHROSCOPIC ENERGY SYSTEM

K140578 · Conmed Corporation · GEI · Jul 23, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140578
• Device Name: ARTHROSCOPIC ENERGY SYSTEM
• Applicant: Conmed Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Arthroscopic Energy System comprises RF generator, single-use monopolar/bipolar probes/electrodes, dispersive pad, and wired/wireless foot controls. Used in arthroscopic/orthopedic surgery for soft tissue resection, ablation, and coagulation, plus hemostasis. Generator features LCD touch screen for numeric power adjustment; controlled via hand-piece, wired, or wireless foot pedals. Physician operates system to deliver RF energy to target tissue. Output allows precise tissue management, potentially reducing surgical time and improving patient outcomes through controlled thermal effects.

Clinical Evidence

Bench testing only. No clinical data. Testing included probe functional testing; system testing (suction rate, ablation rate, temperature accuracy, decibel level, short detection, comparative dissection/ablation/hemostasis); and standards testing (biocompatibility ISO 10993-1, packaging ISO 11607-1, sterilization ISO 11135-1, shelf-life ISO 10993-7, EMC IEC 60601-1-2/IEC 60601-2-2, and electrical safety IEC 60601-1).

Technological Characteristics

Radiofrequency (RF) electrosurgical generator; bipolar and monopolar modes. Features LCD touch screen interface. Compatible with single-use disposable probes. Standards: ISO 10993-1 (biocompatibility), ISO 11607-1 (packaging), ISO 11135-1 (sterilization), ISO 10993-7 (shelf-life), IEC 60601-1-2/60601-2-2 (EMC), IEC 60601-1 (electrical safety).

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in patients undergoing arthroscopic and orthopedic surgical procedures.

Regulatory Classification

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.

Predicate Devices

• ArthroCare® System 12000 (K082666)
• ConMed Sabre Genesis Electrosurgical Generator (K103665)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### C. Device Name

| Trade Name: | Arthroscopic Energy System |
|------------------------|-------------------------------------------------------------------|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Names: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| 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.

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.

#### 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 DEVICE<br>ConMed Corporation | PREDICATE DEVICE<br>ArthroCare System 12000 | REFERENCE DEVICE<br>Sabre Genesis |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | Arthroscopic Energy System<br>(AES-1) | (Quantum)<br>K082666 | K103665 |
| Brief<br>Description | A radiofrequency generator<br>that is intended to be used<br>with a selection of bipolar or<br>monopolar probes and<br>electrodes, a dispersive pad<br>(as needed), and wired or<br>wireless foot controls. | A bipolar, high frequency,<br>electrosurgical generator<br>called the Controller that is<br>intended to be used with a<br>family of disposable, bipolar,<br>single use Wands. | An electrosurgical generator<br>with the basic modes of<br>operation being conventional<br>electrosurgical cutting and<br>coagulation. |
| Intended<br>Use/<br>Indications<br>for Use | Indicated for resection,<br>ablation, and coagulation of<br>soft tissue and hemostasis of<br>blood vessels in arthroscopic<br>and orthopedic surgical<br>procedures. | Indicated for resection,<br>ablation, and coagulation of<br>soft tissue and hemostasis of<br>blood vessels in arthroscopic<br>and orthopedic procedures. | Intended for use in open and<br>laparoscopic surgery and in<br>office based surgical<br>procedures. |
| Functionality | Bipolar and Monopolar<br>radiofrequency | Bipolar<br>radiofrequency | Bipolar and Monopolar<br>radiofrequency |
| Operating<br>modes | Cut and Coagulation | Cut and Coagulation | Cut and Coagulation |
| Probes | Single-use, disposable bipolar<br>and monopolar probes | Single-use, disposable<br>bipolar wands | Single-use, disposable bipolar<br>and 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 [phone] or [phone] 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 [phone] or [phone] 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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