Who is the manufacturer of Arthrex Synergy RF System?

Arthrex, Inc. filed the 510(k) submission for Arthrex Synergy RF System (K161581).

What is the FDA product code for Arthrex Synergy RF System?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Arthrex Synergy RF System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Arthrex Synergy RF System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arthrex Synergy RF System

Q: What are the predicate devices for Arthrex Synergy RF System?

ArthroCare System 12000 (K082666).

K161581 · Arthrex, Inc. · GEI · Sep 9, 2016 · General, Plastic Surgery

Device Facts

Record ID	K161581
Device Name	Arthrex Synergy RF System
Applicant	Arthrex, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Sep 9, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle.

Device Story

Arthrex Synergy RF System comprises RF generator/console, Apollo RF probe/ablator, and RF footswitch; designed as closed system. Input: electrical energy delivered to bipolar RF probe. Transformation: generator converts electrical energy to high-frequency current for tissue resection, ablation, coagulation, and hemostasis. Output: thermal effect on soft tissue/blood vessels. Used in OR by surgeons during arthroscopic/orthopedic procedures. Surgeon controls power settings via probe handle buttons or footswitch; console features touch screen for override options. Benefits: precise tissue management and hemostasis in minimally invasive joint surgery.

Clinical Evidence

Bench testing only. In-vitro study compared coagulation/ablation zone measurements and visual similarity of tissue effects between subject and predicate device. Measured temperatures of adjacent tissue to ensure safety equivalence.

Technological Characteristics

Bipolar electrosurgical system; high-frequency electrical current. Components: RF generator, aspirating RF probe, footswitch. Proprietary system architecture (not compatible with other generators). Touch screen interface for parameter control. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot, and ankle requiring soft tissue resection, ablation, coagulation, or hemostasis.

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)

Related Devices

K140578 — ARTHROSCOPIC ENERGY SYSTEM · Conmed Corporation · Jul 23, 2014
K041810 — SERFAS ENERGY SYSTEM · Stryker Endoscopy · Dec 21, 2004
K153499 — EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension · Conmed Corporation · Dec 18, 2015
K963783 — MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE · ETHICON, Inc. · Nov 25, 1996
K974022 — VAPR · Mitek Products · Jan 12, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of an eagle with its wings spread, facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 9, 2016 Arthrex, Inc. Mr. William Heard Regulatory Affairs Project Manager 1370 Creekside Blvd. Naples, Florida 34108-1945 Re: K161581 Trade/Device Name: Arthrex Synergy RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 25, 2016 Received: August 29, 2016 Dear Mr. Heard: 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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth {1}------------------------------------------------ in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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" (21 CFR 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. Christopher J. Ronk -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | Traditional 510(k) | K161581 | |--------------------|---------------------------| | Device Name | Arthrex Synergy RF System | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration **Indications for Use** | Form Approved: OMB No. | 0910-0120 | |--------------------------|------------------| | Expiration Date: | January 31, 2017 | | See PRA Statement below. | | | 510(k) Number ( if known ) | K161581 | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Arthrex Synergy RF System | | Indications for Use (Describe) | | | RF Console | The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | | RF Probe | The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <label><input checked="checked" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (8/14) | Page 1 of 1 | |----------------------|-------------| |----------------------|-------------| {3}------------------------------------------------ ## 510(k) Summary | Date Summary Prepared | August 25, 2016 | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer/ Distributor/ Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA | | 510(k) Contact | William Heard Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643-5553, ext.71813 Fax: 239/598-5508 Email: William.Heard@arthrex.com | | Trade Name | Arthrex Synergy RF System | | Common Name | Electrosurgical, Cutting & Coagulation device and accessories | | Product Code | GEI | | Classification Name | Electrosurgical cutting and coagulation device and accessories | | CFR | 21 CFR 878.4400: 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. | | Classification | Class II | | Review Panel | General & Plastic Surgery | | Predicate Devices | ArthroCare System 12000 (K082666) | | Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Synergy RF System. | | Device Description | The Arthrex Synergy RF System consists of the Arthrex Synergy RF Generator/Console, Apollo RF probe/ablator and the Synergy RF Footswitch. The system is designed specifically to work together and is not compatible with any other electrosurgical generator. The aspirating RF probe/ablator provides a bipolar | | | RF probe/ablator handle, the black button adjusts the default power setting for the specific RF probe/ablator connected to the Synergy RF console; the button with the yellow ablate invokes the Ablate function and the blue coagulation button invokes the Coagulation function. A Synergy RF Footswitch can be connected to the front panel of the console to override the control buttons. The user has the option to override this feature through the console touch screen options. | | Intended Use | RF Console | | | The Arthrex Synergy RF System, when used with an Apollo RF Ablation Device (Probe), is intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Specifically, the ablation devices, electrosurgical generator and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | | | RF Probe | | | The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | | Summary of Performance Testing | The performance testing of the Arthrex Synergy RF System has been shown to be substantially equivalent to the predicate ArthroCare 12000 system by evaluation of coagulation/ablation zone measurements and/or visual similarity of coagulation/ablation of tissue samples, and with respect to the measured temperatures of adjacent tissue, in-vitro. | | Substantial Equivalence Summary | Arthrex Synergy RF System is substantially equivalent to the predicate device ArthroCare System 12000 based on the same indications, FDA product code, CFR Regulation number, classification and indications for use. Any differences between the Arthrex Synergy RF System and the predicate are considered minor and do not raise questions concerning safety and effectiveness. The proposed device is substantially equivalent to the predicate device in regards to its intended use, design, energy source and function. | | | The submitted performance testing data demonstrated that the coagulation and ablation of the proposed device is substantially equivalent to the coagulation and ablation of the predicate device. | | Conclusion | Based on the indications for use, intended use, biocompatibility, technological characteristics, and the comparison of the performance testing to the predicate device, Arthrex, Inc. has determined that the Arthrex Synergy RF System is substantially equivalent to the currently marketed predicate device. | {4}------------------------------------------------ {5}------------------------------------------------