Werewolf RF20000 Controller, FLOW 50 Wand

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 22, 2016 ArthroCare Corporation Ms. Shirley Hyink Director, Regulatory Affairs 7000 W. William Cannon Drive Austin, Texas 78735 Re: K162074 Trade/Device Name: Werewolf Coblation System (RF20000) with FLOW IQ Technology: Werewolf System Controller (RF20000), and FLOW 50 Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 25, 2016 Received: July 27, 2016 Dear Ms. Hyink: 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 device {1}------------------------------------------------ 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" (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 yours, # 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}------------------------------------------------ | Form Approved: OMB No. | 0910-0120 | |--------------------------|------------------| | Expiration Date: | January 31, 2017 | | See PRA Statement below. | | | 510(k) Number (if known) | K162074 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------| | Device Name | Werewolf Coblation System (RF20000) with FLOW IQ Technology: Werewolf System Controller (RF20000) and FLOW 50 Wand | | Indications for Use (Describe) | Please see attached. | | Type of Use (Select one or both, as applicable) | <div><span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D)</div> <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ # 1762674 ്കിരുന്നും വന്നും വന്നു വട സവീപുള്ളവും പ്രത്യസ്തരം എന്നാലവന്റെ വി.പി. പ്രവേശന സ്വീതിച്ചു. പാലിക്കുടവും വി. വന്നും വടക്സിന്റെയും നല്ലാത്തിനും എന്നാലവന് | All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) | Hip | Knee | Shoulder | Wrist | Ablation/Debridement | Excision/Resection | |---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------------|-------|----------------------|---------------------------------------------------------------------------------------------------------------------| | Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon | Tendon | ACL/PCL Notchplasty | Acromioplasty Subacromial Decompression | | | Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon | | | Acetabular Labrum Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy | | | | | | | | | | Frozen Shoulder Release Glenoid Labrum Triangular Fibrocartilage (TFCC) | | | | {4}------------------------------------------------ u # 510(k) Summary ### ArthroCare® Corporation ### Werewolf Coblation System (RF20000) with FLOW IQ Technology This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ### General Information | Submitter Name: | ArthroCare Corporation | |-----------------|----------------------------------------------------------------------------------------------------------------------------------------| | Address: | 7000 West William Cannon Drive<br>Austin, TX 78735 | | Contact Person: | Shirley Hyink, BS<br>Director, Regulatory Affairs<br>Email: Shirley.hyink@smith-nephew.com<br>Phone: 512-895-1372<br>Fax: 512-895-1489 | | Date Prepared: | July 25, 2016 | ### Device Name | Proprietary Name: | Werewolf Coblation System (RF20000) with FLOW IQ Technology | |-------------------|-------------------------------------------------------------| | | Werewolf System Controller (RF20000) and | | | FLOW 50 Wand | | Common Name: | Electrosurgical cutting and Coagulation Device and Accessories | |--------------------|----------------------------------------------------------------| | Regulation Name: | Electrosurgical cutting and Coagulation Device and Accessories | | Regulatory Class: | II | | Product Code: | GEI | | Regulation Number: | 21 CFR 878.4400 | ### Predicate Devices RF20000a Coblation System (K143235) ### Description ### Werewolf Coblation System(RF20000) The RF20000 Coblation System is an electrosurgical system consisting of a bipolar radiofrequency Controller with Integrated Fluid Outflow Regulator; a sterile, disposable, single-use FLOW 50 Wand; Black Connector Quantum Wands, and a non-sterile, reusable wired Foot Control or wireless Foot Control. {5}------------------------------------------------ This System utilizes bipolar technology specifically designed for the resection, and ablation of soft tissue and hemostasis of blood vessels in various arthroscopic and orthopedic procedures. The System offers five distinct Modes of operation: Hi (Ablation), Med (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis), Each Ablation (Coblation) mode allows for precise ablation with minimal damage to surrounding healthy tissue. The COAG mode allows for consistent and precise hemostasis of blood vessels. ### FLOW 50 Wand The FLOW 50 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the RF20000a Controller and the Fluid Outflow Regulator, respectively. The handle has finger switches that enable Ablation Mode switching (Lo. Med. Hi) as well as activation of the Wand (Vac. Coag, or Ablate). The Foot Control provides an alternate means of controlling these same functions. The Wand is provided sterile and is single-use only. ### RF20000 Controller The RF20000 Controller is designed to deliver radiofrequency energy to the electrodes of the FLOW 50 Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels, volume, etc. Ports for connecting the FLOW 50 Wand, Black Connector Quantum Compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed. The Controller incorporates a peristaltic integrated Fluid Outflow Regulator, which provides dynamic control of the rate of removal of conductive irrigating solution and/or fine, less dense, free-floating debris. ### Intended Use/Indications for Use The Werewolf Coblation System, comprised of the FLOW 50 Wand and the RF20000 Controller, is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: | | Ablation/Debridement | Excision/Resection | |----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | All Joints<br>(Hip, Knee,<br>Shoulder,<br>Wrist,<br>Ankle,<br>Elbow) | ■ Articular Cartilage<br>■ Bursectomy<br>■ Chondroplasty<br>■ Fascia<br>■ Ligament<br>■ Scar Tissue<br>■ Soft Tissue<br>■ Synovectomy<br>■ Tendon | ■ Articular Labrum<br>■ Capsule<br>■ Cysts<br>■ Ligament<br>■ Loose Bodies<br>■ Plica Removal<br>■ Scar Tissue<br>■ Soft Tissue<br>■ Synovial Membrane<br>■ Tendon | | Hip | | ■ Acetabular Labrum | | Knee | ■ ACL/PCL<br>■ Notchplasty | ■ Capsular Release<br>■ Cartilage Flaps<br>■ Discoid Meniscus<br>■ Lateral Release<br>■ Meniscal<br>■ Cystectomy | {6}------------------------------------------------ # K162074 | | | • Meniscectomy<br>• Villusectomy | |----------|---------------------------------------------------|--------------------------------------------------| | Shoulder | • Acromioplasty<br>• Subacromial<br>Decompression | • Frozen Shoulder<br>Release<br>• Glenoid Labrum | | Wrist | | • Triangular<br>Fibrocartilage<br>(TFCC) | ### Summary of Technological Characteristics The subject devices have the same technological characteristics (i.e., design, material, chemical composition, and energy source) as the predicate devices with the following exceptions (in bold font): | | Predicate<br>Controller: RF20000a<br>Wand: FLOW 50<br>(K143235) | Subject<br>Controller: Werewolf<br>Wand: FLOW 50 | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Intended Uses | | | | Ablation / Resection | Yes | Same | | Hemostasis / Coagulation | Yes | Same | | Controller Specifications/Features | | | | Input Power | 100-240V<br>50/60Hz | Same | | Fuse Rating | 15 A | Same | | Output Frequency<br>(Fundamental) | 100kHz | Same | | Default Ablation<br>Set Point / Output Voltage<br>(Vrms) | Med. / 279 | Same | | Ablation Set Point Range /<br>Output Voltage (Vrms) | Lo Minus - Hi Plus / 257-340 | Same | | Coagulation Set Point<br>Range / Output Voltage<br>(Vrms) | Coag - Coag Plus / 65-85 | Same | | Outflow Control<br>Mechanism | Controller has an integrated low<br>pressure rotational peristaltic pump<br>Range: 0-600 rpm | Same | | Software Program | Graphic User Interface V 0.2<br>RF controller software for | Graphic User Interface V<br>1.1 | | | Predicate<br>Controller: RF20000a<br>Wand: FLOW 50<br>(K143235) | Subject<br>Controller: Werewolf<br>Wand: FLOW 50 | | | RF20000a, V 1.0 | RF controller software for<br>RF20000, V 2.3 | | Weight | 10 kg | Same | | Controller crest factor (350<br>ohm load) | 1.4 | Same | | Controller waveforms | Square | Same | | Controller input power (W) | 460 (290 ohms) | Same | | Rated Wand voltage | 340 Vrms | Same | | Output Voltage (Vrms) at<br>350 ohm load | Lo - /126 | Same | | | Lo • / 150 | Same | | | Lo + / 175 | Same | | | Med - / 200 | Same | | | Med • / 224 | Same | | | Med + / 248 | Same | | | Hi - / 272 | Same | | | Hi • / 297 | Same | | | Hi + / 323 | Same | | | Coag / 53.2 | Same | | | Coag + / 102 | Same | | Wand Materials | | | | Electrode | Tungsten | Same | | Shaft | 304 Stainless Steel | Same | | Outer Shaft Insulation | Black Pebax | Same | | Spacer | Ceramic (Alumina) | Same | | Adhesive | Epoxy (Loctite 3984) | Same | | Handle Material | Iupilon S3001R | Same | | Wand Suction Line | PVC | Same | | Wand Specifications/Features | | | | Shaft length | 5.31 ± 0.20 inches | Same | | Distal Bend Angle | 40 ° | Same | | Handle length | 6.13 inches | Same | | Number of Electrodes | 1 active & 1 return | Same | | Screen | Tungsten screen with welded | Same | | | Predicate<br>Controller: RF20000a<br>Wand: FLOW 50<br>(K143235) | Subject<br>Controller: Werewolf<br>Wand: FLOW 50 | | (active electrode) | platinum iridium leads bonded to<br>holes in spacer with epoxy | | | Number of Internal Suction<br>Ports | 1 | Same | | Suction | Yes | Same | | Shaft Rigid Construction | Yes | Same | | Use Limiting Feature | Yes (microchip in the handle of the<br>Wand that only allows the Wand to<br>be used for 24 hours after activation) | Same | | Temperature Measure | 10 to 60 °C measured with a<br>thermistor<br>Ambient alarm: Audible & visual<br>alarms active if measured irrigation<br>fluid temp exceeds alarm set point.<br>Measurement of tube in handle,<br>preventing excessive tube<br>temperature. Output pulsed or shut-<br>off if temperatures exceeded. | Same | | Finger Switch Activation | Yes | Same | | Foot Switch Activation | Yes | Same | | Software in Wand | FLOW 50 Wand<br>Product Code<br>V 3.2<br>Config File 48649 | FLOW 50 Wand<br>Product Code<br>V 3.2<br>Config File 68909<br>(includes Wand Wear and<br>LVI parameters) | | Packaged Sterile | Yes | Same | | Single Use Disposable | Yes | Same | | Operates in Conductive<br>Media Environment | Yes | Same | | Bipolar/ Monopolar | Bipolar | Same | | Sterilization | Radiation | Same | | Recommended Active<br>Ablation Time | Lo Mode: 10 minutes<br>Med Mode: 4 minutes<br>Hi Mode: 2 minutes | Same | {7}------------------------------------------------ # K162074 {8}------------------------------------------------ # K162074 | Reference Comparator | Subject | |------------------------------------|----------------------| | Controller: Quantum 2<br>(K082666) | Controller: Werewolf | | Wand: BCQC Wands (Various) | Wand: BCQC Wands | {9}------------------------------------------------ | | Reference Comparator<br>Controller: Quantum 2<br>(K082666)<br>Wand: BCQC Wands (Various) | Subject<br>Controller: Werewolf<br>Wand: BCQC Wands | |------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Intended Uses | | | | Ablation / Resection | Yes | Same | | Hemostasis /<br>Coagulation | Yes | Same | | Controller Specifications/Features | | | | Input Power | 100-240V<br>50/60Hz | Same | | Fuse Rating | 8 A | Same | | Output Frequency<br>(Fundamental) | 100kHz | Same | | Default Ablation<br>Set Point / Output<br>Voltage (Vrms) | Set Point 7 / 260 | Same | | Ablation Set Point<br>Range / Output Voltage<br>(Vrms) | Set Points 1-9 / 100-314 | Same | | Coagulation Set Point<br>Range / Output Voltage<br>(Vrms) | Set Points 1-2 / 65-100 | Same | | Outflow Control<br>Mechanism | Hospital Suction with Roller<br>clamp to adjust flow control.<br>Recommended suction: 200-400<br>mmHg | Same | | Software Program | Software for Quantum 2, V 2.03 | Graphic User Interface V 1.1<br>RF controller software for<br>RF20000, V 2.3 | | Weight | <5 kg | 10 kg | | Controller crest factor<br>(350 ohm load) | 1.4 | Same | | Controller waveforms | Square | Same | | Controller input power<br>(W) | 460 (290 ohms) | Same | | Rated Wand voltage | 320 Vrms | Same | | Output Voltage (Vrms)<br>at 350 ohm load | Set Point 0 / 0 | Same | | | Set Point 1 / 95 | Same | | | Set Point 2 / 120 | Same | | | Set Point 3 / 146 | Same | | | Set Point 4 / 171 | Same | | | Set Point 5 / 198 | Same | | Reference Comparator<br>Controller: Quantum 2<br>(K082666)<br>Wand: BCQC Wands (Various) | Subject<br>Controller: Werewolf<br>Wand: BCQC Wands | | | Set Point 6 / 224 | Same | | | Set Point 7 / 247 | Same | | | Set Point 8 / 273 | Same | | | Set Point 9 / 299 | Same | | | Set Point 10 / 320* | Same | | | Coag 1 / 65 | Same | | | Coag 2 / 98 | Same | | {10}------------------------------------------------ The modifications made to the RF20000a Controller were: - Rebranding The system will be marketed under the name "Werewolf Coblation System ロ with FLOW IQ Technology". - ם Software algorithm changes to detect electrode wear - i Software algorithm changes to add dynamic sensing of Low Voltage Impedance - I Backwards compatibility of the Controller with existing, previously cleared Quantum Coblation Wands - Ability to customize user profile - I Compatibility with a wireless Foot Control ### Non-Clinical Data Bench testing was performed on bother the proposed and predicate devices. The test results demonstrate that the proposed Werewolf Coblation System meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling. ### Clinical Data No clinical or animal data are included in this submission. ### Substantial Equivalence Non-clinical performance data such as design verification, software validation, demonstrated that the subject devices are substantially equivalent to the predicate devices and are safe and effective when used as intended. ### Summary The Werewolf Coblation System (RF20000) is substantially equivalent to the predicate devices. The differences between the Werewolf RF20000 Coblation System and the predicate devices do not raise any new concerns about the safety or effectiveness of the subject devices.