ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 26, 2023 Arthrocare Corporation Pragnya Bakka Senior Regulatory Affairs Specialist 7000 West William Cannon Drive Austin, Texas 78735 Re: K230914 Trade/Device Name: ARIS; COBLATION; Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 2, 2023 Received: June 5, 2023 Dear Pragnya Bakka: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Mark Trumbore. The date of the signature is June 26, 2023 at 13:56:49 -04'00'. Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K230914 Device Name ARISO COBLATION Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) Indications for Use (Describe) The ARIS Wand, used with the WEREWOLF COBLATION System, is Indicated for ablation, resection and coaqulation of soft tissue and hemostasis of blood vessels in otorhinolarynqology (ENT) surgery including; nasal airway obstruction of hypertrophic nasal turbinates and submucosal tissue shrinkage. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for ArthroCare. The logo consists of a stylized, abstract graphic to the left of the company name. The graphic is composed of several curved, parallel lines in a deep red color, arranged in a semi-circular or orbital pattern, suggesting movement or energy. To the right of the graphic, the name "ArthroCare" is written in a clean, sans-serif font, with the "A" and "C" capitalized and the rest of the letters in lowercase. The color of the text is a dark gray, providing a contrast against the white background. # 510(k) Summary #### ARIS® COBLATION® Turbinate Reduction Wand and WEREWOLF COBLATION Systems 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. #### 1 GENERAL INFORMATION | Submitter Name | ArthroCare Corporation | |----------------|-------------------------------------------------------------------------------------------------| | Address | 7000 West William Cannon Drive<br>Austin, TX 78735 | | Contact Person | Pragnya Bakka<br>Senior Regulatory Affairs Specialist<br>e-mail: pragnya.bakka@smith-nephew.com | - Date Prepared March 29, 2023 CFR Section - 2 DEVICE NAME(S) Subject Device Proprietary Name ARISº COBLATIONº Turbinate Reduction Wand; and WEREWOLF COBLATION System WEREWOLF+ COBLATION System Common Name ARIS Wand, Turbinate Reduction Wand, Electrosurgical devices and accessories Classification Name Electrosurgical, cutting & coagulation & accessories Device Class Class II Product Code GEI 7000 W.William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com CFR 878.4400 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic on the left and the company name "ArthroCare" on the right. The graphic is composed of several curved, parallel lines in a deep red color, arranged to suggest movement or flow. The text "ArthroCare" is written in a gray, sans-serif font, with a registered trademark symbol (®) placed after the word "Care". 3 PREDICATE DEVICE (s) ArthroCare Turbinator Wand (K122652) compatible with WEREWOLF COBLATION System (K202006) > WEREWOLF COBLATION SYSTEM - K210423 WEREWOLF + COBLATION SYSTEM- K192027 FLOW 90º Wand - K183346 #### 4 DEVICE DESCRIPTION REFERENCE DEVICE: The purpose of this submission is to obtain clearance for the subject device ARIS® COBLATION® Turbinate Reduction Wand, that is intended to be used exclusively with the WEREWOLF COBLATION Systems; WEREWOLF+ COBLATION system (K210423) and WEREWOLF COBLATION System (K192027). # 4.1 ARIS COBLATION Turbinate Reduction Wand: The ARIS COBLATION Turbinate Reduction Wand (Figure 1) is a single-use, disposable, bipolar, radio frequency, electrosurgical device intended for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue. There are no changes to the WEREWOLF Controllers or Irrigation pump for use with ARIS Wand. The ARIS Turbinate Reduction Wand consists of three integrated lines built into the handpiece that allow the wand to work as intended: - An integrated suction line with universal barb allows connection to suction source within the operating environment. - An integrated saline tube set designed to be compatible with the WEREWOLF controller . pump module allows connection with saline source within the operating environment. - . An integrated cable to be compatible with the WEREWOLF controller. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic to the left of the company name. The graphic is composed of several curved, parallel lines in a reddish-purple color, arranged in a circular or spherical shape. To the right of the graphic is the name "ArthroCare" in a dark gray, sans-serif font, with a registered trademark symbol next to it. Image /page/5/Figure/1 description: The image shows a medical device with several labeled components. The device has a handpiece, a working length, and a distal tip. Additionally, there are integrated saline and suction lines, as well as an integrated cable connected to the handpiece. Figure 1 ARIS COBLATION Turbinate Reduction Wand Note: The subject device, ARIS COBLATION Turbinate Reduction Wand is also referred to as WW Turbinate Wand, ENC504 or ARIS Wand in the test reports associated with this device. Along with the Wand, a tip clearing component will be included within the packaging of the wand to support removal of clogs. # 4.2 WEREWOLF COBLATION Systems # WEREWOLF COBLATION SYSTEM (K192027) The WEREWOLF COBLATION System consists of: - . A bipolar, radiofrequency (RF) generator (Controller) with Integrated Fluid Module and Operational Interface Screen, - Re-usable, non-sterile Foot Control (wired or wireless) - . Sterile, disposable, single-use COBLATION Wand(s) - . Reusable, non-sterile power cord. The WEREWOLF COBLATION System (cleared via 510(k) K192027) utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of blood {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic on the left and the word "ArthroCare" on the right. The graphic is composed of several curved, parallel lines in a deep red color, arranged to suggest a spherical or orbital shape. The word "ArthroCare" is written in a gray, sans-serif font, with the registered trademark symbol (®) placed to the upper right of the word "Care". vessels in various arthroscopic, orthopedic (cleared via K162074) and otorhinolaryngology (ENT) procedures (cleared via K192074). The WEREWOLF controller (or WW ENT Controller) is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface which the user can control various modes, levels, volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed. The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site. The system offers five distinct Modes of Operation (cleared via K162074) for arthroscopic and orthopedic procedures: Hi (Ablation), Med (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis), and four modes for ENT procedures (cleared via K192027). #### WEREWOLF+ COBLATION SYSTEM (K210423) The WEREWOLF COBLATION System consists of: - A bipolar, radiofrequency (RF) generator (COBLATION System) with . Integrated Fluid Module (FLOW IQTM Pump) and Operational Interface Screen. - Re-usable, non-sterile Foot Control (wired or wireless) - Sterile, disposable, single-use COBLATION Wand(s) ● - Reusable, non-sterile power cord. ● The WEREWOLF+ COBLATION System (K210423) is an iteration of WEREWOLF COBLATION system (cleared via 510(k) K192027). The WEREWOLF+ COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of blood vessels in various arthroscopic, orthopedic (cleared via K162074), otorhinolaryngology (ENT) procedures (cleared via K192074), and hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures (cleared via K210423). {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic on the left and the word "ArthroCare" on the right. The graphic is composed of several curved, parallel lines in a deep red color, arranged in a semi-circular shape. The word "ArthroCare" is written in a dark gray, sans-serif font, with the registered trademark symbol (®) appearing in superscript next to the word. The WEREWOLF+ controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface which the user can control various modes, levels, volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed. The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site. The system offers five distinct Modes of Operation (cleared via K 162074) for arthroscopic and orthopedic procedures: Hi (Ablation), Med (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis), and four modes for ENT Image /page/7/Picture/2 description: The image shows a medical device and its accessories. The main device is a white box with an orange stripe and a screen. There are several handpieces with cables, and two foot pedals with yellow and blue buttons. The device and accessories are arranged on a white surface. Figure 2 WEREWOLF Coblation System procedures (cleared via K192027), and one mode (COAG) for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures (cleared via K210423). {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the ArthroCare logo. The logo consists of a circular design on the left and the word "ArthroCare" on the right. The circular design is made up of several curved lines that are arranged in a circular pattern. The word "ArthroCare" is written in a sans-serif font and is in gray color. There is a registered trademark symbol next to the word "ArthroCare". #### 5 INDICATIONS FOR USE #### 5.1 ARIS COBLATION Turbinate Reduction Wand The ARIS COBLATION Turbinate Reduction Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage. #### 6 SUMMARY OF THE TECHNOLOGICAL FEATURES OF SUBJECT DEVICE AND PREDICATE DEVICE SYSTEMS The subject device (ARIS Wand) and predicate device (ArthroCare Turbinator) are bipolar electrosurgical wands and share the same technological characteristics (i.e., design, similar material, and energy source), intended use, principle of operation and fundamental scientific technology. As the subject device and predicate device are intended to be used with controllers that generated radiofrequency, the comparison of these wands along with controllers is detailed in the below sections Table 1 below presents summary of the technological characteristics with exceptions highlighted in bold italicized font. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines that are arranged in a circular pattern. The word "ArthroCare" is written in a sans-serif font and is in a dark gray color. There is a registered trademark symbol next to the word "Care". Table 1 Comparison Of Technological Characteristics Between The Predicate And Subject Device Systems | Parameter | Predicate Device | Subject Device | | |-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ArthroCare Turbinator<br>with WEREWOLF<br>COBLATION System<br>(K202006) | ARIS COBLATION<br>Turbinate Reduction<br>Wand with WEREWOLF<br>COBLATION System<br>(K192027) | ARIS COBLATION<br>Turbinate Reduction<br>Wand with<br>WEREWOLF+<br>COBLATION System<br>(K210423) | | Wand Specifications/Features | | | | | Intended use | Indicated for ablation,<br>resection, and<br>coagulation of soft tissue<br>and hemostasis of blood<br>vessels in<br>otorhinolaryngology<br>(ENT) sinus surgery<br>involving nasal airway<br>obstruction by reduction<br>of hypertrophic nasal<br>turbinates and<br>submucosal tissue<br>shrinkage. | The ARIS COBLATION<br>Turbinate Reduction Wand,<br>used with the WEREWOLF<br>COBLATION System, is<br>indicated for ablation,<br>resection and coagulation of<br>soft tissue and hemostasis of<br>blood vessels in<br>otorhinolaryngology (ENT)<br>surgery including: nasal<br>airway obstruction by<br>reduction of hypertrophic<br>nasal turbinates and<br>submucosal tissue<br>shrinkage. | The ARIS COBLATION<br>Turbinate Reduction Wand,<br>used with the WEREWOLF<br>COBLATION System, is<br>indicated for ablation,<br>resection and coagulation of<br>soft tissue and hemostasis of<br>blood vessels in<br>otorhinolaryngology (ENT)<br>surgery including: nasal<br>airway obstruction by<br>reduction of hypertrophic<br>nasal turbinates and<br>submucosal tissue<br>shrinkage. | | | The Wand is designed to<br>be used exclusively with<br>the COBLATOR II(CII)<br>controller and Irrigation<br>pump or the<br>WEREWOLF<br>COBLATION system (in<br>conjunction with the<br>ENT adapter and<br>Irrigation Tube Set).<br>Other controllers/pumps | | | | Wand Materials | must not be used | | | | Electrode Materials | Tungsten | Same | Same | | Shaft Material and Return<br>electrode material | 304 Stainless steel | 17-4 stainless steel<br>(Elevator tip) | 17-4 stainless steel<br>(Elevator tip) | | | | (Return tube) | (Return tube) | | Return Electrode Insulation | Polyolefin | Pebax extruded tube | Pebax extruded tube | | Active electrode Insulation | Polyolefin heat shrink tube | Same | Same | | Spacer | 99.5% Alumina | Same | Same | | Suction/Saline Tubing | Nylon (internal)/PVC (external) | Pebax extruded tube (internal) / PVC (external) | Pebax extruded tube (internal) / PVC (external) | | Integrated Suction | | Contains Integrated Suction. Colorite 8088G-015 | | | | 0.082 inch ID, 0.155 inch OD | 0.091 inch ID, 0.155 inch OD | 0.091 inch ID, 0.155 inch OD | | Adhesive | Epoxy, Cyanoacrylate, UV Adhesive | HV-10 heat cure epoxy PN 95389<br>UV Adhesive | HV-10 heat cure epoxy PN 95389UV Adhesive | | Handle/Bushing Material | Polycarbonate | Same | Same | | Wand Specifications | | | | | Total Length | 85±10mm | 85±10mm | 85±10mm | | Handle Length | 4.4 inches | Same | Same | | Distal Tip Diameter | 2.9mm | 2.4mm | 2.4mm | | Distal Tip Shape | Blunt Shape | Elevator tip | Elevator tip | | Number of Electrodes | 1 (active)<br>1 (return) | Same | Same | | Number of Internal Suction Channels | 1 | Same | Same | | Materials Biocompatible | Yes | Same | Same | | Electrode Configurations | Electrode on one side of wand tip | Same | Same | | Wand cable | Integrated cable | Same | Same | | Rigid/Flexible Construction | Rigid | Same | Same | | Spacer Configuration | Single-Lumen | Same | Same | | Suction and/or Irrigation Line | Present | Same | Same | | Packaged Sterile | Yes | Same | Same | | Single Use Disposable | Yes | Same | Same | | Bipolar/Monopolar | Bipolar | Same | Same | | Packaged sterile | Yes | Same | Same | | Sterilization | Radiation | Ethylene Oxide | Ethylene Oxide | | Use limit | Mechanical use limit<br>(fuse in the handle of<br>the Wand that is blown<br>after the device is<br>connected to the<br>Controller) | 24-hour life from when<br>wand is first activated<br>(microchip in the handle of<br>the Wand that only allows<br>the Wand to be used for 24<br>hours after activation) | 24-hour life from when<br>wand is first activated<br>(microchip in the handle of<br>the Wand that only allows<br>the Wand to be used for 24<br>hours after activation) | | Cable Assembly -<br>Connector (Does the<br>Wand need Adaptor?) | WEREWOLF ENT<br>Adaptor is required to<br>connect with WW<br>controller | No ENT adaptor required.<br>The Wand comes with a<br>WEREWOLF compatible<br>cable with custom<br>connector and Integrated<br>micro-chip | No ENT adaptor required.<br>The Wand comes with a<br>WEREWOLF compatible<br>cable with custom<br>connector and Integrated<br>micro-chip | | Tip Clearing tool | None | Included with device<br>Nitinol wire, .020-inch<br>diameter Polycarbonate<br>handle | Included with device<br>Nitinol wire, .020-inch<br>diameter Polycarbonate<br>handle | | Operating life | 1.5 min (1Xlife) | 2 minutes (1x life)<br>3 minutes (use limit) | 2 minutes (1x life)<br>3 minutes (use limit) | | Saline Source | External Saline Delivery | Same | Same | | Electrical safety/EMC | IEC 60601-2-2 compliant | Same | Same | | Suction and/or Irrigation | Yes | Same | Same | | Tyvek<br>packaging/Adhesive | Yes | Same | Same | | Operates in saline<br>environment | Yes | Same | Same | | Software in Wand | No | Yes | Yes | | Controller Specifications/Features | | | | | Ablation / Resection | Yes | Same | Same | | Homeostasis/Coagulation | Yes | Same | Same | | Input power | 100-120/220-240V | Same | Same | | Output Frequency | 100 KHz | Same | Same | | Fuse Rating | 16Amps…