Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System

{0}------------------------------------------------ September 1, 2022 Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. Arthrocare Corporation Alexander Brankner International Regulatory Affairs Manager 7000 West William Cannon Drive Building One Austin, Texas 78735 Re: K220563 Trade/Device Name: Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 29, 2022 Received: August 1, 2022 Dear Alexander Brankner: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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, Colin K. Chen, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220563 ### Device Name Ambient HipVac 50 Wand with Integrated Finger Switches w/ RF20000 Coblation System. WEREWOLF Coblation System and WEREWOLF+ Coblation System. ### Indications for Use (Describe) The Ambient Hip Vac 50 Wand with Integrated Finger Switches is indicated for the resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures: | Joint | Ablation/Debridement | Excision/Resection | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | All Joints (Hip, Knee,<br>Shoulder, Wrist, 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 Cystectomy<br>• Meniscectomy<br>• Villusectomy | | Shoulder | • Acromioplasty<br>• Subacromial Decompression | • Frozen Shoulder Release<br>• Glenoidale Labrum | | Wrist | | • Triangular Fibrocartilage (TFCC) | 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. 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K220563 # Section 7 - 510(k) Summary ArthroCare® Corporation Ambient HipVac 50 Wand with Integrated Finger Switches 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. #### GENERAL INFORMATION 7.1 | Submitter Name | ArthroCare Corporation | |----------------|-------------------------------------------------------------------------------------------------------------------------------------| | Address | 7000 West William Cannon Drive<br>Austin, TX 78735 | | Contact Person | Alexander Brankner<br>International Regulatory Affairs Manager<br>Phone: 512-673-3090<br>Email: Alexander.Brankner@smith_nephew.com | Date Prepared August 31, 2022 #### 7.2 DEVICE NAME(S) ### Subject Device Proprietary Name Ambient HipVac 50 Wand with Integrated Finger Switches and RF20000 COBLATION System WEREWOLF COBLATION System WEREWOLF+COBLATION System | Common Name | Electrosurgical devices and accessories | |---------------------|----------------------------------------------------------------| | Classification Name | Electrosurgical cutting and coagulation device and accessories | | Device Class | Class II | | Product Code | GEI | | CFR Section | 21 CFR 878.4400 | #### PREDICATE DEVICE(S) 7.3 | Ambient HipVac 50 Wand with Integrated Finger Switches | K161481 | |--------------------------------------------------------|---------| | ArthroCare System 12000 (Quantum II) | K082666 | {4}------------------------------------------------ Image /page/4/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 deep red color, arranged to suggest a sphere or globe. To the right of the graphic, the name "ArthroCare" is written in a gray, sans-serif font, with the registered trademark symbol (®) positioned next to the word "Care". Note: The Ambient HipVac 50 Wand with Integrated Finger Switches may be identified as Ambient HipVac 50 wand. Note: ArthroCare System 12000 may be identified as QUANTUM II. Note: The RF20000 COBLATION System (K162074), WEREWOLF COBLATION System (K192027), and the WEREWOLF+COBLATION system (K210423) collectively may be identified as WEREWOLF COBLATION Systems. #### 7.4 DEVICE DESCRIPTION ### 7.4.1 Ambient HipVac 50 Wand with Integrated Finger Switches The Ambient HipVac 50 Wand is a bipolar, high frequency (HF) electrosurgical device designed for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the indicated arthroscopic and orthopedic procedures (K161481). The Ambient HipVac 50 Wand consist of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached to the proximal end of the handle and connect to the Controller and hospital wall suction, respectively. The plastic molded handle includes three integrated finger switches (IFS) used to activate and adjust the Coblation (ablation) and Coagulation modes: CUT (ablation), COAG (coagulation), and set point adjustment. The Ambient feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20°C and includes a user adjustable alarm set point. The Wand is designed for use up to 15 minutes of cumulative active ablation and is currently cleared to be used with ArthroCare System 12000 (QUANTUM II). Alternately, the surgeon can control these functions with the optional foot pedal. A representative image of the Ambient HipVac 50 Wand is provided (Figure 1). Image /page/4/Figure/8 description: The image shows a medical device with several labeled parts. The device includes a handle with finger switches, a shaft, and an electrode tip. An integrated cable and suction tubing are also connected to the device. Figure 1: Ambient HipVac 50 Wand {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the ArthroCare logo. The logo consists of a stylized red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that create a sense of movement. The word "ArthroCare" is written in a sans-serif font, and there is a registered trademark symbol after the word. ## 7.4.2 WEREWOLF COBLATION Systems (RF20000, WEREWOLF, WEREWOLF+) ### RF20000 COBLATION System (K162074) The RF20000 COBLATION System consist of: - A bipolar, radiofrequency (RF) generator (COBLATION System) with Integrated . Fluid Module (FLOW IQ Pump) and Operational Interface Screen. - Re-usable, non-sterile Foot Control (wired or wireless); ● - Sterile, disposable, single-use COBLATION Wand(s); o - Reusable, non-sterile power cord. . The RF20000 Coblation System (K162074) 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 RF20000 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): Hi (Ablation), Med (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis). ### WEREWOLF COBLATION SYSTEM (K192027) The WEREWOLF COBLATION System consist of: - A bipolar, radiofrequency (RF) generator (COBLATION System) with Integrated . Fluid Module (FLOW IQ™ 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the ArthroCare logo. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that converge in the center. The WEREWOLF COBLATION System (cleared via 510(k) K192027) is an iteration of the RF20000 COBLATION system (K162074) and utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of blood vessels in various arthroscopic, orthopedic (cleared via K162074) and otorhinolaryngology (ENT) procedures (cleared via K192074). The WEREWOLF COBLATION controller has the same hardware as the RF20000 (K162074); the software has been updated to increase functionality per the additional ENT indications. There have been no changes to the 18-pin wand functionality cleared in K162074. 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 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 consist 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 the RF20000 and WEREWOLF COBLATION system (cleared via 510(k)s K162074 and K192027, respectively). The WEREWOLF+ COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of blood vessels in various {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red sphere made of curved lines on the left and the word "ArthroCare" in gray on the right. The "R" in "ArthroCare" has a registered trademark symbol next to it. 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). The WEREWOLF+ COBLATION controller has the same hardware as the RF20000 (K162074) and WEREWOLF Coblation System (K192027); the software has been updated to increase functionality per the additional indications: hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. There have been no changes to the 18-pin wand functionality cleared in K162074. 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 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), and one mode (COAG) for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures (cleared via K210423). Image /page/7/Picture/3 description: The image shows a medical device with various components. The main unit is a white box with an orange stripe and a screen. There are several hand-held instruments with cords, two foot pedal control units, and a clear plastic tube. The device appears to be for surgical or medical procedures. Figure 2: Werewolf Coblation Systems {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that create a sense of movement. ### INDICATIONS FOR USE 7.5 The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for the resection and ablation of soft tissue, and hemostasis of blood vessels less than 1mm (via coagulation) in the following arthroscopic and orthopedic procedures: | Joint | Ablation/Debridement | Excision/Resection | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | All Joints (Hip, Knee,<br>Shoulder, Wrist, 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 Cystectomy<br>• Meniscectomy<br>• Villusectomy | | Shoulder | • Acromioplasty<br>• Subacromial Decompression | • Frozen Shoulder Release<br>• Glenoidale Labrum | | Wrist | | • Triangular Fibrocartilage (TFCC) | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that come together to form a sphere-like shape. The word "ArthroCare" is written in a sans-serif font, and the registered trademark symbol is located to the right of the word. # 7.6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS The subject devices (Ambient HipVac 50 Wand used with the WEREWOLF COBLATION Systems) have the same technological characteristics (i.e., design, material, chemical composition, and energy source) as the predicate device (Ambient HipVac 50 Wand used with QUANTUM II) with the following exceptions highlighted in bold font (Table 7.1) {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular design on the left, made up of several curved, maroon-colored lines. To the right of this design is the company name, "ArthroCare," written in a gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care." ## Table 7.1: Comparison of Technological Characteristics between the Predicate and Subject Systems | Parameter | Primary Predicate System | Subject Device System 1 | Subject Device System 2 | Subject Device System 3 | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | | HipVac 50 IFS (K161481)<br>Predicate: Quantum II (K082666) | HipVac 50 IFS (K161481)<br>RF20000 (K162074) | HipVac 50 IFS (K161481)<br>Werewolf (K192027) | HipVac 50 IFS (K161481)<br>Werewolf+ (K210423) | | Controller Intended Uses | | | | | | Ablation / Resection | Yes | Same | Same | Same | | Hemostasis / Coagulation | Yes | Same | Same | Same | | Controller Specifications/Features | | | | | | Input Power | 100-120/220-240V | Same | Same | Same | | Fuse Rating | 50/60 Hz | Same | Same | Same | | Output Frequency | 100 KHz | Same | Same | Same | | Default Ablation Set Point /<br>Output Voltage (Vrms) | Set Point 7 / 260 | Same | Same | Same | | Ablation Set Point Range /<br>Output Voltage (Vrms) | Set Points 1-9 / 100-314 | Same | Same | Same | | Coagulation Set Point Range /<br>Output Voltage (Vrms) | Set Points 1-2 / 65-100 | Same | Same | Same | | Output Control<br>Mechanism | Wired or wireless foot pedal | Same | Same | Same | | Weight | <5kg | 10 kg* | 10 kg* | 10 kg* | | Controller crest factor | ≤2 | Same | Same | Same | | Controller waveforms | Square wave | Same | Same | Same | | Rated Wand voltage | 320±10% Vrms | Same | Same | Same | | Output Voltage (Vrms) at 350 ohm<br>load | Set Point 0 / 0 | Same | Same | Same | | | Set Point 1 / 95 | Same | Same | Same | | | Set Point 2 / 120 | Same | Same | Same | | | Set Point 3 / 146 | Same | Same | Same | | | Set Point 4 / 171 | Same | Same | Same | | | Set Point 5 / 198 | Same | Same | Same | | | Set Point 6 / 224 | Same | Same | Same | | | Set Point 7 / 247 | Same | Same | Same | | | Set Point 8 / 273 | Same | Same | Same | | | Set Point 9 / 299 | Same | Same | Same | | | Set Point 10 / 320* | Same | Same | Same | | | Coag 1 / 65 | Same | Same | Same | | | Coag 2 / 98 | Same | Same | Same | | Software Program | Software for Quantum II,<br>V 2.03 | Graphic User Interface (GUI)<br>V 1.4<br>Main RF controller software<br>V 2.5 | Graphic User Interface (GUI)<br>V 3.0<br>Main RF controller software<br>V 4.1 | Graphic User Interface (GUI)<br>V 5.0<br>Main RF controller software<br>V 6.1 | | Graphical User Interface (GUI) | No | Yes* | Yes* | Yes* | | Integrated Fluid Outflow Regulator | No | Yes* | Yes* | Yes* | | Wand Specifications / Features | | | | | | Intended Use | Resection and ablation of soft<br>tissues, and hemostasis of<br>blood vessels less than 1mm<br>(via coagulation) in the<br>indicated arthroscopic and<br>orthopedic procedures | Same | Same | Same | | Shaft Length | 176 mm | | | | | Handle Length | 141.75 mm | Same | Same | Same | | Distal Bend Angle | 50° | Same | Same | Same | | Outer Diameter of Shaft | 4.6 mm | Same | Same | Same | | Sterilization | Radiation | Same | Same | Same | | Electrical Safety/EMC | IEC 60601-2-2 compliant | Same | Same | Same | | Suction and/or Irrigation | Yes | Same | Same | Same | | Packaged Sterile | Yes | Same | Same | Same | | Tyvek Packaging/Adhesive | Yes | Same | Same | Same | | Operates in Saline Environment | Yes | Same | Same | Same | | Bipolar / Monopolar | Bipolar | Same | Same | Same | | Use Limiting Feature | Yes | Same | Same | Same | | Software in Wand | No | Same | Same | Same | | Single Use Disposable | Yes | Same | Same | Same | | Recommended Active Ablation<br>Time | 15 min (cumulative ablation) at<br>set point 7 | Same | Same | Same | | Wand Temperature Sensor (i.e.,<br>Ambient Feature) | T-Type thermocouple with<br>range of 20-60°C ± 3°C | Same | Same | Same | | Activation | Foot Control or Integrated<br>Finger Switches | Same | Same | Same | {11}------------------------------------------------ Image /page/11/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 form a circular shape. The text is in a sans-serif font and is a dark gray color. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains 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 that converge to form a circular shape, and the lines are colored in a dark red hue. The word "ArthroCare" is written in a bold, sans-serif font, and it is colored in a dark gray hue. A small registered trademark symbol is placed to the upper right of the word "ArthroCare". *Differences discussed below in section 7.5 Comparison of Subject and Predicate Devices {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the ArthroCare logo. The logo consists of a stylized red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that create a sense of movement. The word "ArthroCare" is written in a simple, sans-serif font, and there is a registered trademark symbol next to the word. #### COMPARISON OF SUBJECT AND PREDICATE DEVICES 7.6 ### 7.6.1 WEREWOLF COBLATION Systems Both the subject systems and the primary predicate system share the same intended use, indications of use, fundamental technology, and principle of operation. The technological differences include: - . Touch-controlled Graphical User Interface (GUI): The graphical user interface was an advancement of technology to improve ease of use and expand visual feedback options. No changes have been made to the interface screens cleared in K162074, K192027, K210423. - Integrated Fluid Outflow Regulator: The integrated fluid outflow regulator was an ● advancement of technology which provides adjustable control of the rate of flow of conductive irrigating solution to or from the surgical site. No changes have been made to the Integrated Fluid Outflow Regulator cleared in K162074, K192027, K210423. - Software Program: There were no changes required to WEREWOLF software as part of ● this submission. The previously cleared versions of the WEREWOLF COBLATION System referenced in this submission have already undergone all required testing to support use of 18 pin wands, (used by the HipVac 50 IFS). Please see K162074, K192027, and K210423 for all required software documentation. - Weight: controller weight is a function of internal components, housing, and size. ● {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved, parallel lines in a maroon color, creating a sense of movement or rotation. The text "ArthroCare" is written in a dark gray, sans-serif font, with a registered trademark symbol next to it. ## 7.6.2 AMBIENT HIPVAC 50 WAND The technological characteristics for the Ambient HipVac 50 Wand subject device accessory has not changed compared to the predicate device accessory with the following exception highlighted in bold font (Table 7.2). | | | Table 7.2: Technological characteristics with the predicate device | | | | |--|--|--------------------------------------------------------------------|--|--|--| |--|--|--------------------------------------------------------------------|--|--|--| | PARAMETER | PREDICATE DEVICE (K161481)<br>Ambient HipVac 50 IFS Wand | SUBJECT DEVICE (K220563)<br>Ambient HipVac 50 IFS Wand | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | | | | | Controller | QUANTUM 2* | RF20000 COBLATION System*<br>WEREWOLF COBLATION SYSTEM*<br>WEREWOLF+ COBLATION SYSTEM* | | Intended Use | Resection and ablation of soft tissues, and<br>hemostasis of blood vessels less than 1mm (via<br>coagulation) in the indicated arthroscopic and<br>orthopedic procedures | Same | | Wand Materials | | | | Electrode | Tungsten Alloy Metal Injection Molded (MIM) | Same | | Spacer | Ceramic (Alumina) | Same | | Adhesive | Epoxy (Loctite 3984) | Same | | Shaft Suction line | PEEK | Same | | Suction line | PVC | Same | | Shaft | 304 Stainless Steel | Same | | Outer Shaft Insulation | Black PET Heat Shrink Tubing | Same | | Wand Specifications | | | | Shaft Length | 176 mm | Same | | Handle Length | 141.75 mm | Same | | Distal Bend Angle | 50° | Same | | Outer Diameter of Shaft | 4.6 mm | Same | | Sterilization | Radiation | Same | | Electrical Safety/EMC | IEC 60601-2-2 compliant | Same | | Suction and/or Irrigation | Yes | Same | | Packaged Sterile | Yes | Same | | Tyvek Packaging/Adhesive | Yes | Same | | Operates in Saline Environment | Yes | Same | | Bipolar / Monopolar | Bipolar | Same | | Use Limiting Feature | Yes | Same | | Software in Wand | No | Same | | Single Use Disposable | Yes | Same | | Recommended Active Ablation Time | 15 min (cumulative ablation) at set point 7 | Same | | Wand Temperature Sensor (i.e., Ambient Feature) | T-Type thermocouple with range of 20-60° C ± 3 ° C | Same | | Activation | Foot Control or Integrated Finger Switches | Same | | 18-pin | Yes | Same | *Controller: use of Ambient HipVac 50 with newer coblation system; WEREWOLF COBLATION SYSTEMS. {15}------------------------------------------------ Image /page/15/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 made up of several curved, parallel lines in a deep red color, arranged in a semi-circular shape. The word "ArthroCare" is written in a simple, sans-serif font in a dark gray color, with the registered trademark symbol (®) placed after the word. #### 7.7 PERFORMANCE TESTING - NON-CLINICAL For the non-clinical performance testing, the RF20000 COBLATION system was selected as the representative model for the WEREWOLF COBLATION Systems. Hardware and 18-pin software functionality (cleared via K161481) is identical across all controllers (RF20000, WEREWOLF, WEREWOLF+), therefore the non-clinical testing results are representative of the Ambient HipVac 50 wand with the WEREWOLF COBLATION system (K192027) and WEREWOLF+ COBLATION System (K210423). ### Functional tests included: - · Coagulation testing - Ablation life (at 1X, 2X, 3X life) - Ambient accuracy - Finger switch functionality - Shaft temperature - Suction tube temperature Because all required system level testing was previously conducted (cleared via K162074) and no changes have been made to impact device or system level requirements, the non-clinical testing conducted for this submission verified the RF20000 COBLATION System supports the wand specific requirements of the Ambient HipVac 50 wand; results are representative of the Ambient HipVac 50 wand with the WEREWOLF COBLATION system (K192027) and WEREWOLF+ COBLATION System (K210423) based on the rationale above. #### PERFORMANCE TESTING - PRE-CLINICAL 7.8 Pre-clinical bench testing (ex vivo testing) was conducted on the predicate (Ambient HipVac 50 Wand with QUANTUM II) and the representative subject (Ambient HipVac 50 Wand with RF20000 COBLATION System). Thermal effect width, ablation depth (amount of tissue removed) and thermal effect depth was measured in tissue models representing bovine myocardium (muscle), cartilage, meniscus, and tendon at the minimum, default, and maximum {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a series of curved, red lines on the left side, resembling a stylized globe or sphere. To the right of the lines is the word "ArthroCare" in a gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care". ablation set points. Evidence obtained from preclinical bench testing (ex vivo) demonstrated that the Ambient HipVac 50 with RF20000 COBLATION System performs substantially equivalent to the predicate, Ambient HipVac 50 with QUANTUM 2. Since hardware and 18-pin functionality is identical across WEREWOLF COBLATION Systems (RF20000, WEREWOLF, WEREWOLF+), the pre-clinical testing results are representative of the Ambient HipVac 50 wand with the WEREWOLF COBLATION system (K192027) and WEREWOLF+ COBLATION System (K210423) and support substantial equivalence to the predicate. #### PERFORMANCE TESTING - ADDITIONAL 7.9 A comparison of the peak temperature of the electrode of the subject Ambient HipVac 50 wand in conjunction with the predicate QUANTUM II and representative subject RF20000 COBLATION system was conducted during ablation at the maximum set point. The data was measured using a Neoptix T1 fiber optic temperature probe (model T1S-02-W05-PT05) using a beef heart tissue model. Both controllers with the Ambient HipVac 50 wand were activated directly over the temperature probe for ten (10) seconds at maximum ablation setpoint (9) with auxiliary suction, as required by the device IFU. The maximum temperatures recorded using both controllers were similar and support evidence of substantial equivalence. Since hardware and 18-pin functionality is identical across WEREWOLF COBLATION Systems (RF20000, WEREWOLF, WEREWOLF+), the additional testing results are representative of the Ambient HipVac 50 wand with the WEREWOLF COBLATION system (K192027) and WEREWOLF+COBLATION System (K210423) and support substantial equivalence to the predicate. #### 7.10 PERFORMANCE TESTING - ANIMAL No animal data are included in this submission. #### PERFORMANCE TESTING - CLINICAL 7.11 No clinical data are included in this submission. {17}------------------------------------------------ Image /page/17/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 made up of several curved, parallel lines in a maroon color, creating a sense of movement or flow. The text "ArthroCare" is written in a dark gray, sans-serif font, with a registered trademark symbol to the upper right of the word "Care". #### CONCLUSION 7.12 All testing demonstrates that the Ambient HipVac 50 Wand with the RF20000 COBLATION system performs as intended and has acceptable performance when used in accordance with its labeling. Hardware and 18-pin software functionality is identical across subject controllers (RF20000, WEREWOLF, WEREWOLF+), therefore testing results are representative of the Ambient HipVac 50 wand with the WEREWOLF COBLATION system (K192027) and WEREWOLF+ COBLATION System (K210423). The intended use, principle of operation, and fundamental scientific technology are equivalent to the primary predicate device (Ambient HipVac 50 Wand with QUANTUM II), the Ambient HipVac 50 Wand with WEREWOLF COBLATION systems is as safe and effective as the predicate device.