(87 days)
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.
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.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical effectiveness, particularly in the way one would describe an AI/ML medical device.
The document is a 510(k) Premarket Notification for an electrosurgical cutting and coagulation device. The "performance testing" sections refer to:
- Non-clinical performance testing: Bench testing for coagulation, ablation, active life, suction, tip clearing, mechanical, EMC, and functional tests. These tests are about the physical and electrical performance of the device, not its diagnostic accuracy or clinical outcomes based on patient data.
- Pre-clinical (ex vivo) testing: Testing on bovine myocardial tissue to compare insertion channel diameters, thermal zone areas, and thermal zone volumes between the new device and a predicate device. This is a bench/lab test, not a clinical study involving human patients.
- No animal testing was performed.
- No clinical data (human study) was included in the submission.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them in the context of diagnostic performance or comparative effectiveness with human readers supported by AI. The device described is a physical electrosurgical tool, not an AI/ML-driven diagnostic or assistive system for which such studies would be conducted and reported in this format.
The acceptance criteria mentioned are general performance specifications for an electrosurgical device (e.g., meeting established electrical safety standards, functional specifications, sterilization efficacy, shelf life, biocompatibility) rather than statistical performance metrics (like accuracy, sensitivity, specificity, or reader agreement) derived from a test set of labeled patient data for an AI/ML device.
{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)
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 DriveAustin, TX 78735 |
| Contact Person | Pragnya BakkaSenior Regulatory Affairs Specialiste-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 Turbinatorwith WEREWOLFCOBLATION System(K202006) | ARIS COBLATIONTurbinate ReductionWand with WEREWOLFCOBLATION System(K192027) | ARIS COBLATIONTurbinate ReductionWand withWEREWOLF+COBLATION System(K210423) | |
| Wand Specifications/Features | |||
| Intended use | Indicated for ablation,resection, andcoagulation of soft tissueand hemostasis of bloodvessels inotorhinolaryngology(ENT) sinus surgeryinvolving nasal airwayobstruction by reductionof hypertrophic nasalturbinates andsubmucosal tissueshrinkage. | The ARIS COBLATIONTurbinate Reduction Wand,used with the WEREWOLFCOBLATION System, isindicated for ablation,resection and coagulation ofsoft tissue and hemostasis ofblood vessels inotorhinolaryngology (ENT)surgery including: nasalairway obstruction byreduction of hypertrophicnasal turbinates andsubmucosal tissueshrinkage. | The ARIS COBLATIONTurbinate Reduction Wand,used with the WEREWOLFCOBLATION System, isindicated for ablation,resection and coagulation ofsoft tissue and hemostasis ofblood vessels inotorhinolaryngology (ENT)surgery including: nasalairway obstruction byreduction of hypertrophicnasal turbinates andsubmucosal tissueshrinkage. |
| The Wand is designed tobe used exclusively withthe COBLATOR II(CII)controller and Irrigationpump or theWEREWOLFCOBLATION system (inconjunction with theENT adapter andIrrigation Tube Set).Other controllers/pumps | |||
| Wand Materials | must not be used | ||
| Electrode Materials | Tungsten | Same | Same |
| Shaft Material and Returnelectrode material | 304 Stainless steel | 17-4 stainless steel(Elevator tip) | 17-4 stainless steel(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 95389UV 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)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(fuse in the handle ofthe Wand that is blownafter the device isconnected to theController) | 24-hour life from whenwand is first activated(microchip in the handle ofthe Wand that only allowsthe Wand to be used for 24hours after activation) | 24-hour life from whenwand is first activated(microchip in the handle ofthe Wand that only allowsthe Wand to be used for 24hours after activation) |
| Cable Assembly -Connector (Does theWand need Adaptor?) | WEREWOLF ENTAdaptor is required toconnect with WWcontroller | No ENT adaptor required.The Wand comes with aWEREWOLF compatiblecable with customconnector and Integratedmicro-chip | No ENT adaptor required.The Wand comes with aWEREWOLF compatiblecable with customconnector and Integratedmicro-chip |
| Tip Clearing tool | None | Included with deviceNitinol wire, .020-inchdiameter Polycarbonatehandle | Included with deviceNitinol wire, .020-inchdiameter Polycarbonatehandle |
| Operating life | 1.5 min (1Xlife) | 2 minutes (1x life)3 minutes (use limit) | 2 minutes (1x life)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 |
| Tyvekpackaging/Adhesive | Yes | Same | Same |
| Operates in salineenvironment | 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 | 16Amps | 16Amps |
| Output NominalVoltage Maximum | 340 Vrms | Same | Same |
| Rated Wand Voltage | 340 Vrms | Same | Same |
| DefaultCoblation/Ablation SetPoint/Output Voltage(Vrms) | Set Point 7/265 | Med • (265 Vrms) | Med • (265 Vrms) |
| Coblation/Ablation SetPoints/Output Voltage(Vrms) | Set Point 1-9/100-300 | Lo - to Hi + / 245-280 | Lo - to Hi + / 245-280 |
| Default Coagulation SetPoint/Output Voltage | Set Point 3 (75 Vrms) | Coag• (66 Vrms at 200Ohm load) | Coag• (66 Vrms at 200Ohm load) |
| Coagulation Set Point /Output | Set Point 1-5/ 65-87Vrms | 66-79 Vrms at 200 Ohmload | 66-79 Vrms at 200 Ohmload |
| Controller wave form | Square wave | Same | Same |
| Output Controlmechanism | Wired or wireless footpedal | Same | Same |
| Saline Outflow | Connects to hospital wallsuction | Same | Same |
| Saline Delivery | Contains integratedsaline lumen. PVCUnichem 7077GTX-015,0.108-inch ID, 0.152-inch OD | Contains integrated salinelumen. PVC, Colorite8088G-015, 0.091-inch ID,0.155-inch OD | Contains integrated salinelumen. PVC, Colorite8088G-015, 0.091-inch ID,0.155-inch OD |
| Integrated peristalticpump (FLOW IQ pump -K192027) on theCOBLATION Systemcontrols saline deliveryto the Wand. | Same | Same | |
| Activation | Foot Control | Same | Same |
| Software Program | Graphic User Interface(GUI) V 3.0Main RF controllersoftware V 4.1 | Same | Graphic User Interface(GUI) V 5.0Main RF controller softwareV 6.1 |
| Graphical User Interface | Yes | Yes | Yes |
| Weight | 10Kg | Same | Same |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | إراري 512.391.3901 | www.arthrocare.com
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left, composed of several curved, red lines. To the right of the graphic is the company name, "ArthroCare," in a gray, sans-serif font. A registered trademark symbol is present to the upper right of the word "Care".
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ۾/ഗ്ഗം 512.391.3901 | www.arthrocare.com
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red circular design on the left, resembling curved lines converging towards a central point. To the right of this design is the company name, "ArthroCare," in a gray, sans-serif font. A registered trademark symbol is present next to the word "Care."
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρώονε 512.391.3901 | www.arthrocare.com
{12}------------------------------------------------
Image /page/12/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" in a gray, sans-serif font on the right. The graphic is made up of several curved, red lines that create a sense of motion or energy.
7 COMPARISON OF SUBJECT AND PREDICATE DEVICES
7.1 WEREWOLF COBLATION Systems
Both the subject systems and the predicate system share same intended use, indications of use, fundamental technology and principle of operation.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | إرارات 512.391.3901 | www.arthrocare.com
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved red lines. To the right of the circular design is the company name, "ArthroCare," in a dark gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
The Predicate device ArthroCare Turbinator is intended to be used with WEREWOLF COBLATION System and COBLATOR II controller (via K202006), whereas, the subject device ARIS Wand can be used either with WEREWOLF controller or WEREWOLF+ controller. Both the WEREWOLF controllers share, same fundamental technology, and principle of operation when used for ENT procedures.
There are no technological (hardware or software) changes made to the controllers (WEREWOLF COBLATION System, WEREWOLF+ COBLATION System were cleared previously via K192027 and K210423 respectively) to be compatible with ARIS wand.
Output Voltage Settings: As identified in the Table 1 above, the output voltage settings (Coblation, Ablation and coagulation) in the controllers, for the use with ARIS Wand have been made specific to simplify setting selection.
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 ENT Wands. Please see K192027, and K210423 for all required software documentation
7.2 ARIS COBLATION Turbinate Reduction Wand
The differences in technological characteristics for ARIS wand and ArthroCare Turbinator wand are summarized in table below and highlighted in italics.
The technological differences include wand software, smaller distal tip diameter, elevated distal tip, tip clearing tool in ARIS Wand. There are differences in materials used for return electrode, suction line tubing, along with sterilization methods used, and these changes are made to ensure manufacturability and logistical flexibility.
{14}------------------------------------------------
Image /page/14/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 a registered trademark symbol (®) placed after the word.
| Table.2 Comparison Of Technological Characteristics Of Turbinator Wand And ARIS Wand | |||||
|---|---|---|---|---|---|
| -------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| Parameter | Predicate DeviceArthroCare Turbinator Wand | Subject Device |
|---|---|---|
| ARIS Wand | ||
| Controller Used | WW COBLATION SYSTEM (WW ENTController) or COBLATOR II Controller | WW COBLATION SYSTEM (WW ENTController) or WW+ COBLATIONSYSTEM |
| Intended use | Indicated for ablation, resection, andcoagulation of soft tissue and hemostasisof blood vessels in otorhinolaryngology(ENT) sinus surgery involving nasalairway obstruction by reduction ofhypertrophic nasal turbinates andsubmucosal tissue shrinkage.The Wand is designed to be usedexclusively with the COBLATOR II (CII)controller and Irrigation pump or theWEREWOLF COBLATION System (inconjunction with the ENT Adapter andIrrigation Tube Set). Othercontrollers/pumps must not be used. | The ARIS COBLATION TurbinateReduction Wand, used with theWEREWOLF COBLATION System, isindicated for ablation, resection andcoagulation of soft tissue and hemostasisof blood vessels in otorhinolaryngology(ENT) surgery including: nasal airwayobstruction by reduction of hypertrophicnasal turbinates and submucosal tissueshrinkage. |
| Wand Materials | ||
| Electrode Materials | Tungsten | Same |
| Spacer | 99.5% Alumina | Same |
| Adhesive | Epoxy, Cyanoacrylate, UV Adhesive | HV-10 heat cure epoxyPN 95389UV Adhesive |
| Shaft Materials | Stainless Steel (SS304) | Stainless Steel (SS304, SS17-4) |
| Suction/Saline Tubing | Nylon (internal)/PVC (external) | Pebax extruded tube (internal) / PVC(external) |
| Return electrode Material | 304 Stainless steel | 17-4 stainless steel(Elevator tip)304 stainless steel(Return tube) |
| Active electrode Insulation | Polyolefin heat shrink tube | Same |
| Return Electrode Insulation | Polyolefin | Pebax extruded tube |
| Handle/Bushing Material | Polycarbonate | Same |
| Integrated Suction | Contains Integrated Suction. Colorite 8088G-015 | |
| Wand Specifications | 0.082 inch ID, 0.155 inch OD | 0.091 inch ID, 0.155 inch OD |
| Total Length | 85±10mm | 85±10mm |
| Handle Length | 4.4 inches | Same |
| Distal Tip Diameter | 2.9mm | 2.4mm |
| Distal Tip Shape | Blunt Shape | Elevator tip |
| Number of Electrodes | 1 (active)1 (return) | Same |
| Number of Internal SuctionChannels | 1 | Same |
| Materials Biocompatible | Yes | Same |
| Electrode Configurations | Electrode on one side of wand tip | Same |
| Wand cable | Integrated cable | Same |
| Rigid/Flexible Construction | Rigid | Same |
| Spacer Configuration | Single-Lumen | Same |
| Suction and/or Irrigation Line | Present | Same |
| Packaged Sterile | Yes | Same |
| Single Use Disposable | Yes | Same |
| Bipolar/Monopolar | Bipolar | Same |
| Sterilization | Radiation | Ethylene Oxide |
| Use limit | Mechanical use limit (fuse in the handleof the Wand that is blown after thedevice is connected to the Controller) | 24-hour life from when wand is firstactivated (microchip in the handle of theWand that only allows the Wand to beused for 24 hours after activation) |
| Cable Assembly - Connector | WEREWOLF ENT Adaptor is requiredto connect with WW controller | No ENT adaptor required. The Wandcomes with a WEREWOLF compatiblecable with custom connector andIntegrated micro-chip |
| Tip Clearing tool | None | Included with deviceNitinol wire, .020-inch diameterPolycarbonate handle |
| Operating life | 1.5 min (1Xlife) | 2 minutes (1x life)3 minutes (use limit) |
| Saline Source | External Saline Delivery | Same |
| Electrical safety/EMC | IEC 60601-2-2 compliant | Same |
| Suction and/or Irrigation | Yes | Same |
| Tyvek packaging/Adhesive | Yes | Same |
| Operates in salineenvironment | Yes | Same |
| Software in Wand | No | Yes |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ۾/ഗ്ഗം 512.391.3901 | www.arthrocare.com
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a series of red curved lines on the left side, resembling a stylized wave or a medical symbol. To the right of the lines is the company name "ArthroCare" in a gray, sans-serif font, with the registered trademark symbol (®) next to it.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ۾/ഗ്ഗം 512.391.3901 | www.arthrocare.com
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the ArthroCare logo. The logo consists of a stylized red graphic on the left and the word "ArthroCare" in gray on the right. The graphic is made up of several curved lines that converge to form a circular shape. The word "ArthroCare" is written in a sans-serif font, and there is a registered trademark symbol next to the word.
8. PERFORMANCE TESTING - NON CLINICAL
For the non-clinical performance testing, either of WW controller were selected as representative model for the Werewolf coblation systems, as both the controllers have ENT functionality in common. The functional tests performed on the ARIS wand included:
- 1.Coagulation performance 2.Ablation performance 3.Active life 4.Suction performance 5.Tip clearing component functionality 6.Mechanical testing 7.EMC testing 8.Functional tests
Based on the bench testing, the ARIS Wand was found to meet all performance specifications.
9. PERFORMANCE TESTING – PRE-CLINICAL
Pre-clinical (ex vivo) testing was conducted on the on a bovine myocardial tissue model using predicate (ArthroCare Turbinator Wand) and the subject device, ARIS Wand. The insertion channel diameters, thermal zone areas, and thermal zone volumes of the Aris Wand were substantially equivalent to the predicate Turbinator Wand in both the ablation and coagulation settings.
10. PERFORMANCE TESTING - ADDITIONAL
Additional bench testing was performed to compare the peak temperature at the active electrode of the proposed ARIS Wand to the predicate ArthroCare Turbinaor Wand after 10 seconds of activation at maximum setting. The maximum temperatures recorded for the ARIS device were lower than the Turbinator Wand. Average peak temperatures for the wands were in the range of 50-67°C.
{17}------------------------------------------------
Image /page/17/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, red lines that are arranged in a circular pattern. The word "ArthroCare" is written in a dark gray, sans-serif font. A registered trademark symbol is located to the right of the word "Care".
11. PERFORMANCE TESTING - ANIMAL
No animal testing was performed on this product.
12.0 PERFORMANCE TESTING - CLINICAL
No clinical data are included in this submission.
13.0 STERILIZATION:
The ARIS Wand is sterilized utilizing 100% Etyhlene Oxide (Eto or EO) gas via an existing validated EO Cycle. The evaluation and adoption are based on the principles outlined in AAMI TIR 28:2016. The sterilization method ensures a minimum sterility assurance level of 10t6
14. SHELF LIFE:
Shelf life testing included environmental conditioning (T=0), transit conditioning, accelerated aging studies at T=8 months, packaging integrity testing - visual inspection of seal, gross leak (bubble emission), dye penetration, peel strength testing, and delamination.
15. PACKAGING:
The ARIS Wand is supplied sterile and is intended for single use only. The Wand is not cleaned or re-sterilised for re-use. All packaging has been validated in accordance with ASTM D4332:2014, ASTM D4169:2016, ISO 11607-1:2019 and ISO 11607-2:2019.
The WEREWOLF Controllers are supplied non-sterile and are reusable; cleaning measures are provided in the manual. There were no changes to the Controller that required packaging testing to be repeated for this 510(k) submission.
16. BIOCOMPATIBILITY:
ARIS Wand is classified as an externally communicating medical device with tissue/bone/dentin contact with limited duration (<24 h) per ISO 10993-1:2018. The subject Wand met the acceptance criteria under the conditions of the chemical characterization and biological testing performed.
7000 W.William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
{18}------------------------------------------------
Image /page/18/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 circular or spherical shape. The word "ArthroCare" is written in a bold, sans-serif font in a dark gray color, with the "®" symbol in superscript next to the word "Care".
WEREWOLF Controller does not require biocompatibility testing as the Controller has no direct or indirect patient-contacting materials.
17. Electrical safety and electromagnetic compatibility Testing
The subject device complies with IEC60601-1:2005+A1:2012, IEC60601-2-2:2017, IEC 60601-1-6: 2010 Ed.3+A1 standards for safety and the IEC 60601-1-2:2014 standard for EMC.
18. Software verification and Validation testing
The ARIS Wand software (version 4.8) is identical to the wand software cleared via K183346 (FLOW 90). The software for the subject devices was considered as a "moderate" level of concern and software verification and validation testing conducted in accordance to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The overall software architecture for the WEREWOLF Controllers is the same as the previously cleared WEREWOLF Controller (K192027) and WEREWOLF+ Controller (K210423).
19. CYBERSECURITY
The ARIS Wand software (version 4.8) is identical to the wand software cleared via K183346 (FLOW 90). The Cyber Failure Modes and Effects Analysis (CMEA) confirms that there are no known unacceptable cybersecurity hazards when ARIS Wand is used with the WEREWOLF COBLATION Systems.
20. CONCLUSION
All testing demonstrates that the ARIS COBLATION Turbinate Reduction Wand performs as intended and has acceptable performance when used with WEREWOLF COBLATION system (K192027) and WEREWOLF+ COBLATION System (K210423) in accordance with its labeling. As hardware and software supporting ENT functionality are identical across the controllers used with the subject device, the performance testing results are representative of ARIS Wand with
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρόνοια 512.391.3901 | www.arthrocare.com
{19}------------------------------------------------
Image /page/19/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 circular or spherical shape. The word "ArthroCare" is written in a bold, sans-serif font in a dark gray color, with the registered trademark symbol "®" appearing in superscript next to the word.
WEREWOLF COBLATION system (K192027) and WEREWOLF+ COBLATION System (K210423).
The software in ARIS Wand is identical to the reference predicate FLOW 90 (K183346). As the intended use, principle of operation and fundamental scientific technology are equivalent to the predicate device system (TURBINATOR Wand with WEREWOLF COBLATION System), the subject device system, (ARIS Wand used with WEREWOLF COBLATION systems) is as safe and effective as the predicate device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.