Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrosurgical device (radio frequency ablation/coagulation) and does not mention any AI or ML components, algorithms, or data processing related to learning or prediction.

Therapeutic

Yes

The device is explicitly indicated for "ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery," which are therapeutic interventions.

Diagnostic

No

The device is indicated for surgical procedures (ablation, resection, coagulation, hemostasis) of soft tissue, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, single-use, disposable electrosurgical device (the ARIS Wand) with integrated hardware components (suction line, saline tube set, cable). It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the ARIS Wand is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for "ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery". This describes a surgical procedure performed directly on a patient's body.
Device Description: The description details a surgical instrument used for tissue manipulation and hemostasis during surgery.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue samples, etc.) outside of the body to provide information about a patient's health status. IVDs are designed for testing samples in a laboratory or similar setting.

Therefore, the ARIS Wand is a surgical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

GEI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

otorhinolaryngology (ENT) surgery including: nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing: Functional tests were performed on the ARIS wand, including: Coagulation performance, Ablation performance, Active life, Suction performance, Tip clearing component functionality, Mechanical testing, EMC testing, and Functional tests. Based on bench testing, the ARIS Wand met all performance specifications.

Pre-Clinical Performance Testing: (ex vivo) testing was conducted 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.

Additional Performance Testing: Additional bench testing was performed to compare the peak temperature at the active electrode of the proposed ARIS Wand to the predicate ArthroCare Turbinator 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.

Animal Testing: No animal testing was performed on this product.

Clinical Testing: No clinical data are included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

ArthroCare Turbinator Wand (K122652) compatible with WEREWOLF COBLATION System (K202006)

Reference Device(s)

WEREWOLF COBLATION SYSTEM - K210423, WEREWOLF + COBLATION SYSTEM- K192027, FLOW 90º Wand - K183346

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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."

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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
Austin, TX 78735
Contact Person	Pragnya Bakka
Senior Regulatory Affairs Specialist
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

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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.

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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

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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).

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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).

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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.

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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
with WEREWOLF
COBLATION System
(K202006)	ARIS COBLATION
Turbinate Reduction
Wand with WEREWOLF
COBLATION System
(K192027)	ARIS COBLATION
Turbinate Reduction
Wand with
WEREWOLF+
COBLATION System
(K210423)
Wand Specifications/Features
Intended use	Indicated for ablation,
resection, and
coagulation of soft tissue
and hemostasis of blood
vessels in
otorhinolaryngology
(ENT) sinus surgery
involving nasal airway
obstruction by reduction
of hypertrophic nasal
turbinates and
submucosal tissue
shrinkage.	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.	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.
	The Wand is designed to
be used exclusively with
the COBLATOR II(CII)
controller and Irrigation
pump or the
WEREWOLF
COBLATION system (in
conjunction with the
ENT adapter and
Irrigation Tube Set).
Other controllers/pumps
Wand Materials	must not be used
Electrode Materials	Tungsten	Same	Same
Shaft Material and Return
electrode 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 95389
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)
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 of
the Wand that is blown
after the device is
connected to the
Controller)	24-hour life from when
wand is first activated
(microchip in the handle of
the Wand that only allows
the Wand to be used for 24
hours after activation)	24-hour life from when
wand is first activated
(microchip in the handle of
the Wand that only allows
the Wand to be used for 24
hours after activation)
Cable Assembly -
Connector (Does the
Wand need Adaptor?)	WEREWOLF ENT
Adaptor is required to
connect with WW
controller	No ENT adaptor required.
The Wand comes with a
WEREWOLF compatible
cable with custom
connector and Integrated
micro-chip	No ENT adaptor required.
The Wand comes with a
WEREWOLF compatible
cable with custom
connector and Integrated
micro-chip
Tip Clearing tool	None	Included with device
Nitinol wire, .020-inch
diameter Polycarbonate
handle	Included with device
Nitinol wire, .020-inch
diameter Polycarbonate
handle
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
Tyvek
packaging/Adhesive	Yes	Same	Same
Operates in saline
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	16Amps	16Amps
Output Nominal
Voltage Maximum	340 Vrms	Same	Same
Rated Wand Voltage	340 Vrms	Same	Same
Default
Coblation/Ablation Set
Point/Output Voltage
(Vrms)	Set Point 7/265	Med • (265 Vrms)	Med • (265 Vrms)
Coblation/Ablation Set
Points/Output Voltage
(Vrms)	Set Point 1-9/100-300	Lo - to Hi + / 245-280	Lo - to Hi + / 245-280
Default Coagulation Set
Point/Output Voltage	Set Point 3 (75 Vrms)	Coag• (66 Vrms at 200
Ohm load)	Coag• (66 Vrms at 200
Ohm load)
Coagulation Set Point /
Output	Set Point 1-5/ 65-87
Vrms	66-79 Vrms at 200 Ohm
load	66-79 Vrms at 200 Ohm
load
Controller wave form	Square wave	Same	Same
Output Control
mechanism	Wired or wireless foot
pedal	Same	Same
Saline Outflow	Connects to hospital wall
suction	Same	Same
Saline Delivery	Contains integrated
saline lumen. PVC
Unichem 7077GTX-015,
0.108-inch ID, 0.152-
inch OD	Contains integrated saline
lumen. PVC, Colorite
8088G-015, 0.091-inch ID,
0.155-inch OD	Contains integrated saline
lumen. PVC, Colorite
8088G-015, 0.091-inch ID,
0.155-inch OD
Integrated peristaltic
pump (FLOW IQ pump -
K192027) on the
COBLATION System
controls saline delivery
to the Wand.	Same	Same
Activation	Foot Control	Same	Same
Software Program	Graphic User Interface
(GUI) V 3.0
Main RF controller
software V 4.1	Same	Graphic User Interface
(GUI) V 5.0
Main RF controller software
V 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

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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

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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.

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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 Device
ArthroCare Turbinator Wand | Subject Device |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | ARIS Wand |
| Controller Used | WW COBLATION SYSTEM (WW ENT
Controller) or COBLATOR II Controller | WW COBLATION SYSTEM (WW ENT
Controller) or WW+ COBLATION
SYSTEM |
| Intended use | Indicated for ablation, resection, and
coagulation of soft tissue and hemostasis
of blood vessels in otorhinolaryngology
(ENT) sinus surgery involving nasal
airway obstruction by reduction of
hypertrophic nasal turbinates and
submucosal tissue shrinkage.

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 (