Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction of hypertrophic nasal turbinates, nasopharyngeal/ laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring.

Turbinator Wands

Indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) sinus surgery involving nasal airway obstruction 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 must not be used.

WEREWOLF ENT Adapter

The WEREWOLF ENT Adapter, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF Irrigation Tube Set (as needed) are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.

WEREWOLF Irrigation Tube Set

The WEREWOLF Irrigation Tube Set, in conjunction with the Smith & Nephew COBLATOR II Compatible ENT Wands, the Smith & Nephew WEREWOLF COBLATION System and the WEREWOLF ENT Adapter are indicated for the ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT/otorhinolaryngology procedures.

Device Description

The ENT Plasma Wands (K070374 and K142999) and Turbinator Wand (K122652) are currently cleared to be used with the ArthroCare ENT Coblator Surgery System (COBLATOR II) (K030108). This 510(k) is to obtain clearance for the use of ENT Wands, in conjunction with two accessories, with the recently cleared WEREWOLF COBLATION System (K192027 - Dec 20, 2019). The accessories are the WEREWOLF ENT Adapter and the WEREWOLF Irrigation Tube Set The extended compatibility does not result in any changes to the overall design or to the indications of use for the ENT Wands nor the WEREWOLF COBLATION System.

ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for use in ablation, resection and coagulation of soft tissue, and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.

Turbinator Wand is a bipolar, single use, high frequency electrosurgical device designed for use for specific turbinate indications in otorhinolaryngology (ENT) procedures.

The WEREWOLF ENT Adapter is a reusable, electrically-activated adapter with an 8pin connector at the distal end an 18-pin connector at the proximal end. The reusable WEREWOLF ENT Adapter is designed to be used with the COBLATOR II Compatible ENT Wands (8-pin connector) and WEREWOLF COBLATION System (18-pin connector), along with the WEREWOLF Irrigation Tube Set, as needed.

The WEREWOLF Irrigation Tube Set is a single use, disposable, sterile device. The Irrigation Tube Set is designed to be used with COBLATOR II compatible ENT Wands and WEREWOLF COBLATION System, along with the reusable WEREWOLF ENT Adapter. The spike of the Irrigation Tube Set is connected to an irrigation source for select ENT Wands; that is, the ENT wands that use a conductive media, such as normal saline intraoperatively.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study proving the device meets these criteria in the format requested. The document describes a 510(k) submission for ENT Plasma Wands, Turbinator Wands, and accessories for use with the WEREWOLF COBLATION System. This submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to meet specific, quantitatively defined acceptance criteria through a dedicated study.

However, based on the non-clinical performance testing section, we can infer some aspects of what would typically be considered "acceptance criteria" through design verification.

Here's an attempt to extract and describe the information, inferring where necessary based on the context of a 510(k) submission for substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Design Verification)	Reported Device Performance (Summary from Non-Clinical Testing)
Electrical Safety & Performance	Met established design criteria.
* Input Power Range (100-240 VAC, 50-60 Hz)	Same as predicate devices.
* Fuse Rating (16 Amps)	Differs from predicate (8 Amps) but met design criteria.
* Output Nominal Voltage Max (340 Vrms)	Differs slightly from predicate (320 +/- 10% Vrms) but met design criteria.
* Rated Wand Voltage (320 +/- 10% Vrms)	Same as predicate devices.
* Ablation/Coagulation Set Points/Output Voltage	Default set points are same; ablation range adjusted (0-300Vrms) from predicate (100-300Vrms) but met design criteria.
* COBLATION System Waveform (Square)	Same as predicate devices.
* Output Frequency (100kHz)	Same as predicate devices.
Mechanical/Functional Performance	Met established design criteria.
* Suction System Compatibility	Same as predicate devices (connects to hospital suction).
* Saline Delivery System	Demonstrated effective saline delivery (integrated peristaltic pump vs. external flow control unit in predicate), met design criteria.
* Activation Method (Foot Control)	Same as predicate devices.
* User Interface Functionality (GUI)	Functional and simplified system performance (new feature).
* Software Control and Performance	Main 4.1 and GUI 3.0 effectively controlled intended use.
* Weight (10 kg)	Differs from predicate (8.2 kg) but met design criteria.
Biocompatibility	Met requirements for clinical use.
* ENT Wands	Materials unchanged, therefore no new testing required.
* ENT Adapter & WEREWOLF Controller	Non-patient contacting, no biocompatibility testing required.
* Irrigation Tube Set	Met ISO 10993-1:2018 for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, materials mediated pyrogenicity, and hemocompatibility (leveraged from K192027).
Sterilization Assurance	Validated sterilization methods achieving SAL of 10^-6.
* ENT Wands	Radiation sterilization, SAL 10^-6 (unchanged).
* Irrigation Tube Set	EtO gas sterilization, SAL 10^-6.
Thermal Effects (Ablation/Coagulation Modes)	Ex-vivo bench testing demonstrated performance substantially equivalent to predicate devices.
	Verified that subject devices performed substantially equivalent to predicate devices for ablation and coagulation mode thermal effects.

1. Sample sized used for the test set and the data provenance:

Test Sample Size: Not explicitly stated as a numerical sample size. The testing involved "ex-vivo bench testing" on "bovine myocardial tissue" for thermal effects. Other tests (electrical, mechanical/functional) likely involved multiple units or measurements but specific numbers are not provided.
Data Provenance: The ex-vivo bench testing used bovine myocardial tissue. This implies laboratory-controlled experiments rather than human patient data. The country of origin is not specified but implicitly within the ArthroCare Corporation's testing facilities (likely in the US, given the FDA submission). This was a retrospective evaluation in the sense that it was conducted for the 510(k) submission, confirming design aspects before market release for this specific compatibility.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing described is primarily engineering and bench testing, demonstrating technical equivalence and safety rather than diagnostic accuracy requiring expert interpretation.

3. Adjudication method for the test set:

Not applicable. The testing described does not involve expert adjudication as it's not a diagnostic study requiring human interpretation of output.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical instrument. Performance is inherently tied to its physical and energetic effects, not an algorithm's output in isolation from human use. While the device does have "Software controlled" and a "Graphical User Interface," the "standalone" performance notion as used in AI/diagnostic studies does not apply here.

6. The type of ground truth used:

For electrical and mechanical performance: Engineering specifications and standards.
For biocompatibility: ISO 10993-1:2018 standards; leverage from previously cleared device (K192027).
For sterilization: Validated sterilization cycles achieving specific Sterility Assurance Levels (SAL).
For thermal effects: Direct measurement of ablation and coagulation thermal effects on ex-vivo bovine tissue, likely compared against established performance metrics or the predicate devices.

7. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

December 18, 2020

ArthroCare Corporation Jean Asquith Senior Regulatory Affairs Specialist 7000 West William Cannon Drive, Building One Austin, Texas 78749

Re: K202006

Trade/Device Name: ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewoff ENT Adapter. 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 20, 2020 Received: November 19, 2020

Dear Jean Asquith:

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/cdrl/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.

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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 (OS) 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-devices/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 (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,

Long Chen, Ph.D. Assistant Director 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

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Indications for Use

510(k) Number (if known) K202006

Device Name

ENT Plasma Wands and Turbinator Wands

Indications for Use (Describe)

Subject Device(s) Indications of Use ENT Wands ENT Plasma Wands

Turbinator Wands

-Continued-

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)

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K202006

Accessories

WEREWOLF ENT Adapter

WEREWOLF Irrigation Tube Set

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K202006

Image /page/4/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized red graphic on the left and the name "ArthroCare" in gray text 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 there is a registered trademark symbol next to the word "Care".

510(k) Summary ArthroCare® Corporation

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

ArthroCare® Corporation 7000 W. William Cannon Drive Building One Austin, TX 78735

Company Contact:	Jean Asquith
	Tel: (512) 680-5802
	Fax: (512) 895-1489
Email:	jean.asquith@smith-nephew.com

Date Prepared: December 18, 2020

2. DEVICE IDENTIFICATION

Device Trade Name:	ENT Plasma Wands, Turbinator Wand, WerewolfIrrigation Tube Set, Werewolf ENT Adapter, WerewolfCoblation System
Device Common Name:	Electrosurgical Devices and Accessories
Regulation Number:	21 CFR 878.4400
Regulation Description:	Electrosurgical Cutting and Coagulation Devices andAccessories
Product Code:	GEI
Device Class:	Class II
Classification Panel:	General & Plastic Surgery
Predicate Device:	ENT Plasma Wands (K070374 – February 7, 2007 andK142999 – Nov 19, 2014) and Turbinator Wand(K122652- July 02, 2013) used with the ENT CoblatorSurgery System (K030108 – Feb 03, 2003)

3. DEVICE DESCRIPTION

7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com

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Image /page/5/Picture/1 description: The image contains the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved, parallel lines that create a sense of motion or flow. The word "ArthroCare" is written in a dark gray, sans-serif font, with the "®" symbol in superscript next to the word.

not result in any changes to the overall design or to the indications of use for the ENT Wands nor the WEREWOLF COBLATION System.

Turbinator Wand is a bipolar, single use, high frequency electrosurgical device designed for use for specific turbinate indications in otorhinolaryngology (ENT) procedures.

Subject Device(s)

Indications of Use

ENT Wands

ENT Plasma Wands

Indicated for ablation, resection, and coagulation of soft tissueand hemostasis of blood vessels in otorhinolaryngology (ENT)surgery including: adenoidectomy, cysts, head, neck, oral, andsinus surgery, mastoidectomy, myringotomy with effectivehemorrhage control, nasal airway obstruction by reduction ofhypertrophic nasal turbinates, nasopharyngeal/laryngealindications including tracheal procedures, laryngealpolypectomy, and laryngeal lesion debulking, neck mass,papilloma keloids, submucosal palatal shrinkage, submucosaltissue shrinkage, tonsillectomy (including palatine tonsils),traditional uvulopalatoplasty (RAUP), tumors, and tissue in theuvula/soft palate for the treatment of snoring.

4. INDICATIONS FOR USE

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K202006

Image /page/6/Picture/1 description: The image contains the logo for ArthroCare. The logo features a stylized graphic on the left, consisting of several curved red lines arranged in a semi-circular shape. To the right of the graphic is the company name, "ArthroCare," written in a bold, sans-serif font. The wordmark is in a dark gray color, and a registered trademark symbol is visible next to the name.

Subject Device(s)	Indications of Use
ENT Wands
Turbinator Wands	Indicated for ablation, resection, and coagulation of soft tissueand hemostasis of blood vessels in otorhinolaryngology (ENT)sinus surgery involving nasal airway obstruction by reductionof hypertrophic nasal turbinates and submucosal tissueshrinkage. The Wand is designed to be used exclusively withthe COBLATOR II (CII) controller and Irrigation pump or theWEREWOLF COBLATION System (in conjunction with theENT Adapter and Irrigation Tube Set). Other controllers/pumpsmust not be used.
Accessories
WEREWOLF ENTAdapter	The WEREWOLF ENT Adapter, in conjunction with the Smith& Nephew COBLATOR II Compatible ENT Wands, the Smith& Nephew WEREWOLF COBLATION System and theWEREWOLF Irrigation Tube Set (as needed) are indicated forthe ablation, resection, and coagulation of soft tissue andhemostasis of blood vessels in ENT/otorhinolaryngologyprocedures.
WEREWOLFIrrigation Tube Set	The WEREWOLF Irrigation Tube Set, in conjunction with theSmith & Nephew COBLATOR II Compatible ENT Wands, theSmith & Nephew WEREWOLF COBLATION System and theWEREWOLF ENT Adapter are indicated for the ablation,resection, and coagulation of soft tissue and hemostasis ofblood vessels in ENT/otorhinolaryngology procedures

5. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

The overall technological characteristics of the proposed devices are the same as the predicate devices with exceptions listed in Table 1.

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Image /page/7/Picture/1 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 "R" is a registered trademark symbol.

Table 1: Summary of Comparison of the Technological Features of Subject and Predicate
Devices

Parameter	PREDICATE DEVICE(S):	SUBJECT DEVICE(S):
	Wands: ENT Wands(K070374, K142999 andK122652)+COBLATION System:COBLATOR IICOBLATION System(K030108)	Wands: ENT Wands(K070374, K142999 andK122652)+Accessories(ENT Adapter + IrrigationTube Set)+COBLATION System:WEREWOLFCOBLATION System(K192027)
Intended Useand Indicationsof Use	Indicated for ablation,resection, and coagulation ofsoft tissue and hemostasis ofblood vessels inotorhinolaryngology (ENT)procedures	Same
Input power	100-240 VAC	Same
Frequency	50-60 Hz	Same
Fuse Rating	8 Amps	16 Amps
OutputNominalVoltageMaximum	$320\pm10%$ Vrms	340 Vrms
COBLATIONSystem inputpower	100-120V ~ 8A220-240V ~ 4A	Same
Rated WandVoltage	$320\pm10%$ Vrms	Same
DefaultAblationSet Point /Output Voltage	Set Point 7(265 Vrms)	Same
DefaultCoagulationSet Point /Output Voltage	Set Point 3(75 Vrms)	Same
Ablation SetPoint Range /Output Voltage	Set Points 1 - 9(100-300 Vrms)	Set Points 0 - 9(0-300 Vrms)
Parameter	PREDICATE DEVICE(S):Wands: ENT Wands(K070374, K142999 and K122652)+COBLATION System:COBLATOR IICOBLATION System(K030108)	SUBJECT DEVICE(S):Wands: ENT Wands(K070374, K142999 and K122652)+Accessories(ENT Adapter + Irrigation Tube Set)+COBLATION System:WEREWOLFCOBLATION System(K192027)
CoagulationSet PointRange / OutputVoltage	Set Points 1 - 5(65-87 Vrms)	Same
CoagulationSetting	Adjustable (5 Set Points)	Same
COBLATIONSystem waveform	Square	Same
OutputFrequency	100kHz	Same
Suction	Connects to hospital suction system	Same
Saline Delivery	External Flow Control Unitused with the COBLATION System supplies saline to the wand.	Integrated peristaltic pump (FLOW IQ pump – K192027) on the COBLATION System controls saline delivery to the wand.
Activation	Foot Control	Same
Softwarecontrolled	No	Yes
SoftwareVersion	N/A	Main 4.1 and GUI 3.0
Graphical UserInterface	No	Yes
Weight	8.2kg	10 kg

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Image /page/8/Picture/1 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 resemble a stylized wave or swirl.

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Image /page/9/Picture/1 description: The image shows the ArthroCare logo. The logo consists of a stylized wave-like graphic in red on the left, followed by the word "ArthroCare" in a gray, sans-serif font. A small registered trademark symbol is present to the upper right of the word "ArthroCare". The logo appears to be part of a larger document or presentation, as there is text visible below it.

COMPARISON TO PREDICATE DEVICES

The ENT Wands with the accessories (subject) when used in conjunction with the WEREWOLF COBLATION System are substantially equivalent to the ENT Wands when used with ENT Coblator Surgery System (predicate devices).

The intended use, indications of use, fundamental technology and principle of operation of the subject devices are same as the predicate devices with exceptions including: 1. Compatibility of the subject device wands with the WEREWOLF COBLATION System; 2. Touch-controlled Graphical User Interface (GUI); 3. Integration of software to the WEREWOLF COBLATION System for controlling the wands; and 4. Integrated fluid control module for saline delivery.

7. STERILIZATION

The sterilization nor the shelf life has changed for the ENT wands since the 510(k) clearances. All legacy ENT Wands are still sterilized using radiation with a minimum sterilization assurance level (SAL) of 10-6.

The ENT Adapter and WEREWOLF Controller are supplied non-sterile and reusable. Cleaning measures are provided in the IFU and manual, respectively.

The Irrigation Tube Set is sterilized utilizing 100% Ethylene Oxide (EtO) gas via an existing validated EtO Cycle. The sterilization method ensures a minimum sterility assurance level of 10-6.

8. BIOCOMAPTIBILITY

There is no change in the materials used to manufacture the ENT Wands. Therefore, biocompatibility testing of the ENT Wands was not required for this 510(k) submission.

The ENT Adapter and the WEREWOLF Controller are non-patient contacting; therefore, biocompatibility testing was not required for this 510(k) submission.

The Irrigation Tube Set has indirect patient contact and is classified as an external communicating medical device with tissue/bone/dentin with indirect blood contact with limited duration (<24 h) per ISO 10993-1:2018. Biocompatibility testing was leveraged from the recently cleared HALO Wand (K192027), which met the requirements for ISO 10993-1:2018 for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, materials mediated pyrogenicity, and hemocompatibility

9. SOFTWARE

The software for the WEREWOLF Controller, in conjunction with the ENT Adapter, was designed to control performance for intended use. The software version is Main 4.1 and

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Image /page/10/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design in red on the left, followed by the company name "ArthroCare" in a dark gray, sans-serif font. A registered trademark symbol is present to the upper right of the company name.

GUI 3.0. A Graphical User Interface is utilized for the advancement of technology and to simplify system performance.

10. PERFORMANCE TESTING

Non-clinical performance testing:

Non-clinical performance testing of the ENT Wands with the accessories used in conjunction with the WEREWOLF COBLATION System verified that the subject devices met the established design criteria and supported substantial equivalence with the predicate devices, ENT Wands in conjunction with COBLATOR II System. It included design verification testing, consisting of electrical and mechanical/functional testing, which verified that the design meets the performance specifications. Pre-clinical ex-vivo bench testing was conducted to assess ablation and coagulation mode thermal effects, as well as suction, on bovine myocardial tissue, which verified that the subject devices performed substantially equivalent to the predicate devices.

Neither "Performance Testing - Animal" nor "Performance Testing - Clinical" was conducted to support this 510(k).

11. CONCLUSION

All testing demonstrated that the ENT Wands in conjunction with the accessories perform as intended and have acceptable performance when used in accordance with its labeling.

ArthroCare Corporation evaluated the indications for use, materials, technology, design and performance specification requirements of the subject devices to demonstrate that they are substantially equivalent to the predicate devices for their intended use, principle for operation and fundamental scientific technology.

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.