The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

Adenoidectomy
Head, Neck, Oral, and Sinus Surgery
Myringotomy with Effective Hemorrhage Control
Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
Papilloma Keloids
Submucosal Tissue Shrinkage
Traditional Uvulopalatoplasty (RAUP)
Tissue in the Uvula/Soft Palate for the treatment of Snoring
Cysts
Mastoidectomy
Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
Neck Mass
Submucosal Palatal Shrinkage
Tonsillectomy (including palatine tonsils)
Tumors

Device Description

The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ ENT Plasma Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).

The CIQ Wands are bipolar, single use, radiofrequency-based electrosurgical devices designed for use with the CIQ Controller for specific indications in otorhinolaryngology (ENT) procedures.

The CIQ Controller is a bipolar, high frequency electrosurgical generator with an integrated peristaltic pump for saline delivery.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the ArthroCare® Coblator IQTM ENT System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome	Reported Device Performance
Bench Testing	Evaluate the performance of the Coblator IQ ENT System compared to predicate devices.	"The test results demonstrate that the Coblator IQ ENT System meets all design and performance specifications."
Animal Testing	Compare the tissue effects using the Coblator IQ ENT System as compared to predicate devices.	"Based on the test results, the proposed devices are substantially equivalent to the predicate devices."
Clinical Testing	(Not applicable for this submission)	"No clinical data are included in this submission."
Substantial Equivalence	Demonstrated equivalence to predicate devices (ArthroCare ENT Plasma Wands & ArthroCare Coblator IQ System (Controller)) in terms of safety and effectiveness, despite minor changes in performance specifications, materials, labeling, and minor software changes to the controller. The changes should not affect the safety or efficacy of the devices.	"The modified CIQ Wands are substantially equivalent to the predicate ArthroCare ENT Plasma Wands. The modification to performance specifications, materials, and labeling are minor changes, and do not affect the safety or efficacy of the devices. ... However, these changes do not affect the safety or efficacy of the device."

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The specific number of devices or tests conducted for bench testing is not explicitly stated. The data provenance is internal to the manufacturer (ArthroCare Corporation).
- Animal Testing: The specific number of animals or studies is not explicitly stated. The data provenance is internal to the manufacturer (ArthroCare Corporation).
- Clinical Testing: No clinical test set was used, as "No clinical data are included in this submission."
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable/Not specified. The studies conducted (bench and animal) for substantial equivalence typically rely on predefined specifications and direct observational/measurement comparisons, not expert human interpretation for ground truth.
Adjudication Method for the Test Set:
- Not applicable/Not specified. Given the nature of the bench and animal testing described (comparison to predicate devices and specifications), an adjudication method relying on multiple human reviewers is not relevant.
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:
- No MRMC study was done. This device is an electrosurgical system, not an AI-powered diagnostic or assistive tool for human readers.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a surgical instrument system, not an algorithm. Its performance is evaluated through its physical and functional characteristics.
The Type of Ground Truth Used:
- Bench Testing: Engineering specifications and performance metrics derived from predicate devices or established industry standards.
- Animal Testing: Macroscopic and microscopic tissue effects, likely evaluated against established biological responses or direct comparison to predicate device effects.
The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device's design and operation would implicitly come from the extensive history and development of similar electrosurgical technologies and predicate devices.
How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set was explicitly used in the context of AI/ML. The device's "ground truth" for design and manufacturing would be based on established engineering principles, material science, and regulatory requirements for medical devices.

Summary

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K123357

Page 1 of 2

510(k) Summary

ArthroCare® Corporation

COBLATOR IQTM ENT SYSTEM

APR 5 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	ArthroCare Corporation
Address:	7000 West William Cannon DriveAustin, TX 78735
Contact Person:	Mitchell DhorityVice President, Clinical and Regulatory Affairs
Date Prepared:	October 29, 2012

Device System Names/Components

Proprietary:	Coblator IQTM ENT System
Common:	ENT System
Classification:	Class II
Product Code:	GEI
CFR Section:	21 CFR 878.4400

Predicate Device

ArthroCare ENT Plasma Wands	K070374 (April 25, 2007)
	K063538 (December 1, 2006)
	K033257 (October 29, 2003)
	K014290 (March 28, 2002)

ArthroCare Coblator IQ System (Controller)

K091674 (January 15, 2010)

Description

The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ ENT Plasma Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).

The CIQ Wands are bipolar, single use, radiofrequency-based electrosurgical devices designed for use with the CIQ Controller for specific indications in otorhinolaryngology (ENT) procedures.

The CIQ Controller is a bipolar, high frequency electrosurgical generator with an integrated peristaltic pump for saline delivery.

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Intended Use/Indications For Use

The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: 1 ... ..

. Adenoidectomy
1 Head, Neck, Oral, and Sinus Surgery
. Myringotomy with Effective Hemorrhage Control
. Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
1 Papilloma Keloids
Submucosal Tissue Shrinkage
1 Traditional Uvulopalatoplasty (RAUP)
. Tissue in the Uvula/Soft Palate for the treatment of Snoring

Performance Testing - Bench

Cysts
123353
Mastoidectomy 트
l Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
l Neck Mass
Submucosal Palatal Shrinkage 트
Tonsillectomy (including palatine tonsils)
Tumors

Bench testing was conducted to evaluate the performance of the Coblator IQ ENT System compared to the predicate devices. The test results demonstrate that the Coblator IQ ENT System meets all design and performance specifications.

Performance Testing - Animal

Pre-Clinical animal studies were conducted to compare the tissue effects using the Coblator IQ ENT System as compared to the predicate devices. Based on the test results, the proposed devices are substantially equivalent to the predicate devices.

Performance Testing - Clinical

No clinical data are included in this submission.

Summary

The ArthroCare Coblator IQ ENT System (CIQ System) is comprised of eight ArthroCare Coblator IQ : ENT Wands (CIQ Wands) and the ArthroCare Coblator IQ Controller (CIQ Controller).

The modified CIQ Wands are substantially equivalent to the predicate ArthroCare ENT Plasma Wands. The modification to performance specifications, materials, and labeling are minor changes, and do not affect the safety or efficacy of the devices.

There have also been minor software changes to the CIQ Controller cleared in 2010. However, these changes do not affect the safety or efficacy of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: April 5, 2013

Arthrocare Corporation % Mr. Mitchell Dhority Vice President, Clinical and Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

Re: K123353 Trade/Device Name: ArthroCare® Coblator IQ™ ENT System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 12, 2013 Received: March 27, 2013

Dear Mr. Dhority:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mitchell Dhority

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N.Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K123353 510(k) Number (if known):

Device Name: ArthroCare® Coblator IQTM ENT System

Indications for Use:

The ArthroCare® Coblator IQTM ENT System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

Adenoidectomy
Head, Neck, Oral, and Sinus Surgery
Myringotomy with Effective Hemorrhage Control
다 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
Papilloma Keloids
Submucosal Tissue Shrinkage
Traditional Uvulopalatoplasty (RAUP)
트 Tissue in the Uvula/Soft Palate for the treatment of Snoring
. Cysts
Mastoidectomy 미
l Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
0 Neck Mass
트 Submucosal Palatal Shrinkage
이 Tonsillectomy (including palatine tonsils)
트 Tumors

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . Concurrence of CDRH. Office of Device Evaluation (ODE)

Joshua C.
Nipper -S
For

(Division Sign-Off) Division of Surgical Devices

K123353 510(k) Number

Page 1 of 1

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.