ARTHROCARE COBLATOR IQ SYSTEM

K091674 · Arthrocare Corp. · GEI · Jan 15, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K091674
• Device Name: ARTHROCARE COBLATOR IQ SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare Coblator IQ System is indicated for the following procedures: - For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and - 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 by Reduction of Hypertrophic Nasal Turbinates י - Nasopharyngeal/Laryngeal indications including Tracheal Procedures, . Laryngeal Polypectomy, and Laryngeal Lesion Debulking - Neck Mass . - Papilloma Keloids י - Submucosal Palatal Shrinkage 내 - Submucosal Tissue Shrinkage . - Tonsillectomy ﻻ - Traditional Uvulopalatoplasty (RAUP) י - Tumors # - Tissue in the Uvula/Soft Palate for the Treatment of Snoring g

Device Story

Bipolar, high-frequency electrosurgical generator (Controller) used with disposable, single-use bipolar Wands; system performs soft tissue resection, ablation, coagulation, and hemostasis. Operated by surgeons in clinical/surgical settings. Device transforms electrical energy into plasma-mediated tissue effects. Output allows precise tissue removal and bleeding control, benefiting patients by minimizing thermal damage to surrounding tissue during ENT, spinal, and neurological surgeries.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bipolar, high-frequency electrosurgical generator; disposable bipolar Wands; intended for soft tissue ablation/coagulation; electrical energy source.

Indications for Use

Indicated for soft tissue resection, ablation, coagulation, and hemostasis in spinal, neurological, and ENT surgical procedures (e.g., adenoidectomy, tonsillectomy, turbinate reduction, laryngeal procedures) in patients requiring such surgical intervention.

Regulatory Classification

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.

Predicate Devices

• ArthroCare Coblator ENT Surgery System (K030108)
• ArthroCare 8000S Coblator Surgery System (K053297)
• ArthroCare Irrigation Pump (K080482)

Submission Summary (Full Text)

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K091674

# JAN 1 5 2010

## 510(k) Summary

## ArthroCare® Corporation ArthroCare® Coblator IQ™ System

## General Information

| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | December 18, 2009 |

**Device Description**

| Trade Name: | ArthroCare® Coblator IQ™ System |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation<br>Device and Accessories (Class II, 21 CFR<br>878.4400, Product Code 79G - - EI) |

## Predicate Devices

F

ArthroCare Coblator ENT Surgery System K030108 (February 3, 2003) ArthroCare 8000S Coblator Surgery System K053297 (December 6, 2005) ArthroCare Irrigation Pump K080482 (March 20, 2008)

#### Product Description

The ArthroCare Coblator IQ System is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.

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### Intended Uses

The ArthroCare Coblator IQ System is indicated for the following procedures:

- For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels . in spinal and neurological procedures; and
- 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 by Reduction of Hypertrophic Nasal Turbinates י
- Nasopharyngeal/Laryngeal indications including Tracheal Procedures, . Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass .
- Papilloma Keloids י
- Submucosal Palatal Shrinkage 내
- Submucosal Tissue Shrinkage .
- Tonsillectomy ﻻ
- Traditional Uvulopalatoplasty (RAUP) י
- Tumors #
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring g

#### Substantial Equivalence

In establishing substantial equivalence to the predicate device. ArthroCare compared the indications for use, dimensional specifications, and performance specifications of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Coblator IQ System to the predicate devices. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.

#### Summary of Safety and Effectiveness

The ArthroCare Coblator IO System, as described in this premarket notification 510(k), is substantially equivalent to the predicate device. The differences in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the proposed device.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure with outstretched arms, overlaid with an eagle-like symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Arthrocare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085

JAN 1 5 2010

Re: K091674

Trade/Device Name: ArthroCare® Coblator IOTM System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 18, 2009 Received: December 22, 2009

Dear Ms. Defiesta-ng:

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, listing 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 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.

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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/ucm115800.htm fast 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 tolloffree no [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

ArthroCare® Coblator IQ™ System Device Name

510(k) Number: K

Indications for Use:

The ArthroCare Coblator IQ System is indicated for the following procedures:

- For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and
- 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 파
- Mastoidectomy .
- Myringotomy with Effective Hemorthage Control .
- Nasal Airway Obstruction by Reduction 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
- Traditional Uvulopalatoplasty (RAUP)

X

- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring

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

Prescription Use (Per 21 CFR 801.109)

OR

**Over-the-Counter Use**

FOR M.MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091674

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