ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND

K132099 · ArthroCare Corporation · GEI · Aug 22, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132099
• Device Name: ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
• Applicant: ArthroCare Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare Coblator IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCare Coblator IQ Controller.

Device Story

Single-use, disposable, high-frequency electrosurgical wands (DLR and DLG models) for percutaneous spinal disc decompression. Used exclusively with ArthroCare Coblator IQ Controller. Device consists of stainless steel shaft and polycarbonate handle with integrated cable. Principle of operation: Coblation process; uses conductive media to create plasma layer for tissue ablation. Operated by physicians in clinical setting. Output is plasma-mediated tissue ablation/coagulation. Benefits include minimally invasive decompression of herniated lumbosacral discs.

Clinical Evidence

No clinical data included. Bench testing only.

Technological Characteristics

High-frequency electrosurgical device. Materials: stainless steel shaft, polycarbonate handle. Energy source: ArthroCare Coblator IQ Controller (RF/plasma). Form factor: wand with straight electrode configuration. Sterilization: not specified. Connectivity: wired to controller.

Indications for Use

Indicated for ablation, coagulation, and decompression of disc material in symptomatic patients with contained herniated lumbosacral discs.

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 IQ Perc-D SpineWand (K100353)

Submission Summary (Full Text)

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K132099 Paqe 1 of 2

# 510(k) Summary ArthroCare® Corporation ArthroCare® Coblator IQ™ Perc-D® SpineWands®

#### General Information

Submitter Name/Address:

ArthroCare Corporation 7000 West William Cannon Dr. Austin, TX 78735

Establishment Registration Number:

Contact Person:

Date Prepared:

3006524618

Shirlev Hyink

AUG 2 2 2013

Sr. Manager, Regulatory Affairs

July 2, 2013

Device Description Trade Name:

ArthroCare® Coblator IQ™ Perc-D® SpineWand® (Coblator IQ DLR and DLG SpineWands)

Electrosurgical Device and Accessories

Generic/Common Name: .

Classification Name:

Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

## Predicate Devices

K100353 - ArthroCare Coblator IQ Perc-D SpineWand (May 13, 2010)

#### Product Description

The Coblator IQ Perc-D SpineWands consist of two Wands, the Coblator IQ DLR Spine Wand and the Coblator IQ DLG SpineWand, intended for use only with the Coblator IQ Controller.

These wands are single use, disposable, high frequency electrosurgery devices intended for use in percutaneous spinal disc decompression surgery. The Wands consist of a stainless steel shaft with a straight electrode configuration design. The proximal end of the devices is housed in a handle composed of polycarbonate. A cable integrated into the handle connects the Wand to the ArthroCare Coblator IQ Controller.

The Wand electrode is activated using the CIO Controller System energy which starts the Coblation process to ablate the disc tissue. The Coblation process involves use of a conductive media to create a plasma layer to ablate tissue.

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# Intended Use/Indications For Use

The ArthroCare Coblator IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCare Coblator IQ Controller.

## Non-Clinical Data

This submission seeks only to clarify the indication for use statement of the predicate device and there have been no other device, design or material changes since the previous clearance of these predicate devices (K100353), new testing was deemed to be unnecessary. The performance testing previously conducted as part of the design control activities include device acceptance criteria testing, biological testing, and packaging testing.

## Clinical Data

No clinical data are included in this submission.

## Summary

The purpose of this submission is to clarify the current indication for use statement to specifically denote use of the Wands within the lumbosacral spine. Other than the change to the indication of use statement the Wands are identical to the predicate devices in:

- 트 Performance specification,
- . Materials,
- Technological characteristics,
- 트 Sterilization, and
- Principle of operation

The proposed Indications for Use do not significantly affect the safety or efficacy of the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 22, 2013

Shirley Hyink Senior Manager, Regulatory Affairs ArthroCare Corporation 7000 West William Cannon Drive Austin. Texas 78735

Re: K132099

Trade/Device Name: ArthroCare® Coblator IQ™ Perc-D® SpineWand® (Coblator IQ DLR and DLG SpineWands) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2013 Received: July 10, 2013

Dear Ms. Hyink:

We have reviewed your Section 510(k) promarket 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 10 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. 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.

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 - Shirley Hyink

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

510(k) Number (if known):

Device Name: ArthroCare® Coblator IQ™ Perc-D® SpineWand® (Coblator IQ DLR and DLG SpineWands)

#### Indications for Use:

The ArthroCare Coblator IQ Perc-D Spine Wands (Coblator IQ DLR and Coblator IQ DLG SpineWands) are indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated lumbosacral discs. The Wands are designed to be used exclusively with the ArthroCare Coblator IQ Controller.

Prescription Use × (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

(Division Sign-off) Division of Surgical Devices 510(k) Number K132099