ARTHROCARE SPINEWAND

K072089 · Arthrocare Corp. · GEI · Aug 17, 2007 · General, Plastic Surgery

Device Facts

Record IDK072089
Device NameARTHROCARE SPINEWAND
ApplicantArthrocare Corp.
Product CodeGEI · General, Plastic Surgery
Decision DateAug 17, 2007
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.4400
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

Device Story

ArthroCare SpineWand is a bipolar, single-use, high-frequency electrosurgical device. It functions by delivering electrical energy to soft tissue to perform resection, ablation, and coagulation, as well as hemostasis of blood vessels. The device is utilized by clinicians in orthopedic, arthroscopic, spinal, and neurological surgical settings. It operates as a component of an electrosurgical system, where the clinician manually manipulates the wand to target specific tissue areas. The output of the device—controlled thermal energy—allows for precise tissue modification, which can reduce the need for traditional mechanical cutting tools and potentially minimize collateral tissue damage during surgery.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and the determination of substantial equivalence to previously cleared predicate devices.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Operates via electrosurgical cutting and coagulation principles. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels during orthopedic, arthroscopic, spinal, and neurological procedures. Intended for prescription use.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K072089 510(k) Summary AUG 1 7 2007 ArthroCare Corporation ArthroCare® SpineWand® Page 1 of ② General Information Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 Establishment Registration Number: 2951580 July 27, 2007 Contact Person: Valerie Defiesta-Ng Director, Regulatory Affairs Date Prepared: Device Description Trade Name: Generic/Common Name: Classification Name: ArthroCare® SpineWand® Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) ## Predicate Devices ArthroCare SpineWand ArthroCare Wand ArthroCare System 2000 K070851 (April 13, 2007) K060823 (April 10, 2006) K001588 (August 17, 2000) #### Product Description The Wands are bipolar, single use, high frequency electrosurgical devices. ### Intended Use The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures. {1}------------------------------------------------ # KO72089 ## Substantial Equivalence Page 2 of 2 This Special 510(k) proposes modifications to the packaging of the ArthroCare SpineWands. The indications for use, materials, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k). ## Summary of Safety and Effectiveness The proposed modifications to the Wands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices. {2}------------------------------------------------ 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 stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 7 2007 ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523 Re: K072089 Trade/Device Name: ArthroCare® SpineWand® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GXI Dated: July 27, 2007 Received: July 30, 2007 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 such 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); 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. {3}------------------------------------------------ Page 2 – Ms. Valerie Defiesta-Ng This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Soall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement 510(k) Number: KOJ72089 Device Name: ArthroCare® SpineWand® Indications for use: The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures. (Division Si (Division Sign-OH) Division of General, Restorative, and Neurological General, Restor 510(k) Number K072089 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR X Over-the-Counter Use (21 CFR 807 Subpart ರಿ) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Innolitics
510(k) Summary
Decision Summary
Classification Order
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