SPINEWAND SURGICAL DEVICE

K091228 · Arthrocare Corp. · GEI · Sep 28, 2009 · General, Plastic Surgery

Device Facts

Record IDK091228
Device NameSPINEWAND SURGICAL DEVICE
ApplicantArthrocare Corp.
Product CodeGEI · General, Plastic Surgery
Decision DateSep 28, 2009
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 procedures. It operates as an accessory to an electrosurgical system. The device provides a surgical tool for tissue management, allowing the surgeon to precisely remove or coagulate tissue during invasive procedures, potentially improving surgical outcomes through controlled energy delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar, high-frequency electrosurgical device; single-use; intended for soft tissue resection, ablation, and coagulation. Technical specifications include dimensional and material modifications compared to predicates. Energy source is an electrosurgical generator.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

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}------------------------------------------------ K091228 SEP 2 8 2009 ### 510(k) Summary ### ArthroCare Corporation ArthroCare® SpineWand® ### General Information Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 Establishment Registration Number: Contact Person: Date Prepared: Device Description Trade Name: Generic/Common Name: Classification Name: Predicate Devices ArthroCare SpineWand ArthroCare System 2000 ArthroCare System 2000 2951580 Valerie Defiesta-Ng Director, Regulatory Affairs April 22, 2009 ArthroCare® SpineWand® Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) g K072089 (August 17, 2007) K011634 (June 19, 2001) 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}------------------------------------------------ ### Substantial Equivalence This Special 510(k) proposes modifications to the dimensional specifications, materials and package of the ArthroCare SpineWands. The indications for use, 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping shapes. To the left of the figure, the text "DEPARTMENT OF HEALTH &" is arranged vertically, followed by "HUMAN SERVICES" below it. SEP 2 8 2009 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 ArthroCare Corporation % Ms. Valerie Defiesta-Ng 680 Vaqueros Avenue Sunnyvale, California 94085-3523 Re: K091228 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 Dated: September 18, 2009 Received: September 23, 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, ilsting 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. Yourmust 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. {3}------------------------------------------------ ### Page 2 - Ms. Valerie Defiesta-Ng 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/CDRH0ffices/uccr1111800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305 milli Isse note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFFR Proct 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 frea no (800) 638-2041 or (301) 796-7100 or at its Internet address . http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Sincerely yours, Mark M. Milliman Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement 510(k) Number: Device Name: ArthroCare® SpineWand® K 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR X Over-the-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) FOR M. MELKERSON (Division Sign-Off) rivision of Surgical, Orthopedic, I Restorative Devices 310(k) Number K09/228 ರಿ
Innolitics
510(k) Summary
Decision Summary
Classification Order
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