(14 days)
The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for orthopedic, arthroscopic, and spinal, and neurosurgical procedures.
This document is a 510(k) summary for the ArthroCare Wands. It describes modifications to an already cleared device and asserts substantial equivalence to its predicate. The document does not contain information about acceptance criteria or a study proving the device meets them. This type of regulatory submission (510(k)) typically focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than performing new clinical efficacy studies with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
The provided text only includes:
- Device Description: ArthroCare Wands are bipolar, single-use, high-frequency electrosurgical devices.
- Intended Use: Resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
- Modifications: Dimensional specifications, material, and labeling.
- Claim of Equivalence: The modifications are not substantial changes and do not significantly affect safety or efficacy.
- Predicate Device: ArthroCare 8000S Coblator Surgery Systems K053297.
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Image /page/0/Picture/0 description: The image shows the logo for "ArthroCare Corporation". The logo consists of a stylized graphic to the left of the text. The graphic is composed of several curved black lines that create a circular shape. To the right of the graphic is the word "ArthroCare" in a bold, sans-serif font, with a trademark symbol next to it. Below "ArthroCare" is the word "Corporation" in a smaller, less bold font.
APR 1 0 2006
510(k) Summary KO6082 ArthroCare Corporation ArthroCare Wands
Page 1 of 2
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
2951580
March 24, 2006
Valerie Defiesta-Ng Director, Regulatory Affairs
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare® Wands
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Device
ArthroCare 8000S Coblator Surgery Systems K053297
Product Description
The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for orthopedic, arthroscopic, and spinal, and neurosurgical procedures.
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
Substantial Equivalence
This Special 510(k) proposes modifications in dimensional specifications, material, and labeling for the ArthroCare Wands, which were previously cleared under K053297 on December 6, 2005. The indications for use, technology, principle of operation, performance specifications, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).
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060823
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Summary of Safety and Effectiveness
The modified ArthroCare Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its wings, symbolizing strength and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2006
ArthroCare Corporation c/o Ms. Valerie Defiesta-NG Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K060823
Trade/Device Name: ArthroCare Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GXI Dated: March 24, 2006 Received: March 27, 2006
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
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Page 2 - Ms. Valerie Defiesta-NG
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. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
elmalle
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use Statement
KO60823 510(k) Number:
Device Name: ArthroCare Wands
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 (21 CFR 801 Subpart D)
AND/OR
X
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of C
Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number ko60823
§ 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.