(16 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 Wands are bipolar, single use, high frequency electrosurgical devices.
The provided text is a 510(k) summary for the ArthroCare® SpineWand™, a high-frequency electrosurgical device. The document states that this is a Special 510(k) submission proposing modifications to the packaging and labeling of the device. Crucially, it explicitly states:
"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)."
This indicates that the current submission (K070851) is not for a new device requiring a new study to prove performance against acceptance criteria. Instead, it's a modification to an already cleared device, and thus relies on the substantial equivalence determination to its predicate devices (ArthroCare Wands K060823 and ArthroCare System 2000 K001588).
Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria for the K070851 submission. If such a study or acceptance criteria existed, they would have been part of the predicate 510(k) submissions, not this Special 510(k) for packaging/labeling changes.
Based on the provided text, I cannot complete the requested information for acceptance criteria and a study to prove the device meets these criteria because the K070851 submission is for packaging and labeling modifications, and explicitly states that performance specifications remain the same as the predicate devices.
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APR 1 3 2007
510(k) Summarv
ArthroCare Corporation ArthroCare® ArthroWand
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
Valerie Defiesta-Ng
Director, Regulatory Affairs
2951580
March 27, 2007
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 Wands ArthroCare System 2000 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.
Image /page/0/Picture/25 description: The image shows a document with the text "FDA/CDRH/ODE/PMO" at the top. Below that, the text "2007 MAR 28 A 9:41" is visible. The word "RECEIVED" is at the bottom of the image.
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( ర్యాల 2
X
Substantial Equivalence
This Special 510(k) proposes modifications to the packaging and labeling of the ArthroCare Wands. 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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936
APR 1 3 2007
Re: K070851
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: March 27, 2007 Received: March 28, 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.
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Page 2 - 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 Small 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
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
510(k) Number:
KO70851
Device Name:
ArthroCare® SpincWand™
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 Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number
Prescription Use (Part 21 CFR 801 Subpart D)
X
AND/OR
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)
viii
§ 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.