(18 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.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the ArthroCare® SpineWand®, which focuses on establishing substantial equivalence to predicate devices for modifications to its packaging. It explicitly states that "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 suggests that performance testing information would be found in the predicate 510(k)s (K070851, K060823, K001588), which are not provided here.
Therefore, I cannot provide the requested table or any of the detailed study information regarding acceptance criteria, sample sizes, ground truth, or MRMC studies.
{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)
§ 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.