(90 days)
The ArthroCare® Coblator IQ™ Perc-D® SpineWand® is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
The Wands are bipolar, single use, high frequency electrosurgical devices. The Coblator IQ Perc-D SpineWands include the following Wands: Coblator IQ DC SpineWand, Coblator IQ DLR SpineWand, and the Coblator IQ DLG SpineWand.
This 510(k) premarket notification (K000353) is for the ArthroCare® Coblator IQTM Perc-D® SpineWand®. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics or clinical outcomes.
Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to previously cleared predicate devices. The key points are:
- Substantial Equivalence: The document states that "This Special 510(k) proposes modifications to the performance specifications and labeling of the ArthroCare Coblator IQ™ Perc-D® SpineWand". It further clarifies that "The indications for use, materials, technology, sterilization, and principle of operation of the SpineWands remain the same as in the predicate device."
- Safety and Effectiveness: It asserts that "The proposed modifications to the SpineWands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices."
Therefore, the request for acceptance criteria and a study proving device performance using metrics like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance cannot be fulfilled from the provided text. The FDA's letter (pages 2-4) confirms the substantial equivalence determination but does not delve into specific performance study results.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than new performance criteria.
- Sample size used for the test set and the data provenance: Not provided. No specific test set data is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment related to a test set is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so an MRMC study is not applicable here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This is an electrosurgical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
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MAY 1 3 2010
510(k) Summary
ArthroCare Corporation ArthroCare® Coblator IQTM Perc-D® SpineWand®
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
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
February 11, 2010
2951580
ArthroCare® Coblator IQTM Perc-D® SpineWand®
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
K053447 (December 27, 2005) ArthroCare Perc-D SpineWand ArthroCare Perc-D SpineWand K030954 (April 16, 2003) ArthroCare Perc-D SpineWand K020621 (March 28, 2002) ArthroCare Perc-D SpineWand K010811 (May 30, 2001)
Product Description
The Wands are bipolar, single use, high frequency electrosurgical devices.
The Coblator IQ Perc-D SpineWands include the following Wands: Coblator IQ DC SpineWand, Coblator IQ DLR SpineWand, and the Coblator IQ DLG SpineWand.
Intended Use
The ArthroCare® Coblator IQ™ Perc-D® SpineWand® is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
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Substantial Equivalence
This Special 510(k) proposes modifications to the performance specifications and
labeling of the ArthroCare Coblator IQ™ Perc-D® SpineWand". The indications for use, materials, technology, sterilization, and principle of operation of the SpineWands remain the same as in the predicate device.
Summary of Safety and Effectiveness
The proposed modifications to the SpineWands 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ArthroCare® Corporation % Ms. Valerie Defiesta-Ng 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
MAY 1 3 2010
Re: K100353
Trade/Device Name: ArthroCare® Coblator IQ™ Perc-D® SpineWand® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 11, 2010 Received: February 12, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. 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); 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.
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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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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-free number (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 A. Milburn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K 510(k) Number:
ArthroCare® Coblator IQ™ Perc-D® SpineWand® Device Name:
Indications for use:
The ArthroCare® Coblator IQ™ Perc-D® SpineWand® is indicated for ablation, I he Arthroome - Southere som of disc material to treat symptomatic patients with contained herniated discs.
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)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100353
§ 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.