(191 days)
The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.
The ArthroCare Cavity SpineWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in spinal procedures.
This 510(k) summary (K063172) is for the ArthroCare® Cavity SpineWands®. It describes a new indication for use, stating that the device is substantially equivalent to previously cleared predicate devices and does not present new acceptance criteria or a new study proving the device meets new acceptance criteria. Instead, it relies on the previously established safety and efficacy of the predicate devices.
Therefore, many of the requested details, such as a table of acceptance criteria, sample sizes for test and training sets, and details of ground truth establishment, are not applicable or available in this document. This submission focuses on demonstrating substantial equivalence for an expanded intended use based on existing technology and performance.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
Not applicable. This 510(k) is for a new indication for an existing device. It does not present new performance data against specific acceptance criteria. The submission relies on the substantial equivalence to predicate devices, implying that the device's performance for the new indication is considered safe and effective based on the predicate's established performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set data is presented for this 510(k) submission. The device is being cleared for an expanded indication based on its existing technology and substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new ground truth establishment for a test set is reported in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or adjudication method is reported.
5. 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 applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (electrosurgical tool), not an algorithm. Standalone performance as typically described for software or AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth is established or reported in this submission for the purpose of demonstrating performance for new acceptance criteria. The safety and effectiveness are established through substantial equivalence to predicate devices, which would have undergone their own testing and validation with relevant "ground truth" (e.g., surgical outcomes, tissue effects) at the time of their clearance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning model, there is no training set or associated ground truth.
Summary of the 510(k) Content:
The K063172 submission for the ArthroCare® Cavity SpineWands® is a re-indication 510(k). The core of this submission is to demonstrate substantial equivalence to predicate devices (ArthroCare® Wands and RITA System) for a new, expanded indication: "creation of a cavity in malignant lesions in a vertebral body."
The document explicitly states:
- "This 510(k) proposes a new indication and labeling for the ArthroCare Cavity SpineWands."
- "The technology, principle of operation, materials, and sterilization parameters of the ArthroCare Cavity SpineWands remain the same as those Wands cleared in the ArthroCare predicate 510(k)s."
- "The ArthroCare Cavity SpineWands, as described in this 510(k), are substantially equivalent to the predicate devices. The new proposed indication and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Therefore, this 510(k) does not introduce new performance acceptance criteria or a study that proves the device meets new acceptance criteria. Instead, it leverages the pre-existing safety and efficacy data, and the established regulatory clearance, of the predicate devices for the expanded use.
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14063172 510(k) Summary
APR 2 7 2007
ArthroCare Corporation ArthroCare® Cavity SpineWands®
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Establishment Registration Number: Contact Person:
2951580
Valerie Defiesta-Ng Director, Regulatory Affairs October 17, 2006
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare® Cavity SpineWands®
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare® Wands RITA System
Product Description
The ArthroCare Cavity SpineWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in spinal procedures.
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Intended Uses
The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.
Substantial Equivalence
This 510(k) proposes a new indication and labeling for the ArthroCare Cavity The technology, principle of operation, materials, and sterilization SpineWands. parameters of the ArthroCare Cavity SpineWands remain the same as those Wands cleared in the ArthroCare predicate 510(k)s. The ArthroCare Cavity SpineWands are also substantially to the RITA System in indications for use and technology.
Summary of Safety and Effectiveness
The ArthroCare Cavity SpineWands, as described in this 510(k), are substantially equivalent to the predicate devices. The new proposed indication 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 logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion 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 94085-3523
APR 2 7 2007
Re: K063172
Trade/Device Name: ArthroCare® Cavity SpineWands® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 14, 2007 Received: March 15, 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 - 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 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. Me 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:
KO63172
Device Name:
ArthroCare® Cavity SpineWands®
Indications for Use:
The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.
Prescription Use (Part 21 CFR 801 Subpart D)
X
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number L063172
§ 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.