(191 days)
No
The summary describes a standard electrosurgical device and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance metrics typically associated with AI/ML models.
Yes
The device is used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels, which are therapeutic medical interventions.
No
Explanation: The device is described as an electrosurgical device for resection, ablation, coagulation, and hemostasis of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "bipolar, single use, high frequency electrosurgical device," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's body (resection, ablation, coagulation of soft tissue, hemostasis of blood vessels, creation of a cavity in malignant lesions). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to diagnose or monitor conditions.
- Device Description: The device is described as a "high frequency electrosurgical device" used in spinal procedures. This is consistent with a surgical tool, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the ArthroCare Cavity SpineWands are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
The ArthroCare Cavity SpineWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in spinal procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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