(154 days)
Not Found
No
The summary describes a standard electrosurgical device and makes no mention of AI or ML.
Yes
The device is used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels, which are therapeutic actions to treat medical conditions.
No
The "Intended Use / Indications for Use" section states that the device is for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels," which are therapeutic rather than diagnostic functions.
No
The device description explicitly states "The Wands are bipolar, single use, high frequency electrosurgical devices," indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description as a "bipolar, single use, high frequency electrosurgical device" further reinforces its function as a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for a disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is entirely focused on surgical intervention in vivo.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
The Wands are bipolar, single use, high frequency electrosurgical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
SEP 2 8 2009
510(k) Summary
ArthroCare Corporation ArthroCare® SpineWand®
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
Predicate Devices
ArthroCare SpineWand ArthroCare System 2000 ArthroCare System 2000 2951580
Valerie Defiesta-Ng Director, Regulatory Affairs
April 22, 2009
ArthroCare® SpineWand®
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
g
K072089 (August 17, 2007) K011634 (June 19, 2001) 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
Substantial Equivalence
This Special 510(k) proposes modifications to the dimensional specifications, materials and package of the ArthroCare SpineWands. The indications for use, 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping shapes. To the left of the figure, the text "DEPARTMENT OF HEALTH &" is arranged vertically, followed by "HUMAN SERVICES" below it.
SEP 2 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
ArthroCare Corporation % Ms. Valerie Defiesta-Ng 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K091228
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 Dated: September 18, 2009 Received: September 23, 2009
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, ilsting 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 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. Yourmust 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.
3
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/CDRH0ffices/uccr1111800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305 milli Isse note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFFR Proct 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 frea no (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 M. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
Device Name:
ArthroCare® SpineWand®
K
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
X
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)
FOR M. MELKERSON
(Division Sign-Off)
rivision of Surgical, Orthopedic, I Restorative Devices
310(k) Number K09/228
ರಿ