(102 days)
Not Found
No
The summary describes a standard electrosurgical device and system, with no mention of AI or ML capabilities in its description, intended use, or performance studies.
Yes
The device is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels, which are therapeutic actions.
No
The device is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels, which are surgical therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "bipolar, single use, electrosurgical device" and is designed for use with a "Surgery System Controller" and "Flow Control Unit," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ArthroCare Head and Neck Coblation Wand is an electrosurgical device used during surgery to ablate, resect, and coagulate soft tissue and control bleeding. It directly interacts with tissue within the body.
- Intended Use: The intended use clearly states it's for use in otorhinolaryngology (ENT) surgery for procedures like removing cysts and tumors. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical tool, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The ArthroCare Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- . Cysts
- . Tumors
- . Head, neck, and oral surgery
- . Neck mass
The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator II (CII) Surgery System Controller and ArthroCare Flow Control Unit.
Product codes
GEI
Device Description
The ArthroCare Head and Neck Coblation Wand is a bipolar, single use, electrosurgical device designed for use with the ArthroCare Coblator II System Controller for specific head and neck indications in otorhinolaryngology (ENT) procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head, neck, oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Otorhinolaryngology (ENT) surgery
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)
Performance Testing - Bench: Bench testing was performed to evaluate the performance of the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. The Design Verification test results demonstrate that the Head and Neck Wand meets all design and performance specifications and performs comparably to the predicate device.
Performance Testing - Animal: A Pre-Clinical study was conducted in sheep to evaluate the tissue effects using the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. Based on the test results, the proposed device is substantially equivalent to the predicate.
Performance Testing - Clinical: No clinical data are included in this submission.
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
510(k) Summary
ArthroCare® Corporation Head and Neck Coblation® Wand
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
ﻟﻤﺴﻠﻤ
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Ashley J Dawson, PhD |
| Manager, Regulatory Affairs | |
| Phone: 512-358-5773 | |
| Fax: 512-895-1489 |
Date Prepared: August 9, 2013
Device Name
| Proprietary Name: | ArthroCare® Head and Neck Coblation® Wand |
|---|---|
| Common Name: | Head and Neck Coblation Wand |
| Classification Name: | Electrosurgical Device and Accessories |
| Device Class: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
Gyrus ACMI G3 Generator and Accessories-Dissector Plasma Knife
K080844 (August 13, 2009)
Description
The ArthroCare Head and Neck Coblation Wand is a bipolar, single use, electrosurgical device designed for use with the ArthroCare Coblator II System Controller for specific head and neck indications in otorhinolaryngology (ENT) procedures.
1
Intended Use/Indications For Use
The ArthroCare Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- . Cysts
- . Tumors
- . Head, neck, and oral surgery
- . Neck mass
The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator II (CII) Surgery System Controller and ArthroCare Flow Control Unit.
Performance Testing - Bench
Bench testing was performed to evaluate the performance of the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. The Design Verification test results demonstrate that the Head and Neck Wand meets all design and performance specifications and performs comparably to the predicate device.
Performance Testing - Animal
A Pre-Clinical study was conducted in sheep to evaluate the tissue effects using the Head and Neck Wand compared to the predicate Gyrus Dissector Plasma Knife. Based on the test results, the proposed device is substantially equivalent to the predicate.
Performance Testing - Clinical
No clinical data are included in this submission.
Summary
All testing conducted demonstrates that the ArthroCare Head and Neck Coblation Wand performs as intended when used in accordance with its labeling. The ArthroCare Head and Neck Coblation Wand is substantially equivalent to the predicate Gyrus Dissector Plasma Knife in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized abstract symbol that resembles a human figure with three wavy lines emanating from it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2013
Ashley J. Dawson, Ph.D. Manager, Regulatory Affairs ArthroCare Corporation 7000 West William Cannon Drive Austin, Texas 78735
Re: K131205
Trade/Device Name: ArthroCare® Head and Neck Coblation® Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 15, 2013 Received: July 16, 2013
Dear Dr. Dawson:
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. Iisting 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
3
Page 2 - Ashley J. Dawson, Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ArthroCare® Head and Neck Coblation® Wand
Indications for Use:
The Head and Neck Coblation Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- . Cysts
- Tumors
- Head, neck, and oral surgery
- Neck mass
The ArthroCare Head and Neck Wand is designed to be used only with the ArthroCare ENT Coblator II (CII) Surgery System Controller and ArthroCare Flow Control Unit.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Joshua C. Nipper -S
(Division Sign-off) Division of Surgical Devices 510(k) Number
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