(305 days)
Not Found
No
The document describes a standard electrosurgical device and does not mention any AI or ML capabilities.
Yes
The device is used for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in ENT surgery, specifically for reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage, which are therapeutic medical procedures.
No
Explanation: The device is described as an electrosurgical device indicated for "ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels," which are therapeutic procedures, not diagnostic ones. It is used to treat existing conditions rather than to identify or characterize them.
No
The device description explicitly states it is a "bipolar, single use, electrosurgical device," which is 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 that the device is for "ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "bipolar, single use, electrosurgical device." Electrosurgical devices are used for surgical procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Turbinator Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery involving nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The wand is designed to be used exclusively with the ArthroCare Coblator II (CII) controller and ArthroCare Irrigation pump. Other controllers/pumps must not be used.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ArthroCare Turbinator Wand is a bipolar, single use, electrosurgical device designed for use with the ArthroCare Coblator II System Controller for specific turbinate indications in otorhinolaryngology (ENT) procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal turbinates
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)
Bench testing was performed to evaluate the performance of the Turbinator Wand compared to the predicate ReFlex Ultra 45. The test results demonstrate that the Turbinator Wand meets all design and performance specifications. A Pre-Clinical study was also conducted to evaluate the tissue effects using the Turbinator Wand compared to the ReFlex Ultra 45. Based on the test results, the proposed device is substantially equivalent to the predicate device. No clinical data are included in this submission. All testing demonstrates that the ArthroCare Turbinator Wand performs as intended when used in accordance with its labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 TURBINATOR™ WAND
JUL 0 2 2013
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address: | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Ashley J Dawson, PhD |
| Manager, Regulatory Affairs | |
| Date Prepared: | August 21, 2012 |
Device System Names/Components
| Proprietary: | ArthroCare® Turbinator™ Wand |
|---|---|
| Common: | Turbinator Wand |
| Classification: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
ReFlex Ultra 45 included in:
ArthroCare® ENT Plasma Wands™
K070374 (April 25, 2007)
Description
The ArthroCare Turbinator Wand is a bipolar, single use, electrosurgical device designed for use with the ArthroCare Coblator II System Controller for specific turbinate indications in otorhinolaryngology (ENT) procedures.
Intended Use/Indications For Use
The Turbinator Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery involving nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The wand is designed to be used exclusively with the ArthroCare Coblator II (CII) controller and ArthroCare Irrigation pump. Other controllers/pumps must not be used.
1
Performance Testing - Bench
Bench testing was performed to evaluate the performance of the Turbinator Wand compared to the predicate ReFlex Ultra 45. The test results demonstrate that the Turbinator Wand meets all design and performance specifications.
Performance Testing - Animal
A Pre-Clinical study was also conducted to evaluate the tissue effects using the Turbinator Wand compared to the ReFlex Ultra 45. Based on the test results, the proposed device is substantially equivalent to the predicate device.
Performance Testing - Clinical
No clinical data are included in this submission.
Summary
All testing demonstrates that the ArthroCare Turbinator Wand performs as intended when used in accordance with its labeling. The ArthroCare Turbinator Wand has similar technological characteristics (i.e., design, material, chemical composition, energy source) as compared to the predicate ArthroCare ReFlex Ultra 45 Wand. The Turbinator Wand incorporates conductive media delivery and suction as well as higher setpoints for Coblation The modified ArthroCare Turbinator Wand, as described in this plasma formation. submission, is substantially equivalent to the predicate ArthroCare ReFlex Ultra 45 Wand. The proposed modifications in Indications for Use, performance specifications, materials, and labeling are not substantial changes or modifications, and do not raise new questions of safety or effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2013
ArthroCare Corporation C/O Mitchell Dhority Vice President, Clinical and Regulatory Affairs 7000 West William Cannon Drive Austin, TX 78735
Re: K122652 .
Trade/Device Name: ArthroCare™ Turbinator" Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 27, 2013 Received: June 28, 2013
Dear Mr. Dhority:
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 docs 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 or any reading 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 - Mr. Mitchell Dhority
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/MedicalDcvices/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
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Indications for Use
510(k) Number (if known):
Device Name: · ArthroCare® Turbinator™ Wand
Indications for Use:
The Turbinator Wand is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery involving nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage. The wand is designed to be used exclusively with the ArthroCare Coblator II (CII) controller and ArthroCare Irrigation pump. Other controllers/pumps must not be used.
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 K122652
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