(305 days)
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.
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.
This document describes the ArthroCare® Turbinator™ Wand, a bipolar electrosurgical device. The information provided heavily emphasizes its substantial equivalence to a predicate device, the ReFlex Ultra 45, implying that the acceptance criteria are met by demonstrating similar performance to this existing, approved device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Meet all design and performance specifications | Turbinator Wand meets all design and performance specifications. |
| Evaluate tissue effects similar to predicate device | Proposed device is substantially equivalent to the predicate device. |
| Perform as intended when used as labeled | Turbinator Wand performs as intended when used in accordance with its labeling. |
| Similar technological characteristics to predicate device (design, material, chemical composition, energy source) | Turbinator Wand has similar technological characteristics as compared to the predicate ArthroCare ReFlex Ultra 45 Wand. |
| Modifications do not raise new questions of safety or effectiveness | Modifications (Indications for Use, performance specifications, materials, labeling) are not substantial changes or modifications, and do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a numerical sample size for the "Performance Testing - Bench" or "Performance Testing - Animal" studies. For the animal study, it refers to "Pre-Clinical study" without specifying the number of animals or trials.
- Data Provenance:
- Bench Testing: Performed internally by ArthroCare Corporation.
- Animal Testing: A "Pre-Clinical study" was conducted, implying prospective data collection. The country of origin is not specified, but it's presumed to be the USA, given the submitting company's location and the FDA submission.
- Clinical Testing: "No clinical data are included in this submission."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The provided document does not describe any studies involving human experts to establish ground truth for a test set in the context of diagnostic or interpretive performance. The performance evaluations are against engineering specifications and comparisons to a predicate device's functional characteristics.
4. Adjudication Method for the Test Set
Not applicable, as no studies involving human interpretation or subjective assessment of a test set are reported in the document. The performance evaluations were objective measurements and comparisons.
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 wand, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical electrosurgical tool and not a standalone algorithm or AI. Performance is evaluated on its physical and functional characteristics.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The type of "ground truth" for this device can be inferred from the performance testing:
- Bench Testing: The ground truth would be defined by the design and performance specifications for the wand (e.g., power output, temperature, tissue ablation characteristics).
- Animal Testing: The ground truth for tissue effects would be based on histopathological examination of the treated tissue in comparison to tissue treated with the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a physical electrosurgical tool, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used for this type of medical device.
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510(k) Summary
ArthroCare® Corporation TURBINATOR™ WAND
JUL 0 2 2013
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address: | 7000 West William Cannon DriveAustin, TX 78735 |
| Contact Person: | Ashley J Dawson, PhDManager, 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.
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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.
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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
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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
Page 1 of 1
§ 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.