The TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch is indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Procedure	Body Structure as Described Below
Fasciotomy	Foot
Synovectomy	Foot
Tendonotomy	Knee, Wrist, Elbow, Ankle, Shoulder, Foot
Rotator Cuff Tendonotomy	Shoulder
Capsulotomy	Foot

Device Description

The TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch (Topaz EZ IFS) is a bipolar, sterile, high frequency electrosurgical device, which consists of a distal electrode tip composed of tungsten, an alumina ceramic spacer, stainless steel shaft, saline irrigation tubing and a molded handle with an integrated single finger switch used to activate the Wand. The handle connects proximally to the radiofrequency Controller via an electrical cable. The Topaz EZ IFS is only compatible with the ArthroCare Quantum Controllers.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch:

1. Table of Acceptance Criteria and Reported Device Performance:

Testing Type	Acceptance Criteria	Reported Device Performance
Verification Testing	Performance within established testing specifications, demonstrating substantial equivalence to the predicate device.	Both the Topaz EZ IFS and predicate device had substantially equivalent testing specifications and both performed within acceptance criteria. Results support substantial equivalence.
• Visual Inspection	Implicit: Meet visual specifications, no defects.	Performed within acceptance criteria.
• Dimensional Inspection	Implicit: Meet dimensional specifications.	Performed within acceptance criteria.
• Hi-Pot Testing	Implicit: Meet electrical insulation and dielectric strength requirements.	Performed within acceptance criteria.
• Electrical Impedance	Implicit: Meet specified electrical impedance values.	Performed within acceptance criteria.
• Saline Flow Rate	Implicit: Meet specified saline flow rates.	Performed within acceptance criteria.
• Controller Ablation Set Points	Implicit: Respond correctly to controller ablation set points.	Performed within acceptance criteria.
• Finger Switch Actuation Testing	Implicit: Finger switch functions reliably and as intended.	Performed within acceptance criteria.
• Ablation Testing	Implicit: Achieve expected ablation performance.	Performed within acceptance criteria.
• Shaft Stiffness	Implicit: Meet specified stiffness requirements.	Performed within acceptance criteria.
• Axial Compression Force Testing	Implicit: Withstand specified axial compression forces.	Performed within acceptance criteria.
Biocompatibility Testing	No adverse biological reactions (cytotoxicity, sensitization, maximization).	The Topaz EZ IFS and the predicate device are biocompatible. Results support substantial equivalence.
• Cytotoxicity	No cytotoxic effects.	Biocompatible.
• Sensitization	No sensitization reactions.	Biocompatible.
• Maximization	No maximization reactions.	Biocompatible.
Electrical Safety Testing (IEC 60601-2-2:2009)	Meet all acceptance criteria detailed in IEC 60601-2-2:2009 (e.g., patient protection from electrical shock, electromagnetic compatibility, insulation).	The Topaz EZ IFS and the predicate device met all acceptance criteria in accordance with IEC 60601-2-2: 2009. Results support substantial equivalence.

2. Sample Size for the Test Set and Data Provenance:

The document describes non-clinical performance testing to support substantial equivalence. It does not explicitly state the sample sizes for each specific test (e.g., how many wands were used for ablation testing or shaft stiffness tests). It also does not specify the provenance of "data" in the sense of patient data, as the tests are non-clinical, mechanical, and electrical in nature.

The changes are largely related to materials and manufacturing, and the data provenance for such tests would typically be laboratory-based (e.g., in-house testing at ArthroCare Corporation), rather than geo-specific or patient-derived. The study is not based on human or animal subjects, but on the device's physical and electrical characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable. The "ground truth" for non-clinical performance and safety testing (e.g., dimensions, electrical impedance, biocompatibility) is established by engineering specifications, international standards (like IEC 60601-2-2:2009), and material science principles, not by human expert interpretation of results in the way it would be for a diagnostic AI.

4. Adjudication Method for the Test Set:

Not applicable. As this is not a diagnostic or interpretative study involving human readers, there is no adjudication method used. The results are quantitative measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and an AI might assist or replace them. The TOPAZ® EZ Microdebrider Coblation® Wand is a surgical tool, and its efficacy is evaluated through non-clinical performance, safety, and substantial equivalence to a predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This concept is not applicable as the device is a physical surgical tool, not an algorithm. The performance described is inherently "standalone" in the sense that the device's functional characteristics (e.g., ablation, electrical safety) are tested on their own.

7. Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

Engineering Specifications: Designed dimensions, material properties, electrical characteristics.
Performance Requirements: Defined operational parameters (e.g., saline flow rate, ablation efficacy).
International Standards: e.g., IEC 60601-2-2:2009 for electrical safety.
Biocompatibility Standards: Standards for assessing biological reactions to materials.
Predicate Device Performance: The predicate device's established performance serves as a benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its design and manufacturing process are based on engineering principles.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

JUN | 0 2014

K140521

510(k) Summary

ArthroCare® Corporation TOPAZ® EZ Microdebrider Coblation® Wand With Integrated Finger Switch

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

Submitter Name:	ArthroCare Corporation
Address	7000 West William Cannon DriveAustin, TX 78735
Contact Person:	Mitchell A. DhorityVice President, Regulatory AffairsPhone: 512-358-5995Fax: 512-895-1489
Date Prepared:	February 27, 2014

Device Name

Proprietary Name:	TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch
Regulation Name:	Electrosurgical cutting and coagulation device and accessories
Regulatory Class:	I I
Product Code:	GEI
Regulation Number:	21 CFR 878.4400

Predicate Device

TOPAZ® Microdebrider Coblation® Wand with Integrated Finger Switch included in: ArthroCare Topaz Wand, K080282 (cleared February 15, 2008)

Description

{1}------------------------------------------------

.. ......... Intended Use/Indications for Use

Procedure	Body Structure as Described Below
Fasciotomy	Foot
Synovectomy	Foot
Tendonotomy	Knee, Wrist, Elbow, Ankle, Shoulder, Foot
Rotator Cuff Tendonotomy	Shoulder
Capsulotomy	Foot

Summary of Technological Characteristics

This Special 510(k) proposes modifications to the materials, dimensional specifications, and performance specifications of the ArthroCare Topaz Wand cleared under K080282. The indications for use, fundamental scientific technology, principle of operation, and sterilization methodology remain the same as in the previously cleared 510(k).

The following table summarizes the technological differences between the subject and predicate devices and describes the rationale for the change.

Parameter	Predicate Device:Topaz Wand(K080282)	Subject Device:TOPAZ EZ IFSWand	Rationale for Change
Spacer Material	Thermal-Set SiliconeElastomer (Silicone)	Alumina	Facilitates consistency inmanufacturability
Shaft Length	2.91 inches (74mm)	1.57 inches (40mm)	Length shortened based on userfeedback (decreases theworking distance between theuser and the surgical site)
External ShaftInsulationMaterial	Nylon	Polyester	Material now used to insulatethe shaft as opposed to alsoserving as the saline sheath
Saline Delivery(irrigantcontactingmaterial)	Nylon and stainlesssteel	Pebax and stainlesssteel	Provides saline delivery close tothe tip of the wand and greatervisibility for the surgeon
Shaft OD	$0.032 \pm .005"$(.812± .13mm)	$0.042 \pm .005"$ (1.067±.13mm)	Increased stiffness of the shaft
Active ElectrodeInsulationMaterial	Polyimide	Pebax	Manufacturability
Shaft Y -Connector andBushing	Separate componentscomprised of PVC andpolycarbonate,respectively	Single integratedcomponentcomprised ofpolycarbonate	Cost savings and processimprovement. Adhesive wasincreased to prevent the shaftfrom sliding within Y-connector.
Active/ReturnElectrodeInsulator	N/A	Clear Pebax	Insulates electrodes; centerselectrode components duringmanufacturing
Internal	N/A	Nylon	Holds cured adhesive to

{2}------------------------------------------------

Parameter	Predicate Device:Topaz Wand(K080282)	Subject Device:TOPAZ EZ IFSWand	Rationale for Change
ReinforcementTubing			facilitate bonding of electrodesduring manufacturing
Labeling	Topaz IFS	Topaz EZ IFS	Proprietary name change.Instructions strengthened.

Summary of Non-Clinical Performance Data

Non-clinical performance testing verifies that the Topaz EZ IFS performs as intended and that no additional risks or hazards have been identified as a result of the changes described in this Special 510(k). As such, results from this testing support the determination that the Topaz EZ IFS is substantially equivalent to the predicate device. The following table lists the non-clinical testing performed and the results obtained in support of substantial equivalence.

Testing Type	Test Description	Result Supporting SubstantialEquivalence
Verification Testing	• Visual Inspection• Dimensional Inspection• Hi-Pot Testing• Electrical Impedance• Saline Flow Rate• Controller Ablation Set Points• Finger Switch Actuation Testing• Ablation Testing• Shaft Stiffness• Axial Compression Force Testing	Both the Topaz EZ IFS andpredicate device have substantiallyequivalent testing specificationsand both performed withinacceptance criteria. These resultssupport that the Topaz EZ IFS andpredicate device are substantiallyequivalent.
BiocompatibilityTesting	• Cytotoxicity• Sensitization• Maximization	The Topaz EZ IFS and thepredicate device are biocompatible.These results support that theTopaz EZ IFS and predicate deviceare substantially equivalent.
Electrical SafetyTesting	Testing in accordance with IEC60601-2-2:2009.	The Topaz EZ IFS and thepredicate met all acceptancecriteria in accordance with IEC60601-2-2: 2009. These resultssupport that the Topaz EZ IFS andpredicate device are substantiallyequivalent.

Clinical Data

No clinical data are included in this submission

Summary

The Topaz EZ IFS is substantially equivalent to the predicate Topaz Wand (K080282). Both the subject and predicate devices have the same indications for use and utilize the same fundamental scientific technology. All product performance testing demonstrates that the Topaz EZ IFS performs as intended and has acceptable mechanical properties when used in accordance with its labeling. The minor differences between the Topaz EZ IFS and the predicate device do not raise any new questions of safety or effectiveness.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2014

ArthroCare Coporation Mr. Mitchell A. Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

Re: K140521 Trade/Device Name: TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 13, 2014 Received: May 14, 2014

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 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

Image /page/3/Picture/10 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

{4}------------------------------------------------

Page 2 - Mr. Mitchell A. Dhority

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,

510(k) Number (if known)

K140521

Device Name

TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch

Indications for Use (Describe)

Body Structure Procedure Fasciotomy Foot Synovectomy Foot Knee, Wrist, Elbow, Ankle, Shoulder, Foot Tendonotomy Rotator Cuff Tendonotomy Shoulder Capsulotomy Foot

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CONSTITUTION CONTROLLER COLLECTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR MONDENT OF CONSULTION

Concurrence of Center for Davices and Radiological Health (CDRH) (Signalure)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

·DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Offica of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Regulation Number and Section

§ 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.