(98 days)
Not Found
No
The device description and performance studies focus on the electrosurgical function and physical characteristics, with no mention of AI or ML.
Yes
The device is indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical tool for debridement, resection, ablation, and coagulation of soft tissue, indicating its therapeutic function in surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines a physical medical device with hardware components (electrode tip, shaft, handle, switch, tubing, cable) and connects to a radiofrequency controller. It is not solely software.
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 "debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures." These are surgical procedures performed directly on the patient's body.
- Device Description: The description details a surgical tool (a bipolar electrosurgical device) used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgical procedures.
N/A
Intended Use / Indications for Use
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 |
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, Knee, Wrist, Elbow, Ankle, Shoulder
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)
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.
Testing Type: Verification Testing
Test Description:
• 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
Result Supporting Substantial Equivalence: Both the Topaz EZ IFS and predicate device have substantially equivalent testing specifications and both performed within acceptance criteria. These results support that the Topaz EZ IFS and predicate device are substantially equivalent.
Testing Type: Biocompatibility Testing
Test Description:
• Cytotoxicity
• Sensitization
• Maximization
Result Supporting Substantial Equivalence: The Topaz EZ IFS and the predicate device are biocompatible. These results support that the Topaz EZ IFS and predicate device are substantially equivalent.
Testing Type: Electrical Safety Testing
Test Description: Testing in accordance with IEC 60601-2-2:2009.
Result Supporting Substantial Equivalence: The Topaz EZ IFS and the predicate met all acceptance criteria in accordance with IEC 60601-2-2: 2009. These results support that the Topaz EZ IFS and predicate device are substantially equivalent.
No clinical data are included in this submission.
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
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 Drive |
| Austin, TX 78735 | |
| Contact Person: | Mitchell A. Dhority |
| Vice President, Regulatory Affairs | |
| Phone: 512-358-5995 | |
| Fax: 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
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.
1
.. ......... Intended Use/Indications for Use
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 |
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 IFS
Wand | Rationale for Change |
|---------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Spacer Material | Thermal-Set Silicone
Elastomer (Silicone) | Alumina | Facilitates consistency in
manufacturability |
| Shaft Length | 2.91 inches (74mm) | 1.57 inches (40mm) | Length shortened based on user
feedback (decreases the
working distance between the
user and the surgical site) |
| External Shaft
Insulation
Material | Nylon | Polyester | Material now used to insulate
the shaft as opposed to also
serving as the saline sheath |
| Saline Delivery
(irrigant
contacting
material) | Nylon and stainless
steel | Pebax and stainless
steel | Provides saline delivery close to
the tip of the wand and greater
visibility for the surgeon |
| Shaft OD | $0.032 \pm .005"$
(.812± .13mm) | $0.042 \pm .005"$ (1.067
±.13mm) | Increased stiffness of the shaft |
| Active Electrode
Insulation
Material | Polyimide | Pebax | Manufacturability |
| Shaft Y -
Connector and
Bushing | Separate components
comprised of PVC and
polycarbonate,
respectively | Single integrated
component
comprised of
polycarbonate | Cost savings and process
improvement. Adhesive was
increased to prevent the shaft
from sliding within Y-
connector. |
| Active/Return
Electrode
Insulator | N/A | Clear Pebax | Insulates electrodes; centers
electrode components during
manufacturing |
| Internal | N/A | Nylon | Holds cured adhesive to |
2
| Parameter | Predicate Device:
Topaz Wand
(K080282) | Subject Device:
TOPAZ EZ IFS
Wand | Rationale for Change |
|-------------------------|----------------------------------------------|-----------------------------------------|----------------------------------------------------------|
| Reinforcement
Tubing | | | facilitate bonding of electrodes
during 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 Substantial
Equivalence |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 and
predicate device have substantially
equivalent testing specifications
and both performed within
acceptance criteria. These results
support that the Topaz EZ IFS and
predicate device are substantially
equivalent. |
| Biocompatibility
Testing | • Cytotoxicity
• Sensitization
• Maximization | The Topaz EZ IFS and the
predicate device are biocompatible.
These results support that the
Topaz EZ IFS and predicate device
are substantially equivalent. |
| Electrical Safety
Testing | Testing in accordance with IEC
60601-2-2:2009. | The Topaz EZ IFS and the
predicate met all acceptance
criteria in accordance with IEC
60601-2-2: 2009. These results
support that the Topaz EZ IFS and
predicate device are substantially
equivalent. |
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)
Device Name
TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch
T
Indications for Use (Describe)
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 procedures:
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)