Paragon T2 Wand with Integrated Cable
Device Facts
| Record ID | K153675 |
|---|---|
| Device Name | Paragon T2 Wand with Integrated Cable |
| Applicant | ArthroCare Corporation |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jan 15, 2016 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Arthroscopic and Orthopedic Procedures Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) Ablation and Debridement • ACL/PCL Knee • Acromioplasty Shoulder • Articular Cartilage All Joints • Bursectomy All Joints • Chondroplasty All Joints • Facia All Joints • Ligament All Joints • Notchplasty Knee • Scar Tissue All Joints • Soft Tissue All Joints • Subacromial Decompression Shoulder • Synovectomy All Joints • Tendon All Joints Excision and Resection • Acetabular Labrum Hip • Articular Labrum All Joints • Capsule All Joints • Capsular Release Knee • Cartilage Flaps Knee • Cysts All Joints • Discoid Meniscus Knee • Frozen Shoulder Release Shoulder • Glenoidale Labrum Shoulder • Lateral Release Knee • Ligament All Joints • Loose Bodies All Joints • Meniscal Cystectomy Knee • Meniscectomy Knee • Plica Removal All Joints • Scar Tissue All Joints • Soft Tissue All Joints • Synovial Membrane All Joints • Tendon All Joints • Triangular Fibrocartilage (TFCC) Wrist • Villusectomy Knee Coagulation • ACL/PCL Knee • Articular Cartilage All Joints • Carpal Ligaments Wrist • Glenohumeral Capsule Shoulder • Ligament All Joints • Medial Retinaculum Knee • Rotator Cuff Shoulder • Tendon All Joints • Wrist Tendons Wrist
Device Story
Bipolar, single-use, sterile, high-frequency electrosurgical wand; used in arthroscopic/orthopedic procedures. Device connects to ArthroCare System 2000, Quantum, Quantum 2, or Atlas controllers. Delivers radiofrequency energy to active electrode at distal tip to ablate/resect soft tissue and coagulate blood vessels. Features bendable shaft and Temperature Indicating Marker (TIM) providing visual feedback when tip temperature reaches 43°C-57°C. Operated by surgeon via hand switch or foot control. Benefits include effective tissue ablation with minimal thermal effect on surrounding tissue.
Clinical Evidence
No clinical data included. Substantial equivalence supported by bench testing including visual inspection, TIM color change, ablation life testing (1X, 2X, 3X), coagulation testing, dielectric/HiPot testing, side load testing, temperature testing, accelerated aging, and biocompatibility (cytotoxicity, sensitization, irritation, toxicity, chemical analysis).
Technological Characteristics
Bipolar electrosurgical wand; single-use; sterile (irradiation SAL 10^-6). Components: active electrode, return electrode, temperature indicator epoxy, spacer, insulation, connector block, bent bead-blasted shaft, nylon tubing, handle with integrated cable. Operates in saline environment. Compatible with ArthroCare controllers. Electrical safety/EMC compliant with IEC 60601-2-2.
Indications for Use
Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures (ankle, elbow, hip, knee, shoulder, wrist).
Regulatory Classification
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.
Predicate Devices
- ArthroCare ArthroWands (K033584)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image is a black and white 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 an abstract symbol that resembles a stylized caduceus, with three intertwined strands and three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
ArthroCare Corporation Ms. Krystle Danuz Regulatory Affairs Specialist 7000 West William Cannon Drive Austin, Texas 78735
Re: K153675
Trade/Device Name: Paragon T2 Wand with Integrated Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 16, 2015 Received: December 21, 2015
Dear Ms. Danuz:
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 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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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Jennifer R. Stevenson -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
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# Indications for Use
510(k) Number (if known) K153675
Device Name Paragon T2 Wand with Integrated Cable
Indications for Use (Describe) Please see attached.
Type of Use (Select one or both, as applicable)
> 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.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Image /page/3/Picture/0 description: The image contains the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved lines, arranged in a way that suggests movement or flow. The word "ArthroCare" is written in a clear, sans-serif font, with the "A" in "ArthroCare" being slightly larger than the other letters.
# Indications for Use
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow,<br>hip, knee, shoulder, and wrist) |
|----------------------------------------|--------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Facia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
| • Meniscectomy | Knee |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |
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Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that come together to form a circle.
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Image /page/5/Picture/0 description: The image contains the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved lines in a maroon color. To the right of the circular design is the word "ArthroCare" in a gray, sans-serif font. The word is slightly italicized, giving it a sense of movement.
# 510(k) Summary
ArthroCare Corporation Paragon T2 Wand with Integrated Cable
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<br>Austin, TX 78735 |
| Contact Person: | Ms. Krystle Danuz, B.A., B.S.<br>Regulatory Affairs Specialist<br>Phone: 512-385-5769<br>Fax: 512-895-1489 |
| Date Prepared: | December 16, 2015 |
| Device Name | |
| Proprietary Name: | Paragon T2 Wand with Integrated Cable |
| Common Name: | Electrosurgical devices and accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Device Class: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
| Predicate Device | |
ArthroCare ArthroWands (Paragon T2 Wand with Integrated Cable)
K033584 (November 28, 2003)
#### Description
The ArthroCare ArthroWands are bipolar, single use, sterile, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
The Paragon T2 Wand with Integrated Cable is a part of the family of ArthroCare ArthroWands and is specifically indicated for resection, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures of the knee.
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Consistent with the predicate device, the Paragon T2 Wand with Integrated Cable is compatible with the System 2000, Quantum, Quantum 2, or Atlas System Controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. The Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired.
The wand consists of an active electrode, temperature indicator epoxy, a return electrode, a spacer, insulation, a connector block, a bent bead blasted shaft, nylon tubing, and a handle that connects via an integrated cable to the controller. The cable consists of wires that communicate with the active and return electrodes as well as the controller.
The Paragon T2 Wand with Integrated Cable is a Coblation wand designed to effectively ablate articular cartilage with minimal thermal effect on surrounding tissue. This Wand incorporates a Temperature Indicating Marker (TIM) as a visual indicator to the user that the temperature around the tip has reached 43°C-57°C degrees.
#### Intended Use/Indications For Use
The ArthroCare ArthroWands are indicated for resection, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints<br>(ankle, elbow, hip, knee,<br>shoulder, and wrist) |
|----------------------------------------|-----------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Facia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
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| | Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints<br>(ankle, elbow, hip, knee,<br>shoulder, and wrist) |
|--------------------|----------------------------------------|-----------------------------------------------------------------------------------|
| ● | Ligament | All Joints |
| ● | Loose Bodies | All Joints |
| ● | Meniscal Cystectomy | Knee |
| ● | Meniscectomy | Knee |
| ● | Plica Removal | All Joints |
| ● | Scar Tissue | All Joints |
| ● | Soft Tissue | All Joints |
| ● | Synovial Membrane | All Joints |
| ● | Tendon | All Joints |
| ● | Triangular Fibrocartilage (TFCC) | Wrist |
| ● | Villusectomy | Knee |
| <b>Coagulation</b> | | |
| ● | ACL/PCL | Knee |
| ● | Articular Cartilage | All Joints |
| ● | Carpal Ligaments | Wrist |
| ● | Glenohumeral Capsule | Shoulder |
| ● | Ligament | All Joints |
| ● | Medial Retinaculum | Knee |
| ● | Rotator Cuff | Shoulder |
| ● | Tendon | All Joints |
| ● | Wrist Tendons | Wrist |
### Summary of Technological Characteristics
No changes or modifications have been made to the indications for use, technology, or principle of operation previously cleared in 510(k) K033584. The following table represents a summary of the technological characteristics of the modified device.
| | PREDICATE DEVICE:<br>ArthroCare ArthroWands<br>(K033584) | MODIFIED DEVICE:<br>Paragon T2 Wand with Integrated<br>Cable |
|-----------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------|
| Electrical<br>Safety/EMC | IEC 60601-2-2 compliant | Same as predicate |
| Electrode<br>Configurations | Straight, Screen, Loop, Sheet,<br>"Multi-Electrodes in Series",<br>Tube | Loop |
| Spacer Configurations | Multi-Lumen, Single Lumen (Tube) | Single Lumen |
| Rigid Construction | Yes | Same as predicate |
| Single use disposable | Yes | Same as predicate |
| Operates in saline<br>environment | Yes | Same as predicate |
| Bipolar/monopolar | Bipolar | Same as predicate |
| Activation | Foot Control, Hand Switch or<br>Wand with Integrated Finger<br>Switch | Hand Switch or Foot Control |
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| Coagulation Voltage<br>Setting | Non-adjustable (1 set point)<br>Adjustable (3 set points),<br>2 Active Set Points | Adjustable (3 set points) |
|----------------------------------|-----------------------------------------------------------------------------------|---------------------------|
| Temperature<br>Indicating Marker | Yes | Yes |
| Bendable Shaft<br>Feature | No | Yes |
| Patient Usage | Single Use | Same as predicate |
| Sterilization | Irradiation to SAL of 10-6 | Same as predicate |
# Clinical Data
No clinical data are included in this submission.
# Performance Data
Performance bench testing, including functional testing, ablation life, and biocompatibility testing were performed on the proposed Paragon T2 Wand with Integrated Cable, which demonstrated the modified temperature sensitive dye met the required specifications.
| Testing Type | Test Description | Result Supporting Substantial<br>Equivalence |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Verification<br>Testing | ■ Visual Inspection<br>■ TIM Color Change (Pre-Ablation and<br>Post-1X Life Ablation)<br>■ Ablation 1X Life / 1st Insertion Testing<br>■ Ablation 2X Life Testing<br>■ Ablation 3X Life Testing at Maximum<br>Set Point<br>■ Coagulation Testing<br>■ Dielectric Withstand / HiPot Testing<br>■ Side Load Testing<br>■ Ablation Testing<br>■ Temperature Testing<br>■ Accelerated Aging | Both the Paragon T2 Wand with<br>Integrated Cable and predicate<br>device have substantially<br>equivalent testing specifications<br>and both performed within<br>acceptance criteria. These results<br>support that the Paragon T2 Wand<br>with Integrated Cable and<br>predicate device are substantially<br>equivalent. |
| Biocompatibility<br>Testing | ■ Cytotoxicity<br>■ Sensitization<br>■ Irritation<br>■ Toxicity<br>■ Chemical Analysis | The Paragon T2 Wand with<br>Integrated Cable and the predicate<br>device are biocompatible. These<br>results support that the Paragon T2<br>Wand with Integrated Cable and<br>predicate device are substantially<br>equivalent. |
# Conclusion
All testing demonstrates that the Paragon T2 Wand with Integrated Cable performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
As the intended use, operating principle, materials and technological characteristics are unchanged from the predicate device, the Paragon T2 Wands with Integrated Cable are substantially equivalent. The modifications do not affect the safety or efficacy of the devices.
