Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
Device Facts
| Record ID | K210423 |
|---|---|
| Device Name | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand |
| Applicant | ArthroCare Corporation |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jun 24, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The FASTSEAL 6.0 Wand, used with the WEREWOLF™ + COBLATION System, is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures.
Device Story
The WEREWOLF+ COBLATION System is a bipolar radiofrequency (RF) electrosurgical system consisting of a controller unit, a reusable foot control, and a sterile, single-use FASTSEAL 6.0 Hemostasis Wand. The system uses bipolar RF energy delivered through the wand tip in conjunction with saline irrigation to achieve hemostasis of soft tissue and bone. The controller features an integrated fluid module (FLOW-IQ Pump) and a graphical user interface for adjusting energy levels and saline flow. The device is used in orthopedic procedures by surgeons. The system transforms electrical energy into RF output, which is applied to the target tissue to coagulate blood vessels. The healthcare provider monitors the procedure via the controller interface and foot pedal activation. The device benefits patients by providing effective hemostasis during orthopedic surgery.
Clinical Evidence
No clinical data included. Evidence provided via non-clinical bench testing (ex vivo) using bovine myocardium, porcine skeletal muscle, and porcine bone models. Testing compared peak tip temperatures and thermal damage profiles between the subject and predicate devices under various flow rates and clinical misuse scenarios (e.g., no auxiliary suction). Results confirmed comparable thermal effects and performance.
Technological Characteristics
Bipolar RF electrosurgical system. Wand: Polyolefin heat shrink insulation, dual stainless steel alloy shafts, HV-10 heat cure epoxy tip sealing. Controller: Integrated fluid module (peristaltic pump), GUI interface. Energy: 350kHz RF, square waveform. Connectivity: Wired/wireless foot control. Sterilization: Ethylene Oxide (EtO). Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 10993-1.
Indications for Use
Indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. Intended for use by qualified medical personnel.
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
- Aquamantys Pump Generator System and Aquamantys 6.0 Bipolar Sealer (K052859)
Reference Devices
- WEREWOLF Controller (K143235)
- WEREWOLF Controller (K162074)
- WEREWOLF Controller (K192027)
- WEREWOLF Controller (K202006)
- Foot Control (K053510)
- Smith and Nephew INTELLIO Tablet Application (K192876)
- FASTSEAL 6.0 Wand software (K183346)
Related Devices
- K183346 — FLOW 90 Wand · ArthroCare Corporation · Jan 24, 2019
- K162074 — Werewolf RF20000 Controller, FLOW 50 Wand · ArthroCare Corporation · Aug 22, 2016
- K192027 — WEREWOLF COBLATION System, COBLATION HALO Wand · ArthroCare Corporation · Dec 20, 2019
- K092149 — BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 · Bovie Medical · Mar 18, 2010
- K143235 — RF20000a Controller, FLOW 50 Wand · ArthroCare Corporation · Oct 23, 2015
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2021
ArthroCare Corporation Piedad Pena Senior Regulatory Affairs Specialist 7000 West William Cannon Drive Building One Austin, Texas 78735
Re: K210423
Trade/Device Name: Werewolf+ Coblation System, Werewolf+Controller, Werewolf Fastseal 6.0 Hemostasis Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 19, 2021 Received: May 21, 2021
Dear Piedad Pena:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K210423
Device Name WEREWOLF™ + COBLATION™ SYSTEM WEREWOLF™ + CONTROLLER WEREWOLF™ FASTSEAL 6.0 Hemostasis Wand
Indications for Use (Describe) WEREWOLF™ FASTSEAL 6.0 Hemostasis Wand:
The FASTSEAL 6.0 Wand, used with the WEREWOLF™ + COBLATION System, is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures.
WEREWOLF™ + COBLATION™ SYSTEM - See Page 2
Type of Use (Select one or both, as applicable)
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a red, stylized globe-like shape on the left and the word "ArthroCare" in a dark gray sans-serif font on the right. The "®" symbol is located at the upper right of the word "ArthroCare".
The WEREWOLF"+ COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic, orthopedic and otorhinolaryngology [ENT] procedures:
| | Ablation/Debridement | Excision/Resection |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| All Joints<br>(Hip, Knee, Shoulder,<br>Wrist, Ankle, Elbow) | • Articular Cartilage<br>• Bursectomy<br>• Chondroplasty<br>• Fascia<br>• Ligament | • Articular Labrum<br>• Capsule<br>• Cysts<br>• Ligament<br>• Loose Bodies • Plica Removal<br>• Scar Tissue<br>• Soft Tissue<br>• Synovial Membrane<br>• Tendon |
| Hip | | • Acetabular Labrum |
| Knee | • ACL/PCL<br>• Notchplasty | • Capsular Release<br>• Cartilage Flaps<br>• Discoid Meniscus<br>• Lateral Release • Meniscal Cystectomy<br>• Meniscectomy<br>• Villusectomy |
| Shoulder | • Acromioplasty<br>• Subacromial Decompression | • Frozen Shoulder Release<br>• Glenoid Labrum |
| Wrist | | • Triangular Fibrocartilage (TFCC) |
| ENT | Resection/Ablation/Coagulation | |
| | • Tonsillectomy (including Palatine Tonsils) Tracheal<br>• Adenoidectomy<br>• Uvulopalatopharyngoplasty (UPPP)<br>• Traditional Uvulopalatoplasty Control (RAUP)<br>• Nasal Airway Obstruction<br>• Submucosal Palatal Shrinkage<br>• Submucosal Tissue Shrinkage<br>• Nasal Airway Obstruction by reduction of Hypertrophic Nasal Turbinates<br>• Reduction of Turbinates for the treatment of Nasal Airway Obstruction | • Nasopharyngeal/Laryngeal indications including Tracheal Procedures<br>• Mastoidectomy<br>• Myringotomy with Effective Hemorrhage<br>• Papilloma<br>• Keloids<br>• Nasopharyngeal/Laryngeal Procedures<br>• Polypectomy<br>• Laryngeal Polypectomy<br>• Laryngeal Lesion Debulking<br>• Cysts<br>• Tumors<br>• Neck Mass<br>• Head, Neck, Oral, and Sinus Surgery<br>• Tissue in the Uvula/Soft Palate for the treatment of Snoring |
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Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized 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 converge to form a sphere-like shape. The word "ArthroCare" is written in a sans-serif font, with a registered trademark symbol next to the word "Care".
K210423
# Section 7 - 510(k) Summary
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 7.1
| | Submitter Name | ArthroCare Corporation | | | | | |
|-----|---------------------|---------------------------------------------------------------------------------|--|--|--|--|--|
| | Address | 7000 West William Cannon Drive | | | | | |
| | | Austin, TX 78735 | | | | | |
| | Contact Person | Shruthi Bhat | | | | | |
| | | Senior Regulatory Affairs Specialist | | | | | |
| | | Phone: 512-466-9296 | | | | | |
| | | Email: shruthi.bhat@smith-nephew.com | | | | | |
| | Date Prepared | June 24, 2021 | | | | | |
| 7.2 | DEVICE NAME(S) | | | | | | |
| | Proprietary Name | WEREWOLF® + COBLATION® SYSTEM | | | | | |
| | | WEREWOLF® + Controller | | | | | |
| | | WEREWOLF® FASTSEAL 6.0 Hemostasis Wand | | | | | |
| | 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 | | | | | |
| 7.3 | PREDICATE DEVICE(S) | Aquamantys Pump Generator System and Aquamantys 6.0<br>Bipolar Sealer – K052859 | | | | | |
7000 W.William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
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Image /page/5/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized red circular design on the left, resembling multiple curved lines converging. To the right of the design is the company name "ArthroCare" in a dark gray, sans-serif font, with the registered trademark symbol next to it.
7.4 PRESUBMISSION
- Q192412, Arthroplasty Coagulation Wand (SMC153) approved on March 23, 2020
#### SUBJECT DEVICES 7.5
The subject devices include the WEREWOLF ° + (RF20000) COBLATION System, which includes the WEREWOLF®+Controller and the WEREWOLF® FASTSEAL 6.0 Hemostasis Wand.
The purpose of this traditional 510(k) submission is to obtain clearance for the subject devices; WEREWOLF° + COBLATION System, WEREWOLF° + Controller and WEREWOLF° FASTSEAL 6.0 Hemostasis Wand for additional indications of use i.e hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures.
## 7.5.1 WEREWOLF° + (RF20000) COBLATION* System
The subject WEREWOLF + COBLATION System (System) is an iteration of the WEREWOLF Controllers previously cleared via 510(k)s K143235, K162074, K 192027 and K202006 which utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic (cleared via K143235 and K162074), and otorhinolaryngology (ENT) procedures (K192027 and K202006).
The subject WEREWOLF + COBLATION System consists of:
- A bipolar, radiofrequency (RF) generator (WEREWOLF + Controller, subject . Controller) with Integrated Fluid Module (FLOW~IQ Pump), and Operational Interface Screen,
- Re-usable, non-sterile Foot Control (wired or wireless) .
- . Sterile, disposable, single-use COBLATION Wand(s)/FASTSEAL 6.0 Hemostasis Wand (subject Wand)
- Reusable, non-sterile power cord.
The components are designed to be operated as a single unit and are for prescription use only.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
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Image /page/6/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved, parallel lines in a dark red color, arranged to suggest a sphere or globe. The text "ArthroCare" is written in a dark gray, sans-serif font, with a registered trademark symbol next to the word "Care".
The WEREWOLF+ COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, orthopedic, and otorhinolaryngology (ENT) procedures.
### 7.5.2 WEREWOLF® + Controller
The WEREWOLF + Controller is designed to deliver radiofrequency energy to the electrodes of the compatible Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels (setpoints), volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel.
Accessories to the subject Controller include a Foot Control (wired/ wireless) (K053510, K143235 and K162074) and Smith and Nephew INTELLIO Tablet Application (K192876) (optional accessory which is not subject of this 510(k) submission) for the indications cleared via K162074 (resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic and orthopedic indications). Otorhinolaryngology (ENT) indications (K192027 and K202006) and hemostasis (via) coagulation of soft tissue and bone in orthopedic procedures (proposed indications) are not supported on the INTELLIO Tablet Application.
### 7.5.3 WEREWOLF® FASTSEAL 6.0 Hemostasis Wand
The subject WEREWOLF FASTSEAL 6.0 Hemostasis Wand is a bipolar, RF electrosurgical device used for specific indications in orthopedic surgeries. The Wand is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. It is intended for procedures using normal saline (0.9% NaCl) as the irrigation fluid for the Wand.
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Image /page/7/Picture/1 description: The image shows the ArthroCare logo. The logo consists of a stylized graphic on the left and the word "ArthroCare" on the right. The graphic is a circular shape made up of several curved red lines. The word "ArthroCare" is written in a dark gray, sans-serif font, with a registered trademark symbol next to it.
#### 7.6 PROPOSED INTENDED USE/INDICATIONS FOR USE
# 7.6.1 WEREWOLF° + Controller
The WEREWOLF + COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic, orthopedic and otorhinolaryngology (ENT) procedures:
| | Ablation/Debridement | Excision/Resection | | | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------|
| All Joints<br>(Hip, Knee,<br>Shoulder, Wrist,<br>Ankle, Elbow) | Articular Cartilage Bursectomy Chondroplasty Fascia Ligament | Scar Tissue Soft Tissue Synovectomy Tendon | Articular Labrum Capsule Cysts Ligament Loose Bodies Acetabular Labrum | Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon | |
| Hip | | | | | |
| Knee | ACL/PCL Notchplasty | | Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release | | Meniscal Cystectomy Meniscectomy Villusectomy |
| Shoulder | Acromioplasty Subacromial Decompression | | Frozen Shoulder Release Glenoid Labrum | | |
| Wrist | | | Triangular Fibrocartilage (TFCC) | | |
| ENT | Resection/Ablation/Coagulation | | | | |
| | Tonsillectomy (including Palatine Tonsils) Tracheal Adenoidectomy Uvulopalatopharyngoplasty (UPPP) Traditional Uvulopalatoplasty Control (RAUP) Nasal Airway Obstruction Submucosal Palatal Shrinkage Submucosal Tissue Shrinkage | Nasopharyngeal/Laryngeal indications including Tracheal Procedures Mastoidectomy Myringotomy with Effective Hemorrhage Papilloma Keloids Nasopharyngeal/Laryngeal Procedures Polypectomy | | | |
7000 W.William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
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K210423
Image /page/8/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic on the left and the word "ArthroCare" on the right. The graphic is composed of several curved, parallel lines in a red color, arranged in a circular or spherical shape. The word "ArthroCare" is written in a dark gray, sans-serif font, with the "®" symbol next to the word.
| | Nasal Airway Obstruction by reduction of Hypertrophic Nasal Turbinates Reduction of Turbinates for the treatment of Nasal Airway Obstruction | Laryngeal Lesion Debulking Cysts Tumors Neck Mass Head, Neck, Oral, and Sinus Surgery Tissue in the Uvula/Soft Palate for the treatment of Snoring |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Orthopedic | Hemostasis (via coagulation) of soft tissue and bone. | |
## 7.6.2 WEREWOLF® FASTSEAL 6.0 Hemostasis Wand
The FASTSEAL 6.0 Wand, used with the WEREWOLF + COBLATION System, is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures.
### 7.7 COMPARISON OF SUBJECT and PREDICATE DEVICES WEREWOLF + Controller:
Both the subject and the predicate devices are designed for bipolar electrosurgical wand device operation and share the same intended use, principle of operation and fundamental scientific technology.
The technological differences include different input power/ voltage, operating frequency, controller waveform and output nominal voltage maximum.
## FASTSEAL 6.0 Hemostasis Wand:
Both the subject and the predicate devices are bipolar electrosurgical wands and share the same intended use, principle of operation and fundamental scientific technology.
The technological differences include software in the subject Wand, different shaft materials, tip-sealing materials, number of electrode saline ports, saline port orientation, saline flow rate, activation options and using smaller subset of Coag setpoints for orthopedic use, similar power and output voltage, and reduced current limit.
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Image /page/9/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a circular graphic on the left and the word "ArthroCare" on the right. The circular graphic is made up of several curved lines in a dark red color. The word "ArthroCare" is written in a dark gray color.
| | | | Table 7.1 Comparison of the technological characteristics of subject and predicate devices | | | |
|--|--|--|--------------------------------------------------------------------------------------------|--|--|--|
| | | | | | | |
| Parameter | PREDICATE DEVICE:<br>Aquamantys® 6.0 Bipolar Sealer<br>(K052859) with Aquamantys<br>Pump Generator (K052859) | SUBJECT DEVICE:<br>WEREWOLF FASTSEAL® 6.0<br>Wand with WEREWOLF® +<br>Controller |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Representation | Image: Aquamantys® 6.0 Bipolar Sealer<br><br>Aquamantys® 6.0 Bipolar Sealer | Image: FASTSEAL 6.0 Hemostasis Wand<br><br>FASTSEAL 6.0 Hemostasis<br>Wand |
| | Image: Aquamantys Pump Generator<br><br>Aquamantys Pump Generator | Image: WEREWOLF® + Controller<br><br>WEREWOLF® + Controller |
| Indications of Use<br>for the controllers | The Aquamantys™ Pump<br>Generator is an electrosurgical<br>generator with a rotary peristaltic<br>pump, which is for use only with<br>Aquamantys single-use<br>disposable bipolar devices for<br>concurrent delivery of<br>radiofrequency energy with saline<br>for hemostatic sealing of soft<br>tissue and bone at the operative<br>site. It is intended for, but not<br>limited to, endoscopic and open<br>abdominal, orthopedic, spine and<br>thoracic surgery. The device is<br>not intended for contraceptive<br>tubal coagulation (permanent<br>female sterilization). The<br>Aquamantys System is for use<br>only by qualified medical<br>personnel properly trained in the<br>use of electrosurgical equipment,<br>technology and techniques. | The WEREWOLF®+<br>COBLATION System controller<br>is indicated for the resection,<br>ablation, and coagulation of soft<br>tissues and hemostasis of blood<br>vessels in arthroscopic,<br>orthopedic and<br>otorhinolaryngology (ENT)<br>procedures. |
| Indications of Use<br>for the wands | The Aquamantys™ Bipolar<br>Sealer is a sterile, single-use<br>bipolar electrosurgical device<br>intended to be used in<br>conjunction with a qualified<br>Pump Generator for delivery of<br>RF energy and saline for<br>hemostatic sealing and<br>coagulation of soft tissue and<br>bone at the operative site. It is<br>intended for, but not limited to<br>orthopedic, spine, thoracic, and<br>open abdominal surgery. The<br>device is not intended for<br>contraceptive tubal coagulation<br>(permanent female sterilization). | The FASTSEAL 6.0 Wand, used<br>with the WEREWOLF® +<br>COBLATION System, is<br>indicated for hemostasis (via<br>coagulation) of soft tissue and<br>bone in orthopedic procedures |
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| Functionality | Coagulation | Same |
| Input Power /<br>Voltage | 90-110V ~ 4A<br>104-127V ~ 3.5A<br>207-253V ~ 1.85A | 100-120V ~ 8A<br>220-240V ~ 4A |
| Input Frequency | 50/60 Hz | Same |
| Fuse Rating | 5 Amps @ 100 VAC<br>4 Amps @ 115 VAC<br>2 Amps @ 230 VAC | N/A<br>(16 Amp fuse built into power<br>supply and not replaceable;<br>power supply has overcurrent<br>protection) |
| Operating<br>(Output)<br>Frequency | 370kHz | 350kHz |
| Controller<br>Waveform | Sinusoid | Square |
| Saline Inflow<br>(Fluid Pump<br>Mechanism) | Peristaltic | Same |
| Saline Outflow | None, requires auxiliary suction<br>device | Same |
| Foot Pedal<br>Capability | No | Yes (wired/wireless) |
| Coagulation<br>Activation<br>Indication | Audio and visual | Same |
| Setting<br>Adjustment<br>Interface | Control panel with physical<br>buttons (analog) | Graphical User Interface (GUI)<br>with digital buttons |
| Control Panel or<br>GUI Options | Adjust Coag level, saline flow rate,<br>priming | Same |
| Wand Distal Tip<br>Configuration | Image: Wand Distal Tip Configuration | Image: Wand Distal Tip Configuration |
| Monopolar /<br>Bipolar | Bipolar | Same |
| Activation Limit | None | 15 minutes |
| Bipolar<br>Coagulation<br>Level Range and<br>Scale | 20-100 (increments of 5)<br>100-200 (increments of 10) | 110-200 (increments of 10) |
| Maximum Output<br>Power | 200W | 195W |
| Wand Output<br>Nominal Voltage<br>Maximum | 150Vrms | 130Vrms |
| Handle Length | 6 inches | Same |
| Shaft Materials<br>(Wand Patient-<br>Contacting<br>Materials) | Molded ABS plastic | Polyolefin heat shrink insulation<br>over dual stainless steel alloy<br>shafts |
| Shaft Working<br>Length | 5 inches | Same |
| Distal Shaft Bend<br>Angle (Relative to<br>Rest of Shaft<br>Length) | 30° | Same |
| Rigid Construction | Yes | Same |
| Electrode Material<br>(Wand Patient-<br>Contacting<br>Materials) | Stainless Steel Alloy | Same…
