(133 days)
No
The summary describes a bipolar radiofrequency electrosurgical system for tissue resection, ablation, coagulation, and hemostasis. It mentions incorporated software for controlling energy delivery and a graphical user interface, but there is no mention of AI, ML, or any capabilities that would suggest the use of such technologies for tasks like image processing, data analysis for decision making, or adaptive control based on learned patterns. The performance studies focus on comparing the device's thermal effects and coagulation capabilities to a predicate device, not on evaluating any AI/ML performance metrics.
Yes
The device is indicated for various medical procedures, including resection, ablation, coagulation of tissues, and hemostasis of blood vessels in orthopedic and otorhinolaryngology procedures, which are therapeutic interventions.
No.
Explanation: The device is indicated for resection, ablation, coagulation of tissues, and hemostasis of blood vessels, which are therapeutic medical procedures, not diagnostic ones.
No
The device description clearly states that the system includes hardware components such as a bipolar, radiofrequency (RF) generator (Controller), a Foot Control, and a sterile, disposable, single-use COBLATION Wand/FASTSEAL 6.0 Hemostasis Wand. While the Controller has integrated software, the device is not solely software.
Based on the provided information, the WEREWOLF™ FASTSEAL 6.0 Hemostasis Wand and the WEREWOLF™ + COBLATION System are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the devices are used for hemostasis (coagulation), resection, ablation, and coagulation of soft tissue and bone in orthopedic and ENT procedures. These are surgical procedures performed directly on the patient's body.
- Device Description: The description details a system that delivers radiofrequency energy to electrodes for tissue manipulation and hemostasis. This is a therapeutic device used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of patient specimens.
- Anatomical Site: The anatomical sites listed are parts of the human body where surgical procedures are performed.
- Intended User/Care Setting: The intended users are qualified medical personnel performing surgical procedures.
In summary, the WEREWOLF™ FASTSEAL 6.0 Hemostasis Wand and the WEREWOLF™ + COBLATION System are surgical devices used for therapeutic purposes directly on the patient, not for analyzing specimens outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
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
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:
- All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
- Ablation/Debridement: Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament
- Excision/Resection: Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon
- Hip
- Excision/Resection: Acetabular Labrum
- Knee
- Ablation/Debridement: ACL/PCL, Notchplasty
- Excision/Resection: Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy
- Shoulder
- Ablation/Debridement: Acromioplasty, Subacromial Decompression
- Excision/Resection: Frozen Shoulder Release, Glenoid Labrum
- Wrist
- Excision/Resection: 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, Nasal Airway Obstruction by reduction of Hypertrophic Nasal Turbinates, Reduction of Turbinates for the treatment of Nasal Airway Obstruction, Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Mastoidectomy, Myringotomy with Effective Hemorrhage, Papilloma, Keloids, Nasopharyngeal/Laryngeal Procedures, Polypectomy, Laryngeal Polypectomy, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The subject devices include the WEREWOLF ° + (RF20000) COBLATION System, which includes the WEREWOLF®+Controller and the WEREWOLF® FASTSEAL 6.0 Hemostasis Wand.
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, bone, All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow), Hip, Knee, Shoulder, Wrist, ENT.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.
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 assessed the design and performance of the subject devices to confirm they met the established design criteria and support the substantial equivalence with the predicate devices. It included verification testing of device performance and function which was successfully completed to ensure that the subject devices met the established design specifications. It evaluated the mechanical, electrical, and functional performance of the device and verified that the differences between the subject and predicate devices did not alter the risk profile, performance characteristics, or specifications of the device.
Evidence obtained from preclinical bench testing (ex vivo) on multiple tissue models (bovine myocardium, porcine skeletal muscle, and porcine bone) demonstrated that the subject device, FASTSEAL 6.0 Wand performs substantially equivalent to the predicate device, Aquamantys 6.0 Wand. in relevant aspects associated with the Coagulation mode.
Additional bench testing:
- Peak temperature testing at the distal electrodes included comparing the temperature of saline between the tip of the predicate and subject wands using a Neoptix fiber optic temperature probe and testing using a beef heart tissue model. The average peak tip temperature for the FASTSEAL 6.0 Wand was 97±4℃ compared to 98±4℃ for the Aquamantys 6.0 wand.
- Peak temperature testing in a misuse scenario involved comparing peak saline temperatures of the FASTSEAL 6.0 Wand and Aquamantys 6.0 wand in worst case clinical misuse conditions where no auxiliary suction is used. Testing was conducted using a Neoptix fiber optic temperature probe and beef heart tissue model. The average peak saline temperature in the saline pooling test for the subject Wand was 81±3°C for the subject Wand and 87±2°C for the predicate wand; the average peak saline temperature in the saline runoff test was 79±1℃ for the subject Wand and 83±2℃ for the predicate wand.
- Supplemental bench testing was conducted to assess and compare the potential differences between the FASTSEAL 6.0 Wand (subject device) and Aquamantys 6.0 wand (predicate device) across the range of flow rates in regards to the thermal damage of the surrounding tissue. Myocardium tissue was evaluated at minimum, default, and maximum flow rate settings at the maximum energy setting for both the subject and predicate device. The results from this study demonstrated that saline flow rate has minimal effect on the total thermal effect width or maximum thermal depth for either the subject or predicate devices regardless of the flow setting. These results, as well as the results of the performance testing above, confirm substantial equivalence between the subject and predicate devices.
No in vivo animal testing data are included in this submission.
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.
Aquamantys Pump Generator System and Aquamantys 6.0 Bipolar Sealer – K052859
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.
K143235, K162074, K192027, K202006, K053510, K192876, K183346
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.
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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.
1
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
2
Indications for Use
510(k) Number (if known)
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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 | ||
| (Hip, Knee, Shoulder, | ||
| Wrist, Ankle, Elbow) | • Articular Cartilage | |
| • Bursectomy | ||
| • Chondroplasty | ||
| • Fascia | ||
| • Ligament | • Articular Labrum | |
| • Capsule | ||
| • Cysts | ||
| • Ligament | ||
| • Loose Bodies • Plica Removal | ||
| • Scar Tissue | ||
| • Soft Tissue | ||
| • Synovial Membrane | ||
| • Tendon | ||
| Hip | • Acetabular Labrum | |
| 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 | ||
| • Nasal Airway Obstruction by reduction of Hypertrophic Nasal Turbinates | ||
| • Reduction of Turbinates for the treatment of Nasal Airway Obstruction | • Nasopharyngeal/Laryngeal indications including Tracheal Procedures | |
| • Mastoidectomy | ||
| • Myringotomy with Effective Hemorrhage | ||
| • Papilloma | ||
| • Keloids | ||
| • Nasopharyngeal/Laryngeal Procedures | ||
| • Polypectomy | ||
| • Laryngeal Polypectomy | ||
| • Laryngeal Lesion Debulking | ||
| • Cysts | ||
| • Tumors | ||
| • Neck Mass | ||
| • Head, Neck, Oral, and Sinus Surgery | ||
| • 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".
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 | |||||
| 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 | |||||
| (Hip, Knee, | |||||
| Shoulder, Wrist, | |||||
| 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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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:
Aquamantys® 6.0 Bipolar Sealer
(K052859) with Aquamantys
Pump Generator (K052859) | SUBJECT DEVICE:
WEREWOLF FASTSEAL® 6.0
Wand with WEREWOLF® +
Controller |
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| Representation | Image: Aquamantys® 6.0 Bipolar Sealer
Aquamantys® 6.0 Bipolar Sealer | Image: FASTSEAL 6.0 Hemostasis Wand
FASTSEAL 6.0 Hemostasis
Wand |
| | Image: Aquamantys Pump Generator
Aquamantys Pump Generator | Image: WEREWOLF® + Controller
WEREWOLF® + Controller |
| Indications of Use
for the controllers | The Aquamantys™ Pump
Generator is an electrosurgical
generator with a rotary peristaltic
pump, which is for use only with
Aquamantys single-use
disposable bipolar devices for
concurrent delivery of
radiofrequency energy with saline
for hemostatic sealing of soft
tissue and bone at the operative
site. It is intended for, but not
limited to, endoscopic and open
abdominal, orthopedic, spine and
thoracic surgery. The device is
not intended for contraceptive
tubal coagulation (permanent
female sterilization). The
Aquamantys System is for use
only by qualified medical
personnel properly trained in the
use of electrosurgical equipment,
technology and techniques. | The WEREWOLF®+
COBLATION System controller
is indicated for the resection,
ablation, and coagulation of soft
tissues and hemostasis of blood
vessels in arthroscopic,
orthopedic and
otorhinolaryngology (ENT)
procedures. |
| Indications of Use
for the wands | The Aquamantys™ Bipolar
Sealer is a sterile, single-use
bipolar electrosurgical device
intended to be used in
conjunction with a qualified
Pump Generator for delivery of
RF energy and saline for
hemostatic sealing and
coagulation of soft tissue and
bone at the operative site. It is
intended for, but not limited to
orthopedic, spine, thoracic, and
open abdominal surgery. The
device is not intended for
contraceptive tubal coagulation
(permanent female sterilization). | 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 |
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| Functionality | Coagulation | Same |
| Input Power /
Voltage | 90-110V ~ 4A
104-127V ~ 3.5A
207-253V ~ 1.85A | 100-120V ~ 8A
220-240V ~ 4A |
| Input Frequency | 50/60 Hz | Same |
| Fuse Rating | 5 Amps @ 100 VAC
4 Amps @ 115 VAC
2 Amps @ 230 VAC | N/A
(16 Amp fuse built into power
supply and not replaceable;
power supply has overcurrent
protection) |
| Operating
(Output)
Frequency | 370kHz | 350kHz |
| Controller
Waveform | Sinusoid | Square |
| Saline Inflow
(Fluid Pump
Mechanism) | Peristaltic | Same |
| Saline Outflow | None, requires auxiliary suction
device | Same |
| Foot Pedal
Capability | No | Yes (wired/wireless) |
| Coagulation
Activation
Indication | Audio and visual | Same |
| Setting
Adjustment
Interface | Control panel with physical
buttons (analog) | Graphical User Interface (GUI)
with digital buttons |
| Control Panel or
GUI Options | Adjust Coag level, saline flow rate,
priming | Same |
| Wand Distal Tip
Configuration | Image: Wand Distal Tip Configuration | Image: Wand Distal Tip Configuration |
| Monopolar /
Bipolar | Bipolar | Same |
| Activation Limit | None | 15 minutes |
| Bipolar
Coagulation
Level Range and
Scale | 20-100 (increments of 5)
100-200 (increments of 10) | 110-200 (increments of 10) |
| Maximum Output
Power | 200W | 195W |
| Wand Output
Nominal Voltage
Maximum | 150Vrms | 130Vrms |
| Handle Length | 6 inches | Same |
| Shaft Materials
(Wand Patient-
Contacting
Materials) | Molded ABS plastic | Polyolefin heat shrink insulation
over dual stainless steel alloy
shafts |
| Shaft Working
Length | 5 inches | Same |
| Distal Shaft Bend
Angle (Relative to
Rest of Shaft
Length) | 30° | Same |
| Rigid Construction | Yes | Same |
| Electrode Material
(Wand Patient-
Contacting
Materials) | Stainless Steel Alloy | Same |
| Tip Sealing
Material (Wand
Patient-Contacting
Materials) | Molded ABS plastic
(components welded together) | HV-10 heat cure epoxy |
| Electrode
Dimensions | Width – 0.14 inches
Length – 0.22 inches
Thickness – 0.14 inches | Width – Same
Length – 0.26 inches
Thickness – Same |
| Number of
Saline Ports | 2 | 4 |
| Saline Flow Rate
Range and Scale | 3 total levels: Low, Medium,
High(symbolized by 1-3 droplets
on front panel) | 5 total levels: 1-5(symbolized
by 1-5 droplets on GUI) |
| Saline Delivery
Method | Integrated saline delivery tubing,
enters treatment site through ports
on electrode | Same |
| Priming Options | Automatic (Timed) | Same |
| Saline Outflow | None, managed by external
suction device | Same |
| Activation
Options | Finger Switch | Finger Switch or Foot Pedal |
| Number of Wand
Finger Switches | 1
(Coag) | 2
(Coag and Max Coag) |
| Software in the
Wand | No | Yes |
| Biocompatible | Yes | Same |
| Sterilization | Ethylene Oxide | Same |
| Device Usage | Single use, disposable | Same |
| Prescription
(Rx)/Over the
Counter(OTC) | Prescription (Rx) | Same |
| Packaging | PETG tray and single Tyvek | PETG tray with PETG insert |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ۾/ഗ്ഗം 512.391.3901 | www.arthrocare.com
10
Image /page/10/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a series of red curved lines on the left side, resembling a stylized wave or abstract design. To the right of the design is the word "ArthroCare" in a gray, sans-serif font, with the registered trademark symbol (®) next to the word "Care".
11
Image /page/11/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved red lines that converge to form a spherical shape. The text "ArthroCare" is written in a dark gray sans-serif font, with a registered trademark symbol after the word "Care".
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ۾/ഗ്ഗം 512.391.3901 | www.arthrocare.com
12
Image /page/12/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved red lines. To the right of the design is the word "ArthroCare" in a gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
13
Image /page/13/Picture/1 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 converge at the center.
7.8 STERILIZATION
The FASTSEAL 6.0 Wand is sterilized utilizing 100% Ethylene Oxide (EtO or EO) gas via an existing validated EO Cycle. The evaluation and adoption are based on the principles outlined in AAMI TIR 28:2016. The sterilization method ensures a minimum sterility assurance level of 10-6.
7.9 SHELF LIFE
Shelf life testing included environmental conditioning, transit conditioning, accelerated aging studies at T=1 year, packaging integrity testing - visual inspection of seal, gross leak (bubble emission), dye penetration, peel strength testing, and delamination
PACKAGING 8.0
The FASTSEAL 6.0 Wand is supplied sterile and is intended for single use only. The Wand is not to be cleaned or re-sterilized for re-use. All packaging has been validated in accordance with ASTM D4332:2014, ASTM D4169:2016, ISO 11607-1:2019 and ISO 11607-2:2019.
The WEREWOLF + Controller is supplied non-sterile and is reusable; cleaning measures are provided in the manual. There were no changes to the Controller that required packaging testing to be repeated for this 510(k) submission.
BIOCOMPATIBILITY 8.1
FASTSEAL 6.0 Wand is classified as an externally communicating medical device with tissue/bone/dentin contact with limited duration (