(133 days)
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, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon), 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.
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+ 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.
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.
The provided document is a 510(k) premarket notification for the WEREWOLF+ Coblation System, WEREWOLF+Controller, and Werewolf FASTSEAL 6.0 Hemostasis Wand. It seeks to demonstrate substantial equivalence to a predicate device, the Aquamantys Pump Generator System and Aquamantys 6.0 Bipolar Sealer. The focus of the new submission is "hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against which the device performance is measured in a quantitative manner for clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The performance assessments are comparative to the predicate device.
However, based on the performance testing descriptions, we can infer some criteria and reported performance:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (WEREWOLF FASTSEAL 6.0 Wand) |
|---|---|
| Functional Equivalence (Coagulation mode) | Demonstrated substantial equivalence to Aquamantys 6.0 Wand in relevant aspects associated with the Coagulation mode in preclinical bench testing (ex vivo). |
| Peak Tip Temperature (Normal use) | Average peak tip temperature: 97±4℃ (Averaging 98±4℃ for the predicate, suggesting similar thermal characteristics). |
| Peak Saline Temperature (Misuse scenario - no auxiliary suction, pooling) | Average peak saline temperature: 81±3°C (Averaging 87±2°C for the predicate). |
| Peak Saline Temperature (Misuse scenario - no auxiliary suction, runoff) | Average peak saline temperature: 79±1℃ (Averaging 83±2℃ for the predicate). |
| Thermal Damage (Effect of saline flow rate on total thermal effect width/maximum thermal depth) | Minimal effect on total thermal effect width or maximum thermal depth across the range of flow rates, confirming substantial equivalence with the predicate. |
| Electrical Safety | Complies with IEC60601-1:2005+A1:2012, IEC60601-2-2:2017, IEC 60601-1-6: 2010 Ed.3+A1. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014. |
| Software Verification and Validation | Testing conducted in accordance with FDA guidance for "moderate" level of concern software. |
| Cybersecurity | Cyber Failure Modes and Effects Analysis (CMEA) confirms no known unacceptable cybersecurity hazards. |
| Sterilization Assurance Level | Minimum sterility assurance level of 10-6. |
| Biocompatibility | Met acceptance criteria for an externally communicating medical device with tissue/bone/dentin contact with limited duration (<24 h) per ISO 10993-1:2018. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions preclinical bench testing using "multiple tissue models (bovine myocardium, porcine skeletal muscle, and porcine bone)" for functional equivalence and "beef heart tissue model" for temperature testing. However, specific sample sizes for these preclinical tests are not provided.
The data provenance is from preclinical bench testing (ex vivo). There is no mention of country of origin for the data as it's not human subject data. The studies performed are experimental bench tests, not retrospective or prospective human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the studies are preclinical bench testing and do not involve human subject data or expert assessment of diagnostic outcomes. Ground truth in this context typically refers to the physical measurements and observations made during the bench tests, rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies are preclinical bench testing and do not involve human subject data or diagnostic interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical data are included in this submission." and "No in vivo animal testing data are included in this submission." This submission is focused on demonstrating substantial equivalence through non-clinical (bench) testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the sense of a diagnostic algorithm. However, the performance testing described for the device (e.g., peak temperature, thermal damage) assesses the device's inherent functional characteristics in a standalone manner through bench testing, rather than its performance in conjunction with human interpretation of an output. The device itself is an electrosurgical tool, where its "performance" is its ability to perform hemostasis, not to provide an interpretive output for a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the preclinical bench testing, the "ground truth" is derived from direct physical measurements and observations made during the experiments. For example:
- Temperature measurements (using Neoptix fiber optic temperature probe).
- Thermal damage assessment (e.g., total thermal effect width or maximum thermal depth in myocardium tissue).
- Functional performance (comparative coagulation efficacy, albeit not quantitatively defined in the provided text beyond "substantially equivalent").
8. The sample size for the training set
Not applicable. This submission describes a hardware device (electrosurgical system and wand) with integrated software, not a machine learning or AI algorithm that requires a distinct "training set" for predictive model development. The software verification and validation are for control and operational aspects, not for learning from data.
9. How the ground truth for the training set was established
Not applicable. As the device does not involve a machine learning "training set," the concept of establishing ground truth for it does not apply.
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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)
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 6.0Bipolar 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 AquamantysPump Generator (K052859) | SUBJECT DEVICE:WEREWOLF FASTSEAL® 6.0Wand with WEREWOLF® +Controller |
|---|---|---|
| Representation | Image: Aquamantys® 6.0 Bipolar SealerAquamantys® 6.0 Bipolar Sealer | Image: FASTSEAL 6.0 Hemostasis WandFASTSEAL 6.0 HemostasisWand |
| Image: Aquamantys Pump GeneratorAquamantys Pump Generator | Image: WEREWOLF® + ControllerWEREWOLF® + Controller | |
| Indications of Usefor the controllers | The Aquamantys™ PumpGenerator is an electrosurgicalgenerator with a rotary peristalticpump, which is for use only withAquamantys single-usedisposable bipolar devices forconcurrent delivery ofradiofrequency energy with salinefor hemostatic sealing of softtissue and bone at the operativesite. It is intended for, but notlimited to, endoscopic and openabdominal, orthopedic, spine andthoracic surgery. The device isnot intended for contraceptivetubal coagulation (permanentfemale sterilization). TheAquamantys System is for useonly by qualified medicalpersonnel properly trained in theuse of electrosurgical equipment,technology and techniques. | The WEREWOLF®+COBLATION System controlleris indicated for the resection,ablation, and coagulation of softtissues and hemostasis of bloodvessels in arthroscopic,orthopedic andotorhinolaryngology (ENT)procedures. |
| Indications of Usefor the wands | The Aquamantys™ BipolarSealer is a sterile, single-usebipolar electrosurgical deviceintended to be used inconjunction with a qualifiedPump Generator for delivery ofRF energy and saline forhemostatic sealing andcoagulation of soft tissue andbone at the operative site. It isintended for, but not limited toorthopedic, spine, thoracic, andopen abdominal surgery. Thedevice is not intended forcontraceptive tubal coagulation(permanent female sterilization). | The FASTSEAL 6.0 Wand, usedwith the WEREWOLF® +COBLATION System, isindicated for hemostasis (viacoagulation) of soft tissue andbone in orthopedic procedures |
| Functionality | Coagulation | Same |
| Input Power /Voltage | 90-110V ~ 4A104-127V ~ 3.5A207-253V ~ 1.85A | 100-120V ~ 8A220-240V ~ 4A |
| Input Frequency | 50/60 Hz | Same |
| Fuse Rating | 5 Amps @ 100 VAC4 Amps @ 115 VAC2 Amps @ 230 VAC | N/A(16 Amp fuse built into powersupply and not replaceable;power supply has overcurrentprotection) |
| Operating(Output)Frequency | 370kHz | 350kHz |
| ControllerWaveform | Sinusoid | Square |
| Saline Inflow(Fluid PumpMechanism) | Peristaltic | Same |
| Saline Outflow | None, requires auxiliary suctiondevice | Same |
| Foot PedalCapability | No | Yes (wired/wireless) |
| CoagulationActivationIndication | Audio and visual | Same |
| SettingAdjustmentInterface | Control panel with physicalbuttons (analog) | Graphical User Interface (GUI)with digital buttons |
| Control Panel orGUI Options | Adjust Coag level, saline flow rate,priming | Same |
| Wand Distal TipConfiguration | Image: Wand Distal Tip Configuration | Image: Wand Distal Tip Configuration |
| Monopolar /Bipolar | Bipolar | Same |
| Activation Limit | None | 15 minutes |
| BipolarCoagulationLevel Range andScale | 20-100 (increments of 5)100-200 (increments of 10) | 110-200 (increments of 10) |
| Maximum OutputPower | 200W | 195W |
| Wand OutputNominal VoltageMaximum | 150Vrms | 130Vrms |
| Handle Length | 6 inches | Same |
| Shaft Materials(Wand Patient-ContactingMaterials) | Molded ABS plastic | Polyolefin heat shrink insulationover dual stainless steel alloyshafts |
| Shaft WorkingLength | 5 inches | Same |
| Distal Shaft BendAngle (Relative toRest of ShaftLength) | 30° | Same |
| Rigid Construction | Yes | Same |
| Electrode Material(Wand Patient-ContactingMaterials) | Stainless Steel Alloy | Same |
| Tip SealingMaterial (WandPatient-ContactingMaterials) | Molded ABS plastic(components welded together) | HV-10 heat cure epoxy |
| ElectrodeDimensions | Width – 0.14 inchesLength – 0.22 inchesThickness – 0.14 inches | Width – SameLength – 0.26 inchesThickness – Same |
| Number ofSaline Ports | 2 | 4 |
| Saline Flow RateRange and Scale | 3 total levels: Low, Medium,High(symbolized by 1-3 dropletson front panel) | 5 total levels: 1-5(symbolizedby 1-5 droplets on GUI) |
| Saline DeliveryMethod | Integrated saline delivery tubing,enters treatment site through portson electrode | Same |
| Priming Options | Automatic (Timed) | Same |
| Saline Outflow | None, managed by externalsuction device | Same |
| ActivationOptions | Finger Switch | Finger Switch or Foot Pedal |
| Number of WandFinger Switches | 1(Coag) | 2(Coag and Max Coag) |
| Software in theWand | No | Yes |
| Biocompatible | Yes | Same |
| Sterilization | Ethylene Oxide | Same |
| Device Usage | Single use, disposable | Same |
| Prescription(Rx)/Over theCounter(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
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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".
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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
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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".
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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 (<24 h) per ISO 10993-1:2018. The subject Wand met the acceptance criteria under the conditions of the chemical characterization and biological testing performed.
WEREWOLF+ Controller does not require biocompatibility testing as the Controller has no direct or indirect patient-contacting materials.
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Image /page/14/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 graphic is made up of several curved lines in red, and the word "ArthroCare" is in gray. There is a registered trademark symbol next to the word "Care".
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY 8.2
The subject devices comply with IEC60601-1:2005+A1:2012, IEC60601-2-2:2017, IEC 60601-1-6: 2010 Ed.3+A1 standards for safety and the IEC 60601-1-2:2014 standard for EMC.
8.3 SOFTWARE
The overall software architecture for the WEREWOLF + Controller is the same as the previously cleared WEREWOLF Controller (K202006). The software was updated (Generator (version 6.1) and GUI (version 5.0)) to enable additional functionality of hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures. The FASTSEAL 6.0 Wand software (version 4.8) is identical to the wand software cleared via K183346 and K192027. The software for the subject devices was considered as a "moderate" level of concern and software verification and validation testing conducted in accordance to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
CYBERSECURITY 8.4
For the proposed expansion of indications, the WEREWOLF + ecosystem comprises the WEREWOLF + Controller and the FASTSEAL 6.0 Wand with wired/wireless Foot Control. The Cyber Failure Modes and Effects Analysis (CMEA) confirms that that there are no known unacceptable cybersecurity hazards associated with the subject devices and the WEREWOLF + platform.
PERFORMANCE TESTING 8.5
. Non-clinical:
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
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Image /page/15/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a series of curved, red lines on the left side, resembling a stylized wave or abstract design. To the right of the design is the word "ArthroCare" in a dark gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "ArthroCare".
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.
. Pre-clinical
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 .
- o 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.
- O 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 o potential differences between the FASTSEAL 6.0 Wand (subject device) and Aquamantys 6.0 wand (predicate device) across the range of flow rates in
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρώονε 512.391.3901 | www.arthrocare.com
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Image /page/16/Picture/1 description: The image shows the ArthroCare logo. 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 deep red color, arranged in a circular or spherical shape. The word "ArthroCare" is written in a dark gray, sans-serif font. A small registered trademark symbol is placed to the upper right of the word "Care".
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.
PERFORMANCE TESTING - ANIMAL 8.0
No in vivo animal testing data are included in this submission.
8.1 PERFORMANCE TESTING - CLINICAL
No clinical data are included in this submission.
CONCLUSION 8.2
All testing demonstrates that the subject devices perform as intended and have acceptable performance when used in accordance with its labeling.
ArthroCare Corporation evaluated the indications for use, technology, design and performance specification requirements of the subject devices and demonstrated that are as safe and effective as the predicate devices as intended for use.
§ 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.