(144 days)
Indications for Use - WEREWOLF™COBLATION™ SYSTEM
The WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures:
Resection/Ablation/Coagulation
- Tonsillectomy (Including Palatine Tonsils)
- Adenoidectomy
- Uvulopalatopharyngoplasty (UPPP)
- Traditional Uvulopalatoplasty (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 Control
- 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
Indications for use - COBLATION™ HALO™ Wand
The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectory, adenoidectomy, and uvulopalaty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate.
The proposed WEREWOLF COBLATION System consists of:
- A bipolar, radiofrequency (RF) generator (Controller) with Integrated Fluid . Module and Operational Interface Screen,
- . Re-usable, non-sterile Foot Control (wired or wireless)
- Sterile, disposable, single-use COBLATION Wand(s)
- . Reusable, non-sterile power cord.
The components are designed to be operated as a single unit.
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 proposed Controller is designed to deliver radiofrequency energy to the electrodes of the compatible COBLATION 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, volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed.
The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site.
The proposed Controller operates in 5 modes (Lo, Med, Hi, Coag and Vac mode) for arthroscopic and orthopedic procedures and in 4 modes (Lo, Med, Hi and Coag) for the ENT procedures.
The proposed HALO Wand is designed to be used exclusively with the proposed WEREWOLF™ COBLATION™ System. The HALO Wand is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. The Wands are provided sterile (via ethylene oxide) and are single-use only.
The provided text is a 510(k) summary for the WEREWOLF COBLATION System and COBLATION HALO Wand. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not a report of a study proving a device meets acceptance criteria in the context of clinical efficacy or diagnostic performance. Therefore, detailed information typically found in a clinical study report or performance study for AI/diagnostic devices, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not present in this document.
The document primarily focuses on demonstrating substantial equivalence through non-clinical (mechanical, electrical, functional, biocompatibility) and pre-clinical (ex vivo) bench testing, comparing the proposed device against its predicate.
Here's an attempt to extract relevant information given the constraints of the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a formal table of "acceptance criteria" for clinical efficacy as would be seen in a clinical trial. Instead, it describes various tests conducted to demonstrate the device's safety and effectiveness compared to the predicate. The "performance" reported is primarily that the device meets established design criteria and performs substantially equivalently to the predicate.
| Category of Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Meets established design criteria for mechanical integrity, electrical safety, and specified functions. | Confirmed device meets established design criteria. |
| Mechanical Tests | Cable mechanical integrity, tip insertion/removal force, etc. (Specifics not detailed) | Tests conducted for distal tip, accessory insertion/removal, cable plug insertion/extraction, cable/saline tube integrity; results support substantial equivalence. |
| Electrical Tests | Compliance with IEC 60601-1 and IEC 60601-2-2 (Specifics not detailed) | Tests conducted for continuity, dielectric withstand, impedance, overcurrent, electrical safety; results support substantial equivalence. |
| Functional Tests | Proper functioning in all modes, clog resistance, saline rate, temperature limits, use-limiting features, software validation (Specifics not detailed) | Tests conducted for transit conditioning, gloved surfaces, dimensions, visual inspection, suction clog resistance/removal, suction/saline rate, pinch clamp occlusion, coagulation effect, ablation function (all settings, 1X/2X life), use-limiting check, software usage info check, shutoff timer check, maximum temperature check, software V&V, biocompatibility; results support substantial equivalence. |
| Pre-Clinical Bench Testing (Ex Vivo) | Thermal effects in ablation and coagulation modes are substantially equivalent to the predicate device. | Evidence on bovine myocardial tissue demonstrates HALO device performs substantially equivalent to the PROCISE XP predicate device in relevant aspects of Ablation mode and Coagulation mode thermal effects. |
| Additional Bench Testing | Peak temperature at active electrode within acceptable range and comparable to predicate. | Max temperatures recorded ranged from approximately 61.4 - 74.3°C. (Implicitly acceptable and/or comparable to predicate, though direct comparison values aren't provided here for the predicate). |
2. Sample size used for the test set and the data provenance:
- Non-Clinical/Pre-Clinical Bench Testing: The document does not specify the sample sizes for the various non-clinical and ex vivo bench tests (e.g., number of wands tested, number of bovine tissue samples).
- Data Provenance:
- Non-Clinical/Pre-Clinical: Conducted by ArthroCare Corporation.
- Ex Vivo: Bovine myocardial tissue was used. This is a lab-based study with animal tissue, not human data.
- Retrospective/Prospective: All described testing is of a prospective nature as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the submission relies on physical and functional testing, not expert-derived ground truth for clinical diagnostic performance.
4. Adjudication method for the test set:
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not present here.
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 study was done, as this is a medical device (electrosurgical system) and not an AI/diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is an electrosurgical system, not an algorithm, and intrinsically requires human operation.
7. The type of ground truth used:
- For the non-clinical and ex vivo bench testing, the "ground truth" or reference standard would be the established engineering specifications, performance standards (e.g., IEC 60601 series), and the performance characteristics of the predicate device. For ex vivo testing on bovine tissue, the measured thermal effects serve as the observed performance to be compared.
8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
Arthrocare Corporation Shruthi Bhat Regulatory Affairs Specialist II 7000 West William Cannon Drive Austin, Texas 78735
Re: K192027
Trade/Device Name: WEREWOLF COBLATION System, COBLATION HALO Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 18, 2019 Received: November 19, 2019
Dear Shruthi Bhat:
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/cdrh/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.
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
{1}------------------------------------------------
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 Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K192027
Device Name WEREWOLF™COBLATION™ SYSTEM COBLATION™ HALO™ WAND
Indications for Use (Describe) Indications for Use - WEREWOLF™COBLATION™ SYSTEM
The WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures:
Resection/Ablation/Coagulation
- Tonsillectomy (Including Palatine Tonsils)
- Adenoidectomy
- Uvulopalatopharyngoplasty (UPPP)
- Traditional Uvulopalatoplasty (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 Control
- 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
Indications for use - COBLATION™ HALO™ Wand
The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectory, adenoidectomy, and uvulopalaty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic to the left of the company name. The graphic is composed of several curved, parallel lines in a deep red color, arranged in a semi-circular shape. To the right of the graphic is the company name "ArthroCare" in a dark gray, sans-serif font, with the registered trademark symbol "®" next to the word "Care".
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.
7.1 GENERAL INFORMATION
| Submitter Name | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon DriveAustin, TX 78735 |
| Contact Person | Shruthi Bhat M.Sc., MSRegulatory Affairs Specialist IIArthrocare Corporation7000 West William Cannon DriveAustin, TX 78735Phone: (512) 895-1295Email: shruthi.bhat@smith-nephew.comFax: 512-895-1489 |
| Date Prepared | 20 December 2019 |
7.2 DEVICE NAME(S)
| Proprietary Name | WEREWOLF™COBLATION™ SYSTEM | |
|---|---|---|
| COBLATION™ HALO™ WAND | ||
| Common Name | Electrosurgical devices and accessories | |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
7000 W.William Cannon Drive | Building One | Austin, Texas 78735 | ρέος 512.391.3901 | www.arthrocare.com
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved lines in a maroon color. To the right of the circular design is the word "ArthroCare" in a dark gray sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
| Device Class | Class II |
|---|---|
| Product Code | GEI |
| CFR Section | 21 CFR 878.4400 |
| 7.3 PREDICATE DEVICE(S) | ARTHROCARE ENT COBLATOR II SURGERYSYSTEM cleared via K030108 |
PROCISE XP Wand cleared via K070374
7.4 DESCRIPTION
7.4.1 WEREWOLF™ (RF20000) COBLATION™ System
The proposed WEREWOLF COBLATION System consists of:
- A bipolar, radiofrequency (RF) generator (Controller) with Integrated Fluid . Module and Operational Interface Screen,
- . Re-usable, non-sterile Foot Control (wired or wireless)
- Sterile, disposable, single-use COBLATION Wand(s)
- . Reusable, non-sterile power cord.
The components are designed to be operated as a single unit.
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.
7.4.2 WEREWOLF™ (RF20000) Controller
The proposed Controller is designed to deliver radiofrequency energy to the electrodes of the compatible COBLATION 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,
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a series of red curved lines on the left, resembling a stylized wave or a medical symbol. To the right of the lines is the word "ArthroCare" in a gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
volume, etc. Ports for connecting the compatible Wands and the Foot Control are located on the front panel. An optional wireless Foot Control can be installed.
The Controller also incorporates a peristaltic Integrated Fluid Control Module, which provides dynamic control of saline flow (inflow or outflow) to or from the surgical site.
The proposed Controller operates in 5 modes (Lo, Med, Hi, Coag and Vac mode) for arthroscopic and orthopedic procedures and in 4 modes (Lo, Med, Hi and Coag) for the ENT procedures.
7.4.3 COBLATION™ HALO™ Wand
The proposed HALO Wand is designed to be used exclusively with the proposed WEREWOLF™ COBLATION™ System. The HALO Wand is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. The Wands are provided sterile (via ethylene oxide) and are single-use only.
7.5 PROPOSED INTENDED USE/INDICATIONS FOR USE
7.5.1 WEREWOLF COBLATION System
The proposed WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures:
| Resection/Ablation/Coagulation | |
|---|---|
| ENT | Tonsillectomy (Including Palatine Tonsils) Adenoidectomy Uvulopalatopharyngoplasty (UPPP) Traditional Uvulopalatoplasty (RAUP) |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
{7}------------------------------------------------
Image /page/7/Picture/0 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 circular design is the word "ArthroCare" in a gray, sans-serif font. A small registered trademark symbol is located to the upper right of the word "Care".
| Resection/Ablation/Coagulation |
|---|
| 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 Control 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 |
7.5.2 COBLATION HALO Wand
The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is Indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer's lactate.
7.6 SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
The overall technological characteristics of the proposed devices are the same as the predicate devices with exceptions listed in Table 7.6. The proposed and predicate controller differ in controller specifications due to different controller hardware design, software design and, multiple applications.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρέος 512.391.3901 | www.arthrocare.com
{8}------------------------------------------------
Image /page/8/Picture/0 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 lines that are arranged in a circular pattern. The word "ArthroCare" is written in a sans-serif font and is in a dark gray color. There is a registered trademark symbol next to the word "Care".
Table 7.6: Summary of Technological Characteristics between the predicate and proposed devices.
| Parameter | PREDICATE DEVICE:Procise XP (K070374) withCOBLATOR II Controller(K030108) | PROPOSEDDEVICE:HALO withWEREWOLFController |
|---|---|---|
| Representation | Image: Procise XP (K070374) with COBLATOR II Controller (K030108) | Image: HALO with WEREWOLF Controller |
| Intended Use andIndications of Use | Indicated for ablation, resection,and coagulation of soft tissue andhemostasis of blood vessels inotorhinolaryngology (ENT)procedures | Same |
| Otorhinolaryngology(ENT)procedures | Tonsillectomy (IncludingPalatine Tonsils) Adenoidectomy Uvulopalatopharyngoplasty(UPPP) TraditionalUvulopalatoplasty (RAUP) Nasal Airway Obstruction Submucosal PalatalShrinkage Submucosal TissueShrinkage | Same |
| Parameter | PREDICATE DEVICE:Procise XP (K070374) withCOBLATOR II Controller(K030108) | PROPOSEDDEVICE:HALO withWEREWOLFController |
| Nasal Airway Obstructionby Reduction ofHypertrophic NasalTurbinates Reduction of Turbinatesfor the Treatment of NasalAirway Obstruction Nasopharyngeal/LaryngealIndications IncludingTracheal Procedures Mastoidectomy Myringotomy withEffective HemorrhageControl Papilloma Keloids Nasopharyngeal/LaryngealProcedures Polypectomy Laryngeal Polypectomy Laryngeal LesionDebulking Cysts Tumors Neck Mass Head, Neck, Oral, andSinus Surgery Tissue in the Uvula/ SoftPalate for the Treatment ofSnoring | ||
| Input power | 100-240 VAC | Same |
| Frequency | 50-60 Hz | Same |
| Fuse Rating | 5 Amps | 16 Amps |
| Parameter | PREDICATE DEVICE:Procise XP (K070374) withCOBLATOR II Controller(K030108) | PROPOSEDDEVICE:HALO withWEREWOLFController |
| OutputNominalVoltageMaximum | 320±10% Vrms | 340 Vrms |
| Controller inputpower(W) | 100-120V ~ 8A 220-240V ~ 4A | Same |
| Rated Wand Voltage | 320±10% Vrms | 340 Vrms |
| DefaultAblationSet Point /Output Voltage(Vrms) | Set Point 7 (265 Vrms) | "Med."(175 Vrms) |
| DefaultCoagulationSet Point /Output Voltage(Vrms) | Set Point 3 (75 Vrms) | "Coag."(73 Vrms at 150 OhmLoad) |
| Ablation SetPoint Range /Output Voltage(Vrms) | Set Points 1 - 9(100-300 Vrms) | "Med -" - "Hi +"(167-300 Vrms) |
| CoagulationSet Point Range/ OutputVoltage (Vrms) | Set Points 1 - 5 (65-87 Vrms) | "Coag " – "Coag..."(73-99 Vrms at 150Ohm Load) |
| Coagulation Setting | Adjustable (5 Set Points) | Adjustable (3 SetPoints) |
| Controller waveform | Square | Same |
| Output Frequency | 100kHz | Same |
| Saline Outflow | Connects to hospital wall suction | Same |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρώσιε 512.391.3901 | www.arthrocare.com
{9}------------------------------------------------
Image /page/9/Picture/0 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 are arranged in a circular pattern. The word "ArthroCare" is written in a gray sans-serif font.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρρίου 512.391.3901 | www.arthrocare.com
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red wave-like design on the left and the company name "ArthroCare" in gray text on the right. The "R" in ArthroCare has a registered trademark symbol next to it.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρ/οπε 512.391.3900 | //εκ 512.391.3901 | www.arthrocare.com
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, red, circular design on the left, resembling curved lines or waves. To the right of the design is the company name "ArthroCare" in a dark gray, sans-serif font, with a registered trademark symbol next to it.
PREDICATE DEVICE: PROPOSED Parameter Procise XP (K070374) with DEVICE: COBLATOR II Controller HALO with (K030108) WEREWOLF Controller External Flow Control Unit of the Integrated peristaltic Saline Delivery Controller controls gravity pump (FLOW IQ pump - K143235 and supplied saline to the wand. K162074) on the Controller controls saline delivery to the Wand Foot Control Activation Same Software controlled Yes No Graphical User No Yes Interface Weight 8.2kg 10 kg Total Length 9.1 inches 9.0 inches Handle Length 4.4 inches Same Shaft Materials ASTM A908 Grade 304 Stainless Same Steel Shaft Working 4.6 inches Same Length Rigid Construction Yes Yes
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red wave-like design on the left and the company name "ArthroCare" in gray text on the right. The "R" in ArthroCare has a registered trademark symbol next to it.
| Parameter | PREDICATE DEVICE:Procise XP (K070374) withCOBLATOR II Controller(K030108) | PROPOSEDDEVICE:HALO withWEREWOLFController |
|---|---|---|
| Distal TipConfiguration | Image: Procise XP Distal Tip Configuration | Image: HALO Distal Tip Configuration |
| Electrode Material | Molybdenum | Tungsten Alloy |
| ActiveElectrodeConfiguration | Three (3) Molybdenum wireelectrodes | One (1) Tungstenalloyelectrode |
| ElectrodeOrientation relativetoShaft | 23° | 25° |
| Outer Diameter ofShaft | 4.57 mm (Insulated) | 4.09 mm x 5.03 mm(Obround Shaft,Insulated) |
| Number ofSuction Ports | 1 | Same |
| ElectrodeDimensions | Width: 3.00 mmLength:1.55 mmThickness:0.41 mm | Width: 3.45 mmLength:4.04 mmThickness: 0.30 mm |
| Parameter | PREDICATE DEVICE:Procise XP (K070374) withCOBLATOR II Controller(K030108) | PROPOSEDDEVICE:HALO withWEREWOLFController |
| RecommendedActiveAblation Time | 10 minutes of cumulative ablation(1X life) | 15 minutes ofcumulative ablation(1X life) |
| Electrode | Molybdenum | Tungsten alloy |
| Ceramic Spacer | Alumina | Same |
| Shaft | Grade 304Stainless Steel | Same |
| Shaft Insulation | Black Polyolefin | Same |
| Wire Insulation | Pebax (7033-SA01/MED) | Same |
| Shaft SupportComponent | N/A | Grade 302 StainlessSteel |
| Adhesive(s) | Loctite 3981,Loctite Accelerator 713,Loctite 4013 , UV Adhesive,Loctite 3321, PVC SolventCement | HV-10 Heat-CureAdhesive, CyberbondCyanoacrylate,CyberbondAccelerator, PVCSolvent Cement,Loctite 3321 |
| Saline/ SuctionTubing | PVC (does not contain DEHP),ABS, HDPE | PVC (does not containDEHP), ABS, Nylon12 |
| Parameter | PREDICATE DEVICE:Procise XP (K070374) withCOBLATOR II Controller(K030108) | PROPOSEDDEVICE:HALO withWEREWOLFController |
| Handle Bushing | Polycarbonate | Same |
| Bipolar/Monopolar | Bipolar | Same |
| SpacerConfiguration | Multi-lumen | Same |
| Irrigation Ports | 3 | 5 |
| Activation Method | Foot Pedal | Same |
| Software in Wand | No | Yes |
| Use-limiting Feature | No | Yes – SoftwareControlled |
| Integrated Cable | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterilization | Irradiation | Ethylene Oxide |
| PackagedSterile/ Single UseDisposable | Sterile, Single Use, Disposable | Same |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left, composed of several curved, parallel lines in a dark red color. To the right of the graphic is the company name, "ArthroCare," in a dark gray, sans-serif font. A registered trademark symbol is present to the upper right of the word "Care."
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" in a sans-serif font on the right. The symbol is composed of several curved lines, arranged in a semi-circular shape, and colored in a dark red hue. The text "ArthroCare" is in a dark gray color, and there is a small registered trademark symbol to the upper right of the word "Care".
7.7 PERFORMANCE TESTING
Performance testing to assess the design and performance was conducted on the proposed devices, the HALO Wand (Wand) with WEREWOLF Controller (Controller) to confirm the proposed devices meet the established design criteria and supports the substantial equivalence with the predicate devices, PROCISE XP wand (K070374) and COBLATOR II Controller (K030108). Testing included:
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image contains the logo for ArthroCare. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of several curved red lines that are stacked on top of each other. The company name "ArthroCare" is written in a dark gray sans-serif font to the right of the graphic, with a registered trademark symbol next to it.
Non-Clinical Testing: .
-
Mechanical Tests distal tip mechanical tests, tip clearing accessory insertion and removal force, integrated cable plug insertion and extraction, and cable and saline tube mechanical integrity
-
Electrical Tests electrical continuity, dielectric withstand, electrical impedance, overcurrent, and electrical safety per IEC 60601-1 and IEC 60601-2-2
-
Functional Tests transit conditioning, gloved surfaces testing, dimensional inspection, visual inspection, suction clog resistance and blockage removal, suction and saline rate testing, pinch clamp occlusion testing, coagulation effect, ablation function in all settings, ablation and device function at 1X and 2X life, device use-limiting check, wand software usage information check, device shutoff timer check, and maximum temperature check, software verification and validation, biocompatibility
Pre-Clinical bench testing (ex vivo testing): .
Evidence obtained from preclinical bench tissue testing (ex vivo) on bovine myocardial tissue demonstrates that the HALO device performs substantially equivalent to the PROCISE XP predicate device in relevant aspects associated with Ablation mode and Coagulation mode thermal effects.
Additional Bench Testing .
Additional bench testing was performed to compare the peak temperature at the active electrode of the proposed HALO Wand to the predicate PROCISE XP wand after 10 seconds of activation at maximum setting. The maximum temperatures recorded for the devices ranged from approximately 61.4 - 74.3°C.
{16}------------------------------------------------
Image /page/16/Picture/0 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 circular design is the company name "ArthroCare" in a dark gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
7.8 PERFORMANCE TESTING - ANIMAL
No in vivo animal testing data are included in this submission.
PERFORMANCE TESTING - CLINICAL 7.9
No clinical data are included in this submission.
CONCLUSION 7.10
All testing demonstrates that the proposed WEREWOLF Controller and the HALO Wand performs as intended and has acceptable performance when used in accordance with its labeling.
Arthrocare Corporation evaluated the indications for use, materials, technology, design and performance specification requirements of the subject device to demonstrate that the the proposed devices are substantially equivalent to the predicate devices for their intended use, principle for operation and fundamental scientific technology.
§ 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.