Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

Q: Who is the manufacturer of Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)?

ArthroCare Corporation filed the 510(k) submission for Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) (K162126).

Q: What is the FDA product code for Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K162126 · ArthroCare Corporation · GEI · Sep 29, 2016 · General, Plastic Surgery

Device Facts

Record ID	K162126
Device Name	Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)
Applicant	ArthroCare Corporation
Product Code	GEI · General, Plastic Surgery
Decision Date	Sep 29, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The KVac Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

Device Story

Bipolar, high-frequency electrosurgical wands for arthroscopic/orthopedic surgery; used for soft tissue resection, ablation, and hemostasis. Input: electrical energy from Quantum/Quantum 2 Controller; suction via OR wall vacuum. Operation: electrode tip (tungsten screen) creates plasma field to ablate tissue; suction removes bubbles/debris for visibility. Ambient KVac IFS model includes integrated finger switches and real-time temperature monitoring (20-60°C) with alarm; KVac ICW model uses foot pedal. Used in OR by orthopedic surgeons. Output: thermal tissue effect; real-time temperature data (Ambient model). Benefits: precise tissue removal, improved visibility, and thermal monitoring to prevent joint space overheating.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including functional testing, ablation life, coagulation performance, biocompatibility, and electrical safety. Testing performed in tissue models (muscle, cartilage, meniscus, tendon) comparing ablation depth and thermal effect depth against the predicate.

Technological Characteristics

Bipolar electrosurgical wand; tungsten screen electrode; Platinum/Iridium lead wires; alumina ceramic spacer; 160 mm shaft length; 3.4 mm outer diameter; 3 internal suction ports. Energy source: Quantum/Quantum 2 Controller. Ambient model features thermocouple for temperature monitoring (±3°C). Sterilization: sterile. Connectivity: 18-pin connector to controller.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures across all joints (hip, knee, shoulder, wrist, ankle, elbow). Specific applications include articular cartilage, bursectomy, chondroplasty, fascia, ligament, scar tissue, soft tissue, synovectomy, tendon, articular labrum, capsule, cysts, loose bodies, plica removal, synovial membrane, acetabular labrum, ACL/PCL, notchplasty, capsular release, cartilage flaps, discoid meniscus, lateral release, meniscal cystectomy, meniscectomy, villusectomy, medial retinaculum, acromioplasty, subacromial decompression, frozen shoulder release, glenoidale labrum, glenohumeral capsule, rotator cuff, triangular fibrocartilage (TFCC), carpal ligaments, and wrist tendons.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Ambient Super MultiVac Wand with Integrated Finger Switches (IFS) (K083306)

Related Devices

K180848 — AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches · ArthroCare Corporation · May 1, 2018
K220563 — Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System · ArthroCare Corporation · Sep 1, 2022
K120791 — AMBIENT TURBOFLASH 90 IFS · Arthocare Corporation · Dec 11, 2012
K153675 — Paragon T2 Wand with Integrated Cable · ArthroCare Corporation · Jan 15, 2016
K020557 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS · Arthrocare Corp. · Mar 21, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 29, 2016 ArthoCare Corporation Ms. Ashley Johnston Regulatory Affairs Specialist 7000 West William Cannon Drive Austin, Texas 78735 Re: K162126 Trade/Device Name: Ambient® KVac™ Wand with Integrated Finger Switches (Ambient KVac IFS); KVac™ Integrated Cable Wand (KVac ICW) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 29, 2016 Received: August 1, 2016 Dear Ms. Johnston: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth {1}------------------------------------------------ in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Christopher J. Ronk -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K162126 #### Device Name ArthroCare® KVac® Integrated Cable Wand ArthroCare Ambient® KVac Wand with Integrated Finger Switches Indications for Use (Describe) Please see attached. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ The KVac Wands (Ambient KVac IFS and KVac ICW) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Joint | Ablation/Debridement | Excision/Resection | Coagulation | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | 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 ■ Plica Removal ■ Scar Tissue ■ Soft Tissue ■ Synovial Membrane ■ Tendon | ■ Articular Cartilage ■ Ligament ■ Tendon | | Hip | | ■ Acetabular Labrum | | | Knee | ■ ACL/PCL ■ Notchplasty | ■ Capsular Release ■ Cartilage Flaps ■ Discoid Meniscus ■ Lateral Release ■ Meniscal Cystectomy ■ Meniscectomy ■ Villusectomy | ■ ACL/PCL ■ Medial Retinaculum | | Shoulder | ■ Acromioplasty ■ Subacromial Decompression | ■ Frozen Shoulder Release ■ Glenoidale Labrum | ■ Glenohumeral Capsule ■ Rotator Cuff | | Wrist | | ■ Triangular Fibrocartilage (TECC) | ■ Carpal Ligaments ■ Wrist Tendons | {4}------------------------------------------------ # 510(k) Summary # ArthroCare® Corporation # KVac™ Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### General Information | Submitter Name: | ArthroCare Corporation | |-----------------|----------------------------------------------------------------------------------------------| | Address | 7000 West William Cannon Drive Austin, TX 78735 | | Contact Person: | Ashley Johnston Regulatory Affairs Specialist Phone: 512-358-5762 Fax: 512-895-1489 | | Date Prepared: | September 27, 2016 | # Device Name | Proprietary Name: | Ambient® KVacTM Wand with Integrated Finger Switches (Ambient KVac IFS); KVacTM Integrated Cable Wand (KVac ICW) | |--------------------|---------------------------------------------------------------------------------------------------------------------| | Regulation Name: | Electrosurgical cutting and coagulation device and accessories | | Regulatory Class: | II | | Product Code: | GEI | | Regulation Number: | 21 CFR 878.4400 | ## Predicate Device Ambient Super MultiVac Wand with Integrated Finger Switches (IFS) of the K083306 ArthroCare ArthroWands Family, K083306 (cleared December 10, 2008) ## Description The KVac Wands are bipolar, sterile, high frequency electrosurgical devices designed for ablation, and resection of soft tissue and hemostasis of blood vessels during arthroscopic and orthopedic surgery. The KVac Wands will be offered in two versions: the KVac Wand with Integrated Cable (KVac ICW) and the Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS). The two wands are identical in all design and functional aspects, as well as principle of operation, with the exception of the following: {5}------------------------------------------------ - Integrated Finger Switches - The Ambient KVac IFS Wand will incorporate finger switches into the handle to activate the ablation and coagulation functions. The KVac ICW Wand is controlled via a foot pedal attached to the Controller (note: the foot pedal may also be used with the Ambient KVac IFS Wand to activate ablation and coagulation functions instead of the Integrated Finger Switches). - Proprietary Ambient Technology - The Ambient technology provides accurate (± 3 ℃) real time temperature monitoring of the circulating irrigation fluid in the joint space between 20 ℃ and 60 °C and includes a user adjustable alarm set-point. An alarm on the Quantum 2 Controller sounds if the temperature exceeds the pre-set range. Only the Ambient KVac IFS Wand will offer the Ambient® technology. This feature will not be available on the KVac ICW. Aside from these features, the Wands are identical in all other aspects and are designed for the same intended use. The shafts of the Wands feature a 50 degree bend in the distal end, which terminates in the electrode tip. The electrode tip consists of a flat, tungsten screen welded to Platinum/Iridium lead wires, which pass through an alumina ceramic spacer that serves as a ground. Openings in the electrode screen overlay a spacer suction lumen, which connects with internal suction tubing that runs through and exits the handle and is connected to OR wall suction is used to draw the tissue closer to the active electrode for optimal ablation and also allows for increased user visibility by removing bubbles and floating tissue generated during tissue ablation. The handpiece is connected to the Quantum/Quantum 2 Controller via an integrated cable, which terminates in an 18-pin connector. # Intended Use/Indications for Use The KVac Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Joint | Ablation/Debridement | Excision/Resection | Coagulation | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | 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 ■ Plica Removal ■ Scar Tissue ■ Soft Tissue ■ Synovial Membrane ■ Tendon | ■ Articular Cartilage ■ Ligament ■ Tendon | | Hip | | ■ Acetabular Labrum | | | Knee | ■ ACL/PCL ■ Notchplasty | ■ Capsular Release ■ Cartilage Flaps ■ Discoid Meniscus ■ Lateral Release ■ Meniscal Cystectomy ■ Meniscectomy ■ Villusectomy | ■ ACL/PCL ■ Medial Retinaculum | | Shoulder | ■ Acromioplasty ■ Subacromial Decompression | ■ Frozen Shoulder Release ■ Glenoidale Labrum | ■ Glenohumeral Capsule ■ Rotator Cuff | | Wrist | | ■ Triangular Fibrocartilage (TFCC) | ■ Carpal Ligaments ■ Wrist Tendons | ## Technological Comparison to Predicate The technological characteristics of the proposed subject devices are the same as the predicate device. No changes or modifications have been made to the intended use, fundamental scientific technology, {6}------------------------------------------------ or principle of operation previously cleared in 510(k) K083306. The following table represents a summary of the technological characteristics: | Parameter | Predicate Devices Ambient Super MultiVac Wand (K083306) | Subject Devices Ambient KVac IFS and KVac ICW Wands | Justification of Differences | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Controllers | Quantum 2 | Quantum/Quantum 2 | Ambient KVac IFS Wand is used with Quantum 2 (for the Ambient technology); KVac ICW Wand is used with Quantum or Quantum 2 | | Wand Materials | | | | | Electrode Screen/ Lead Wire Material | Electrode screen attached only by epoxy with the legs of the screen bent into the holes of the spacer for connection with lead wires | Electrode screen attached to a ceramic spacer with epoxy and the legs of the screen laser welded to Platinum/ Iridium lead wires which pass through holes in the spacer | Provides additional fixation of screen to wire leads | | Active Wire Connection Point | Tungsten | Platinum/Iridium | Platinum/Iridium is more resistant to plasma degradation. No effect on safety or efficacy. | | Wand Design | | | | | Shaft Length | 137 mm | 160 mm | Increased length improves access to anatomical sites (e.g. hip) | | Outer Diameter of Shaft | 3.8 mm | 3.4 mm | The smaller OD allows better access to small joint anatomical spaces (e.g. knee) | | Number of Internal Suction Ports | 2 | 3 | An increased number of suction ports improve visibility by clearing bubbles. | | Screen | Tungsten screen with legs bent into holes in spacer and bonded to spacer with epoxy. | Tungsten screen with welded Pt/Ir leads that are bonded to holes in spacer with epoxy. | Provides additional fixation of screen to wire leads. | | Internal Suction Tube Configuration | Stainless steel tube between suction tube and ceramic spacer | Suction tube bonded directly to ceramic spacer | Improves manufacturability of the KVac wands. No effect on safety or efficacy. | | Thermocouple Connection | Autosplice | Autosplice and Solder | Improves stability of connection to thermocouple | | Tyvek Packaging/ Adhesive | Adhesive layer covers entire back of Tyvek lid | Adhesive is zone-coated around the edge of the Tyvek | Packaging was validated to identical parameters | {7}------------------------------------------------ ### Performance Testing - Bench Performance bench testing, inctional testing, ablation life, coagulation, biocompatibility, and electrical safety testing were performed on the KVac Wands, to verify the designs meet performance specifications and to evaluate the performance of the KVac Wands compared to the predicate device. Performance testing was performed in tissue models representing muscle, cartilage, meniscus, and tendon. High, default and low ablation and coagulation settings were used to compare the amount of tissue removed (ablation depth) and thermal effect depth created. The test results demonstrate that the KVac Wands meet all design and performance specifications and are substantially equivalent to the predicate device. #### Performance Testing - Animal No animal data are included in this submission. #### Performance Testing - Clinical No clinical data are included in this submission. #### Substantial Equivalence Non-clinical performance data such as design verification, , tissue effect testing (histology, thermal margins) demonstrated that the subject devices are substantially equivalent to the predicate devices and are safe and effective when used as intended. #### Summary All testing demonstrates that the KVac Wands perform as intended and have acceptable mechanical properties when used in accordance with its labeling. The KVac Wands are substantially equivalent to the predicate Ambient Super Multi Vac Wand with IFS (K083306). The differences between the KVac Wands and the predicate device do not raise any new concerns about the safety or effectiveness of the subject devices.