(59 days)
Not Found
No
The document describes a standard electrosurgical device and its components, with no mention of AI or ML capabilities. The "Proprietary Ambient Technology" is not described in a way that suggests AI/ML.
Yes
The device is described as an electrosurgical device indicated for resection, ablation, coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures, which are therapeutic medical interventions.
No
Explanation: The device is described as an electrosurgical device for resection, ablation, coagulation, and hemostasis of soft tissue and blood vessels. Its function is to perform surgical procedures, not to diagnose conditions or diseases.
No
The device description clearly details physical components like wands, cables, electrodes, and suction lumens, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures." This describes a surgical tool used directly on the patient's tissue during a procedure.
- Device Description: The description details a bipolar electrosurgical device with an electrode tip, suction lumen, and connection to a controller. This is consistent with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to physically interact with and modify tissue during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
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 |
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device 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:
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance bench testing, functional 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.
No animal data are included in this submission.
No clinical data are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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)
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.