Ambient HipVac 50 Wand with Integrated Finger Switches

K161481 · ArthroCare Corporation · GEI · Oct 21, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161481
• Device Name: Ambient HipVac 50 Wand with Integrated Finger Switches
• Applicant: ArthroCare Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures: [Table of joints and procedures including Hip, Knee, Shoulder, Wrist, Ankle, Elbow].

Device Story

Electrosurgical wand for arthroscopic/orthopedic surgery; performs soft tissue resection, ablation, and hemostasis. Device features integrated finger switches for control. Used by surgeons in clinical/OR settings. Operates via electrosurgical energy to ablate/resect tissue and coagulate vessels <1 mm. Provides precise tissue management during joint procedures; benefits patient through controlled tissue removal and bleeding management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical wand; integrated finger switches; energy-based tissue ablation/resection/coagulation; Class II device (21 CFR 878.4400).

Indications for Use

Indicated for patients undergoing arthroscopic and orthopedic procedures requiring soft tissue resection, ablation, and hemostasis of blood vessels <1 mm. Applicable to hip, knee, shoulder, wrist, ankle, and elbow joints.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2016

ArthroCare Corporation Ms. Ashley M. Johnston, Regulatory Affairs Specialist 7000 West William Cannon Drive, Building One Austin, Texas 78735

Re: K161481

Trade/Device Name: Ambient HipVac 50 Wand with Integrated Finger Switches Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 19, 2016 Received: September 20, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth 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 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -A

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

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# Indications for Use

510(k) Number (if known) K161481

#### Device Name

Ambient HipVac 50 Wand with Integrated Finger Switches

Indications for Use (Describe) Please see attached.

| 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.

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."

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## K161481

The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:

| Joint | Ablation/Debridement | Excision/Resection |
|-------------------------------------------------------------|-----------------------------|-----------------------------|
| All Joints (Hip, Knee,<br>Shoulder, Wrist, Ankle,<br>Elbow) | ■ Articular Cartilage | ■ Articular Labrum |
| | ■ Bursectomy | ■ Capsule |
| | ■ Chondroplasty | ■ Cysts |
| | ■ Fascia | ■ Ligament |
| | ■ Ligament | ■ Loose Bodies |
| | ■ Scar Tissue | ■ Plica Removal |
| | ■ Soft Tissue | ■ Scar Tissue |
| | ■ Synovectomy | ■ Soft Tissue |
| | ■ Tendon | ■ Synovial Membrane |
| | | ■ Tendon |
| Hip | | ■ Acetabular Labrum |
| Knee | ■ ACL/PCL | ■ Capsular Release |
| | ■ Notchplasty | ■ Cartilage Flaps |
| | | ■ Discoid Meniscus |
| | | ■ Lateral Release |
| | | ■ Meniscal Cystectomy |
| | | ■ Meniscectomy |
| | | ■ Villusectomy |
| Shoulder | ■ Acromioplasty | ■ Frozen Shoulder Release |
| | ■ Subacromial Decompression | ■ Glenoid Labrum |
| Wrist | | ■ Triangular Fibrocartilage |

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# Indications for Use

510(k) Number (if known) K161481

#### Device Name

Ambient HipVac 50 Wand with Integrated Finger Switches

Indications for Use (Describe) Please see attached.

| 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.

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."

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The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:

| Joint | Ablation/Debridement | Excision/Resection |
|-------------------------------------------------------------|-----------------------------|-----------------------------|
| All Joints (Hip, Knee,<br>Shoulder, Wrist, Ankle,<br>Elbow) | ■ Articular Cartilage | ■ Articular Labrum |
| | ■ Bursectomy | ■ Capsule |
| | ■ Chondroplasty | ■ Cysts |
| | ■ Fascia | ■ Ligament |
| | ■ Ligament | ■ Loose Bodies |
| | ■ Scar Tissue | ■ Plica Removal |
| | ■ Soft Tissue | ■ Scar Tissue |
| | ■ Synovectomy | ■ Soft Tissue |
| | ■ Tendon | ■ Synovial Membrane |
| | | ■ Tendon |
| Hip | | ■ Acetabular Labrum |
| Knee | ■ ACL/PCL | ■ Capsular Release |
| | ■ Notchplasty | ■ Cartilage Flaps |
| | | ■ Discoid Meniscus |
| | | ■ Lateral Release |
| | | ■ Meniscal Cystectomy |
| | | ■ Meniscectomy |
| | | ■ Villusectomy |
| Shoulder | ■ Acromioplasty | ■ Frozen Shoulder Release |
| | ■ Subacromial Decompression | ■ Glenoid Labrum |
| Wrist | | ■ Triangular Fibrocartilage |