VAPR ARCTIC SUCTION ELECTRODE

K140896 · Depuy Mitek, A Johnson & Johnson Company · GEI · Aug 5, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140896
• Device Name: VAPR ARCTIC SUCTION ELECTRODE
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

Device Story

Single-use, bipolar, articulating suction electrode for arthroscopic hip surgery. Device connects to VAPR VUE RF generator; internal capacitor identifies device to generator, automatically setting optimal power/waveforms. Hand-controlled articulating tip (110 degrees) improves access to joint space; integrated suction removes bubbles and debris during activation. Used by surgeons in clinical settings. Output is RF energy delivered to soft tissue for resection/coagulation. Benefits include improved visualization and surgical efficiency via debris removal and enhanced access to joint anatomy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including shaft bending, articulation durability, hipot, activation, cable tensile, suction flow, thermal shock, and temperature rise assessments.

Technological Characteristics

Bipolar electrosurgical electrode; articulating tip (110 degrees); integrated suction. Materials evaluated per ISO 10993-1. Sterilization via gamma radiation (ISO 11137-1). Connectivity: proprietary plug with internal identification capacitor for VAPR VUE generator communication. Standards: EN 60601-1, EN 60601-2-2, EN 60601-1-2.

Indications for Use

Indicated for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

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

• VAPR CP90 Electrode (K113545, K100638)
• VAPR P50 Electrode (K122425, K100638, K082643)
• Smith and Nephew Eflex Ablator (K000691)
• Arthrocare Hip ArthroWand (510(k) # Not Known)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

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

August 5, 2014

Depuy Mitek, A Johnson & Johnson Company % Susan Kagan Project Manager Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K140896

Trade/Device Name: VAPR® ARCTICTM Suction Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 13, 2014 Received: June 16, 2014

Dear Ms. Kagan,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

{1}------------------------------------------------

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 [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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -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}------------------------------------------------

#### Indications for Use

510(k) Number (if known)

Device Name

VAPR® ARCTIC™ Suction Electrode

Indications for Use (Describe)

The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

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)

#### 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)

FORM FDA 3881 (1/14)

{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}------------------------------------------------

| | DePuy |
|-----------------------------------------|--------------------|
| Mitek Inc.<br>a Johnson Johnson company | never stop moving™ |

## 510(k) SUMMARY

Date Prepared April 7, 2014 Submitter's Name DePuy Mitek, Inc. a Johnson & Johnson company and Address: 325 Paramount Drive

- Contact Person Susan Kaqan Project Manager, Regulatory Affairs DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767, USA Telephone: [phone] Facsimile: 508-977-6955 e-mail: [e-mail]
Raynham, MA 02767

- Name of Medical Classification Name: Electrosurqical cutting and coagulation device and accessories: 21 CFR 878.4400 Deice Common/Usual Name: Electrosurgical cutting and coagulation device and accessories VAPR® ARCTIC™ Suction Electrode Proprietary Name: FDA Classification: 11 FDA product code: GEI Predicate The proposed VAPR ARCTIC Electrode is substantially Device(s) equivalent to:
- CP90 Electrode: K113545/ K100638 트
- o (November 11, 2012/ June 18, 2010)
- 트 P50 Electrode: K122425/ K100638/K082643: (November 11, 2012/June 18, 2010) o
- 트 Smith and Nephew Eflex Ablator K000691 o (May 4, 2000)
- . Arthrocare Hip ArthroWand: 510(k) # Not Known

{5}------------------------------------------------

| Device<br>Description | The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar<br>suction articulating electrode for use in arthroscopic surgery of the<br>hip. The electrode has a hand-controlled articulating tip to improve<br>access and suction capabilities. This will enhance the efficiency of<br>the electrode and extend the utility of the system by assisting in<br>the removal of bubbles and debris created during activation within<br>the operating site. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ARCTIC Electrode has been designed to facilitate access and<br>control the delivery of RF energy to the joint space. The plug of the<br>ARCTIC Electrode is designed to fit the VAPR VUE® generator<br>socket only. It has an internal identification capacitor code which<br>automatically adjusts the VAPR VUE Generator to the optimal<br>default and accessible powers and waveforms. If required, the<br>settings for the device can be modified within safe pre-determined<br>limits by accessing the generator or footswitch control. It is<br>intended to be run only off the VAPR VUE electrosurgical generator<br>at pre-determined default settings specific for the device. |
| Indications for<br>Use | The VAPR® ARCTIC™ Suction Electrode for use with the VAPR<br>VUE® RF System is intended for resection, ablation and excision of<br>soft tissue, hemostasis of blood vessels and coagulation of soft<br>tissue in patients requiring arthroscopic surgery of the hip. |
| Comparison to<br>Predicate Device | This submission is intended to demonstrate that the ARCTIC<br>Electrode is substantially equivalent to its legally marketed devices.<br>The Electrode has been carefully compared to legally marketed<br>devices with respect to intended use, essential components and<br>material, performance specifications and technology<br>characteristics. |
| | Comparison to Predicate Devices provided in Table 1. |

{6}------------------------------------------------

| Component<br>/ Feature | VAPR CP90<br>Electrode | VAPR P50<br>Electrode | VAPR ARCTIC<br>Suction<br>Electrode | ArthroCare<br>Hip<br>ArthroWand | Eflex Ablator |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | DePuy Mitek | DePuy Mitek | DePuy Mitek | Arthrocare<br>Sports<br>Medicine | Smith and<br>Nephew |
| 510(k) | K113545<br>K100638 | K122425<br>K100638<br>K082643 | Proposed<br>Device | Not Known | K000691 |
| Indication for<br>Use Statement | The DePuy Mitek VAPR<br>Electrodes for use with the<br>VAPR System are intended<br>for resection, ablation,<br>excision of soft tissue,<br>hemostasis of blood vessels<br>and coagulation of soft tissue<br>in patients requiring<br>arthroscopic surgery of the<br>knee, shoulder, hip, ankle,<br>elbow and wrist. | | The VAPR®<br>ARCTIC™<br>Suction<br>Electrode for<br>use with the<br>VAPR VUE RF<br>System is<br>intended for<br>resection,<br>ablation and<br>excision of<br>soft tissue,<br>hemostasis of<br>blood vessels<br>and<br>coagulation<br>of soft tissue<br>in patients<br>requiring<br>arthroscopic<br>surgery of<br>the hip. | The hip<br>ArthroWand<br>with<br>integrated<br>cable is<br>indicated for<br>resection,<br>ablation and<br>coagulation of<br>soft tissue,<br>and<br>hemostasis of<br>blood vessels<br>in<br>arthroscopic<br>procedures | The VULCAN<br>EFLEX Ablator<br>Electrosurgical<br>Probes, in<br>combination<br>with the<br>VULCAN<br>generator Is<br>intended for<br>general<br>surgical use,<br>including<br>orthopedic and<br>arthroscopic<br>applications,<br>for resection,<br>ablation,<br>excision of soft<br>tissue,<br>hemostatis of<br>blood vessels<br>and in<br>coagulating<br>soft tissues in<br>joints including<br>but not limited<br>to the knee,<br>shoulder,<br>wrist, hip,<br>etc. |
| Fixed vs.<br>Articulating<br>Tip | Fixed | Fixed | Articulating | Articulating | Articulating |
| Degree of<br>Tip Flexion | N/A | N/A | 110 degrees | 90 degrees | 100 degrees |
| Rotating Shaft | No | No | No | Yes | No |

## Table 1: Comparison to Predicate Devices

{7}------------------------------------------------

| Tip<br>Configuration | 90 degree<br>side effect | End Effect | End Effect<br>Dome Shape | Chisel | End Effect<br>Dome Shape |
|----------------------|--------------------------|------------|--------------------------|--------|--------------------------|
| RF Energy | Bipolar | SAME | SAME | SAME | Monopolar |
| Working<br>Length | 160mm | SAME | 220mm | 235mm | 240mm |
| Shaft<br>Diameter | 3.7mm | SAME | 3.4mm | 2.95mm | 3.50mm |

#### Safety and Performance

Verification of the ARCTIC Electrode includes electrical and performance tests to show that the device meets its product specifications over a range of operating conditions. Validation testing includes testing to show the device meets user needs.

Verification testing conforms to the Standards listed in Table 2.

| Standard/Guidance | Description |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN 60601-1:2010 | Medical electrical equipment – Part 1:<br>General requirements for safety |
| EN 60601-2-2:2009 | Medical electrical equipment – Part 2-2:<br>Particular requirements for the safety of<br>high frequency surgical equipment |
| EN 60601-1-2:2007 | Medical electrical equipment – Part 1-2:<br>Collateral standards for Electromagnetic<br>compatibility |
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation and testing based<br>on externally communicating device<br>with limited contact with tissue/bone<br>dentin |
| ISO 11137-1:2013 | Gamma radiation and shelf life testing |
| Software Guidance<br>Document<br>(5/11/2005) | Guidance for the content of 510(k) for<br>software contained in medical<br>devices for a MODERATE level of<br>concern |

### TABLE 2: Standards

Validation testing includes testing to show the device meets user needs are:

- Shaft bending ●
- Articulation durability ●
- . Hipot
- Activation ●

{8}------------------------------------------------

- Polyurethane durability ●
- Cable tensile ●
- Suction tube pull ●
- Fluid ingress
- Distal tip and suction tube sealing ●
- Active tip and shroud retention ●
- Lever actuation force ●
- Articulation angle measurement ●
- System compatibility ●
- Dielectric strength ●
- Suction flow
- Articulation wire pull force
- Lever strength ●
- Thermal shock ●
- Thermal margin assessment ●
- Temperature rise ●
- Clogging frequency

Clinical Testing No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The ARCTIC Electrodes do not differ from the predicate device in fundamental scientific technology or intended use.

Conclusion Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.

> Based on the indications for use, fundamental scientific technology, and comparison to the predicate devices, the ARCTIC Electrode is shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.