Neptune E-SEP Smoke Evacuation Pencil

K160693 · Stryker Corporation · GEI · Apr 13, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160693
• Device Name: Neptune E-SEP Smoke Evacuation Pencil
• Applicant: Stryker Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 13, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.

Device Story

Single-use monopolar electrosurgical pencil; integrates smoke evacuation with electrosurgical cutting/coagulation. Input: electrical current from user-supplied electrosurgical generator; surgical smoke via suction. Operation: operator uses rocker or push-button switches to deliver current to operative site; smoke is evacuated through integrated tubing to external vacuum/filtration system. Output: electrosurgical effect on tissue; smoke removal. Used in surgical settings by clinicians. Benefits: minimizes surgical smoke plume exposure to personnel; provides integrated surgical tool. Modifications include additional blade electrode lengths (70mm, 125mm, 165mm) and PTFE heat-shrink insulation at electrode tips to focus high-density current.

Clinical Evidence

No clinical testing was deemed necessary. Evidence consists of bench testing, including electrical safety (ISO 60601-1, ISO 60601-2-2), biocompatibility (ISO 10993-1), and sterilization validation (ISO 11135).

Technological Characteristics

Monopolar electrosurgical pencil; 303 series stainless steel electrodes; PTFE non-stick coating; PTFE heat-shrink tip insulation; ABS plastic connectors; styrene butadiene copolymer/ABS suction sleeve. Dimensions: 190mm length, 17mm diameter. Power: external generator (max 5.5 kV peak). Connectivity: 3-pin electrical connector, 8mm/22mm smoke evacuation tubing. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for general electrosurgical applications including cutting and coagulation and smoke removal in conjunction with an evacuation system. Contraindicated for use on small appendages, such as in circumcision or finger surgery.

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

• Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil (K153679)

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 13, 2016

Stryker Corporation Mairead Twomey Associate Regulatory Affairs Manager 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K160693

Trade/Device Name: Neptune E-SEP™ Smoke Evacuation Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 10, 2016 Received: March 14, 2016

Dear Mairead Twomey:

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

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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 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,
**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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K160693

Device Name

Neptune® E-SEP™ Smoke Evacuation Pencil

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The Neptune E-SEP is an Integrated Smoke Evacuation Pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.

| <div> <span> <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
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# 510(k) Summary

| Contact Details | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, Michigan 49001 USA<br>Ph: [phone]<br>Fax: [phone] |
| FDA Establishment<br>Registration No. | 1811755 |
| Contact Person | Mairead Twomey<br>Associate Regulatory Affairs Manager<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Submitted | March 10th, 2015 |
| Device Name | |
| Trade Name | Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Classification | Class II |
| Primary Classification<br>Name | Electrosurgical, cutting & coagulation & accessories<br>(21 CFR 878.4400, Product code GEI) |
| Reason for 510(k)<br>Submission | Special 510(k) – Device modifications and line extension with no change<br>to fundamental scientific technology or intended use |
| Device Modification and<br>Line Extension | The following is a list of modifications to the Stryker Neptune E-SEP™<br>Smoke Evacuation Pencil. |
| | Addition of three electrodes (70 mm, 125 mm and 165 mm Blade<br>Electrodes)- this is a line extension to enable marketing of a more<br>competitive offering |
| | The proposed devices have an additional layer of insulation (PTFE) at<br>the tip of the electrodes:PTFE (Polytetraflouroethylene) has been added via heat<br>shrinking to the proposed electrodes to focus the delivery of the<br>high density current to the distal end of the electrode tip |
| | This line extension does not change the intended use, indications for use<br>or the fundamental scientific technology of the system. |

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| Legally Marketed Predicate Device(s) | | | |
|-------------------------------------------------------------------------------|--------------|-----------------------------------------------------|--------------|
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K153679 | GEI | Stryker® Neptune® E-SEP™<br>Smoke Evacuation Pencil | Stryker |
| These predicate devices have not been the subject of a design related recall. | | | |

| Indications for Use | The Neptune E-SEP is an Integrated Smoke Evacuation Pencil<br>(pencil) designed for general electrosurgical applications<br>including cutting and coagulation, and for removing smoke<br>generated by electrosurgery when used in conjunction with an<br>effective smoke evacuation system. The pencil enables the<br>operator to remotely conduct an electrosurgical current from<br>the output connector of an electrosurgical unit (generator) to<br>the operative site for the desired surgical effect. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is a<br>single use monopolar electrosurgical pencil that includes a<br>handpiece with a smoke evacuation function and a range of<br>electrodes (both uncoated and coated). The electrosurgical<br>pencil is compact in size (190 mm long and 17 mm<br>diameter) with 3 m of plastic smoke evacuation tubing and<br>associated electrical cable housed within the tubing. The<br>device is externally powered via an external power<br>generator (supplied by user) connected to a monopolar<br>receptacle using a conventional 3-pin connector. This device<br>remains unchanged from the cleared predicate pencil.<br><br>The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is<br>available in two activation switch configurations, a rocker<br>style and push-button style, which activates monopolar cut or<br>coagulate functions operated by pressing the respective<br>button. The pencil is connected to smoke evacuation tubing<br>which features a dual connector (8 and 22 mm) to allow the<br>user to connect to a variety of smoke evacuation systems<br>including filtration or central vacuum systems, thus<br>minimizing exposure of personnel to surgical smoke plume. |

Blade electrodes are available coated and insulated and are listed in the below table.

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| Model Numbers | Model Descriptions |
|---------------|-------------------------------------------------------------|
| 0703-070-002 | Neptune ® E-SEP TM 70mm Blade Electrode Coated & Insulated |
| 0703-125-002 | Neptune ® E-SEP TM 125mm Blade Electrode Coated & Insulated |
| 0703-165-002 | Neptune ® E-SEP TM 165mm Blade Electrode Coated & Insulated |

#### Table 6-1: Model Numbers and Descriptions of proposed Electrodes

| Performance Data<br>(Non-Clinical Tests) | The results of the performance testing demonstrate that the<br>functionality, integrity, and safety and effectiveness of the<br>electrodes for use with the Neptune E-SEP pencil is sufficient<br>for their intended use and support a determination of<br>substantial equivalence to the predicate device. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Performance<br>Testing | Biocompatibility testing was performed on the subject devices<br>in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological<br>Evaluation of Medical Devices - Part 1: Evaluation and Testing.<br>Results of testing validation the subject device is biocompatible<br>as intended for use.<br><br>The electrodes for use with the Neptune E-SEP pencil are only<br>available in sterile packaged form. The sterile products will be<br>terminally sterilized using ethylene oxide (EO). The sterilization<br>method was validated and performed in accordance with<br>ANSI/AAMI/ISO 11135:2014, Sterilization of health-care<br>products Ethylene oxide. A sterility assurance of 10-6 has been<br>validated for these products.<br><br>Performance testing was conducted on the subject devices as<br>determined by the risk analysis for the products. The following<br>areas were evaluated:<br>Electrical Safety Testing Functional / Performance Testing Thermal spread testing Biocompatibility testing Sterilization and packaging testing |

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| | Results of these tests demonstrate that the functionality,<br>integrity, and safety and effectiveness of the subject devices<br>are sufficient for their intended use and support a<br>determination of substantial equivalence. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Tests | No clinical testing was deemed necessary for this 510(k). |

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| | Description | STRYKER E-SEP Pencil [Predicate] | STRYKER® Neptune® E-SEP™ Smoke Evacuation Pencil | Explanation of<br>Difference |
|-------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| | | | [Proposed] | |
| Regulatory Information | 510(k) | K153679 | K160693 | N/A |
| | Product Code | GEI | GEI | Same |
| | Indication for Use | The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect. | The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect. | Same |
| | Classification of Device | Class II | Class II | Same |
| | Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| | Regulation Name | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Same |
| | Condition of Use | Single Use | Single Use | Same |
| | Type of Use | Prescription Use Only | Prescription Use Only | Same |
| | Patient Population | General | General | Same |
| | Contra -<br>indications | Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery. | Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery. | Same |
| Description | STRYKER E-SEP Pencil [Predicate] | STRYKER® Neptune® E-SEP™ Smoke Evacuation Pencil [Proposed] | Explanation of Difference | |
| Overall Design Concept | Overall Design | Device designed to integrate smoke evacuation into electrosurgery by combining both features into a single handpiece. | Device designed to integrate smoke evacuation into electrosurgery by combining both features into a single handpiece. | Same |
| | Power Supply | Monopolar Generator supplied by user | Monopolar Generator supplied by user | Same |
| | Voltage Rating | Maximum 5.5 kV peak | Maximum 5.5 kV peak | Same |
| | Electrical Connector | US-3-Pin | US-3-Pin | Same |
| | Electrical Safety Testing | ISO 60601-1<br>ISO 60601-2-2 | ISO 60601-1<br>ISO 60601-2-2 | Same |
| | Sterility | Sterile Single Use Only, EtO sterilized<br>SAL = 10-6 | Sterile Single Use Only, EtO sterilized<br>SAL = 10-6 | Same |
| | Packaging | Electrodes will be individually packaged in a Tyvek sealed pouch, sold 10 per box. | Electrodes will be individually packaged in a Tyvek sealed pouch, sold 10 per box. | Same |
| Electrode Technology and Materials | Electrode Rod Material | 303 Series Stainless Steel. | 303 Series Stainless Steel. | Same |
| | Electrode Rod Diameter | 2.36 mm | 2.36 mm | Same |
| | Electrode Connector Feature | Pentagon Connector<br>Image: Pentagon Connector | Pentagon Connector<br>Image: Pentagon Connector | Same |
| | Description | STRYKER E-SEP Pencil [Predicate] | STRYKER® Neptune® E-SEP™ Smoke Evacuation Pencil [Proposed] | Explanation of Difference |
| Electrode Technology and Materials | Electrode Connector Material | ABS Polylac PA-757 (ABS Plastic)<br>Image: Electrode Connector | ABS Polylac PA-757 (ABS Plastic)<br>Image: Electrode Connector | Same |
| | Electrode Over Mould Insulation | ABS Polylac PA-757 (For 125 mm and 165mm blade electrodes)<br>Image: Electrode Over Mould Insulation | ABS Polylac PA-757 (For 125 mm and 165mm blade electrodes)<br>Image: Electrode Over Mould Insulation | Same |
| | Electrode tip material | 303 Series Stainless Steel | 303 Series Stainless Steel | Same |
| | Electrode tip coating | PTFE (Polytetrafluoroethylene) (non-stick coating) | PTFE (Polytetrafluoroethylene) (non-stick coating) | Same |
| | Description | STRYKER E-SEP Pencil [Predicate] | STRYKER® Neptune® E-SEP™ Smoke Evacuation Pencil<br>[Proposed] | Explanation of<br>Difference |
| Electrode Technology and Materials | Electrode tip<br>working length | 70 mm - 165 mm | 70 mm - 165 mm | Same |
| | Electrode tip<br>geometry | Blade<br>Image: Electrode tip geometry | Blade<br>Image: Electrode tip geometry | Same |
| | Electrode Tip<br>Insulation | None<br>Image: Electrode tip insulation | PTFE (Polytetrafluroethylene) has been added via heat<br>shrinking to the electrodes.<br>Image: Tip insulation | Different |
| Smoke Evacuation Technology and Materials | Adjustable<br>Suction Sleeve<br>Material | Styrene butadiene copolymer<br>Acrylonitrile Butadiene Styrene with barium sulfate | Styrene butadiene copolymer<br>Acrylonitrile Butadiene Styrene with barium sulfate | Same |
| | Suction Sleeve<br>Lengths | 70mm, 125mm, 165 mm | 70mm, 125mm, 165 mm | Same |
| | Evacuation<br>Tubing<br>Dimension | 10 mm diameter x 3 m length | 10 mm diameter x 3 m length | Same |
| | Smoke<br>Evacuation<br>System<br>Connector | 8mm, 22mm | 8mm, 22mm | Same |
| Description | STRYKER E-SEP Pencil [Predicate] | STRYKER® Neptune® E-SEP™ Smoke Evacuation Pencil [Proposed] | Explanation of Difference | |
| Pencil Technology and Materials | Handpiece Housing Material | Acrylonitrile Butadiene Styrene with Thermoplastic Elastomer | Acrylonitrile Butadiene Styrene with Thermoplastic Elastomer | Same |
| | Handpiece Dimension | 15mm Diameter x 190 mm Length | 15mm Diameter x 190 mm Length | Same |
| | Operation Function Switches | CUT button labeled yellow and proximal to electrode<br>COAG button labeled blue and distal to electrode | CUT button labeled yellow and proximal to electrode<br>COAG button labeled blue and distal to electrode | Same |

Table 6-2: Summary of Predicate Comparison

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## Conclusion/Substantial Equivalence Rationale

The Stryker E-SEP Pencil and Accessories are either identical or similar in intended use, indications for use, technological characteristics, safety and effectiveness to the previously cleared Pencil. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications and line extension of electrodes introduced raise no new issues of safety and effectiveness.

Therefore, the subject device is at least as safe and effective as the predicate and evidence supports a determination of substantial equivalence.