(30 days)
Not Found
No
The summary describes a standard electrosurgical pencil with smoke evacuation, focusing on its mechanical and electrical functions. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are standard biocompatibility, sterilization, and functional tests, not related to AI/ML model performance.
Yes
The device is an electrosurgical pencil designed for cutting and coagulation, which are therapeutic actions to achieve a surgical effect on tissue.
No
The device is described as an electrosurgical pencil for cutting and coagulation, and for removing smoke during surgery, which are therapeutic and operational functions, not diagnostic.
No
The device description clearly states it is a "single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes" and mentions physical components like tubing and electrical cable. This indicates a hardware device, not software only.
Based on the provided information, the Neptune E-SEP is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery". This describes a surgical tool used directly on a patient during a procedure.
- Device Description: The description details a "single use monopolar electrosurgical pencil" that connects to an "external power generator" and is used at the "operative site". This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Neptune E-SEP does not perform any such analysis of biological samples.
Therefore, the Neptune E-SEP is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
Device Description
The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is a single use monopolar electrosurgical pencil that includes a handpiece with a smoke evacuation function and a range of electrodes (both uncoated and coated). The electrosurgical pencil is compact in size (190 mm long and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and associated electrical cable housed within the tubing. The device is externally powered via an external power generator (supplied by user) connected to a monopolar receptacle using a conventional 3-pin connector. This device remains unchanged from the cleared predicate pencil.
The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is available in two activation switch configurations, a rocker style and push-button style, which activates monopolar cut or coagulate functions operated by pressing the respective button. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
General
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 testing was conducted on the subject devices as determined by the risk analysis for the products. The following areas were evaluated:
Electrical Safety Testing
Functional / Performance Testing
Thermal spread testing
Biocompatibility testing
Sterilization and packaging testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use and support a determination of substantial equivalence.
No clinical testing was deemed necessary for this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.
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
1
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 (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 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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.
| ☑ 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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
| Contact Details | |
|---|---|
| 510(k) Owner | Stryker Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, Michigan 49001 USA | |
| Ph: +353-21-4532988 | |
| Fax: +1-269-324-5412 | |
| FDA Establishment | |
| Registration No. | 1811755 |
| Contact Person | Mairead Twomey |
| Associate Regulatory Affairs Manager | |
| Ph: +353-21-4532988 | |
| Fax: +1-269-389-5412 | |
| Mairead.Twomey@stryker.com | |
| 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 | |
| Name | Electrosurgical, cutting & coagulation & accessories |
| (21 CFR 878.4400, Product code GEI) | |
| Reason for 510(k) | |
| Submission | Special 510(k) – Device modifications and line extension with no change |
| to fundamental scientific technology or intended use | |
| Device Modification and | |
| Line Extension | The following is a list of modifications to the Stryker Neptune E-SEP™ |
| Smoke Evacuation Pencil. | |
| Addition of three electrodes (70 mm, 125 mm and 165 mm Blade | |
| Electrodes)- this is a line extension to enable marketing of a more | |
| competitive offering | |
| The proposed devices have an additional layer of insulation (PTFE) at | |
| the tip of the electrodes:PTFE (Polytetraflouroethylene) has been added via heat | |
| shrinking to the proposed electrodes to focus the delivery of the | |
| high density current to the distal end of the electrode tip | |
| This line extension does not change the intended use, indications for use | |
| or the fundamental scientific technology of the system. |
4
| Legally Marketed Predicate Device(s) | |||
|---|---|---|---|
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| K153679 | GEI | Stryker® Neptune® E-SEP™ | |
| 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
(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 Description | The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is a
single use monopolar electrosurgical pencil that includes a
handpiece with a smoke evacuation function and a range of
electrodes (both uncoated and coated). The electrosurgical
pencil is compact in size (190 mm long and 17 mm
diameter) with 3 m of plastic smoke evacuation tubing and
associated electrical cable housed within the tubing. The
device is externally powered via an external power
generator (supplied by user) connected to a monopolar
receptacle using a conventional 3-pin connector. This device
remains unchanged from the cleared predicate pencil.
The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is
available in two activation switch configurations, a rocker
style and push-button style, which activates monopolar cut or
coagulate functions operated by pressing the respective
button. The pencil is connected to smoke evacuation tubing
which features a dual connector (8 and 22 mm) to allow the
user to connect to a variety of smoke evacuation systems
including filtration or central vacuum systems, thus
minimizing exposure of personnel to surgical smoke plume. |
Blade electrodes are available coated and insulated and are listed in the below table.
5
| 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
(Non-Clinical Tests) | The results of the performance testing demonstrate that the
functionality, integrity, and safety and effectiveness of the
electrodes for use with the Neptune E-SEP pencil is sufficient
for their intended use and support a determination of
substantial equivalence to the predicate device. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Performance
Testing | Biocompatibility testing was performed on the subject devices
in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological
Evaluation of Medical Devices - Part 1: Evaluation and Testing.
Results of testing validation the subject device is biocompatible
as intended for use.
The electrodes for use with the Neptune E-SEP pencil are only
available in sterile packaged form. The sterile products will be
terminally sterilized using ethylene oxide (EO). The sterilization
method was validated and performed in accordance with
ANSI/AAMI/ISO 11135:2014, Sterilization of health-care
products Ethylene oxide. A sterility assurance of 10-6 has been
validated for these products.
Performance testing was conducted on the subject devices as
determined by the risk analysis for the products. The following
areas were evaluated:
Electrical Safety Testing Functional / Performance Testing Thermal spread testing Biocompatibility testing Sterilization and packaging testing |
6
| | Results of these tests demonstrate that the functionality,
integrity, and safety and effectiveness of the subject devices
are sufficient for their intended use and support a
determination of substantial equivalence. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Tests | No clinical testing was deemed necessary for this 510(k). |
7
| | Description | STRYKER E-SEP Pencil [Predicate] | STRYKER® Neptune® E-SEP™ Smoke Evacuation Pencil | Explanation of
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 -
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
ISO 60601-2-2 | ISO 60601-1
ISO 60601-2-2 | Same |
| | Sterility | Sterile Single Use Only, EtO sterilized
SAL = 10-6 | Sterile Single Use Only, EtO sterilized
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
Image: Pentagon Connector | Pentagon Connector
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)
Image: Electrode Connector | ABS Polylac PA-757 (ABS Plastic)
Image: Electrode Connector | Same |
| | Electrode Over Mould Insulation | ABS Polylac PA-757 (For 125 mm and 165mm blade electrodes)
Image: Electrode Over Mould Insulation | ABS Polylac PA-757 (For 125 mm and 165mm blade electrodes)
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
[Proposed] | Explanation of
Difference |
| Electrode Technology and Materials | Electrode tip
working length | 70 mm - 165 mm | 70 mm - 165 mm | Same |
| | Electrode tip
geometry | Blade
Image: Electrode tip geometry | Blade
Image: Electrode tip geometry | Same |
| | Electrode Tip
Insulation | None
Image: Electrode tip insulation | PTFE (Polytetrafluroethylene) has been added via heat
shrinking to the electrodes.
Image: Tip insulation | Different |
| Smoke Evacuation Technology and Materials | Adjustable
Suction Sleeve
Material | Styrene butadiene copolymer
Acrylonitrile Butadiene Styrene with barium sulfate | Styrene butadiene copolymer
Acrylonitrile Butadiene Styrene with barium sulfate | Same |
| | Suction Sleeve
Lengths | 70mm, 125mm, 165 mm | 70mm, 125mm, 165 mm | Same |
| | Evacuation
Tubing
Dimension | 10 mm diameter x 3 m length | 10 mm diameter x 3 m length | Same |
| | Smoke
Evacuation
System
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
COAG button labeled blue and distal to electrode | CUT button labeled yellow and proximal to electrode
COAG button labeled blue and distal to electrode | Same |
Table 6-2: Summary of Predicate Comparison
8
9
10
11
12
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.