(30 days)
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.
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.
The provided text does not contain information about the acceptance criteria and study that proves the device meets them. The document is a 510(k) premarket notification from the FDA for a medical device called the "Neptune E-SEP™ Smoke Evacuation Pencil."
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K153679). This means the manufacturer is asserting that the new device is as safe and effective as the predicate, based on its similarities and the results of non-clinical performance testing.
Here's what can be inferred or stated from the document regarding the device's performance and testing:
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Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed as a table of acceptance criteria and corresponding performance metrics. The document broadly states under "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."
- Evaluation Areas: The performance testing covered:
- Electrical Safety Testing
- Functional / Performance Testing
- Thermal spread testing
- Biocompatibility testing
- Sterilization and packaging testing
- Results: "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."
- Evaluation Areas: The performance testing covered:
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Sample Size Used for the Test Set and Data Provenance: This information is not provided in the document. The document refers to "performance testing" but does not specify sample sizes for these tests or the data provenance.
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Number of Experts Used to Establish Ground Truth and Qualifications: This information is not applicable as the document describes non-clinical performance testing, not a study involving ground truth established by medical experts.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." This indicates that comparative effectiveness studies with human readers were not performed.
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Standalone (Algorithm Only) Performance Study: Not applicable, as this is a physical medical device (an electrosurgical pencil), not an AI algorithm.
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Type of Ground Truth Used: Not applicable. The performance testing described (electrical safety, functional, thermal spread, biocompatibility, sterilization) relies on engineering specifications, standards, and laboratory evaluations rather than a medical "ground truth."
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Sample Size for the Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
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How Ground Truth for the Training Set Was Established: Not applicable.
In summary, the document provides evidence for substantial equivalence through non-clinical performance testing against established standards and comparison to a predicate device, rather than a study with acceptance criteria and clinical performance metrics as might be found for a novel diagnostic or therapeutic device.
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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
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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 (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
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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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
| Contact Details | |
|---|---|
| 510(k) Owner | Stryker Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001 USAPh: +353-21-4532988Fax: +1-269-324-5412 |
| FDA EstablishmentRegistration No. | 1811755 |
| Contact Person | Mairead TwomeyAssociate Regulatory Affairs ManagerPh: +353-21-4532988Fax: +1-269-389-5412Mairead.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 ClassificationName | 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 changeto fundamental scientific technology or intended use |
| Device Modification andLine 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 BladeElectrodes)- this is a line extension to enable marketing of a morecompetitive offering | |
| The proposed devices have an additional layer of insulation (PTFE) atthe tip of the electrodes:PTFE (Polytetraflouroethylene) has been added via heatshrinking to the proposed electrodes to focus the delivery of thehigh density current to the distal end of the electrode tip | |
| This line extension does not change the intended use, indications for useor 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™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 applicationsincluding cutting and coagulation, and for removing smokegenerated by electrosurgery when used in conjunction with aneffective smoke evacuation system. The pencil enables theoperator to remotely conduct an electrosurgical current fromthe output connector of an electrosurgical unit (generator) tothe operative site for the desired surgical effect. |
|---|---|
| Device Description | The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil is asingle use monopolar electrosurgical pencil that includes ahandpiece with a smoke evacuation function and a range ofelectrodes (both uncoated and coated). The electrosurgicalpencil is compact in size (190 mm long and 17 mmdiameter) with 3 m of plastic smoke evacuation tubing andassociated electrical cable housed within the tubing. Thedevice is externally powered via an external powergenerator (supplied by user) connected to a monopolarreceptacle using a conventional 3-pin connector. This deviceremains unchanged from the cleared predicate pencil.The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil isavailable in two activation switch configurations, a rockerstyle and push-button style, which activates monopolar cut orcoagulate functions operated by pressing the respectivebutton. The pencil is connected to smoke evacuation tubingwhich features a dual connector (8 and 22 mm) to allow theuser to connect to a variety of smoke evacuation systemsincluding filtration or central vacuum systems, thusminimizing 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(Non-Clinical Tests) | The results of the performance testing demonstrate that thefunctionality, integrity, and safety and effectiveness of theelectrodes for use with the Neptune E-SEP pencil is sufficientfor their intended use and support a determination ofsubstantial equivalence to the predicate device. |
|---|---|
| Summary of PerformanceTesting | Biocompatibility testing was performed on the subject devicesin accordance with ANSI/AAMI/ISO 10993-1:2009: BiologicalEvaluation of Medical Devices - Part 1: Evaluation and Testing.Results of testing validation the subject device is biocompatibleas intended for use.The electrodes for use with the Neptune E-SEP pencil are onlyavailable in sterile packaged form. The sterile products will beterminally sterilized using ethylene oxide (EO). The sterilizationmethod was validated and performed in accordance withANSI/AAMI/ISO 11135:2014, Sterilization of health-careproducts Ethylene oxide. A sterility assurance of 10-6 has beenvalidated for these products.Performance testing was conducted on the subject devices asdetermined by the risk analysis for the products. The followingareas were evaluated: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,integrity, and safety and effectiveness of the subject devicesare sufficient for their intended use and support adetermination 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 ofDifference | |
|---|---|---|---|---|
| [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 60601-1ISO 60601-2-2 | ISO 60601-1ISO 60601-2-2 | Same | |
| Sterility | Sterile Single Use Only, EtO sterilizedSAL = 10-6 | Sterile Single Use Only, EtO sterilizedSAL = 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 ConnectorImage: Pentagon Connector | Pentagon ConnectorImage: 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 ofDifference | |
| Electrode Technology and Materials | Electrode tipworking length | 70 mm - 165 mm | 70 mm - 165 mm | Same |
| Electrode tipgeometry | BladeImage: Electrode tip geometry | BladeImage: Electrode tip geometry | Same | |
| Electrode TipInsulation | NoneImage: Electrode tip insulation | PTFE (Polytetrafluroethylene) has been added via heatshrinking to the electrodes.Image: Tip insulation | Different | |
| Smoke Evacuation Technology and Materials | AdjustableSuction SleeveMaterial | Styrene butadiene copolymerAcrylonitrile Butadiene Styrene with barium sulfate | Styrene butadiene copolymerAcrylonitrile Butadiene Styrene with barium sulfate | Same |
| Suction SleeveLengths | 70mm, 125mm, 165 mm | 70mm, 125mm, 165 mm | Same | |
| EvacuationTubingDimension | 10 mm diameter x 3 m length | 10 mm diameter x 3 m length | Same | |
| SmokeEvacuationSystemConnector | 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 electrodeCOAG button labeled blue and distal to electrode | CUT button labeled yellow and proximal to electrodeCOAG 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.
§ 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.