Stryker Neptune E-SEP Smoke Evacuation Pencil

K153679 · Stryker Corporation · GEI · Jan 22, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153679
• Device Name: Stryker Neptune E-SEP Smoke Evacuation Pencil
• Applicant: Stryker Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 22, 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) 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 with integrated smoke evacuation; connects to user-supplied electrosurgical generator and smoke evacuation system. Handpiece features rocker or push-button activation for cut/coagulate functions. Smoke evacuation tubing includes dual connector (8/22 mm) for attachment to filtration or central vacuum systems. Used in surgical settings by clinicians to conduct electrosurgical current to operative site while minimizing smoke plume exposure. Device modifications include expanded electrode geometries (Needle, Ball, T-Bar, U-Bar, Conization) and new materials (ABS plastic over-mold, 304 stainless steel).

Clinical Evidence

No clinical data; bench testing only. Evaluated electrical safety, functional performance, thermal spread, biocompatibility, and sterilization/packaging integrity.

Technological Characteristics

Monopolar electrosurgical pencil; 190 mm length, 17 mm diameter. Materials: 303/304/302 series stainless steel, ABS Polylac PA-757, Polypropylene. Energy: Monopolar electrosurgical current (max 5.5 kV peak). Connectivity: 3-pin connector to generator, 8/22 mm tubing to vacuum. Sterilization: EtO (SAL 10^-6). Standards: IEC 60601-1, IEC 60601-2-2.

Indications for Use

Indicated for general electrosurgical applications including cutting and coagulation and smoke removal in conjunction with an evacuation system. Contraindicated for monopolar electrosurgery on small appendages, such as 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

• SafeAir Smoke Pencil (K143145)

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

January 22, 2016

Stryker Corporation Mairead Twomey Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K153679

Trade/Device Name: Stryker 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: December 18, 2015 Received: December 21, 2015

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 -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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K153679

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.

| | <span> <span style="font-size:10pt"> </span> <span style="font-size:10pt">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> | <span> <span style="font-size:10pt"> </span> <span style="font-size:10pt">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |
|--|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
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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>Senior Staff Regulatory Affairs Specialist<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Submitted | December 18, 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 884.4400, Product code GEI) |
| Reason for 510(k)<br>Submission | Special 510(k) – Device modifications and line extension with no<br>change to fundamental scientific technology or intended use |
| Device Modification and<br>Line Extension | The line of electrodes offered for use with the Stryker E-SEP<br>Pencil will be expanded to include the following: |
| | • Addition of different length of electrodes as well as additional<br>geometries (Needle, Ball, Wire (Loop T-Bar, Loop U-Bar,<br>Conization) – this is a line extension to enable marketing of a<br>more competitive offering |
| | • New materials present in new offering of electrodes:<br>◦ ABS Plastic (Polylac PA-757) has been added as a plastic<br>over-mold for longer electrodes<br>◦ Different grade of stainless steel for the rod and tip of the bar<br>and wire [Loop T-Bar, Loop U-Bar, Conization] electrodes |
| | |
| | This line extension does not change the intended use, indications<br>for use or the fundamental scientific technology of the system. |

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| Legally Marketed Predicate Device(s) | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------|------------------|
| 510(k) Number<br>Predicate | Product Code | Trade Name | Manufacturer |
| K143145 | GEI | SafeAir Smoke Pencil* | Lina Medical Aps |
| *SafeAir Smoke Pencil is currently marketed as Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil<br>after acquisition by Stryker in 2014. | | | |
| 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)<br>designed for general electrosurgical applications including cutting and<br>coagulation, and for removing smoke generated by electrosurgery<br>when used in conjunction with an effective smoke evacuation system.<br>The pencil enables the operator to remotely conduct an electrosurgical<br>current from the output connector of an electrosurgical unit<br>(generator) to the operative site for the desired surgical effect. | | | |
| Device Description | | | |
| The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is a single use<br>monopolar electrosurgical pencil that includes a handpiece with a<br>smoke evacuation function and a range of electrodes (both uncoated<br>and coated). The electrosurgical pencil is compact in size (190 mm long<br>and 17 mm diameter) with 3 m of plastic smoke evacuation tubing and<br>associated electrical cable housed within the tubing. The device is<br>externally powered via an external power generator (supplied by user)<br>connected to a monopolar receptacle using a conventional 3-pin<br>connector. This device remains unchanged from the cleared predicate<br>pencil.<br><br>The Stryker® Neptune® E-SEPT™ Smoke Evacuation Pencil is available in<br>two activation switch configurations, a rocker style and push-button<br>style, which activates monopolar cut or coagulate functions operated<br>by pressing the respective button. The pencil is connected to smoke<br>evacuation tubing which features a dual connector (8 and 22 mm) to<br>allow the user to connect to a variety of smoke evacuation systems<br>including filtration or central vacuum systems, thus minimizing<br>exposure of personnel to surgical smoke plume.<br><br>Electrodes are available in Blade, Needle, Ball, T-Bar Loop, U-Bar Loop<br>and Conization geometries and are listed in Table 6-1 below | | | |

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| Model Numbers | Model Descriptions |
|---------------|------------------------------------------------------|
| 0703-070-000 | Neptune ® E-SEP ™ 70mm Blade Electrode Coated * |
| 0703-070-001 | Neptune ® E-SEP ™ 70mm Blade Electrode * |
| 0703-125-000 | Neptune ® E-SEP ™ 125mm Blade Electrode Coated |
| 0703-125-001 | Neptune ® E-SEP ™ 125mm Blade Electrode |
| 0703-165-000 | Neptune ® E-SEP ™ 165mm Blade Electrode Coated |
| 0703-165-001 | Neptune ® E-SEP ™ 165mm Blade Electrode |
| 0703-007-070 | Neptune ® E-SEP ™ 70mm Needle Electrode |
| 0703-120-003 | Neptune ® E-SEP ™ 3mm Ball Electrode |
| 0703-120-005 | Neptune ® E-SEP ™ 5mm Ball Electrode |
| 0703-213-015 | Neptune ® E-SEP ™ Conization Electrode W13 D15 L120 |
| 0703-213-020 | Neptune ® E-SEP ™ Conization Electrode W13 D20 L120 |
| 0703-216-008 | Neptune ® E-SEP ™ Conization Electrode W16 D8 L120 |
| 0703-216-018 | Neptune ® E-SEP ™ Conization Electrode W16 D18 L 120 |
| 0703-220-020 | Neptune ® E-SEP ™ Conization Electrode W20 D20 L120 |
| 0703-310-010 | Neptune ® E-SEP ™ Loop T-bar Electrode W10 D10 L120 |
| 0703-315-012 | Neptune ® E-SEP ™ Loop T-bar Electrode W15 D12 L120 |
| 0703-320-015 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D15 L120 |
| 0703-320-020 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D20 L120 |
| 0703-620-015 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D15 L60 |
| 0703-620-020 | Neptune ® E-SEP ™ Loop T-bar Electrode W20 D20 L60 |
| 0703-720-020 | Neptune ® E-SEP ™ Loop U-Bar Electrode W20 D20 L120 |

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Image /page/6/Picture/2 description: The image shows the logo for Stryker, a medical technology company. The logo is in black and white and features the word "stryker" in a bold, sans-serif font. A registered trademark symbol is located to the right of the word.

| Performance Data<br>(Non-Clinical Tests) | The results of the performance testing demonstrate that the<br>functionality, integrity, and safety and effectiveness of the electrodes<br>for use with the Neptune E-SEP pencil is sufficient for their intended<br>use and support a determination of substantial equivalence to the<br>predicate device. | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Summary of Performance<br>Testing | Performance testing was conducted on the proposed devices as<br>determined by the risk analysis for the products. The following areas<br>were evaluated:<br>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<br>safety and effectiveness of the subject devices are sufficient for their<br>intended use and support a determination of substantial equivalence. | |
| Clinical Tests | No clinical testing was deemed necessary for this 510(k). | |

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Image /page/7/Picture/1 description: The image contains the text "510(k) Summary for K153679" on the left side of the image. To the right of the text is the Stryker logo. The Stryker logo is in bold, black font. There is a registered trademark symbol to the right of the logo.

### Table 6-2: Summary of Predicate Comparison

| | Description | SafeAir Smoke Pencil [Predicate] K143145<br>(Currently marketed as the Neptune® E-SEP™<br>Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation<br>of Difference |
|---------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Regulatory Information | 510(k) | K143145 | Not yet assigned | N/A |
| | Product Code | GEI | GEI | Same |
| | Indication for<br>Use | SafeAir Smoke Pencil is designed for general<br>electrosurgical applications including cutting and<br>coagulation, and for removing smoke generated by<br>electrosurgery when used in conjunction with an<br>effective smoke evacuation system. The pencil<br>enables the operator to remotely conduct an<br>electrosurgical current from the output connector<br>of an electrosurgical unit to the operative site for<br>the desired surgical effect. | 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. | Same.<br>Stryker<br>Corporation<br>acquired the<br>SafeAir<br>Smoke Pencil<br>in 2014. |
| | Classification of<br>Device | Class II | Class II | Same |
| | Regulation<br>Number | 21 CFR 884.4400 | 21 CFR 884.4400 | Same |
| | Regulation<br>Name | Electrosurgical cutting and coagulation device and<br>accessories | Electrosurgical cutting and coagulation device and accessories | Same |
| | Condition of<br>Use | Single Use | Single Use | Same |
| | Type of Use | Prescription Use Only | Prescription Use Only | Same |
| | Patient<br>Population | General | General | Same |
| | Contra -<br>indications | Do not use monopolar electrosurgery on small<br>appendages, as in circumcision or finger surgery. | Do not use monopolar electrosurgery on small appendages, as<br>in circumcision or finger surgery. | Same |
| Description | | SafeAir Smoke Pencil [Predicate] K143145<br>(Currently marketed as the Neptune® E-SEP™<br>Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation<br>of Difference |
| | Overall Design | Device designed to integrate smoke evacuation<br>into electrosurgery by combining both features<br>into a single handpiece. | Device designed to integrate smoke evacuation into<br>electrosurgery by combining both features into a single<br>handpiece. | Same |
| Overall Design Concept | Power Supply | Monopolar Generator supplied by user | Monopolar Generator supplied by user | Same |
| | Voltage Rating | Maximum 6.0 kV peak | Maximum 5.5 kV peak | Similar |
| | | Electrical<br>Connector | US-3-Pin | US-3-Pin |
| | | Electrical Safety<br>Testing | IEC 60601-1<br>IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-2-2 |
| | Sterility | Sterile Single Use Only, EtO sterilized<br>SAL = $10^{-6}$ | Sterile Single Use Only, EtO sterilized<br>SAL = $10^{-6}$ | Same |
| | Packaging | Single pencil unit with preassembled blade and<br>suction sleeve, holster and clip in an individual<br>Tyvek sealed pouch, sold 10 per box. | Single pencil unit with preassembled blade and suction sleeve,<br>holster and clip in an individual Tyvek sealed pouch, sold 10 per<br>box.<br>Electrodes will also be offered individually packaged in a Tyvek<br>sealed pouch, sold 10 per box. | Similar |
| Description | | SafeAir Smoke Pencil [Predicate] K143145<br>(Currently marketed as the Neptune® E-SEP™<br>Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation<br>of Difference |
| | Electrode Rod<br>Material | 303 Series Stainless Steel. | 303 Series Stainless Steel.<br>This material is being used in 7 of the 21 new electrode rods.<br>The rods of the blade and needle electrodes are made from 303<br>series Stainless Steel. | Same |
| | | This grade of stainless steel was not present in the<br>predicate device. | 304 Series Stainless Steel<br>This material is being used in the remaining 14 of the 21 new<br>electrode rods. The rods of the ball, conization and loop<br>electrodes are made from 304 series Stainless Steel. | Similar |
| | Electrode Rod<br>Diameter | 2.36 mm | 2.36 mm | Same |
| Electrode Technology and Materials | Electrode<br>Connector<br>Feature | Pentagon Connector<br>Image: green pentagon connector | Pentagon Connector<br>Image: green pentagon connector | Same |
| | Electrode<br>Connector<br>Material | Polypropylene (Bormed RF830MO)<br>70 mm blade coated | Polypropylene (Bormed RF830MO)<br>70 mm blade coated &<br>70 mm needle | Same |
| | Electrode<br>Connector<br>Material | H1500 Polypropylene<br>70mm Blade Electrode (uncoated) | H1500 Polypropylene<br>70mm Blade Electrode (uncoated) | Same |
| | | Connector material (ABS Polylac PA-757) was not<br>present on the predicate device. | ABS Polylac PA-757 (ABS Plastic) – new connector material<br>present on the Blade, Conization, T-Bar & U-Bar Loop, Ball<br>electrodes.<br>Image: Electrode Connector | Different |
| Description | | SafeAir Smoke Pencil [Predicate] K143145<br>(Currently marketed as the Neptune® E-SEP™<br>Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation<br>of Difference |
| Electrode Technology<br>and Materials | Electrode Over<br>Mold Insulation<br>(only applicable<br>to longer<br>electrode<br>lengths) | Insulation material (ABS Polylac PA-757 ) was not<br>present on the predicate device | ABS Polylac PA-757 is present on longer length electrodes<br>including the 125mm, 165 mm Blade Electrodes, Ball<br>Electrodes, Needle Electrode, T-bar and U-bar Loop Electrodes<br>and the Conization Electrodes.<br>Image: Electrode Over Mold Insulation | Different |
| | Electrode tip<br>material | 303 Series Stainless Steel | 303 Series Stainless Steel<br>This material is being used in 7 of the 21 new electrode tips.<br>The tips of the blade and needle electrodes are made from 303<br>series Stainless Steel. | Same |
| | | This grade of stainless steel was not present in the<br>predicate device. | 302 Series Stainless Steel<br>304 Series Stainless Steel | Similar |
| | Electrode tip<br>coating | PTFE (Polytetraflouroethylene) | PTFE (Polytetrafluoroethylene) | Same |
| | Electrode tip<br>working length | 70 mm | 70 mm - 165 mm | Different |
| | Electrode tip<br>geometry | Blade (coated and uncoated)<br>Image: Electrode tip geometry | Blade (coated and uncoated)<br>Image: Electrode tip geometry | Same |
| Description | | SafeAir Smoke Pencil [Predicate] K143145<br>(Currently marketed as the Neptune® E-SEP™<br>Smoke Evacuation Pencil) | STRYKER® E-SEP Pencil [Proposed] | Explanation<br>of Difference |
| | Electrode tip<br>geometry | Needle<br>Compatibility with the Colorado MicroDissection<br>needle was cleared previously | Needle<br>Image: Needle | Same |
| | | Not applicable – these geometries were not<br>previously cleared | U-Bar, T-Bar, Conization and Ball<br>Image: U-Bar, T-Bar, Conization and Ball | Different |

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Image /page/8/Picture/1 description: The image shows the text "510(k) Summary for K153679" on the top left. To the right of this text is the Stryker logo. The Stryker logo is in black and has a registered trademark symbol next to it.

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Image /page/9/Picture/1 description: The image shows the title "510(k) Summary for K153679" on the left side of the image. On the right side of the image is the Stryker logo. The Stryker logo is in bold, black font and has a registered trademark symbol next to it.

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Image /page/10/Picture/1 description: The image contains the text "510(k) Summary for K153679" on the left side of the image. To the right of the text is the Stryker logo. The Stryker logo is in bold black font with a registered trademark symbol.

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Image /page/11/Picture/1 description: The image shows the text '510(k) Summary for K153679' on the left side. On the right side of the image is the Stryker logo. The Stryker logo is in black and has a registered trademark symbol.

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Image /page/12/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase, and the word is black. There is a registered trademark symbol to the right of the word. The word is likely a company logo.

#### 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.