Sutter CURIS RF Generator

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February 23. 2018 Sutter Medizintechnik GmbH % Andre Kindsvater Senior Consultant, RA/QA Emergo Global Consulting LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 Re: K171869 Trade/Device Name: Sutter CURIS RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2017 Received: January 19, 2018 Dear Andre Kindsvater: 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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ #### Page 2 - Andre Kindsvater and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171869 Device Name Sutter CURIS® RF Generator Indications for Use (Describe) Orthopedic, arthroscopic, spinal and neurosurgical: For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures. For soft tissue resection and coagulation during arthroscopic surgical procedures of knee, show, hip and wrist. Cutting: Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty. Blended Cutting and Coagulation: Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal cell carcinoma, Nevi, Fistulas, Epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps. Hemostasis and nonablative Coagulation: Control of bleeding, Epilation, Teleangiectasia. Bipolar: Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage. Contraindications: This device is not intended for vessel sealing. Type of Use (*Select one or both, as applicable*) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary Sutter CURIS® RF Generator K171869 #### 1. Submission Sponsor Sutter Medizintechnik GmbH Tullastraße 87 Freiburg Germany +49 (0) 761 51551-14 +49 (0) 761 51551-30 CONTACT: Ulrike Zeissler, Title: Manager Regulatory Affairs Email: Zeissler@sutter-med.de ## 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: André Kindsvater, Senior Consultant, RA/QA email: project.management@emergogroup.com ## 3. Date Prepared February 19th, 2018 ## 4. Device Identification | Trade/Proprietary Name: | Sutter CURIS® RF Generator | |-------------------------|------------------------------------------------------| | Common/Usual Name: | RF Generator | | Classification Name: | Electrosurgical, cutting & coagulation & accessories | | Regulation Number: | 21 CFR 878.4400 | | Product Code: | GEI | | Device Class: | Class II | | Classification Panel: | General and Plastic Surgery | ## 5. Legally Marketed Predicate Device(s) Electrosurgical Generator Surgi-Max by Elliquence LLC; K100390 {5}------------------------------------------------ # 6. Indication for Use Statement The Sutter CURIS® RF Generator is intended for: Orthopedic, arthroscopic, spinal and neurosurgical: For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures For soft tissue resection and coaqulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist Cutting: Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin tags, Blepharoplasty Blended Cutting and Coagulation: Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal cell carcinoma, Nevi, Fistulas, Epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps Hemostasis and nonablative Coagulation: Control of bleeding, Epilation, Teleangiectasia Bipolar: Pinpoint. Precise Coagulation. Pinpoint Hemostasis in any field (wet or dry), snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage Contraindications: This device is not intended for vessel sealing. ## 7. Device Description The Sutter CURIS® RF Generator is a compact source of high radiofrequency RF energy to be employed for a variety of electrosurqical procedures. This is achieved by the selection of different wave forms and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Lamps give the operator feedback on the status. The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through foot switch and/or hand switch. Monopolar and bipolar electrodes are available for use. The maximum power output of the device in CUT mode is 100 watts (at 400 Ohms load), and 80 watts maximum in COAG mode at 50 Ohms. Operating frequency of the device is maintained at 4.0 MHz. The device offers both monopolar and bipolar output wave forms. In monopolar mode it offers two CUT wave forms and two COAG wave forms. In bipolar mode it offers three CUT wave forms and three COAG wave forms. The Sutter CURIS® RF Generator is packaged together with power cord and instruction manual. Optional accessories are a foot switch with cable and appropriate monopolar and bipolar cables. {6}------------------------------------------------ ## 8. Sterilization The Sutter CURIS® RF Generator is not distributed as a sterile device, and is not intended to be sterilized at any time. # 9. Biocompatibility The Sutter CURIS® RF Generator is a table-top device which has no contact with the patient. ## 10. Technological Characteristics | Mains supply | 100-240 V; 50/60 Hz | |-------------------------------------------------------------|----------------------------| | Power consumption without RF output | approx. 50 VA | | Power consumption at max. output power | approx. 500 VA | | Protection class | I | | LF and RF<br>leakage currents | according to IEC 60601-2-2 | | Type | CF; defibrillator safe | | Weight | approx. 5.0 kg | | Dimensions W x H x D | 320 mm x 170 mm x 385 mm | | Environmental conditions for transportation<br>and storage: | | | Ambient temperature | 25 °C to +70 °C | | Relative humidity | 10 % to 100 % | | Atmospheric pressure | 500 hPa to 1060 hPa | | Environmental conditions for operation: | | | Ambient temperature | +10 °C to +40 °C | | Relative humidity | 30 % to 75 % | | Atmospheric pressure | 700 hPa to 1060 hPa | ## 11. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of Sutter CURIS® RF Generator and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Sutter Medizintechnik GmbH completed a number of non-clinical performance tests against applicable standards. | | Test | Pass / fail criteria | Results | |---|----------------------------------|-----------------------------------|---------| | 1 | Electrical safety | Compliance to IEC 60601-1: 2005 | Passed | | 2 | Electrical safety | Compliance to IEC 60601-2-2:2009 | Passed | | 3 | Electromagnetic<br>compatibility | Compliance to IEC 60601-1-2: 2007 | Passed | Table 5C - Performance Standards Testing Summary {7}------------------------------------------------ | | Test | Pass / fail criteria | Results | |---|----------------------|------------------------------|---------| | 4 | Risk Management | Compliance to ISO 14971:2007 | Passed | | 5 | Software Performance | Compliance to IEC 62304:2006 | Passed | To demonstrate that the Sutter CURIS® RF Generator meets all design specifications and performance requirements, nonclinical bench testing has been performed in accordance with the internal R&D process in compliance with the proposals and recommendations of FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016. In particular, tests have been planned and carried out with respect to the following subject areas: - Mechanical safety - . Functional safety Testing - . System Performance Testing - . Thermal effects on tissue - Usabilitv ● - Drop Tests ● #### Mechanical safety: Protection against mechanical hazards of ME equipment and ME systems has been tested in compliance with IEC 60601-1:2005. The testing demonstrated that all applicable requirements have been met. #### Functional safety testing: The appropriate delivery of energy from the CURIS® RF Generator to the accessory and patient is controlled by software. The functional safety concept of the CURIS® RF Generator has been tested in compliance with IEC 60601-1:2005, IEC 60601-2-2:2009 and IEC 62304:2006. #### System Performance Testing: System performance testing has been performed in accordance with the internal R&D process and in compliance with the proposals and recommendations of FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016. The review of design requirements was based on the following test methods: Control of labeling and packaging, control of weight and external dimensions, visual inspections, functional inspections and measurements of the generator. The corresponding performance testing demonstrated that all design specifications and performance requirements have been met. #### Thermal effects on tissue The Sutter CURIS® RF Generator has been tested for thermal effects on tissue with commercially available electrosurgical accessories which are widely used and cleared for marketing in the USA. For comparison reasons the predicate device was included. {8}------------------------------------------------ The experimental arrangement was carried out in line with FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" -Guidance for Industry and Food and Drug Administration Staff, August 15, 2016. In all modes, the CURIS® RF Generator delivered adequate coagulation and cutting performance. Generally, CURIS® RF Generator and the predicate device performed similarly. #### Usability: The CURIS® RF Generator has been investigated in order to show that design specifications and performance requirements are met. The results of the thermal effect performance testing, system performance testing, market acceptance tests, and user scenarios tests have been evaluated. It has been assessed that the CURIS® RF Generator fulfills the intended usability and meets the respective design input. #### Drop Tests: Drop tests with the CURIS® RF Generator in its designated packaging have been executed to demonstrate that design specifications and performance requirements are met. Internal verification and validation testing confirms that product specifications are met which are equivalent to the predicate device in design and technological characteristics. The testing results support that the requirements for performance and electrical safety testing were met for the acceptance of the device. The CURIS® RF Generator passed all testing and supports the claims of substantial equivalence to the predicate device. #### 12. Substantial Equivalence Discussion #### Table 5B - Comparison of Characteristics | Manufacturer | Sutter Medizintechnik<br>GmbH | Elliquence LLC | SIGNIFICANT<br>DIFFERENCES | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Trade Name | CURIS® RF Generator | Surgi-Max | N/A | | 510(k) Number | N/A | K100390 | N/A | | Product Code | GEI | GEI | same | | Regulation<br>Number | 21 CFR 878.4400 | 21 CFR 878.4400 | same | | Regulation Name | Electrosurgical, cutting &<br>coagulation & accessories | Electrosurgical, cutting &<br>coagulation & accessories | same | | Intended Use | The Sutter CURIS ® RF<br>Generator is intended for:<br>Orthopedic, arthroscopic,<br>spinal and neurosurgical:<br>For resection and<br>coagulation of soft tissues<br>and hemostasis of blood<br>vessels in orthopedic,<br>arthroscopic, spinal and<br>neurosurgical procedures<br>For soft tissue resection and<br>coagulation during | Orthopedic, arthroscopic,<br>spinal, and neurosurgical:<br>For resection, ablation, and<br>coagulation of soft tissues<br>and hemostasis of blood<br>vessels in orthopedic,<br>arthroscopic, spinal and<br>neurological procedures.<br>For soft tissue resection and<br>ablation during arthroscopic | similar | | Manufacturer | Sutter Medizintechnik<br>GmbH | Elliquence LLC | SIGNIFICANT<br>DIFFERENCES | | Trade Name | CURIS® RF Generator | Surgi-Max | N/A | | | arthroscopic surgical<br>procedures of knee,<br>shoulder, ankle, elbow, hip<br>and wrist. | surgical procedures of knee,<br>shoulder, ankle, elbow, hip<br>and wrist. | | | | Cutting:<br>Snoring, submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective<br>hemorrhage control,<br>epistaxis treatment and<br>turbinate shrinkage, skin<br>incisions, biopsy, cysts,<br>abscesses, tumors, cosmetic<br>repairs, development of skin<br>flaps, skin tags,<br>blepharoplasty | Cutting:<br>Snoring, submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective<br>hemorrhage control,<br>epistaxis treatment, and<br>turbinate shrinkage, skin<br>incisions, biopsy, cysts,<br>abscesses, tumors, cosmetic<br>repairs, development of skin<br>flaps, skin tags,<br>blepharoplasty. | | | | Blended Cutting and<br>Coagulation:<br>Snoring, submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective<br>hemorrhage control,<br>epistaxis treatment and<br>turbinate shrinkage, skin<br>tags, papilloma keloids,<br>keratosis, verrucae, basal<br>cell carcinoma, nevi, fistulas,<br>epithelioma, cosmetic<br>repairs, cysts, abscesses,<br>development of skin flaps | Blended Cutting and<br>Coagulation:<br>Snoring, submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective<br>hemorrhage control,<br>epistaxis treatment, and<br>turbinate shrinkage, skin<br>tags, papilloma keloids,<br>keratosis, verrucae, basal<br>cell carcinoma, nevi, fistulas,<br>epithelioma, cosmetic<br>repairs, cysts, abscesses,<br>Development of skin flaps. | | | | Hemostasis and nonablative<br>Coagulation:<br>Control of bleeding, epilation,<br>teleangiectasia | Hemostasis and Nonablative<br>Coagulation:<br>Control of bleeding, epilation,<br>telangiectasia | | | | Bipolar:<br>Pinpoint, precise coagulation,<br>pinpoint hemostasis in any<br>field (wet or dry), snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective | Bipolar:<br>Pinpoint, precise coagulation,<br>pinpoint hemostasis, in any<br>field (wet or dry), snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective | | | Manufacturer | Sutter Medizintechnik<br>GmbH | Elliquence LLC | SIGNIFICANT<br>DIFFERENCES | | Trade Name | CURIS® RF Generator | Surgi-Max | N/A | | | hemorrhage control,<br>epistaxis treatment and<br>turbinate shrinkage<br>Contraindications:<br>This device is not intended<br>for vessel sealing. | hemorrhage control,<br>epistaxis treatment, and<br>turbinate shrinkage | | | Material | Metal & plastics | Metal & plastics | Similar- the<br>differences do<br>not affect safety<br>and<br>effectiveness | | Battery Operated | no | no | same | | AC Powered | yes | yes | same | | Frequency | 4 MHz | 4 MHz / 1.71 MHz | Similar- the<br>differences do<br>not affect safety<br>and<br>effectiveness | | Delivery Mode | Monopolar and bipolar | Monopolar and bipolar | same | | Waveforms | Mono contact Coag: m<br>Mono Softspray Coag:<br>modulated<br>Mono Cut 1: sinusoidal<br>Mono Cut 2: modulated<br>Bipo precise Coag:<br>modulated<br>Bipo macro Coag: modulated<br>Bipo RaVoR Coag:<br>modulated<br>Bipo Cut1: sinusoidal<br>Bipo Cut 2: modulated<br>Bipo Cut Excise: modulated | Mono Hemo: modulated<br>Mono CUT: sinusoidal<br>Mono CUT/COAG:<br>modulated<br>Bipo Hemo: modulated<br>Bipo Turbo: modulated | Similar- the<br>differences do<br>not affect safety<br>and<br>effectiveness | | Electrical Safety<br>Testing Passed | IEC 60601-1 all applicable<br>requirements met | IEC 60601-1 all applicable<br>requirements met | same | | Electromagnetic<br>compatibility | IEC 60601-1-2 all applicable<br>requirements met | IEC 60601-1-2 all applicable<br>requirements met | same | {9}------------------------------------------------ {10}------------------------------------------------ ## 13. Statement of Substantial Equivalence The CURIS® RF Generator device is substantially equivalent to the predicate device, and does not raise different questions regarding its safety and effectiveness as compared to the predicate device(s).