Who is the manufacturer of Sutter RaVoR Bipolar Electrodes?

Sutter Medizintechnik GmbH filed the 510(k) submission for Sutter RaVoR Bipolar Electrodes (K191732).

What is the FDA product code for Sutter RaVoR Bipolar Electrodes?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Sutter RaVoR Bipolar Electrodes?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Sutter RaVoR Bipolar Electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sutter RaVoR Bipolar Electrodes

K191732 · Sutter Medizintechnik GmbH · GEI · Aug 30, 2019 · General, Plastic Surgery

Device Facts

Record ID	K191732
Device Name	Sutter RaVoR Bipolar Electrodes
Applicant	Sutter Medizintechnik GmbH
Product Code	GEI · General, Plastic Surgery
Decision Date	Aug 30, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter Ra VoR™ Bipolar Electrodes are indicated for ablation of soft tissue in otorhinolaryngology (ENT) surgery. The Ra VoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue coagulation in the uvula/soft palate for the treatment of snoring. The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

Device Story

Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments designed for connection to the Sutter CURIS® RF Generator. The device delivers radiofrequency energy to soft tissue in ENT procedures; specifically for submucosal shrinkage or coagulation. The electrodes feature various angled sheath configurations and are single-use, sterile devices. Operation is performed by qualified medical personnel in a clinical setting. The device functions by applying bipolar RF energy to target tissues, resulting in controlled thermal effects (lesions) for tissue reduction. The healthcare provider uses the device to treat snoring or nasal airway obstruction; the resulting tissue shrinkage/coagulation provides therapeutic benefit by reducing tissue volume. The device is substantially equivalent to the predicate Celon ENT System.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is supported by bench testing, including electromagnetic compatibility, electrical safety (IEC 60601-1, 60601-2-2, 60601-1-2), mechanical strength, thermal damage/spread experiments, and biocompatibility (ISO 10993-1).

Technological Characteristics

Materials: Stainless steel, Fluoropolymer, Polyester. Energy: Bipolar RF. Design: Parallel electrode configuration, various angled sheaths. Connectivity: Connects to Sutter CURIS® RF Generator. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 11137-1/2, ISO 10993-1.

Indications for Use

Indicated for ENT soft tissue ablation/coagulation. Specifically: submucosal tissue coagulation in uvula/soft palate for snoring treatment; submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

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

Celon ENT System (K032838)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. August 30, 2019 Sutter Medizintechnik GmbH Ulrike Zeissler Manager Regulatory Affairs Tullastrasse 87 79108 Freiburg, Germany Re: K191732 Trade/Device Name: Sutter RaVoR Bipolar Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 25, 2019 Received: June 28, 2019 Dear Ulrike Zeissler: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K191732 Device Name Sutter RaVoR™ Bipolar Electrodes #### Indications for Use (Describe) Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter Ra VoR™ Bipolar Electrodes are indicated for ablation of soft tissue in otorhinolaryngology (ENT) surgery. The Ra VoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue coagulation in the uvula/soft palate for the treatment of snoring. The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction. | 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. 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." {3}------------------------------------------------ # 510(k) Summary Section 807.92 Section 807.92 | Date: | August 29, 2019 | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Submitter: | Name: Address: | SUTTER MEDIZINTECHNIK GmbH Tullastrasse 87 79108 Freiburg Germany | | | Contact person: Titel: Telephone: Fax: | Ulrike Zeissler Manager Regulatory Affairs +49 (0) 761 51551-14 +49 (0) 761 51551-30 | | Product: | Trade Name: Common Name: Classification name: Product Code: | Sutter RaVoR™ Bipolar Electrodes Bipolar Electrodes Electrosurgical, cutting & coagulation & accessories GEI | | | Regulation Number: Classification: Classification Panel: | CFR 21 § 878.4400 Class II General and Plastic Surgery | | Predicate Device: | Predicate device to which Sutter RaVoR™ Bipolar Electrodes are claimed to be substantially equivalent is manufactured by Celon AG medical instruments, Celon ENT System (K032838) | | | Device Description: | Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments available in different angled sheath configurations. They are to be connected to the bipolar output of the Sutter CURIS® RF Generator. The electrodes are provided sterile and are single-use devices. | | | Indications for Use: | Sutter RaVoR™ Bipolar Electrodes are to be connected to the bipolar output of the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery. The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring. The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction. | | {4}------------------------------------------------ ### APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES | Techno- logical Characteris- tics: | The table below provides a comparison between the subject device and the predicate device | | | | | |---------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Sutter RaVOR™ Bipolar Electrodes | Predicate device K032838 | Discussion | | | | | Indication for Use | Sutter RaVOR™ Bipolar Electrodes are to be connected to the bipolar output of the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery. The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring. The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction. | This application system, comprising the CelonLab ENT power control unit and the CelonProBreafh, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including: CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates. CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring. CelonPro Sleep PLUS: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. | Same - for the respective electrode designs. | | | | Maximum peak voltage | 600 Vp | 200 Vp | Similar- the difference does not affect safety and effectiveness. | | | | Electrode Design | parallel | coaxial | Similar- the differences do not affect safety and effectiveness. Thermal damage and thermal spread performance tests show equivalence of obtained lesions. | | | | | | | | | | | Dimensions Tip size [mm]: | $Ø$ 0.8 | $Ø$ 1.1-1.3 | | do not affect safety and effectiveness Similar- the differences do not affect safety and effectiveness. Thermal damage and thermal spread performance tests show equivalence of obtained lesions. | | | Material | Stainless steel, Fluoropolymer, Polyester | Stainless steel, Plastic material | | Similar- the difference does not affect safety and effectiveness. | | | Meets IEC 60601-1 | yes | yes | | Same | | | Meets IEC 60601-1-2 | yes | yes | | Same | | | Meets IEC 60601-2-2 | yes | yes | | Same | | | Sterility Assurance Level | 10-6 | 10-6 | | Same | | | Sterilization Method | Ethylene Oxide | Gamma irradiation | | Similar- the differences do not affect safety and effectiveness. Different commonly used sterilization methods, both lead to the same value of sterility assurance level. | | Non-Clinical Performance Data: | | The following performance data has been obtained for the substantial equivalence determination. Bench Testing Performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the 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 carried out with respect to following subject areas: | | | | | | | Performance Data Bench Tests | | | | | | | Test | Conclusion | | | | | | Electromagnetic Compatibility and Electrical Safety | Pass | | | | | | Mechanical strength | Pass | | | | | | System Performance /Bench-top validation testing | Pass | | | | | | Thermal effects on tissue | Pass | | | | | | Transport and Storage | Pass | | | {5}------------------------------------------------ ## APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES {6}------------------------------------------------ | Electromagnetic Compatibility and Electrical Safety Testing Electrical and electromagnetic tests have been performed to demonstrate that design specifications and performance requirements are met. Compliance to the voluntary standards IEC 60601-1 (AAMI/ANSI ES60601-1:2005), IEC 60601-2-2 and IEC 60601-1-2 has been shown. | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterilization Sutter RaVoR™ Bipolar Electrodes are sterilized by using a validated ethylene oxide cycle. The sterilization cycle has been validated to ensure a sterility level of (SAL) 10-6 in accordance with ISO 11137-1 and ISO 11137-2. | | | Shelf Life Testing Shelf-life testing has been conducted in accordance to 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. Sutter RaVoR™ Bipolar Electrodes have been subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for up to 3 years. | | | Biocompatibility Testing Biological evaluation and Biocompatibility testing has been performed in compliance to ISO 10993-1 Fourth edition 2009-10-15, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”. | | | Thermal damage / thermal spread testing Thermal damage / thermal spread experiments were performed for the subject and predicate device. It was possible to examine and determine the tissue cool-down time from RF activation to baseline temperature. Furthermore, results of these experiments showed that subject and predicate device generate comparable thermal effects in tissue with regards to lesion size and cool-down time. | | | Animal Studies No animal studies have been performed as appropriate verification and validation of the subject device has been achieved based on comparison to the predicate device and from results of the bench testing, biocompatibility evaluation, and electrical/safety testing. | | | Clinical Studies No clinical studies have been performed as appropriate verification and validation of the subject device has been achieved based on comparison to the predicate device and from results of the bench testing, biocompatibility evaluation, and electrical/safety testing. | | | Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance, and indications for use, Sutter Medizintechnik GmbH concludes that the subject device, Sutter RaVoR™ Bipolar Electrodes, does not raise any issues of safety or effectiveness and are substantially equivalent to the predicate device as described above. | | | | {7}------------------------------------------------ ## APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES

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