(63 days)
Sutter RaVoR™ Bipolar Electrodes are to be connected to 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.
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.
The Sutter RaVoR™ Bipolar Electrodes are not an AI device, therefore, the information requested is not available in the provided text. The document refers to the device as an electrosurgical instrument for soft tissue ablation and coagulation in ENT surgery. It describes non-clinical performance data and concludes substantial equivalence to a predicate device, but does not pertain to AI/ML or require the typical acceptance criteria and study designs associated with AI devices.
However, based on the provided text, here is a breakdown of the non-clinical performance data and the study types conducted to demonstrate substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by "Pass" for each test, indicating that the device met the design specifications and performance requirements.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility and Electrical Safety | Pass relevant IEC standards | Pass |
| Mechanical Strength | Meet strength requirements | Pass |
| System Performance / Bench-top validation testing | Meet performance requirements | Pass |
| Thermal effects on tissue | Meet thermal effect targets | Pass |
| Transport and Storage | Maintain functionality | Pass |
| Sterility Assurance Level (SAL) | 10⁻⁶ | 10⁻⁶ |
| Shelf Life | Up to 3 years | Up to 3 years |
| Biocompatibility | Compliance to ISO 10993-1 | Performed |
| Thermal damage / thermal spread testing | Comparable to predicate | Comparable to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI device. Instead, it refers to a series of bench tests.
- Sample Sizes: Not explicitly stated for each bench test. For "Thermal damage / thermal spread testing," experiments were performed for both the subject and predicate device, implying multiple tests or observations to draw comparisons.
- Data Provenance: The data is from "Bench Testing" and "Non-Clinical Performance Data" conducted by the applicant, Sutter Medizintechnik GmbH. This is laboratory-based testing, not human data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable, as this is not an AI device and the ground truth for performance was established through engineering and scientific testing standards rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method
Not applicable. The performance was assessed against technical standards and benchmarks, not through expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted as this device is not an AI algorithm requiring human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established through:
- Engineering Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 11137-1, ISO 11137-2, and ISO 10993-1.
- Benchmarking against Predicate Device: Comparison of thermal effects, lesion size, and cool-down time to the legally marketed predicate device (Celon AG medical instruments, Celon ENT System, K032838).
- Laboratory Measurements: Direct measurements of physical properties, electrical characteristics, and biological interactions in controlled environments.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
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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
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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
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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)
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510(k) Summary
Section 807.92
Section 807.92
| Date: | August 29, 2019 | |
|---|---|---|
| Submitter: | Name:Address: | SUTTER MEDIZINTECHNIK GmbHTullastrasse 8779108 FreiburgGermany |
| Contact person:Titel:Telephone:Fax: | Ulrike ZeisslerManager Regulatory Affairs+49 (0) 761 51551-14+49 (0) 761 51551-30 | |
| Product: | Trade Name:Common Name:Classificationname:Product Code: | Sutter RaVoR™ Bipolar ElectrodesBipolar ElectrodesElectrosurgical, cutting & coagulation &accessoriesGEI |
| RegulationNumber:Classification:ClassificationPanel: | CFR 21 § 878.4400Class IIGeneral and Plastic Surgery | |
| PredicateDevice: | Predicate device to which Sutter RaVoR™ Bipolar Electrodes areclaimed to be substantially equivalent is manufactured by Celon AG medical instruments, Celon ENT System (K032838) | |
| DeviceDescription: | Sutter RaVoR™ Bipolar Electrodes are electrosurgical instrumentsavailable in different angled sheath configurations. They are to beconnected to the bipolar output of the Sutter CURIS® RF Generator. Theelectrodes are provided sterile and are single-use devices. | |
| Indicationsfor Use: | Sutter RaVoR™ Bipolar Electrodes are to be connected to the bipolaroutput of the Sutter CURIS® RF Generator. Sutter RaVoR™ BipolarElectrodes are indicated for ablation and coagulation of soft tissue inotorhinolaryngology (ENT) surgery.The RaVoR™ Bipolar Electrode for the soft palate is indicated forsubmucosal tissue shrinkage and tissue coagulation in the uvula/softpalate for the treatment of snoring.The RaVoR™ Bipolar Electrode for the turbinates is indicated forsubmucosal tissue shrinkage for reduction of hypertrophic nasalturbinates in patients with nasal turbinate airway obstruction. |
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES
| Techno-logicalCharacteris-tics: | The table below provides a comparison between the subject device andthe predicate device | ||||
|---|---|---|---|---|---|
| Sutter RaVOR™Bipolar Electrodes | Predicate deviceK032838 | Discussion | |||
| Indication forUse | Sutter RaVOR™Bipolar Electrodes areto be connected to thebipolar output of theSutter CURIS® RFGenerator. SutterRaVoR™ BipolarElectrodes areindicated for ablationand coagulation of softtissue inotorhinolaryngology(ENT) surgery.The RaVoR™ BipolarElectrode for the softpalate is indicated forsubmucosal tissueshrinkage and tissuecoagulation in theuvula/soft palate forthe treatment ofsnoring.The RaVoR™ BipolarElectrode for theturbinates is indicatedfor submucosal tissueshrinkage for reductionof hypertrophic nasalturbinates in patientswith nasal turbinateairway obstruction. | This applicationsystem, comprising theCelonLab ENT powercontrol unit and theCelonProBreafh,CelonProSleep, andCelonProSleep PLUSbipolar coagulationelectrodes, is indicatedfor ablation andcoagulation of softtissue inotorhinolaryngology(ENT) surgeryincluding:CelonProBreath:Submucosal tissueshrinkage for nasalairway obstruction byreduction ofhypertrophic nasalturbinates.CelonProSleep:Submucosal tissueshrinkage and tissuecoagulation in theuvula/soft palate forthe treatment ofsnoring.CelonPro Sleep PLUS:Submucosal tissueshrinkage and tissuecoagulation in theuvula/soft palate forthe treatment ofsnoring.The system is intendedfor use by qualifiedmedical personneltrained in the use ofelectrosurgicalequipment. | Same - for therespective electrodedesigns. | ||
| Maximumpeak voltage | 600 Vp | 200 Vp | Similar- the differencedoes not affect safetyand effectiveness. | ||
| ElectrodeDesign | parallel | coaxial | Similar- the differencesdo not affect safetyand effectiveness.Thermal damage andthermal spreadperformance testsshow equivalence ofobtained lesions. | ||
| DimensionsTip size [mm]: | $Ø$ 0.8 | $Ø$ 1.1-1.3 | do not affect safetyand effectivenessSimilar- the differencesdo not affect safetyand effectiveness.Thermal damage andthermal spreadperformance testsshow equivalence ofobtained lesions. | ||
| Material | Stainless steel,Fluoropolymer,Polyester | Stainless steel,Plastic material | Similar- the differencedoes not affect safetyand 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 differencesdo not affect safetyand effectiveness.Different commonlyused sterilizationmethods, both lead tothe same value ofsterility assurancelevel. | ||
| Non-ClinicalPerformance Data: | The following performance data has been obtained for the substantial equivalence determination.Bench TestingPerformance 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 andElectrical Safety | Pass | ||||
| Mechanical strength | Pass | ||||
| System Performance /Bench-topvalidation testing | Pass | ||||
| Thermal effects on tissue | Pass | ||||
| Transport and Storage | Pass |
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH
DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES
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| Electromagnetic Compatibility and Electrical Safety TestingElectrical and electromagnetic tests have been performed todemonstrate that design specifications and performance requirementsare met. Compliance to the voluntary standards IEC 60601-1(AAMI/ANSI ES60601-1:2005), IEC 60601-2-2 and IEC 60601-1-2 hasbeen shown. | |
|---|---|
| SterilizationSutter RaVoR™ Bipolar Electrodes are sterilized by using a validatedethylene oxide cycle. The sterilization cycle has been validated toensure a sterility level of (SAL) 10-6 in accordance with ISO 11137-1and ISO 11137-2. | |
| Shelf Life TestingShelf-life testing has been conducted in accordance to of FDAguidance: "Premarket Notification [510(k)] Submissions forElectrosurgical Devices for General Surgery" – Guidance for Industryand Food and Drug Administration Staff, August 15, 2016. SutterRaVoR™ Bipolar Electrodes have been subjected to accelerated aging.The aging studies established that the device and packaging remainfunctional and maintain sterility for up to 3 years. | |
| Biocompatibility TestingBiological evaluation and Biocompatibility testing has been performed incompliance to ISO 10993-1 Fourth edition 2009-10-15, “Biologicalevaluation of medical devices - Part 1: Evaluation and testing within arisk management process”. | |
| Thermal damage / thermal spread testingThermal damage / thermal spread experiments were performed for thesubject and predicate device. It was possible to examine and determinethe tissue cool-down time from RF activation to baseline temperature.Furthermore, results of these experiments showed that subject andpredicate device generate comparable thermal effects in tissue withregards to lesion size and cool-down time. | |
| Animal StudiesNo animal studies have been performed as appropriate verification andvalidation of the subject device has been achieved based oncomparison to the predicate device and from results of the benchtesting, biocompatibility evaluation, and electrical/safety testing. | |
| Clinical StudiesNo clinical studies have been performed as appropriate verification andvalidation of the subject device has been achieved based oncomparison to the predicate device and from results of the benchtesting, biocompatibility evaluation, and electrical/safety testing. | |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFRPart 807 and based on the similarity to the predicate device in terms oftechnology, performance, and indications for use, Sutter MedizintechnikGmbH concludes that the subject device, Sutter RaVoR™ BipolarElectrodes, does not raise any issues of safety or effectiveness and aresubstantially equivalent to the predicate device as described above. |
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APPLICANT: SUTTER MEDIZINTECHNIK GMBH
DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES
§ 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.