Who is the manufacturer of Erbe ESU Model VIO 3 with Accessories?

Erbe Elektromedizin GmbH filed the 510(k) submission for Erbe ESU Model VIO 3 with Accessories (K190823).

What is the FDA product code for Erbe ESU Model VIO 3 with Accessories?

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 Erbe ESU Model VIO 3 with Accessories?

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

What are the predicate devices for Erbe ESU Model VIO 3 with Accessories?

Erbe ESU Model VIO® 300 D with Accessories (K083452).

Who can help prepare an FDA 510(k) submission like Erbe ESU Model VIO 3 with Accessories?

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.

Erbe ESU Model VIO 3 with Accessories

K190823 · Erbe Elektromedizin GmbH · GEI · May 22, 2019 · General, Plastic Surgery

Device Facts

Record ID	K190823
Device Name	Erbe ESU Model VIO 3 with Accessories
Applicant	Erbe Elektromedizin GmbH
Product Code	GEI · General, Plastic Surgery
Decision Date	May 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended Use

The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Device Story

Standalone electrosurgical unit (ESU) delivers high-frequency (HF) electrical current to tissue via universal instruments (electrodes); used for cutting and coagulation. Operated by physicians in clinical settings; mounted on carts or ceiling. Features touchscreen interface for settings, operational info, and tutorials; includes automatic start/stop and audio/visual error alerts. Physician selects modes based on electrical waveforms/parameters and adjusts effect levels to control thermal tissue effects. System integrates with argon plasma coagulators and various accessories (footswitches, cables). Output affects tissue via voltage/current/contact; provides flexibility for interventional applications. Device includes service-only WiFi feature.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including output/mode comparison, tissue testing, Contact Quality Monitoring (CQM) verification, capacitive coupling testing per IEC 60601-2-2, and accessory testing. Device complies with electrical safety and performance standards including IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Technological Characteristics

HF electrosurgical generator; 350 kHz frequency; 400W max output. Materials: metal sheet, glass, plastics, wiring, aluminum, rubber. Connectivity: WiFi (service-only, deactivated by default). Interface: Touchscreen. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60529 (IP Code), AAMI IEC 62304 (software), ISO 10993-1 (biocompatibility for cables).

Indications for Use

Indicated for the delivery of high frequency electrical current for cutting and/or coagulation of tissue in patients undergoing electrosurgical procedures.

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

Erbe ESU Model VIO® 300 D with Accessories (K083452)

Related Devices

K251108 — Erbe ESU Model VIO® 3n with Accessories · Erbe Elektromedizin GmbH · Aug 29, 2025
K171717 — AUTOCON III 400 · KARL STORZ Endoscopy-America, Inc. · Aug 2, 2017
K150364 — ERBE ESU Model VIO dV with Accessories · Erbe Elektromedizin GmbH · May 5, 2016
K080715 — ERBE VIO ESU, MODEL VIO 200 S · Erbe USA, Inc. · Apr 2, 2008
K060484 — ERBE VIO ESU, MODEL VIO 300 D · Erbe USA, Inc. · Mar 16, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 22, 2019 Erbe Elektromedizin GmbH % Mr. Mark Job Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K190823 Trade/Device Name: Erbe ESU Model VIO 3 with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 10, 2019 Received: May 9, 2019 Dear Mr. Job: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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. for Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190823 Device Name Erbe's ESU Model VIO® 3 with Accessories Indications for Use (Describe) The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue. | 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 [AS REQUIRED BY 21 CFR 807.92(C)] | Submitted By: | Erbe Elektromedizin GmbH Waldhoernlestrasse 17 72072 Tuebingen Germany Tel: 0049-7071-755-0 Fax: 0049-7071-755-179 | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ms. Julia Weller Specialist Regulatory Affairs | | Date Prepared: | February 13, 2019 | | Trade/Proprietary Name: | Erbe ESU Model VIO® 3 with Accessories | | Common Name: | Electrosurgical Unit | | Classification Name and Code: | Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR Part 878.4400) | | Product Code: | GEI | | Legally Marketed Predicate Device: | Erbe ESU Model VIO® 300 D with Accessories, 510(k) Number K083452 | # Device Description: The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.). # ESU Model VIO 3 The ESU is a standalone Unit that can be mounted/secured to a cart or on a ceiling mount (Note: An A/C power cord is provided with the device.). It can integrate a compatible Erbe argon plasma coagulator as well as be used in conjunction with other equipment. The Generator has a touch-screen monitor (i.e., an interactive display) that provides the user with an onscreen tutorial as well as settings and operational information. The ESU has automatic start and stop features. Also, when activated, the device has an audio and visual error system (i.e., malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered). The Unit has clearly defined cutting and coagulation modes based on various electrical waveforms and electrical parameters. Thermal effects on tissue can be different depending on the voltage, current, and the contact between electrode and tissue. With the available modes, the ESU provides physicians the flexibility in interventional applications. Finally, each mode has effect levels which can be finely adjusted by the physician in order to achieve the desired tissue effect. Note: VIO stands for Variable Cut and Coagulation. {4}------------------------------------------------ ## Accessories ### Footswitches Various types of single and double pedal Footswitches have been designed for the ESU Model VIO 3. Specifically, the Footswitches are used to activate the Generator. Some of the Footswitches have a ReMode button so that the physician can toggle between preset programs. Also, some Footswitches are equipped with a divider and/or bracket (i.e., a bar) so that the operator can, as desired, have better foot control. ## Connecting Cables Monopolar and Bipolar Cables are standard in the industry. They provide HF output from the Generator to associated instruments. ### Fastening Sets The Sets include connecting cables and hardware to attach the ESU to a Cart or Ceiling Mount. - VIO Cart The Cart provides mobility for the ESU and associated Accessories. ## Indications for Use: The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue. Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence): | Characteristics | Current Predicate: Erbe ESU Model VIO 300 D with Accessories | Proposed: Erbe ESU Model VIO 3 with Accessories | Discussion | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Erbe Elektromedizin GmbH (Germany) | Erbe Elektromedizin GmbH (Germany) | Same | | 510(k) Number | K083452 | N/A | N/A | | Trade/ Proprietary Name | ERBE ESU Model VIO® 300 D with Accessories | Erbe ESU Model VIO® 3 with Accessories | New name | | Indications for Use | The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue. | The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue. | Same | | Prescription or OTC | Prescription | Prescription | Same | | Frequency | 350 kHz | 350 kHz | Same | | Maximum Output Power | 370 Watts | 400 Watts | Slightly greater maximum output power possible. | | WiFi Feature | N/A | Available (deactivated by default, for service purposes only) | New feature. | | Characteristics | Current Predicate: Erbe ESU Model VIO 300 D with Accessories | Proposed: Erbe ESU Model VIO 3 with Accessories | Discussion | | Output Modules / Receptacles | · monopolar receptacle · bipolar receptacles · receptacle for neutral electrodes | · monopolar receptacle · bipolar receptacles · universal receptacle · receptacle for neutral electrodes | Additional type of receptacle (universal receptacle). | | Modes | · Monopolar Cutting and Coagulation Modes · Bipolar Cutting and Coagulation Modes If connected to a compatible Argon Plasma Coagulator: · APC Modes · argon-assisted Cutting and Coagulation Modes | · Monopolar Cutting and Coagulation Modes · Bipolar Cutting and Coagulation Modes If connected to a compatible Argon Plasma Coagulator: · APC Modes · argon-assisted Cutting and Coagulation Modes | Same (Note: Amount of Modes available is less in the proposed Unit than in the predicate ESU) | | Mode Adjustment | Select voltage and set power limitation | Select effect (comprises defined power output and voltage limitation) | Different. | | User Interface Screen | LED display and selection buttons | Touchscreen display | Different type of display. Both displays provide the user with an onscreen tutorials as well as relevant information. | | Active Accessories - Cables | · return electrode connecting cable · monopolar connecting cables | · return electrode connecting cable · monopolar connecting cables · bipolar connecting cables | Additional type of cable (bipolar connecting cables). | | Miscellaneous Accessories - Footswitches and Cart | · one- and two-pedal footswitches (only compatible with ESU Model VIO 300 D) • Cart | · one- and two-pedal footswitches (only compatible with ESU Model VIO 3) · Cart | Proposed footswitches are only compatible with VIO 3. New footswitch types added. | | Materials | Unit Metal sheet, glass display screen, plastics, wiring Accessories Insulation plastics, wiring, metals, aluminum, rubber, metal sheet | Unit Metal sheet, glass display screen, plastics, wiring Accessories Insulation plastics, wiring, metals, aluminum, rubber, metal sheet | Same | | Condition provided / Use condition | · Non-sterile / reusable (ESU and Footswitches) · Sterile / reusable (Cables) | · Non-sterile / reusable (ESU and Footswitches) · Sterile / reusable (Cables) | Same | {5}------------------------------------------------ ## Erbe Elektromedizin GmbH Traditional 510(k) for Erbe's ESU Model VIO® 3 with Accessories # Verification/Validation Activities (Including Applied/Certified Standards): - ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and • ANSI AAMI A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)* *Other versions of this standard were also tested to and certified. {6}------------------------------------------------ - IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests* - *Other versions of this standard were also tested to and certified. - ANSI AAMI IEC 60601-2-2:2009 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surqical accessories* - *Other versions of this standard were also tested to and certified. - IEC 60529:2013 Degrees of Protection Provided by Enclosures (IP Code) . - AAMI ANSI IEC 62304:2006 Medical device software Software life cycle processes . - IEC 62366:2007 + A1:2014 Medical Devices Application of Usability Engineering to Medical Devices - IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, . labelling and information to be supplied - Part 1: General requirements - . IEC 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices - . ANSI AAMI ST81:2004 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (only for cables) - ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (only for cables) - . ISTA 2A:2011 Partial Simulation Performance Test - Packaged-Products 150lb (68kg) or Less Performance Evaluations/Testing - · Output/Mode Comparison - · Tissue Testing - · Contact Quality Monitoring (CQM) - · Capacitive Coupling (per Standard Number 60601-2-2) - · Accessory Testing # Conclusion: The Erbe ESU Model VIO 3 with Accessories has the same intended use as well as essentially the same principles of operation and technological characteristics as the predicate devices in the previously cleared 510(k)s. Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the Erbe ESU Model VIO 300 D with Accessories (i.e., the predicate devices).