(51 days)
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.
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.).
The provided document pertains to a 510(k) premarket notification for a medical device, the Erbe ESU Model VIO® 3 with Accessories. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance acceptance criteria through clinical studies in the same way a PMA or a de novo submission might.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or how ground truth for training sets was established. These details would typically be found in clinical study reports or more extensive technical documentation, which are not part of this 510(k) summary.
Instead, the document highlights:
- 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."
- Substantial Equivalence: The submission claims the device is substantially equivalent to the predicate device, Erbe ESU Model VIO® 300 D with Accessories (K083452).
- Verification/Validation Activities: These activities focused on meeting recognized standards, including electrical safety (e.g., IEC 60601 series), software lifecycle (IEC 62304), usability (IEC 62366, IEC 60601-1-6), sterilization information (IEC 17664, AAMI ST81), and biological evaluation (ISO 10993-1).
- Performance Evaluations/Testing:
- Output/Mode Comparison
- Tissue Testing
- Contact Quality Monitoring (CQM)
- Capacitive Coupling (per Standard Number 60601-2-2)
- Accessory Testing
These performance evaluations were likely bench or pre-clinical tests designed to show that the device performs as intended and similarly to the predicate device, but the specifics of acceptance criteria for these tests and their results in a tabular format are not provided in this summary.
In summary, the document does not provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as such detailed performance data is generally not part of a 510(k) summary that focuses on substantial equivalence.
{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 GmbHWaldhoernlestrasse 1772072 TuebingenGermanyTel: 0049-7071-755-0Fax: 0049-7071-755-179 |
|---|---|
| Contact Person: | Ms. Julia WellerSpecialist 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 andAccessories (21 CFR Part 878.4400) |
| Product Code: | GEI |
| Legally MarketedPredicate 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 Dwith Accessories | Proposed:Erbe ESU Model VIO 3 withAccessories | Discussion |
|---|---|---|---|
| Manufacturer | Erbe Elektromedizin GmbH(Germany) | Erbe Elektromedizin GmbH(Germany) | Same |
| 510(k) Number | K083452 | N/A | N/A |
| Trade/ProprietaryName | ERBE ESU Model VIO® 300D with Accessories | Erbe ESU Model VIO® 3with Accessories | New name |
| Indications forUse | The ERBE ESU Model VIO300 D with Accessories isintended to deliver HighFrequency (HF) electricalcurrent for the cutting and/orcoagulation of tissue. | The Erbe ElectrosurgicalUnit (ESU/Generator) ModelVIO® 3 with Accessories isintended to deliver HighFrequency (HF) electricalcurrent for the cutting and/orcoagulation of tissue. | Same |
| Prescription orOTC | Prescription | Prescription | Same |
| Frequency | 350 kHz | 350 kHz | Same |
| MaximumOutput Power | 370 Watts | 400 Watts | Slightly greatermaximumoutput powerpossible. |
| WiFi Feature | N/A | Available(deactivated by default, forservice purposes only) | New feature. |
| Characteristics | Current Predicate:Erbe ESU Model VIO 300 Dwith Accessories | Proposed:Erbe ESU Model VIO 3 withAccessories | Discussion |
| OutputModules /Receptacles | · monopolar receptacle· bipolar receptacles· receptacle for neutralelectrodes | · monopolar receptacle· bipolar receptacles· universal receptacle· receptacle for neutralelectrodes | Additional typeof receptacle(universalreceptacle). |
| Modes | · Monopolar Cutting andCoagulation Modes· Bipolar Cutting andCoagulation ModesIf connected to a compatibleArgon Plasma Coagulator:· APC Modes· argon-assisted Cutting andCoagulation Modes | · Monopolar Cutting andCoagulation Modes· Bipolar Cutting andCoagulation ModesIf connected to a compatibleArgon Plasma Coagulator:· APC Modes· argon-assisted Cutting andCoagulation Modes | Same(Note: Amountof Modesavailable is lessin the proposedUnit than in thepredicate ESU) |
| ModeAdjustment | Select voltage and set powerlimitation | Select effect (comprisesdefined power output andvoltage limitation) | Different. |
| User InterfaceScreen | LED display and selectionbuttons | Touchscreen display | Different type ofdisplay. Bothdisplays providethe user with anonscreentutorials as wellas relevantinformation. |
| ActiveAccessories -Cables | · return electrode connectingcable· monopolar connectingcables | · return electrode connectingcable· monopolar connectingcables· bipolar connecting cables | Additional typeof cable (bipolarconnectingcables). |
| MiscellaneousAccessories -Footswitchesand Cart | · one- and two-pedalfootswitches(only compatible with ESUModel VIO 300 D)• Cart | · one- and two-pedalfootswitches(only compatible with ESUModel VIO 3)· Cart | Proposedfootswitchesare onlycompatible withVIO 3. Newfootswitch typesadded. |
| Materials | UnitMetal sheet, glass displayscreen, plastics, wiringAccessoriesInsulation plastics, wiring,metals, aluminum, rubber,metal sheet | UnitMetal sheet, glass displayscreen, plastics, wiringAccessoriesInsulation plastics, wiring,metals, aluminum, rubber,metal sheet | Same |
| Conditionprovided / Usecondition | · 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).
§ 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.