(140 days)
The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.
The Erbe ESU Model VIO® 3n is an electrosurgical unit (ESU) that delivers high-frequency (HF) electrical current for cutting and/or coagulation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different footswitches are available for activating the ESU. The ESU VIO® 3n has several clearly defined monopolar and bipolar cutting and coagulation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. In combination with the compatible argon plasma coagulation unit APC 3 (K191234), it offers monopolar modes for argon plasma coagulation and argon-supported modes. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle. Connections for the central power supply, for footswitches, for potential equalization of the operating theatre and Erbe Communication Bus (ECB) connections to other Erbe modules are located at the rear. The ESU emits sounds when instruments are activated, and messages are signaled. The actual application is carried out using compatible electrosurgical instruments that are connected to the generator. The VIO® 3n can be combined with matching Erbe devices and modules, instruments, and accessories.
To address various clinical needs, the ESU is available in 5 different configurations which are called "Fire", "Metal", "Stone", "Water" and "Timber". Whereas the configuration "Fire" includes all available modes and functionalities, the other configurations only offer a reduced number of modes and functionalities.
The provided FDA 510(k) clearance letter and summary for the Erbe ESU Model VIO® 3n with Accessories do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI/software as a medical device (SaMD).
This document pertains to an electrosurgical unit, which is a hardware device for cutting and coagulating tissue using high-frequency electrical current. The "software" mentioned in the document refers to the operating software of the ESU itself, not an AI or diagnostic algorithm, and thus the type of performance metrics, ground truth, and study designs you're asking about (e.g., MRMC, standalone performance, expert consensus on diagnostic images) are not applicable to this type of device submission.
Therefore, I cannot provide a table of acceptance criteria and device performance in the context of an AI/SaMD, nor detailed information on test set sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or specific training set details, because this document describes a hardware device.
However, I can extract the information that is present about the non-clinical performance testing and what it aims to demonstrate:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a hardware electrosurgical unit, the "acceptance criteria" are generally related to compliance with electrical safety, EMC, and functional performance standards for tissue cutting/coagulation. The document does not provide specific quantitative acceptance criteria values or detailed performance metrics in a table. It states that the device "performs as intended per the product specifications and requirements."
| Acceptance Criteria Category (Inferred from testing) | Reported Device Performance (Summary from submission) |
|---|---|
| Functional Performance (Cutting and Coagulation Mode) | "Validated the cutting and coagulation mode performance compared to the predicate device(s)." "Performs as intended and meets design specifications." |
| Electromagnetic Compatibility (EMC) | "Tested in compliance with IEC 60601-1-2 and FDA Guidance 'Electromagnetic Compatibility (EMC) of Medical Devices'." |
| Electrical Safety | "Tested in compliance with IEC 60601-1 and IEC 60601-2-2, as applicable." |
| Software Verification | "Provided for an enhanced documentation level in compliance with IEC 62304 and FDA Guidance 'Content of Premarket Submissions for Device Software Functions'." |
| Cybersecurity | "Tested and assessed according to FDA Guidance 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified, but the tests were performed "non-clinical," implying laboratory or bench testing rather than clinical patient data. The manufacturer is Erbe Elektromedizin GmbH (Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to the non-clinical testing of an electrosurgical hardware device. Ground truth, in the context of AI/SaMD, usually refers to labeled diagnostic data. For this device, "ground truth" would be the measurable physical parameters and effects on tissue.
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on ambiguous diagnostic cases in AI/SaMD studies. For an ESU, performance is measured against engineering specifications and observed physical effects.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This type of study is relevant for diagnostic AI tools that assist human readers (e.g., radiologists interpreting images). The Erbe ESU Model VIO® 3n is an interventional hardware device, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The term "standalone performance" for an AI algorithm is not directly applicable here. However, the non-clinical performance testing (functional, EMC, electrical safety) can be considered "standalone" in the sense that the device's technical capabilities were tested independently against specifications without a human operator's diagnostic interpretation loop. The device directly performs an action (cutting/coagulation) rather than providing information for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional testing, the "ground truth" would be the observable physical effects on tissue (e.g., degree of cutting, coagulation depth, eschar formation) and measured electrical parameters (power output, voltage, current) compared to established engineering specifications and the performance of predicate devices.
- For safety and EMC, the "ground truth" is compliance with international standards (e.g., IEC 60601 series).
8. The sample size for the training set
- This question is not applicable. The Erbe ESU Model VIO® 3n is an electrosurgical hardware device. It does not use a "training set" in the machine learning sense to learn and develop an algorithm. Its operating software is developed through traditional software engineering processes, not machine learning model training.
9. How the ground truth for the training set was established
- This question is not applicable as there is no machine learning training set for this device.
FDA 510(k) Clearance Letter - Erbe ESU Model VIO® 3n with Accessories
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
Erbe Elektromedizin GmbH
Matthias Kollek
Regulatory Affairs Specialist
Waldhoernlestrasse 17
Tuebingen, 72072
Germany
Re: K251108
Trade/Device Name: Erbe ESU Model VIO® 3n 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: August 1, 2025
Received: August 1, 2025
Dear Matthias Kollek:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
August 29, 2025
Page 2
U.S. FOOD & DRUG ADMINISTRATION
Erbe Elektromedizin GmbH
Matthias Kollek
Regulatory Affairs Specialist
Waldhoernlestrasse 17
Tuebingen, 72072
Germany
August 29, 2025
Re: K251108
Trade/Device Name: Erbe ESU Model VIO® 3n 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: August 1, 2025
Received: August 1, 2025
Dear Matthias Kollek:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
K251108 - Matthias Kollek Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Colin K. Chen -S
Digitally signed by Colin K. Chen -S
Date: 2025.08.29 10:33:44 -04'00'
Page 3
K251108 - Matthias Kollek Page 3
Colin Kejing Chen
Acting Assistant 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
Page 4
Indications for Use
| Field | Content |
|---|---|
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251108 |
| Please provide the device trade name(s). | Erbe ESU Model VIO® 3n with Accessories |
| Please provide your Indications for Use below. | The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue. |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
Erbe ESU Model VIO® 3n with Accessories
Page 5
Erbe Elektromedizin GmbH
Traditional 510(k) for Erbe ESU Model VIO® 3n with Accessories
K251108
510(k) SUMMARY
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
72072 Tuebingen
Germany
Tel: 0049-7071-755-0
Fax: 0049-7071-755-179
Contact Person
Dr. Matthias Kollek
Regulatory Affairs Specialist
E-Mail: Matthias.Kollek@erbe-med.com
Date Prepared
April 7, 2025
Device Information
Trade/Proprietary Name: Erbe ESU Model VIO® 3n with Accessories
Common Name: Electrosurgical system generator
Classification Name: Electrosurgical cutting and coagulation device and accessories
Regulation Number: 21 CFR 878.4400
Class: II
Product Code: GEI
Legally Marketed Predicate Devices
Primary
Erbe ESU Model VIO 3 with Accessories - K240932
Secondary
Erbe ESU Model VIO 300 D with Accessories - K083452
Page 1 of 5
Page 6
Erbe Elektromedizin GmbH
Traditional 510(k) for Erbe ESU Model VIO® 3n with Accessories
K251108
Device Description
The Erbe ESU Model VIO® 3n is an electrosurgical unit (ESU) that delivers high-frequency (HF) electrical current for cutting and/or coagulation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different footswitches are available for activating the ESU. The ESU VIO® 3n has several clearly defined monopolar and bipolar cutting and coagulation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. In combination with the compatible argon plasma coagulation unit APC 3 (K191234), it offers monopolar modes for argon plasma coagulation and argon-supported modes. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle. Connections for the central power supply, for footswitches, for potential equalization of the operating theatre and Erbe Communication Bus (ECB) connections to other Erbe modules are located at the rear. The ESU emits sounds when instruments are activated, and messages are signaled. The actual application is carried out using compatible electrosurgical instruments that are connected to the generator. The VIO® 3n can be combined with matching Erbe devices and modules, instruments, and accessories.
To address various clinical needs, the ESU is available in 5 different configurations which are called "Fire", "Metal", "Stone", "Water" and "Timber". Whereas the configuration "Fire" includes all available modes and functionalities, the other configurations only offer a reduced number of modes and functionalities.
Indications for Use
The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Page 2 of 5
Page 7
Erbe Elektromedizin GmbH
Traditional 510(k) for Erbe ESU Model VIO® 3n with Accessories
K251108
Comparison of Technological Characteristics
| Characteristics | Subject DeviceErbe ESU Model VIO 3n with Accessories | Primary Predicate DeviceErbe ESU Model VIO 3 with Accessories(K240932) | Secondary Predicate DeviceErbe Model VIO 300 D with Accessories(K083452) | Discussion |
|---|---|---|---|---|
| Manufacturer | Erbe Elektromedizin GmbH (Germany) | Erbe Elektromedizin GmbH (Germany) | Erbe Elektromedizin GmbH (Germany) | N/A |
| Trade/Proprietary Name | Erbe ESU Model VIO® 3n | Erbe ESU Model VIO® 3 | Erbe ESU Model VIO 300 D | N/A |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | Electrosurgical, Cutting & Coagulation & Accessories | Electrosurgical, Cutting & Coagulation & Accessories | Same |
| Classification Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Product Code | GEI | GEI | GEI | Same |
| Device Class | II | II | II | Same |
| Indications for Use | The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and 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 instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation. | 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. | Same |
| Prescription or OTC | Prescription | Prescription | Prescription | Same |
| Dimensions | Width x Height x Depth410 x 165 x 381 mm | Width x Height x Depth415 x 215 x 375 mm | Width x Height x Depth410 x 165 x 380 mm | Similar |
| Weight | 8 kg | 12 kg | 9.5 kg | Similar |
| Energy | Monopolar and Bipolar HF electrical current | Monopolar and Bipolar HF electrical current | Monopolar and Bipolar HF electrical current | Same |
| Technical/Performance Data | Mains voltage100 V - 240 V AC (±10%) | Mains voltage100 - 240 V AC (±10%) | Mains voltage100 - 240 V AC (±10%) | Same |
| Mains current max. 6.3A | Mains current max. 6.3A | Mains current max. 8 A // 4 A | Same as primary predicate device |
Page 3 of 5
Page 8
Erbe Elektromedizin GmbH
Traditional 510(k) for Erbe ESU Model VIO® 3n with Accessories
K251108
Comparison of Technological Characteristics
| Characteristics | Subject DeviceErbe ESU Model VIO 3n with Accessories | Primary Predicate DeviceErbe ESU Model VIO 3 with Accessories(K240932) | Secondary Predicate DeviceErbe Model VIO 300 D with Accessories(K083452) | Discussion |
|---|---|---|---|---|
| Mains frequency | 50 Hz / 60 Hz | 50 Hz / 60 Hz | 50 Hz / 60 Hz | Same |
| Frequency | 350 kHz | 350 kHz | 350 kHz | Same |
| Activation | via footswitch or finger switch (depending on instrument) | via footswitch or finger switch (depending on instrument) | via footswitch or finger switch (depending on instrument) | Same |
| Maximum Power Output | 360 watts | 400 watts | 400 watts | Lower maximum power output |
| Output Modules/Receptacles | Up to 3 HF instrument sockets1 Neutral electrode socket2 Footswitch sockets | 4 HF instrument sockets1 Neutral electrode socket2 Footswitch sockets | 3 HF instrument sockets1 Neutral electrode socket2 Footswitch sockets | Same as secondary predicate device |
| External interfaces | 2 ECB socketsService interface (special USB slot) | 2 ECB sockets | 1 ECB socket | Additional service interface |
| User Interface | Touch screen | Touch screen | No touch screen | Same as primary predicate device |
| Software Version | V1.1.0 | V1.4.5V2.0.0 | V2.7.2 | Different |
| Software Configurations | 5 configurations | 1 configuration | 1 configuration | Different configurations |
The subject device and the predicate devices have the same intended use, fundamental technology, operating principle and supply the same energy.
Differences include the device software, external interfaces, available modes and maximum power output. In addition, the subject device is available in different configurations.
To show safety and effectiveness of the subject device and to substantiate substantial equivalence, performance testing applicable to the subject device was completed to ensure it performs as intended per the product specifications and requirements in accordance with the intended use.
The non-clinical testing described below shows that the different technological characteristics do not negatively affect the safety and effectiveness of the subject device.
Page 4 of 5
Page 9
Erbe Elektromedizin GmbH
Traditional 510(k) for Erbe ESU Model VIO® 3n with Accessories
K251108
Non-clinical performance testing
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate devices.
Functional testing and design controls to verify both safety and performance of the subject device was performed in compliance with 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.
Side-by-side tissue testing was performed in compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", to validate the cutting and coagulation mode performance compared to the predicate device(s).
Electromagnetic compatibility (EMC) was tested in compliance with IEC 60601-1-2 and FDA Guidance "Electromagnetic Compatibility (EMC) of Medical Devices".
Electrical safety of the subject device was tested in compliance with IEC 60601-1 and IEC 60601-2-2, as applicable.
Software verification was provided for an enhanced documentation level in compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions".
Cybersecurity was tested and assessed according to FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Conclusion
The subject device and the predicate devices have the same intended use, fundamental technology, operating principle and supply the same energy.
The subject device was tested as described above to demonstrate reasonable assurance of safety and effectiveness. The subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate device(s).
Page 5 of 5
§ 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.