The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. The ESU has clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. The available Modes are Auto Cut, Dry Cut, Swift Coag, Forced Coag, and Bipolar Soft Coag with and without Auto Stop and BiClamp. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications. The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible. Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables. The VIO dV has a RCB (Remote Communication Bus) for remote control operation by the da da Vinci Xi Surgical System by Intuitive Surgical Inc.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ERBE ESU Model VIO dV with Accessories," an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance data.

Therefore, many of the requested sections below cannot be fully completed or are not applicable based on the provided text. The document states that "Animal or clinical performance testing was not considered necessary," which indicates that a detailed performance study as typically understood for AI/ML devices or novel medical devices with acceptance criteria was not performed.

Here's an attempt to extract and infer information where possible:

Acceptance Criteria and Device Performance Study Summary

The provided document, a 510(k) premarket notification, focuses on demonstrating substantial equivalence of the ERBE ESU Model VIO dV with Accessories (Software Version 3.1) to its predicate device (ERBE ESU Model VIO dV with Accessories, 510(k) Number K133180, and ERBE ESU Model 300 D with Accessories, 510(k) Number K083452). A formal, independent study with explicit acceptance criteria and corresponding reported performance metrics in the format typically seen for AI/ML or diagnostic devices is not detailed in this document.

Instead, compliance and equivalence are demonstrated through design control activities, verification and validation of software and hardware changes, and adherence to recognized consensus standards. The performance aspects discussed relate to the functional operation of the electrosurgical unit (ESU) in terms of its ability to deliver HF current for cutting and coagulation as specified, and the proper functioning of the BiClamp-Mode.

1. Table of Acceptance Criteria and Reported Device Performance

As a formal study with explicit acceptance criteria for a new AI/ML device was not conducted, this table cannot be populated as requested. The document indicates that tests were performed to show the ESU's BiClamp-Mode performs as specified and in accordance with the predicate device. The general "acceptance criteria" here implicitly refer to the device performing according to its design specifications and being substantially equivalent to the predicate.

Criteria Category (Inferred)	Specific Acceptance Criteria (Inferred from Text)	Reported Device Performance (Inferred from Text)
Functional Equivalence	Device generates High Frequency (HF) electrical current for cutting and/or coagulating tissue, maintaining defined cutting and coagulation modes with specific electrical waveforms and parameters (Auto Cut, Dry Cut, Swift Coag, Forced Coag, Bipolar Soft Coag with and without AutoStop and BiClamp).	The device maintains the same intended use, basic technology, protective circuits, and uses the same basic accessories as the predicate. It has the same hardware design, energy source, user interface displays, and modes (Auto Cut, Dry Cut, Swift Coag, Forced Coag, Bipolar Soft Coag with and without AutoStop function).
Software Performance	Updated Software Version 3.1 for RCB remote control functions correctly with the da Vinci Xi Surgical System, activating HF and changing settings as intended.	Software validation for remote control functions has been carried out for VIO dV Software 3.1 as well as for the integrated system (VIO dV and da Vinci system). This implies successful verification that the software performs its intended remote control functions.
BiClamp-Mode Performance	The BiClamp-Mode performs as specified in the updated software 3.1 version and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D.	Testing/measurement of the output parameters of the BiClamp-Mode was carried out. The statement "The BiClamp Mode performs as specified and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D" indicates successful verification of this functionality.
Safety and Efficacy (General)	No new safety or efficacy issues compared to the predicate device.	Design control activities (planning, input, review, verification/validation, transfer, change control) were followed. The device complies with FDA's "Recognized Consensus Standards." The conclusion states, "There are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices." Implies that the device passed general safety and performance checks.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "testing/measurement of the output parameters of the BiClamp-Mode" and "software validation for remote control functions," implying internal testing. The specific number of test cases or samples for these internal verification and validation activities is not provided.
Data Provenance: The testing appears to be internal verification and validation conducted by the manufacturer, ERBE Elektromedizin GmbH, in Germany. This would be considered prospective internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the type of testing described. The "ground truth" for an electrosurgical unit's performance typically refers to its physical output parameters matching design specifications, not expert interpretation of outputs or clinical outcomes from a diagnostic device.

4. Adjudication Method for the Test Set

Not applicable as this was not an expert-based diagnostic study. The "adjudication" would involve comparing measured electrical output parameters against predefined engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed, nor was it considered necessary. The device is an electrosurgical unit, not an AI-assisted diagnostic or decision-making system where human reader improvement with AI would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable in the context of an electrosurgical unit's performance evaluation as described. The software (version 3.1) enabling remote control was validated for its functionality (standalone as software, and integrated with the da Vinci system). The performance is inherent to the machine's operation, not an algorithm providing interpretations that a human might then use or act upon.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this device's performance validation is engineering specifications and verified electrical output parameters. For example, the BiClamp-Mode's output parameters were measured and compared against its specified performance and the performance of the predicate device (ERBE ESU Model VIO 300 D's specifications).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that "learns" from a training set. The software is deterministic and was developed and validated through traditional software engineering paradigms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2016

ERBE Elektromedizin GmbH Mr. Axel Retzlaff Director of Regulatory Affairs Waldhoernlestr. 17 Tuebingen, Germany 72072

Re: K150364

Trade/Device Name: ERBE ESU Model VIO dV with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device Regulatory Class: Class II Product Code: GEI Dated: May 2, 2016 Received: May 4, 2016

Dear Mr. Retzlaff:

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. 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 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 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150364

Device Name

ERBE ESU Model VIO dV with Accessories

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/ or coagulation of tissue.

	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

As Required by 21 CFR 807.92(c)

Owner/Operator:	ERBE Elektromedizin GmbHWaldhoernlestr. 1772072 TuebingenGermanyPhone +49-7071-755-0Fax +49-7071-755-179Contact: Axel Retzlaff, Director RA
Date Prepared:	20/01/2015
Trade (Proprietary) Name:	ERBE ESU Model VIO dV with Accessories
Common Name:	Electrosurgical Unit (ESU/Generator) System
Classification Name:	Electrosurgical Cutting and Coagulation Deviceand Accessories (21 CFR 878.4400)
Product Code:	GEI
Legally Marketed Predicate Device:	ERBE ESU Model VIO dV with Accessories,510(k) Number K133180ERBE ESU Model 300 D with Accessories, 510(k)Number K083452

Description of the Device:

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physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications.

The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible.

Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables

The VIO dV has a RCB (Remote Communication Bus) for remote control operation by the da da Vinci Xi Surgical System by Intuitive Surgical Inc. To have the unit installed as part of the da Vinci Xi Surgical System, contact Intuitive Surgical

Intended Use:

The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/or coagulation of tissue.

Summary of the Technological Characteristics:

Similarities between modified and predicate devices:

Unit:

The proposed device ERBE ESU Model VIO dV (remote) compares to the predicate device ERBE ESU Model VIO dV (standalone) as follows:

Both devices have the same intended use, the same basic technology, protective circuits, and use the same basic accessories. Both devices are identical in hardware design including all materials and are using the same energy source. Both generators have the same user interface displays to select modes, power settings, etc. and both have the same Modes Auto Cut, Dry Cut, Swift Coag, Forced Coag, Bipolar Soft Coag with and without AutoStop function. Also, both units have audio and visual error monitoring.

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The subject ESU and the predicate devices are manufactured by ERBE Elektromedizin GmbH in Germany and are supplied as non-sterile and are reusable. The packaging is also the same for both devices with similar labeling (e.g. Outer Package Label, User Manual, etc.). The proposed device ERBE ESU Model VIO dV (remote) compares to the predicate device ERBE ESU Model VIO 300 D as follows:

Both devices have the same BiClamp Mode.

Accessories:

The one pedal and two pedal footswitches are the same for both the subject and the predicate devices. The packaging is also the same with equal labeling.

Differences between modified and predicate devices:

The proposed device ERBE ESU Model VIO dV (remote) differs from the predicate device ERBE ESU Model VIO dV (standalone) as follows:

The proposed device has an updated Software Version 3.1 (predicate: 3.0) as the device is intended for remote control including HF-activation and change of settings via Intuitive Surgical, Inc.'s Da Vinci Surgical System. The BiClamp Mode which was disabled in the predicate ERBE ESU Model VIO dV is enabled in the proposed device. The User Manual was modified to appropriately address both changes.

Performance Data to determine Substantial Equivalence

The release of the software version 3.1 for the RCB remote control of the ERBE ESU Model VIO dV has been verified and validated as part of the design control. Software validation for remote control functions has been carried out for the VIO dV Software 3.1 as well as for the integrated system (VIO dV and da Vinci system). Testing/measurement of the output parameters of the BiClamp-Mode was carried out to show that the ESU's BiClamp-Mode performs as specified and in accordance with the specifications of the predicate device ERBE ESU Model VIO 300 D.

ERBE Elektromedizin GmbH, in accordance with established procedures, directs and controls design activities. These procedures involve design and development planning,

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design input, design review, design verification/design validation, design transfer, as well as design change control. The activities provide the oversight and forum for project approval, formal management/design review, evaluation, and final project approval. This work is documented within design review and the approvals are documented as part of the current change control system.

The ERBE ESU Model VIO dV, software version 3.1 for the RCB remote control complies to FDA's "Recognized Consensus Standards". Animal or clinical performance testing was not considered necessary.

Conclusion:

The software release version 3.1 and modification of the ERBE ESU Model VIO dV has the same intended use, principles of operation and technological characteristics as the predicate devices in the previously cleared 510(k)s. The subject device has been verified and validated in design control. There are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices.

Regulation Number and Section

§ 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.