The ERBE ESU Model VIO 100 C with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of issue.

Device Description

The ERBE ESU Model VIO 100 C is a Generator that uses High Frequency (HF) electrical current waveforms to cut and/or coagulate tissue. It has a display as well as various cutting and coagulation modes to provide the physician standard modalities in interventional applications (i.e. its ability to generate the HF current). The System has an automatic start feature. The equipment is programmable and various accessories (e.g. footswitches, hand instruments, etc.) as well as modes may be assigned to perform specific functions. When activated, the Device has an audio as well as a visual erroring 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 is supplied non-sterile and is reusable.

Designated Footswitches have been developed for use with the ERBE ESU Model VIO 100 C. A Footswitch provides the physician a means to activate a mode of the ESU by depressing a foot pedal. There is a choice of two different types of Footswitches as follows: VIO C One (Single) Pedal Coag Footswitch (Note: Activates coagulation mode.) VIO C Two (Dual/Double) Pedal Footswitch (Note: Activates respectively cut and coagulation modes.)

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the ERBE ESU Model VIO 100 C with Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced safety or effectiveness through extensive clinical trials. Therefore, the information provided does not align with the typical structure of a study proving a device meets specific acceptance criteria based on performance data.

Instead, the document asserts substantial equivalence based on similarities in intended use, principles of operation, and technological characteristics, while highlighting differences that do not raise new safety or efficacy concerns.

Based on the provided text, here's a breakdown of what can and cannot be answered regarding acceptance criteria and a study:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) notification focuses on comparing the new device to a predicate device rather than presenting specific quantitative acceptance criteria and then demonstrating the new device's performance against those criteria. The document states "all the changes were verified or validated," but it does not detail what those validations entailed or specific performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. This type of detail would typically be found in a study report, which is not part of this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document. No "test set" or "ground truth" establishment by experts is mentioned, as this is not a clinical study designed to evaluate diagnostic or treatment accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document. As there is no mention of a test set or expert evaluation for ground truth, no adjudication method is discussed.

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:

This information is not applicable/provided in the document. The device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided in the document. The device is an electrosurgical unit, not an algorithm. Its operation inherently involves a human operator (physician) in the loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the document. As this is not a study assessing diagnostic accuracy or treatment efficacy against a specific "ground truth," this concept is not discussed. The evaluation instead focuses on confirming that the modified device functions as intended and safely.

8. The sample size for the training set:

This information is not provided in the document. The device is a hardware electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in the context of this submission. Device "verification or validation" refers to engineering and performance testing, not model training.

9. How the ground truth for the training set was established:
This information is not provided in the document, as there is no "training set" for this type of medical device submission.

Summary of the "Study" (or rather, the basis for substantial equivalence):

The document describes a Special 510(k) Notification for the ERBE ESU Model VIO 100 C. This submission method is used when modifications to a legally marketed device do not significantly alter its safety or effectiveness. The "study" in this context is the comparison to the predicate device (ERBE VIO ESU, Model VIO 200 S, K080715) to establish substantial equivalence.

Key points of the "study"/comparison:
- Similarities: Same intended use (cutting/coagulation of tissue), same basic accessories, Monopolar, Bipolar, and Neutral Electrode Receptacles, same available modes (Auto Cut, Soft Coag, Forced Coag, Bipolar Soft Coag), user interface displays, programmable with Auto Start feature (Bipolar Soft Coag Mode), audio and visual error monitoring, manufactured in Germany as non-sterile and reusable, similar packaging and labeling.
- Differences (and justification that they do not raise new safety/efficacy concerns):
  - Basic Model: Lighter, smaller, designed for tabletop use, intended as a more cost-effective system.
  - Neutral Electrode Monitoring System: Does not monitor current density and symmetry of a split return electrode but monitors pad connection and skin contact with a split return electrode. This is deemed adequate and industry standard due to the modified unit's lower power.
  - Less Programming Capabilities: Four program possibilities vs. nine for the predicate, making it "less complicated."
  - Lower Wattage: 100 watts max vs. 200 watts. Justified as "adequate" with many ESUs on the market having <100 watts.
  - Slightly Higher Frequency: 380 kHz vs. 350 kHz for the predicate. No safety or efficacy concerns raised.
  - No "Effect" Settings: A single power setting increases or decreases wattage, simplifying user operation.
  - Fewer Modes: Excludes Endo Cut Q, Endo Cut I, APC Forced, and argon-assisted modes. An additional mode (Dry Cut) was included, which is present in other cleared ERBE ESUs. The remaining modes are considered "principal ones to perform basic cutting and coagulating activities."
  - Designated Footswitches: While different from the predicate's, they are made with similar materials and activate cut/coagulation modes.
Conclusion: The submission concludes that "all the changes were verified or validated. As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness." This statement implies that internal testing and design verification were performed to ensure the modified device still functions safely and effectively within the established requirements for an ESU, but specific details of these verification and validation activities are not provided in this 510(k) summary.

Summary

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Kl01108

ERBE USA Incorporated Special 510(k): ERBE ESU Model VIO 100 C with Accessories

510(k) SUMMARY

Submitted By:	ERBE USA, Inc.2225 Northwest ParkwayMarietta, GA 30067Tel: 770-955-4400Fax: 770-955-2577
Contact Person:	John TartalQA/RA Manager
Date Prepared:	March 30, 2010
Common Name:	ElectroSurgical Unit (ESU/Generator) System
Trade/Proprietary Name:	ERBE ESU Model VIO 100 C with Accessories
Classification Name:	Electrosurgical cutting and coagulation device andaccessories (21 CFR 878.4400)
Product Code:	79GEI
Legally MarketedPredicate Device:	ERBE VIO ESU (Model VIO 200 S), 510(k) Number:K080715

Device Description:

Unit

Note: VIO stands for Variable Cut and Coagulation.

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ERBE USA Incorporated Special 510(k): ERBE ESU Model VIO 100 C with Accessories

Footswitches (Accessories)

VIO C One (Single) Pedal Coag Footswitch (Note: Activates coagulation mode.) VIO C Two (Dual/Double) Pedal Footswitch (Note: Activates respectively cut and coagulation modes.)

Intended Use:

The ERBE ESU Model VIO 100 C is intended to deliver high frequency 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):

Similarities

The modified ESU (ERBE Model VIO 100 C) has the same intended use and uses the same basic accessories (i.e. A/C Cord, Adapters, Connecting Cables, etc.) as the predicate ESU (ERBE Model VIO 200 C). Both Units have a Monopolar, Bipolar, and Neutral Electrode Receptacle. Also, available modes [i.e., Auto Cut, Soft Coaq, Forced Coag, Bipolar Soft Coag] in the modified device are the same Modes that are in the predicate (Note: Modes do not have effect settings and have power limitations with the modified device as compared to the predicate.). Both Generators have user interface displays to select modes, power settings, etc. The modified and predicate devices are programmable and have the Auto Start feature with the Bipolar Soft Coag Mode. Also, each Unit has audio and visual error monitoring. The modified ESU is manufactured by ERBE Elektromedizin GmbH in Germany and like the predicate Generator will be supplied as non-sterile and is reusable. The packaging and labeling (e.g. Outer Package Label, User Manual, etc.) is similar for each device as well.

Differences

The ERBE ESU Model VIO 100 C is different than the predicate VIO 200 S Model in that the modified ESU is a basic Model with standard market features. It is lighter, smaller, and designed for use on a tabletop. Compared to the predicate device, the modified Unit has a Neutral Electrode Monitoring System which does not monitor the current density and symmetry of a split return electrode. However, the modified Unit monitors pad connection and with a split return electrode it monitors skin contact. Since the VIO 100 C provides less power than the predicate device, the monitoring system is adequate and according to the industry standard. Also, there are less programming capabilities [i.e., four (4) program possibilities] for the proposed device compared with nine (9) for the predicate ESU which makes the Unit Jess complicated.

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ERBE USA Incorporated Special 510(k): ERBE ESU Model VIQ 100 C with Accessories

The ERBE ESU Model VIO 100 C also is different than the ERBE VIO 200 S ESU in that the available wattage is less (i.e., 100 watts as compared to 200 watts). However, a maximum 100 watt Generator has been found to be adequate (Note: There are many ESUs on the U.S. market with maximum wattage being less than 100 watts.). The New Model also operates at slightly higher frequency (380 kHz) as compared to 350 kHz for the predicate device. Also there are no "Effect" settings for each of the modes with the modified Unit as compared to the predicate. Simply a power setting is used to increase or decrease the available wattage for delivery to target tissue (i.e., with a wattage setting increase, the effect is greater) for the modified ESU which eliminates the need for effect settings.

Modes that are in the predicate and not in the modified device are Endo Cut Q, Endo Cut I, and APC Forced as well as argon-assisted modes. An additional cut mode (Dry Cut) was included in the modified Unit as compared to the predicate (Note: This mode is in other 510(k) cleared ERBE ESU Models.). In summary, the modes in the ERBE Model VIO 100 C are principal ones to perform basic cutting and coagulating activities.

Finally, the ERBE ESU Model VIO 100 C also is different than the ERBE VIO 200 S ESU in that both Units have designated Footswitches. However, both of the ESU's Footswitches are made with similar materials and activate, via a foot pedal, cut as well as coagulation modes.

Conclusion:

The ERBE ESU Model VIO 100 C with Accessories has the same intended use, principles of operation, and similar technological characteristics as the predicate ESU in the previously cleared 510(k). The modifications involve having a Generator that is more basic (i.e., less complicated with fundamental modes) with designated Footswitches thus having a more cost effective System. In conclusion, all the changes were verified or validated. As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three distinct, curved lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

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

ERBE USA, Inc. % Mr. John Tartal 2225 Northwest Parkway Marietta, GA 30067

JUL 1 5 2010

Re: K101108

Trade/Device Name: ERBE ESU Model VIO 100 C with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 2, 2010 Received: April 20, 2010

Dear Mr. Tartal:

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

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Page 2 - Mr. John Tartal

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm117809.html 1 the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Barbara Bauer up

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ERBE USA, Inc.'s ERBE ESU Model VIO 100 C with Accessories

Indications For Use:

The ERBE ESU Model VIO 100 C with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of issue.

Prescription Use X (Part 21 CFR 801 Subpart D)

· AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101108

Page 1 of 1

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.