The ERBE VIO ESU with Accessories is an electrosurgical system that uses high frequency (HF) electrical current waveforms to cut and/or coagulate tissue. There were no modifications to the Accessories from the previously cleared 510(k) K023886; therefore, they are not included with this submission.

Unit (Model VIO 300 D)

General Description. The ESU has a color monitor display that provides the user with an on-screen tutorial as well as setting and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in interventional applications (i.e., its ability to generate HF current). The system has automatic start and stop features. 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 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). Upon activation, the energy delivered (in watts) from the ESU to the tissue is displayed on the display screen. Also, the unit can be used in association with an ERBE compatible Argon Plasma Coagulator (APC). The unit is supplied non-sterile and is reusable.

Note: VIO stands for Variable Cut and Coagulation.

AI/ML Overview

This document is a 510(k) premarket notification for an electrosurgical generator (ESU) system. It details modifications made to the ERBE VIO ESU (Model VIO 300 D) compared to its predicate device (K023886). The primary focus of the submission is to demonstrate substantial equivalence, rather than present a study with explicit acceptance criteria and device performance metrics in the way a clinical trial for a diagnostic algorithm would.

Therefore, many of the requested elements for describing acceptance criteria and a study proving those criteria are not directly applicable or present in this regulatory submission. However, I will extract and infer information where possible based on the provided text.

Here's an attempt to answer your questions based on the provided input:

A table of acceptance criteria and the reported device performance
The document does not present a table of quantitative acceptance criteria typical for a diagnostic or AI device study (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device, specifically regarding safety and efficacy. The performance is described in terms of features, modes, power output, and protective circuits being "the same" or "unaffected."

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Efficacy (not adversely affected by modifications)	"These modifications do not affect the safety or efficacy of the VIO 300 D ESU." (Monopolar Modes)
	"The addition of these modes does not affect the safety or efficacy of the modified ESU." (Bipolar Modes)
Consistency with Predicate (Protective Circuits, Intended Use)	"The modified ESU (ERBE VIO 300 D ESU) has the same protective circuits and intended use as the predicate ESU..."
	"The ERBE VIO ESU (Model VIO 300 D) has the same intended use, principles of operation, and technological characteristics as the predicate ESU..."
Equivalence in Monopolar Modes (Cut/Coagulation, Power, Voltage)	"The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums." The ENDO CUT program "1" has the same settings as the predicate. ENDO CUT program "Q" has modified default settings but "control/regulation... was improved."
Equivalence in Bipolar Modes (Cut/Coagulation, Power, Voltage)	"The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums." Note: Two additional modes were added, but confirmed not to affect safety/efficacy.
Equivalence in BiClamp, APC, Argon-Assisted Modes	"The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums specific to BiClamp, APC, and Argon-Assisted Modes." Note: Hardware modification (capacitor) to reduce NMS effect was added.
All modifications verified/validated in design control	"All the unit modifications have been verified or validated in design control."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes an engineering and regulatory comparison to a predicate device, not a clinical study involving a "test set" of patient data or samples. The "test set" would primarily refer to the modified ESU hardware and software features themselves. There is no mention of patient data. The device is manufactured by ERBE Elektromedizin GmbH in Germany.
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)
Not applicable to this type of submission. There are references to "feedback from the physicians" which led to the addition of bipolar modes and "field experience of the predicate Mode" which led to improvement in the ENDO CUT Q mode. However, these are general feedback mechanisms, not the establishment of ground truth by a specific number of qualified experts for a predefined test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" in the context of clinical or diagnostic performance with an adjudication method is described.
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
Not applicable. This device is an electrosurgical generator, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a medical device (hardware and software) that a human operates.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the modifications, the "ground truth" for safety and efficacy is based on design control verification and validation activities and the established safety and efficacy of the predicate device. For the reduction of neuromuscular stimulation (NMS), the "ground truth" is that NMS is a known issue with high-frequency electrical current generators, and adding a capacitor lowers the susceptibility of patients to NMS. This relies on engineering principles and potentially prior clinical evidence/understanding of NMS. The specific "type" of clinical ground truth (e.g., pathology, outcomes) in a study sense is not detailed.
The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established
Not applicable.

Summary

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MAR 1 6 2006

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Submitted By:

ERBE USA. Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577

Contact Person:

Julie Stephens, President/Consultant Regulatory Resources Group, Inc.

February 23, 2006 Date Prepared:

Electrosurgical Generator (ESU) System Common Name:

ERBE VIO ESU (Model VIO 300 D) Trade/Proprietary Name:

GEI

Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)

Product Code:

Legally Marketed Predicate Device: ERBE VIO ESU (Model VIO 300 D) with Accessories 510(k) Number: K023886

Device Description:

Unit (Model VIO 300 D)

Note: VIO stands for Variable Cut and Coagulation.

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K060484

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Indications for Use:

The ERBE VIO ESU 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):

ERBE VIO 300 D ESU

Similarities

The modified ESU (ERBE VIO 300 D ESU) has the same protective circuits and intended use as the predicate ESU (ERBE VIO 300 D ESU) and most of the performance specifications are the same. The modified ESU has the same protective circuits as the predicate ESU, which displays the Equipment Output Error on the monitor screen with a graphic representation so that you can readily determine the cause of the error. The modified ESU will also be manufactured by ERBE Elektromedizin GmbH in Germany and will be supplied as a non-sterile, reusable ESU system. The packaging and labeling (User Manual, etc.) components are similar except in the descriptions of specific user instructions.

Monopolar Modes:

The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums. The User Manual remains the same in the statement to the physician: "The power output setting should be set as low as possible for the desired tissue affect. The purpose of this is to help reduce the potential for capacitive coupling and inadvertent burning at higher wattages/ voltages."

Bipolar Modes:

BiClamp, APC, and Argon-Assisted Modes:

The modified ESU has the same cut and coagulation modes, Effect levels, power maximums (wattages) and voltage maximums specific to BiClamp, APC, and Argon-Assisted Modes. The User Manual remains the same in the statement to the physician: "The power output setting should be set as low as possible for the desired tissue affect. The purpose of this is to help reduce the potential for capacitive coupling and inadvertent burning at higher wattages/ voltages."

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K060484

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The ENDO CUT is a function in which the incision is automatically controlled in such a way that alternating short cuts are combined with soft coagulation. Although both of these modes were available on the original 510(k) ESU, the product was not initially launched on the marketplace with this combination available. The predicate ESU has this feature specified as ENDO CUT I and ENDO CUT Q and has been in use for approximately two years. The modified ESU will continue with these same features except for slight differences as described below.

Differences

Monopolar Modes:

The ENDO CUT function was modified to more consistently emulate the original ENDO CUT technology from the ERBE ICC Series (Models) of ESUs. The ENDO CUT program, "1" (for use with needle instruments), has the same settings as the predicate product. The ENDO CUT program, "Q" (for use with loop instruments), has modified default settings from the predicate product. The control/ regulation of the ENDO CUT Q Mode was improved based on the field experience of the predicate Mode. These modifications do not affect the safety or efficacy of the VIO 300 D ESU. The labeling reflects the changes.

Bipolar Modes:

The modified ESU has two additional modes than in the predicate ESU. Additional modes were added per feedback from the physicians. A Bipolar Cut + mode and a Bipolar Soft Coag + mode were added for greater flexibility of use with Bipolar resection instruments. The addition of these modes does not affect the safety or efficacy of the modified ESU. The labeling reflects the changes.

BiClamp, APC, and Argon-Assisted Modes:

A modification was completed on the internal hardware of the high frequency (HF) generator printed circuit board (PCB). An additional decoupling capacitor was added on the HF-generator board to reduce the neuromuscular stimulation (NMS) effect during APC Pulsed Mode usage. Many of the gastrointestinal (GI) operative procedures are completed under minimal usage of anesthesia; therefore, the additional capacitor will assist in reduction of NMS during the usage of the APC Pulsed Mode. While NMS is a known issue with all high frequency electrical current generators, the APC Pulsed Mode is ideal for some operative procedures and the addition of the capacitor lowers the susceptibility of patients to NMS during use of the mode.

All the unit modifications have been verified or validated in design control.

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060484

Conclusion:

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The ERBE VIO ESU (Model VIO 300 D) has the same intended use, principles of operation, and technological characteristics as the predicate ESU in the previously cleared 510(k). The main modifications in the ESU reflect an ongoing commitment by ERBE to satisfy customer feedback. In conclusion, there are no issues with the ERBE VIO ESU (Model VIO 300 D) that would raise additional safety or efficacy issues when compared to the predicate device.

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Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services USA. The logo features a stylized symbol resembling a caduceus, with three curved lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2006

ERBE USA, Incorporated c/o Regulatory Resources Group, Inc. Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K060484

Trade/Device Name: ERBE USA Inc. – ERBE VIO ESU (Model VIO 300 D) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 23, 2006 Received: February 27, 2006

Dear Ms. Stephens:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Julie Stephens

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applienble, the clect ================================================================================= product radiation control provisions (Sections 531-542 of the Acl); 2 i CFR 1000-1050. product rackences of the begin marketing your device as described in your Section 510(k) rmarket notification. The FDA finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Macr gacturers, International and Consumer Assistance at its toll-free number (800) 638-2(04) or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
el.gmall

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ K 060484

Device Name: ERBE USA Inc. - ERBE VIO ESU (Model VIO 300 D)

Indications For Use:

The ERBE VIO ESU with Accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.

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)

ellMall

Bivis of General, Restorative, a do a clogical Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.