The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

Device Description

The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. On the front side it features a touch screen display that displays the connection status of accessories and peripherals connected to the electrosurgical generator. It is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition the ESG-400 has a bipolar socket, two monopolar sockets, a neutral electrode socket, and a universal socket to connect applicators with instrument recognition. The power switch turns the generator on and off. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign the footswitches to specific output sockets (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. On the rear panel the volume control, a ventilation hole, the equipotential bonding point, the AC power socket, and two footswitch sockets can be found. Furthermore, for the connection of peripheral equipment 26-pin plugs respectively 14-pin plugs can be connected to the LINK-IN or to the LINK-OUT socket. On the bottom panel, a docking socket is featured. In future it might be used to connect the ESG-400 directly to upcoming devices.

AI/ML Overview

The provided text describes an electrosurgical unit (ESG-400), not an AI/ML device, and therefore the concepts of acceptance criteria, test sets, ground truth, and human reader studies (MRMC) as typically applied to AI/ML device submissions are not directly addressed. The submission focuses on demonstrating substantial equivalence to predicate electrosurgical devices through compliance with established safety standards and bench testing.

However, I can extract information related to the device's performance and the types of tests conducted to support its safety and effectiveness, based on the provided document. I will interpret "acceptance criteria" as the demonstration of substantial equivalence to predicate devices, primarily through adherence to recognized consensus standards and comparative bench testing of output characteristics.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations due to the nature of the device:

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

For a traditional medical device like an electrosurgical unit, "acceptance criteria" are typically defined by compliance with recognized standards and demonstrated equivalence in performance characteristics to legally marketed predicate devices. The document implies:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with recognized consensus standards (e.g., IEC 60601 series, IEC 62304, IEC 62366, ISO 14971)	"The design of the ESG-400 complies with the following recognized consensus standards:" (lists standards)
Safety and Efficacy comparable to predicate devices	"The data show that the differences between the subject ESG-400 and the predicate devices do not affect the safety and efficacy..."
Output characteristics, application modes, max output power, and handling do not change safety/effectiveness or create new risks compared to predicates	"There are differences in the output characteristics and the quantity of the application modes, the maximum output power, or the handling, but they do not change the safety and effectiveness or result in new potential risks."
Bench test performance comparable to predicate devices	"...bench tests of the subject ESG-400 and the predicate devices VIO 300 D and XUES-41 were performed and demonstrate substantial equivalence."

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

The document does not specify a "sample size" in the context of a data test set for an AI/ML model. The testing described is primarily bench testing to compare performance characteristics of the ESG-400 against predicate devices. This typically involves a single device or a small set of devices undergoing various electrical and functional tests.

Sample Size: Not applicable in the AI/ML sense. It refers to a limited number of physical units for bench testing.
Data Provenance: The testing was conducted by or on behalf of Olympus Winter & Ibe (Germany) and Olympus America Inc. (USA). The data would originate from these tests. It is retrospective in the sense that the testing was completed before the submission.

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 is not applicable as the device is an electrosurgical unit, not an AI/ML model for which ground truth is established by human experts. The "ground truth" for an ESU's performance is determined by adherence to engineering specifications and international safety standards benchmarked against predicate devices and their established safe and effective performance.

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

Not applicable. This is a concept used in AI/ML model validation involving disagreement resolution among human readers. For an ESU, performance is measured objectively through physical tests (e.g., power output, safety features).

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

Not applicable. An MRMC study is designed to evaluate the impact of an AI system on human diagnosticians' performance. The ESG-400 is an electrosurgical generator, not a diagnostic AI tool that assists human readers.

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

This concept is not directly applicable. The "standalone performance" of the ESG-400 is its intrinsic performance as measured by its output characteristics (e.g., power, mode settings) during bench testing, independent of direct interaction with a human operator during a clinical procedure. The device is designed to be operated by a human, but its core functional performance can be assessed independently. The document states "bench tests... were performed and demonstrate substantial equivalence," which can be considered analogous to standalone performance assessment.

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

The "ground truth" for an electrosurgical unit's safety and effectiveness is established through:

Compliance with recognized industry standards: IEC 60601 series, IEC 62304, IEC 62366, ISO 14971. These standards define acceptable performance, safety limits, and testing methodologies.
Performance data from legally marketed predicate devices: The ESG-400's performance (e.g., output power, mode characteristics) is compared to that of the Erbe VIO ESU and Olympus XUES-41, which are already deemed safe and effective.
Bench test data: Objective measurements of the device's electrical output and functional operation.

8. The sample size for the training set

Not applicable. The ESG-400 is a hardware device, not an AI/ML algorithm that requires a training set.

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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K 103032

05 510(k) Summary

Applicant:

Olympus Winter & Ibe Kuehnstr. 61 22045 Hamburg Germany

Tel.: +49-40-66966-0 Fax: +49-40-66966-2109 Establishment Registration Number: 9610773

Contact Person:

Ms. Stacy Abbatiello Kluesner M.S., RAC Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 USA

Phone: (484) 896-5405 Fax: (484) 896-7128 Email: stacy.kluesner@olympus.com Establishment Registration Number: 2429304

Manufacturer:

Olympus Winter & Ibe Kuehnstr. 61 22045 Hamburg Germany

Tel .: +49-40-66966-0 Fax: +49-40-66966-2109 Establishment Registration Number: 9610773

Date Prepared:

Trade Name:

August 9, 2010

Common Name:

ESG-400

Electrosurgical Unit (ESU)

JAN 1 4 2011

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K103032

Page 2 of

Classification Name:	Electrosurgical cutting and coagulation device and accessories
Regulation No:	878.4400
Product Code:	GEI
Device Class:	II

	Trade Name	510(k)	Applicant
Legally Marketed Predicate Devices:	Erbe VIO ESU (Model VIO 300 D) with Accessories	K023886	Erbe USA, Inc.
	Erbe VIO ESU (Model VIO 300 D)	K060484	Erbe USA, Inc.
	XUES-41	K030194	Olympus Optical Co.Ltd.

Device Description:	The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. On the front side it features a touch screen display that displays the connection status of accessories and peripherals connected to the electrosurgical generator. It is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition the ESG-400 has a bipolar socket, two monopolar sockets, a neutral electrode socket, and a universal socket to connect applicators with instrument recognition. The power switch turns the generator on and off. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign the footswitches to specific output sockets (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. On the rear panel the volume control, a ventilation hole, the equipotential bonding point, the AC power socket, and two footswitch sockets can be found. Furthermore, for the connection of peripheral equipment 26-pin plugs respectively 14-pin plugs can be connected to the LINK-IN or to the LINK-OUT socket. On the bottom panel, a docking socket is featured. In future it might be used to connect the ESG-400 directly to upcoming devices.
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Device Description:

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Application Modes

Monopolar Cut:
PureCut (Cutting of varying tissue structures; 3 Effects)
BlendCut (Cutting of varying tissue structures: 3 Effects)

BlendCut (Cutting of varying tissue structures; 3 Effects)
PulseCut slow (Intermittent cutting; 3 Effects)
=

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K 10303

Page 3 of 4

PulseCut fast (Intermittent cutting; 3 Effects) -

Monopolar Coagulation:

SoftCoag (Coagulation of tissue with little sticking and carbonization: 3 Effects)
ForcedCoag (Fast and effective coagulation; 3 Effects) -
SprayCoag (Contact-free surface coagulation with little penetration depth; 3 Effects)
PowerCoag (Fast and effective coagulation with increased dissection capabilities; 3 Effects)

Bipolar Cut:

BipolarCut (All bipolar cutting procedures of tissue structures; . 3 Effects)
SalineCut (Cutting in conductive fluid; 3 Effects; only available via . UNIVERSAL socket )

Bipolar Coagulation:

BiSoftCoag (Coagulation with little sticking and carbonization; 3 -Effects)
AutoCoag (Coagulation with little sticking and carbonization; 3 -Effects)
SalineCoag (Coagulation in conductive fluid; 3 Effects: only available via UNIVERSAL socket )
-HardCoag (Controlled tissue coagulation; 3 Effects)
RFCoag (Controlled deep tissue coagulation; with and without -RCAP)
-FineCoag (Coagulation of tissue with little sticking and carbonization: 1 Effect)

The modes have preset power levels that may be customized by the user in a defined range.

Design

The design of the ESG-400 complies with the following recognized consensus standards:

IEC 60601-1
- IEC 60601-1-2
IEC 60601-1-4 .
IEC 60601-1-8 · · · -
IEC 60601-2-2 .
-IEC 62304
-IEC 62366
-ISO 14971

Accessories

Footswitch Double Pedal (WB50402W): It has a blue pedal that is used to activate the selected coagulation mode and a yellow pedal

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K103032

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that is used to activate the selected cutting mode.

Footswitch Single Pedal (optional; WB50403W): It has a blue pedal that is used to activate the selected coagulation mode
P-Cord (optional; MAJ-814): The P-cord is used to connect a patient plate to the ESG-400.

Intended Use:

Comparison to Predicate Devices:

The ESG-400 is an electrosurgical generator intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The ESG-400 has a similar indication statement as the predicate devices VIO 300 D and XUES-41. Furthermore, the subject ESG-400 has similar technological characteristics.

There are differences in the output characteristics and the quantity of the application modes, the maximum output power, or the handling, but they do not change the safety and effectiveness or result in new potential risks.

The data show that the differences between the subject ESG-400 and the predicate devices do not affect the safety and efficacy, as no changes were incorporated in the intended use, in the performance. and in the physical principles that the device is based upon. Therefore, no additional tests are necessary for evaluation of safety and efficacy. Nevertheless bench tests of the subject ESG-400 and the predicate devices VIO 300 D and XUES-41 were performed and demonstrate substantial equivalence.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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

Olympus Winter & Ibe % Olympus America, Inc. Ms. Stacy Abbatiello Kluesner, M.S., RAC 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610

JAN 1 4 2011

Re: K103032

Trade/Device Name: ESG-400 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 06, 2011 Received: January 07, 2011

Dear Ms. Kluesner:

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.

and the state of the state of the states of the states of the states

and the commend of the country of the states of the

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Page 2 - Ms. Stacy Abbatiello Kluesner, M.S., RAC

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 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/ucm115809.html for 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 vours,

Az. B. nh

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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04 Indications for Use

510(k) Number (if known):

JAN 1 4 2011

Device Name:

ESG-400

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103032 12

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.