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. It is intended for cutting and coagulation of tissue in open, laparoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The updated ESG-400 allows Olympus Plasma Kinetic (PK) instruments to be connected at the device.

AI/ML Overview

The provided document is a 510(k) premarket notification for an electrosurgical generator, the Olympus ESG-400, detailing its comparison to a predicate device and safety information. It focuses on demonstrating substantial equivalence rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a device to "meet" those criteria in the way a diagnostic or AI-driven device would.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for an electrosurgical generator.

However, I can extract information related to general performance testing and compliance with standards.

Here's the information that can be extracted, and where applicable, a note that the requested information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Electrosurgical generators are assessed for safety and performance against recognized standards, rather than specific diagnostic accuracy metrics. The "acceptance criteria" here relate to meeting the specifications and safety requirements outlined in the standards and showing equivalence to a predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (from Standards/Equivalence Claim)	Reported Device Performance (from "Summary of Performance Testing")
Safety and Essential Performance	Compliance with ES60601-1:2005/A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	The design of the ESG-400 complies with this standard. Performance testing was conducted.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 Edition 3:2007-03 (EMC Requirements and tests)	The design of the ESG-400 complies with this standard. Performance testing was conducted.
Alarm Systems	Compliance with IEC 60601-1-8:2012-11 Edition 2.1 (General requirements, tests and guidance for alarm systems)	The design of the ESG-400 complies with this standard. Performance testing was conducted.
High Frequency Surgery Equipment	Compliance with IEC 60601-2-2 Edition 5.0 2009-2 (Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories)	The design of the ESG-400 complies with this standard. Performance testing was conducted.
Software Life Cycle Processes	Compliance with IEC 62304 First edition 2006-05 (Medical device software - Software life cycle processes)	Software validation activities were performed in accordance with FDA Guidance. The device software is considered a "Minor Level of Concern."
Usability Engineering	Compliance with IEC 62366: 2007 First edition (Medical devices - Application of usability engineering to medical devices)	The design of the ESG-400 complies with this standard. Performance testing was conducted.
Risk Management	Compliance with ISO 14971 Second edition 2007-03-01 (Medical devices - Application of risk management to medical devices)	Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO-14971:2007.
Performance with PK Instruments	Capability to use PlasmaKinetic (PK) instruments in the same manner as supported by the legally distributed/FDA cleared predicate Gyrus G400 generator (K081954). The same range of waveform output and power levels.	Bench Test Validation versus Gyrus G400 demonstrating this capability. Waveform and test results were compared directly to the predicate device.
Reprocessing	Adherence to "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance – April 1996."	Reprocessing validation was carried out in accordance with the guidance.
Flare Out Detection	Integration as an additional safety feature in PK cut modes; HF immediately disabled and automatically re-activated; warning tone and error display.	Flare out detection was integrated and functions as described.
Monopolar Cut Mode	Addition of a monopolar cut mode (Monopolar Cut E) to complete the range for High Frequency (HF) instruments.	Monopolar Cut E was added/implemented.
Substantial Equivalence	Identical technology, performance, dimensions, and materials to predicate, with modifications supported by performance tests.	Acknowledged verification methodologies demonstrated substantial equivalence.

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

Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a typical clinical study. Performance testing involved bench tests and validation with representative HF instruments.
Data Provenance: Not applicable in the sense of patient data. The testing was conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) as bench validation.

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

This information is not applicable and not provided in the document. The testing involved comparing device outputs and functionality against a predicate device and industry standards, not against human expert diagnoses or interpretations.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to bench testing and comparison against a predicate device, not diagnostic interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This type of study is not relevant for an electrosurgical generator, which is a therapeutic device, not an AI-driven diagnostic tool.

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

Not applicable. This is an electrosurgical generator, not an algorithm that performs without human involvement. The device itself is the "standalone" component in its intended function.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" for this device's performance is defined by:
- Compliance with recognized international standards (e.g., IEC, ISO for safety, performance, EMC, software, risk management).
- Direct comparison of waveform output and power levels to legally marketed predicate devices (Gyrus G400, K081954).
- Internal engineering specifications and risk analysis based on ISO-14971.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" in the conventional sense.

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

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

Summary

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

August 12, 2014

Olympus Winter & Ibe GmbH % Mr. Graham Baillie Gyrus ACMI Incorporated Olympus Surgical Technologies America (OSTA) 136 Turnpike Road Southborough, Massachusetts 01722

Re: K141225 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: July 18, 2014 Received: July 21, 2014

Dear Mr. Baillie:

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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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 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/Resourcesfor You/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.

for

Sincerely yours,

David Krause -S

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)

K141225

Device Name ESG-400

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

David Krause -SA 2014.08.12 12:42:38 -04'00'

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Electrosurgical Generator ESG-400 Olympus Winter & Ibe

510(k) Summary of Safety and Effectiveness

General information

Applicant:	Olympus Winter & Ibe GmbHKuehnstrasse 6122045 HamburgGermany
Establishment Registration No.:	9610773
Manufacturer:	Olympus Winter & Ibe GmbHKuehnstrasse 6122045 HamburgGermany
510(k) Submitter:	Gyrus ACMI, Inc.Olympus surgical Technologies America (OSTA)136 Turnpike RoadSouthborough, MA 01772Phone (508) 804-2738Fax (508) 804-2624Establishment Registration No. 3003790304
Official Correspondent:	Graham BaillieRegulatory Affairs ManagerPhone: 508.804.2738Fax: 508.804.2624Email: Graham.baillie@olympus-osta.com
Contact person:	Mr. Holger NadlerPhone: +49-66966-2860Fax: +49-66966-2134Email: holger.nadler@olympus-oste.eu
Date Prepared:	May 8th, 2014
Trade Name:	ESG-400

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Device identification

Proprietary name:	ESG-400
Device Classification name:	Electrosurgical cutting and coagulation deviceand accessories.
Regulation Medical Specialty:	General & Plastic Surgery
Regulations Number:	21 CFR 878.4400
Regulatory class:	Class II
Product code:	GEI

Predicate device

K103032: ESG-400

Description of device

The updated ESG-400 allows Olympus Plasma Kinetic (PK) instruments to be connected at the device.

Intended use

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

Comparison of Technological characteristics

The ESG-400 upgrade has the identical intended use. The existing functionalities stay unaffected/unchanged and are not influenced by the modifications.

The proposed ESG-400 extends the portfolio of instruments which can be driven by the generator. Olympus plasma kinetic (PK) instruments can be connected at the existing universal socket with integrated self-recognition. To support the additional PK hand instruments, the generator's database of connectable bipolar and monopolar instruments was expanded and new output modes were implemented. Additional modes were implemented specifically for the PK instruments.

Bipolar Coag* H
Bipolar Coag N
Bipolar Coag O
Bipolar Cut** D
I Bipolar Cut F
Bipolar Cut J
Bipolar Cut K ■
*: Coagulation mode, **: Cutting mode

The range of output waveforms and power levels are identical to the FDA cleared Gyrus G400 electrosurgical generator, K081954.

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Flare out detection was integrated as an additional safety feature which is available only in PK cut modes. Flare out could result from electrical current peaks during activation. The HF is immediately disabled and automatically re-activated. A warning tone is given and an error is displayed to inform the user.

User Interface (UI) modifications specifically for the additional PK instruments were amended but did not change the basic design philosophy. The GUI flow chart concept was not changed.

A monopolar cut mode (Monopolar Cut E) was added/implemented to complete the range for High Frequency (HF) instruments.

Compliance to Voluntary Standards

Standard No.	Standard Title
ES60601-1:2005/A1:2012	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2 Edition3:2007-03	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
IEC 60601-1-8:2012-11Edition 2.1	Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance -Collateral Standard: General requirements, tests andguidance for alarm systems in medical electrical equipmentand medical electrical systems
IEC 60601-2-2 Edition 5.02009-2	Medical electrical equipment - Part 2-2: Particular requirements forthe basic safety and essential performance of high frequencysurgery equipment and high frequency surgical accessories.
IEC 62304 First edition2006-05	Medical device software - Software life cycle processes
IEC 62366: 2007 Firstedition	Medical devices - Application of usability engineering tomedical devices
ISO 14971 Second edition2007-03-01	Medical devices - Application of risk management to medical devices

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

Table A10-1: List of FDA recognized consensus standards

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Summary of Performance Testing

The following performance testing was conducted.

1. Bench Testing
- . Bench Test Validation versus Gyrus G400 Demonstrating the capability to use PlasmaKinetic (PK) instruments in the same manner as they are currently supported by the legally distributed/FDA cleared predicate Gyrus G400 generator, K081954.

The same range of waveform output and power levels were used for performance and validation testing. During the validation, the waveform and test results were compared directly to the predicate device.

. Validation with representative HF instruments.
. Validation Comparison to Predicate Generators:

Device code	Predicate device	510(k)
I	ESG-400, Olympus Electrosurgical Generator,SW 3.06-A	K103032, K111202
II	G400 Gyrus ACMI General SurgeryWorkstation, SW 2.06	K081954
III	Force FX, Valleylab Electrosurgical Generator	K944602

Table A10-2: Comparison to Predicate Devices

Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO-14971:2007.

Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance – April 1996."

The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

Substantial Equivalence

Substantial equivalence is demonstrated by acknowledged verification methodologies. The subject devices have identical technology, performance, dimensions and materials. The difference between the predicate and new ESG-400 is to extend the portfolio of instruments which can be driven by the generator. Olympus plasma kinetic (PK) instruments can be connected at the existing universal socket with integrated self-recognition. The proposed modifications are supported by the performance tests summarized above.

Conclusion

In summary, the upgraded ESG-400 is substantially equivalent to its predicate device.

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.