The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.

The electrosurgical generator is intended to be used in the following medical fields:

· Open surgery
· Laparoscopic surgery, including single-site surgery
· Endoscopic surgery

Only for use by a qualified physician in an adequate medical environment.

Device Description

The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different high frequency monopolar and bipolar cutting and coagulation modes with a maximum output power of 320 W, as well as capability to power the existing Olympus ultrasonic THUNDERBEAT and SONICBEAT devices via a redesigned HYBRID ULTRASONIC socket and four new modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy. The maximum RF output power for the THUNDERBEAT mode is 110 W.

The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of soft tissue in open surgery, laparoscopic surgery (including single-site surgery), endoscopic surgery and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.

The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket.

The touch screen GUI displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the menu in order to edit settings/procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to access user-defined settings and procedures.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the ESG-410 (Models: WA91327U, WA91327W), based on the provided document:

This device is an electrosurgical generator, and the information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific clinical endpoints. Therefore, many of the typical acceptance criteria and study details for AI/ML devices aiming to improve diagnostic accuracy are not applicable here. This submission relies heavily on demonstrating equivalent technical characteristics and safety performance to existing, cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Functional Equivalence	Output modes: The range of bipolar and monopolar output waveforms and power levels are identical to the primary predicate (K203277).	Confirmed: "The range of bipolar and monopolar output waveforms and the power levels are identical in comparison to the predicate ESG-410 electrosurgical generator, K203277." (Page 5) The ultrasonic and high-frequency output waveforms and power levels are equivalent to the secondary predicate (K211838). (Page 5)
Tissue Effects	Comparable tissue effects must be achieved for applicable modes of operation with applicable tissue types as predicate devices.	Confirmed: "For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." (Page 8) "Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with applicable tissue types." (Page 9)
Thermal Safety	Thermal spread in vessels: Smaller than or not statistically significantly different from control groups (predicate devices or established norms).	Confirmed via non-clinical bench testing: "The thermal spread in vessels of test article (subject device) is smaller than or not statistically significantly different from those of control groups." (Page 8) Design complies with recognized standards (Section 2.8.3, Page 7).
Vessel Burst Pressure	Burst pressure in vessels (veins and arteries): Higher than or not statistically significantly different from control groups.	Confirmed via non-clinical bench testing: "The burst pressure in vessels (veins and arteries) of test article (subject device) is higher than or not statistically significantly different from those of control groups." (Page 7-8)
Electrical Safety & EMC	Compliance with recognized electrical safety and electromagnetic compatibility (EMC) standards.	Confirmed: Design "complies with recognized standards as listed in section 2.8.8." (Page 7) and FDA guidance followed.
Software Validation	Follow FDA guidances for software in medical devices, including "Major Level of Concern" and off-the-shelf software. Cybersecurity measures implemented.	Confirmed: Software validation activities performed in accordance with FDA Guidance (May 11, 2005) and "General Principles of Software Validation" (Jan 11, 2002). "Major Level of Concern". Off-the-shelf software guidance followed (Sept 27, 2019). Cybersecurity documented per AAMI TIR57 and FDA Guidance (Oct 02, 2014). (Page 8)
Usability	Assessment according to risk management plan; use-related hazardous situations assessed, risk mitigation defined, residual risk acceptable.	Confirmed: "Usability and user interface were also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable." (Page 9)
Risk Management	Risk analysis carried out in accordance with established internal acceptance criteria based on ISO 14971:2019.	Confirmed: "Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2019." (Page 9)
Biocompatibility	Not required if no direct or indirect patient contact.	Confirmed: "The ESG-410 and foot switches do not come into direct or indirect patient contact. Therefore, biocompatibility evaluation and testing according to ISO 10993-1 is not required." (Page 7)
Reprocessing	Required cleaning, disinfecting, and drying procedures must be described in IFU.	Confirmed: "Required cleaning, disinfecting and drying procedures are described in the instructions for use." (Page 9)
Compliance with Standards	Compliance with specified FDA-recognized international standards (e.g., AAMI/ANSI/ES 60601 series, IEC 62304, ISO 14971, ASTM D4169-22, D4332-14).	Confirmed: "All standards applied are FDA recognized international standards." (Page 7) A detailed list of applied standards is provided in Section 2.8.8 (Pages 10-11).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients, as this is primarily a device safety and performance equivalence submission, not a diagnostic accuracy study.
- For Vessel Burst Pressure and Thermal Spread, studies were conducted on "vessels" which implies a quantity of biological samples (e.g., animal tissue, ex vivo human tissue) but the exact number is not provided. The comparison was to "control groups."
- For Performance Bench Testing (tissue effects, electrical waveforms, functional performance), the testing involved various "modes, instruments and test protocols/plans." The nature of these tests is laboratory bench testing using simulation and comparison.
Data Provenance: The studies were non-clinical bench testing and preclinical (simulated use) evaluation.
- No information on country of origin of data or whether it was retrospective or prospective is relevant or provided, as these are not clinical studies on human subjects.

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 to this 510(k) submission. The ground truth for functional equivalence, tissue effects, thermal safety, etc., was established through objective engineering measurements, comparisons to predicate device measurements, and compliance with recognized standards, rather than expert consensus on clinical cases.

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

This information is not applicable. Adjudication methods like 2+1 are used in clinical diagnostic studies where expert reviewers resolve discrepancies in ground truth labeling. This submission relies on objective physical measurements and engineering evaluations.

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 study was done. This is not an AI-assisted diagnostic device; it is an electrosurgical generator used for cutting and coagulation. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

This is not an algorithm-only device. The device is hardware (an electrosurgical generator) with integrated software. Its performance is always "standalone" in the sense that the generator produces desired electrical outputs or ultrasonic vibrations based on its internal programming and user settings. The human operator is "in-the-loop" by controlling the device during a surgical procedure. The software validation tests mentioned (Section 2.8.5) assess the software's performance as part of the overall device.

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

The "ground truth" for the performance claims in this submission is primarily based on:
- Objective engineering measurements: Verifying electrical waveform outputs, power levels, and adherence to specified performance parameters.
- Direct comparisons to predicate devices: Establishing that the new device's performance (e.g., tissue effects, thermal spread, burst pressure) is either identical, equivalent, or statistically non-inferior/superior to the legally marketed predicate devices.
- Compliance with recognized international standards: Demonstrating that the device meets established safety and performance benchmarks (e.g., AAMI/ANSI/IEC 60601 series for electrical safety, ISO 14971 for risk management).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set in the typical sense for learning models. The software development and validation followed standard engineering practices, not machine learning model training.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 18, 2023

Olympus Winter & Ibe GmbH % Mr. Dolan Mills Program Manager, Regulatory Affairs Olympus Surgical Tech. America; Gyrus ACMI, Inc. 800 West Park Drive Westborough, Massachusetts 01581

Re: K231777 Trade/Device Name: ESG-410 (Models: WA91327U, WA91327W)

Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 16, 2023 Received: June 16, 2023

Dear Mr. Mills:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.08.18
09:21:24 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231777

Device Name ESG-410 (Models: WA91327U, WA91327W)

Indications for Use (Describe)

The electrosurgical generator is intended to be used in the following medical fields:

· Open surgery
· Laparoscopic surgery, including single-site surgery
· Endoscopic surgery

Only for use by a qualified physician in an adequate medical environment.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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2 510(k) Summary

2.1 General Information

Applicant:	Olympus Winter & Ibe GmbHKuehnstrasse 6122045 HamburgGermany
	Establishment Registration Number: 9610773
Manufacturer:	Olympus Winter & Ibe GmbHBerlin FacilityRheinstrasse 814513 TeltowGermanyEstablishment Registration Number: 3003724334
510(k) Correspondent:	Mr. Dolan MillsProgram Manager, Regulatory AffairsOlympus Surgical Tech. AmericaGyrus ACMI, Inc.800 West Park DriveWestborough, MA 01581Phone: (901) 355-0007Email: dolan.mills@olympus.comEstablishment Registration Number: 3003790304
Date prepared:	Aug 15, 2023

2.2 Device Identification

Tradename:	ESG-410 (Models: WA91327U, WA91327W)
Footswitch Model numbers:	WA91311W, WA91321W
Classification Number:	21 CFR 878.4400
Classification name:	Electrosurgical cutting and coagulation device andaccessories
Product code:	GEI
Regulatory class:	Class II
Review Panel:	General & Plastic Surgery

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2.3 Predicate Device

The electrosurgical generator ESG-410 and accessories are considered substantially equivalent to the following legally marketed devices:

Predicate Device	Manufacturer	510(k) No.
Primary Predicate	Electrosurgical GeneratorESG-410 and Accessories	Olympus Winter & IbeGmbH	K203277
Secondary Predicate	Olympus ULTRASONICBIPOLAR GENERATORUSG-410	OLYMPUS MEDICALSYSTEMS	K211838

Table 2.1: Identification of predicate device

2.4 Product Description

The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket.

It is compliant with FDA recognized consensus safety standards as listed in section 2.8.8 below.

2.5 Indications for Use

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The electrosurgical generator is intended to be used in the following medical fields:

. Open surgerv
Laparoscopic surgery, including single-site surgery .
Endoscopic surgery ●

Only for use by a qualified physician in an adequate medical environment.

2.6 Technological Characteristics

The subject ESG-410 has an equivalent intended use and technological characteristics as the primary predicate device ESG-410 (K203277).

Various instruments can be connected to the two monopolar sockets or one bipolar socket as well as to the two universal sockets. In addition, dedicated Olympus instruments or Olympus cables can be connected to the two universal sockets with instrument recognition.

The basic design philosophy of the User Interface (UI) and GUI flow chart concept is equivalent. Compared to the predicate ESG-410 (K203277), the ESG-410 subject to this submission offers four additional output modes which are equivalent to the modes in the secondary predicate device USG-410 (K211838). Furthermore, the GUI of 2 existing modes from the primary predicate (K203277) adds level 1-5 as an alternative to the existing power/effect settings. The new level concept does not exceed the predicate power/effect settings. It provides another option to deliver an easy setup for users to account for user preference.

The capability to connect THUNDERBEAT and SONICBEAT devices via the HYBRID ULTRASONIC socket is equivalent to the function provided by the secondary predicate device USG-410 (K211838).

2.6.1 Output modes in comparison to the primary predicate device ESG-410

The range of bipolar and monopolar output waveforms and the power levels are identical in comparison to the predicate ESG-410 electrosurgical generator, K203277.

2.6.2 Output modes in comparison to the secondary predicate device USG-410

The range of ultrasonic and high frequency output waveforms and the power levels are equivalent in comparison to the secondary predicate USG-410 electrosurgical generator, K211838.

2.7 Substantial Equivalence

Substantial equivalence is demonstrated by acknowledged verification/validation methodologies. The subject devices have equivalent technology, performance, dimensions, and materials. The differences from the primary predicate device ESG-410 (K203277) are:

One HYBRID ULTRASONIC socket, compared to one Surgisaber socket ●
. The GUI is modified to support the four new modes.

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The GUI is modified to integrate the new level concept of two modes.
. Intelligent Tissue Monitoring (ITM) is provided for two modes used in conjunction with THUNDERBEAT and SONICBEAT devices to detect small impedance changes of ultrasonic vibrations, so that the electrosurgical generator is able to automatically stop the output after the target tissue is divided.

To support the additionally implemented HYBRID ULTRASONIC socket and the additional four modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy, a secondary predicate device has been selected. Substantial equivalence for the secondary predicate device is demonstrated by acknowledged verification/ validation methodologies. The secondary predicate device has equivalent technology and performance in respect to the compared modes.

There have been no changes to the technological characteristics or intended use of the predicate devices since its clearance.

The intended use for the subject device in comparison to the primary predicate ESG-410 (K203277) is complemented by the ability to support ultrasonic instruments by way of the secondary predicate USG-410 (K211838). The indication wording differences do not represent an extension of the indications for use but add clarity to the indications for use that are already covered by the predicates.

Items ofComparison	Subject device:ESG-410 andaccessories	Primary PredicateDevice: ESG-410and accessories(K203277)	SecondaryPredicatedevice:USG-410(K211838)	Evaluationofdifferences
Device Name	ElectrosurgicalGenerator ESG-410 andAccessories	ElectrosurgicalGenerator ESG-410 andAccessories	USG-410Ultrasonic BipolarGenerator	Same
RegulationSpecialty	General &Plastic Surgery	General & PlasticSurgery	General & PlasticSurgery	Identical
DeviceClassificationName	Electrosurgicalcutting andcoagulationdevice andaccessories	Electrosurgicalcutting andcoagulation deviceand accessories	Electrosurgicalcutting andcoagulationdevice andaccessories	Identical
Intended Use/Indications forUse	Intended forcutting andcoagulation ofsoft tissue andfor ligation ofvessels.Opensurgery	Intended for cuttingand coagulation oftissue:Open surgeryLaparoscopicsurgery	Intended foropen,laparoscopic(including single-site surgery), andendoscopicsurgery to cut(dissect) or	Same in total

The basic compatibility testing and electrical testing demonstrate equivalence.

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Items ofComparison	Subject device:ESG-410 andaccessories	Primary PredicateDevice: ESG-410and accessories(K203277)	SecondaryPredicatedevice:USG-410(K211838)	Evaluationofdifferences
	Laparoscopic surgery,including single-sitesurgery Endoscopic surgery	Endoscopic surgery	coagulate softtissue or to ligate(seal and cut)vessels.

2.8 Performance Data

The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.

All data was prepared in accordance with the FDA guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The guidance was followed for all relevant sections.

2.8.1 Biocompatibility testing

The ESG-410 and foot switches do not come into direct or indirect patient contact. Therefore, biocompatibility evaluation and testing according to ISO 10993-1 is not required.

2.8.2 Electrical safety and electromagnetic compatibility (EMC)

The design of the ESG-410 complies with recognized standards as listed in section 2.8.8 below.

The FDA quidance, Electromagnetic Compatibility (EMC) of Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued June 6, 2022, has been followed.

2.8.3 Thermal Safety

The design of the ESG-410 complies with recognized standards as listed in section 2.8.8 below.

2.8.4 Clinical and animal Studies

Clinical and animal studies were not necessary to prove equivalence.

This determination was based on the test results obtained during the non-clinical bench testing, which confirmed:

i. Vessel Burst Pressure: The burst pressure in vessels (veins and arteries) of test article (subject device) is higher than or not statistically significantly different from those of control groups.

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ii. Thermal Spread: The thermal spread in vessels of test article (subject device) is smaller than or not statistically significantly different from those of control groups.

2.8.5 Software

The subject ESG-410 generator contains software. The software validation activities were performed in accordance with the FDA Guidance. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The device software is considered a "Major Level of Concern". Furthermore, the FDA Guidance, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", issued January 11, 2002 was followed.

As parts of the software are off-the-shelf software. The guidance "Off-The-Shelf Software Use in Medical Devices" Guidance for Industry and Food and Drug Administration Staff, issued on September 27, 2019, was taken into account for the relevant sections.

To fulfill the requirements with regard to cybersecurity the FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 02, 2014" was followed. Cybersecurity is documented according to AAMI TIR57 "Principles for medical device security - Risk management", 2016. The wired foot switches which are subject to this submission do not contain software.

2.8.6 Performance Bench Testing

To demonstrate substantial equivalence the following aspects were considered within the verification and validation versus the predicate devices:

1. Performance and validation tests incorporated the same range of waveform outputs and power levels.
1. During the validation testing the waveforms and tissue effects were compared directly between the subject and predicate devices.

Bench testing supports the claim of substantial equivalence to the predicate devices. The validation plan specifies modes, instruments and test protocols/plans for tissue effects and electrical waveforms. Beside tissue effects, the waveforms of the generators were compared. For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms.

The following non-clinical and preclinical tests were conducted:

1. non-clinical (electrical, dimensional, functional, stability),
1. preclinical (simulated use) evaluation and testing of tissue effects and thermal safety

Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the functional performance.

Testing of equivalence was performed in comparison to the predicate devices in relevant aspects associated with usability, tissue effects, and thermal effects.

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These comprehensive validation bench tests support equivalence to the predicate devices. Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with applicable tissue types.

Usability and user interface were also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable.

Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2019.

2.8.7 Reprocessing

Required cleaning, disinfecting and drying procedures are described in the instructions for use.

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2.8.8 Applied standards

Standard No.	Standard Title	FDA-Recognitionno + date
AAMI/ANSI/ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012(Cons. Text) [Incl.AMD2:2021]	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD)[Including Amendment 2 (2021)]	19-4605/30/2022
ANSI/AAMI/ES60601-1:2005/(R)2012 andC1:2009/(R)2012and,A2:2010/(R)2012(Consolidated Text)	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD)	19-407/09/2014(foot switches)
ANSI/AAMI/IEC60601-1-2:2014[including AMD1:2021]	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests [including Amendment 1 (2021)]	19-3612/21/2020
ANSI/AAMI/IEC60601-1-8:2006 andA1:2012 [IncludingAMD 2:2021]	Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarmsystems in medical electrical equipment andmedical electrical systems [IncludingAmendment 2 (2021)]	5-13112/21/2020
ANSI/AAMI/IEC60601-2-2:2017	Medical electrical equipment - Part 2-2:Particular requirements for the basic safety andessential performance of high frequencysurgical equipment and high frequency surgicalaccessories	6-38906/07/2021
IEC62304Edition 1.1 2015-06CONSOLIDATEDVERSION	Medical device software - Software life cycleprocesses	13-7901/14/2019
IEC60601-1-6Edition 3.2:2020-07CONSOLIDATEDVERSION	Medical electrical equipment Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability	5-13212/21/2020
IEC 62366-1 Edition1.1 2020-06CONSOLIDATEDVERSION	Medical devices - Part 1: Application ofusability engineering to medical devices	5-12907/06/2020
Standard No.	Standard Title	FDA-Recognitionno + date
ISO 14971 ThirdEdition 2019-12	Medical devices – Application of riskmanagement to medical devices	5-12512/23/2019
ASTM D4169-22	Standard Practice for Performance Testing ofShipping Containers and Systems	14-57605/30/2022
ASTM D4332-14	Standard Practice for Conditioning Containers,Packages, or Packaging Components forTesting	5-9904/04/2016

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Table 2.2: Applied standards

2.9 Conclusion

The performance data support the safety of the devices and demonstrate that the subject devices comply with the recognized standards as specified.

In summary, we believe the ESG-410 and accessories are substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The ESG-410 and accessories raise no new concerns of safety or effectiveness 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.