The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

Device Description

The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.

AI/ML Overview

This is an electrosurgical generator, not an AI/ML powered device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance
Electrical Safety (IEC 60601-1)	Compliant
Electromagnetic Compatibility (IEC 60601-1-2)	Compliant
Performance (IEC 60601-2-2)	Compliant
System Performance	Compliant
Thermal Effects (FDA Guidance for Electrosurgical Devices)	Compliant
Software Validation (FDA Guidance for Software in Medical Devices)	Compliant

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

Not applicable. This is not an AI/ML powered device that uses a "test set" in the context of data analysis. The testing involved hardware and software validation against established medical device standards.

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

Not applicable. Ground truth, in the context of data for AI/ML, is not relevant for this device. Compliance was assessed against engineering and performance standards by qualified testing personnel and regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" for adjudication as it's understood in AI/ML studies. Compliance was determined by meeting predefined standards and test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is typically conducted for diagnostic AI tools involving human interpretation of data. This device is an electrosurgical generator, and such a study is not relevant to its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a hardware device with embedded software. It does not operate as a standalone algorithm in the sense of AI/ML. Its performance is evaluated through its physical and electrical outputs.

7. The Type of Ground Truth Used:

Ground truth for this device is established by:

Engineering and Performance Standards: International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) set the objective criteria for electrical safety, electromagnetic compatibility, and specific electrosurgical device performance.
FDA Guidance: FDA guidance documents for electrosurgical devices provide criteria for aspects like thermal effects.
Software Validation Principles: Ground truth for software validation involves adherence to established software engineering principles and documentation requirements outlined in FDA guidance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. As there is no training set of data, no ground truth needs to be established for it.

Summary

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October 25, 2021

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma OARA Director No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi, Zhejiang 315301 China

Re: K210488

Trade/Device Name: Ultrasonic Surgical & Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 10, 2021 Received: August 30, 2021

Dear Guofang Ma:

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.

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

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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 mediation-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,

Long Chen, 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) K210488

Device Name Energy Generator

Indications for Use (Describe)

The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

**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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510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

There is no prior submission for the device.

3.1 Submitter Information

510(k) Submitter/Holder: .

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, China

Contact ●

Guofang Ma QARA Director Telephone: +86-10-64116115 Fax: +86-10-64113261 Email: QARA@surgnova.com

Date Prepared: October 22, 2021 ●

3.2 Proposed Device Information

Device Common Name: Electrosurgical cutting and coagulation device and accessories Device Trade/Proprietary Name: Energy Generator Model: ES300, ES200, ES100 Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Class: II Panel: General & Plastic Surgery

3.3 Predicate Device

510(k) Number: K944602 Device Trade/Proprietary Name: Valleylab Force Fx Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Regulatory Class: II Panel: General & Plastic Surgery Manufacturer: VALLEYLAB, INC.

3.4 Device Description

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The device working mode is shown in the following table:

Model	Working mode
	Monopolar						Bipolar
	Low purecut	Purecut	Blend	Desiccate	Fulgurate	Spray	Precise	Standard	Macro
ES300	√	√	√	√	√	√	√	√	√
ES200	N/A	√	√	N/A	√	√	N/A	√	√
ES100	N/A	N/A	√	N/A	N/A	√	N/A	N/A	√

ce working mode is shown in the following table:

Table 1 Device working mode

Monopolar

Low pure cut mode: applicable to cutting of fine tissues and endoscopic surgery ●
Pure cut mode: applicable to fine non-invasive cutting ●
Blend mode: providing good coagulant effect when cutting
. Desiccate mode: applicable to the coagulation of endoscopic surgery and other fine tissues
. Fulgurate mode: applicable to the superficial coagulation of most surgeries and laparoscopic surgeries
. Spray mode: applicable to large area of tissue bleeding, and only forming a scab in superficial tissue structure.

Bipolar

Precise mode: applicable to neurosurgery, ophthalmology and other microsurgeries
Standard mode: applicable to neurosurgery and general surgeries
Macro mode: applicable to open and endoscopic surgeries

The monopolar Low pure cut mode, Pure cut mode, Blend mode, Desiccate mode, Fulgurate mode and Spray mode are designed for use with conventional hand switching or foot switching electrosurgical devices. The three bipolar output modes are designed for use with conventional hand switching or foot switching electrosurgical bipolar forceps. When using conventional electrosurgical devices, the user selects the mode and desired power using a touch screen display on the generator.

The monopolar mode requires use of neutral electrode. The Energy Generator can be compatible with neutral electrode based on their output rating with FDA clearance. For

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example: FDA 510k cleared Electorsurgical pad: K130027 or other FDA cleared neutral electrode. Bipolar devices do not require neutral electrode.

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3.5 Comparison list of the technological characteristics

Based on the components of the Energy Generator, the subject device is compared with Valleylab Force Fx (K944602). The technological characteristics, features, specifications and intended use of Energy Generator is substantially equivalent to the predicated devices quoted above. The specific results are as follows:

Comparison Elements	Subject Device	Predicated device(K944602)
Product Name	Energy Generator	Valleylab Force Fx
Regulation No.	21 CFR 878.4400	21 CFR 878.4400
Classification	II	II
Classification Name	Electrosurgical cutting and coagulation device and accessories	Electrosurgical cutting and coagulation device and accessories
Indications for Use	The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The ESU generator is equipped with monopolar and bipolar outputs.	The Valleylab Force Fx is an isolated microprocessor based ESU generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The generator is equipped with monopolar and bipolar outputs.
Working principle	Monopolar: ESU generator connects its accessories and split ESU neutral electrode (adhered to patient skin) to form a cyclic circuit, the HF current generated	Monopolar: ESU generator connects its accessories of a ESU pencil and a split ESU pad (adhered to patient skin) to form a cyclic circuit, the HF current

Table 2 Comparison between Energy Generator and Valleylab Force Fx (K944602)

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			from the generator and through the ESU accessories(such as electrosurgical pencil and laparoscopicelectrode) to achieve CUT or COAG, then return togenerator by the ESU neutral electrode.	generated from the generator and through the ESUpencil to achieve CUT or COAG, then return togenerator by the ESU pad.
			Bipolar: HF current generated from the generator andthe cyclic circuit formed between the two tips of thebipolar forceps, the HF power through the two tips towork on patient obtaining COAG, no need extra ESUneutral electrode.	Bipolar: HF current generated from the generatorand the cyclic circuit formed between the two tips ofthe bipolar forceps, the HF power through the twotips to work on patient obtaining COAG, no needextra ESU pad.
Energy			HF energy	HF energy
Input power			100V -240V AC	100-120V/220-240V, 60Hz/50Hz
Performance Specifications	Waveform	MonopolarCUT	Low Pure Cut ModePure Cut ModeBlend Mode	Low Pure Cut ModePure Cut ModeBlend Mode
		MonopolarCOAG	Desiccate ModeFulgurate ModeSpray Mode	Desiccate ModeFulgurate ModeSpray Mode
		Bipolar	Precise ModeStandard ModeMacro Mode	Precise ModeStandard ModeMacro Mode
	Operation mode		Intermittent use 10s on, 30s off	Under maximum power settings and rated loadconditions (pure cut 300W, 300ohm load) thegenerator is suitable for activation times of 10s on,30s off for 1 hour

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CQMS	The Neutral Electrode Contact Quality Monitor will measure the resistance, if the resistance was beyond the range of defined by an upper and lower limit, the alarm system will be activated.	Force FX (REM): The Return Electrode Contact Quality Monitor will measure the resistance, if the resistance was beyond the range of defined by an upper and lower limit, the alarm system will be activated.
Memory	The previous power setting digits presented when restart	Recall the last activated previous setting when Power On next time by pressing RECALL
Power ON self diagnostics	The generator starts self diagnosis after power on, if the self diagnosis fail, an alarm sounds and an Error Code is displayed on the display panel.	Force Fx: When the generator senses a system alarm conditions, an alarm sounds and an alarm number is displayed on the front panel. A system alarm condition deactivates the generator.
Operating	Only one output device to be activated at any given time	Only one output device to be activated at any given time

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3.6 Indications for Use

The Eenergy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The ESU generator is equipped with monopolar and bipolar outputs.

3.7 Testing

Non-Clinical Testing

The Energy Generator and the predicate device are substantially equivalent in design concepts and technologies. The Energy Generator has been designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

• IEC 60601-1: 2005/A1:2012 Medical Electrical Equipment-Part 1: General requirements for safety.

· IEC 60601-2-2:2009 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical accessories.

· IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The list of non-clinical test performed on the proposed device.

No.	Test Name
1	Electrical Safety Test According to IEC 60601-1
2	Electromagnetic Compatibility Test According to IEC 60601-1-2
3	Performance Test according to IEC 60601-2-2
4	System Performance Test
5	Thermal Effects test according to FDA Guidance Premarket Notification(510(K)) Submissions for Electrosurgical Devices for General Surgery

Clinical Testing

Clinical studies were not required to demonstrate the substantial equivalence of the Energy Generator and the predicated device.

3.8 Determination of substantial equivalence

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The subject device is equivalent with respect to the basic system design and function to that of the predicate device. The subject device isn't the implants and high-risk device. And it doesn't have new intended purposes, new medical, new target populations, and new users and so on. What's more, it can't use the medicinal substances or animal tissues. So differences between the predicate and proposed device do not raise new questions of safety or effectiveness. So the proposed device is determined to be substantially equivalent to the 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.