Single Use Electrosurgical Knife:
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

Fluid Pump System:
The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

Device Description

The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System.

The Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract. The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa. The Fluid Pump System is included as an accessory to the Single Use Electrosurgical Knife.

The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the Cutting Knife. The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.

Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm. Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.

The Fluid Pump System included in the proposed device is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

The Fluid Pump System consists of a Foot Pedal, a Fluid Pump Console (with a Power Cord and a Control Button Cord), a Disposable Pump Cartridge, a Disposable Tubing Set, and a Disposable Control Button. The Disposable Pump Cartridge adopts the structure of a reciprocating pump, and the purpose of conveying sterile fluid is achieved through the piston's reciprocating movement. The Disposable Tubing Set is used to connect the Disposable Pump Cartridge's fluid outlet and Single Use Electrosurgical Knife's fluid injection port. The Fluid Pump Console provides a drive the Disposable Pump Cartridge to achieve reciprocating motion. The user can set the Effect value via the touch button on the touch screen or the physical knob. The Effect setting value range is 10 to 40, where Effect 10 corresponds to the minimum flow rate of 25mL/min, and Effect 40 corresponds to the maximum flow rate of 100mL/min. When Fluid Pump System used with Single Use Electrosurgical Knife, the recommended Effect is 10-30. The user can control the fluid delivery through the Foot Pedal or the Disposable Control Button, stepping on the Foot Pedal or pressing the Disposable Control Button to start fluid delivery, releasing the Foot Pedal or the Disposable Control Button, and immediately stop the fluid delivery.

The Single Use Electrosurgical Knife are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year.

The Disposable Pump Cartridge, Disposable Tubing Set and Disposable Control Button of Fluid Pump System are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year. The Foot Pedal and Fluid Pump Console of Fluid Pump System are non-sterile and reusable, the service life of the Foot Pedal and Fluid Pump Console are 8 years.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are not detailed in the provided text in the way the request specifies (e.g., a table with reported device performance, sample sizes for test sets, expert qualifications, etc.). The document is a 510(k) summary, which provides an overview of the device and its substantial equivalence to a predicate device, rather than a detailed report of individual study methodologies and results.

However, based on the Performance Data section (page 9-10), I can infer the types of acceptance criteria indirectly from the performed tests and provide a general overview of the supporting studies.

Here's a breakdown of what can be extracted and what information is missing:

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

The document states: "The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Single Use Electrosurgical Knife (K193601)."

While the specific numerical acceptance criteria and reported device performance values are not provided, the types of tests conducted imply the categories of criteria the device had to meet.

Acceptance Criteria Category (Inferred)	Reported Device Performance (General Statement in Document)
Physical Dimensions	Met predetermined acceptance criteria
Actuation Performance	Met predetermined acceptance criteria
Compatible Performance	Met predetermined acceptance criteria
Sealing Performance	Met predetermined acceptance criteria
Flowing Performance	Met predetermined acceptance criteria
Mucosa Lift Performance	Met predetermined acceptance criteria
Cutting Performance	Met predetermined acceptance criteria
Connected Force Performance	Met predetermined acceptance criteria
Shelf-life & Packaging Integrity	Demonstrated stability and integrity for one year
Sterilization Validation	Achieved Sterility Assurance Level (SAL) of 10⁻⁶
Biocompatibility	Complied with ISO 10993-1
Electromagnetic Compatibility (EMC)	Complied with IEC 60601-1-2:2014
Electrical Safety	Complied with IEC 60601-1:2012
Software Safety	Complied with IEC 62304:2015 and FDA guidance

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

Sample Size: Not specified for any of the tests.
Data Provenance (country of origin, retrospective/prospective): Not specified. These appear to be laboratory/bench tests, not clinical data sets.

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 as the described performance data pertains to bench testing against established standards and internal criteria for physical, mechanical, and safety aspects, not interpretation of medical images or clinical outcomes requiring clinical expert ground truth.

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

This information is not applicable as the described performance data pertains to bench testing against established standards and internal criteria, not interpretation of medical images or clinical outcomes.

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

This information is not applicable as no clinical or MRMC study using AI assistance is mentioned. The device is a physical electrosurgical knife and fluid pump system.

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

This information is not applicable as the device is not an algorithm or AI system. Its performance evaluation is based on bench testing.

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

The "ground truth" for the performance data appears to be established industry standards and predetermined internal specifications/criteria for device function, safety, and performance (e.g., ISO, IEC, ASTM standards, and internal material/design specifications). No clinical ground truth (like pathology or outcomes data) is mentioned as part of the performance data for this 510(k) submission.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML system requiring a training set.

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

This information is not applicable as the device is not an AI/ML system requiring a training set.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of a physical medical device (electrosurgical knife and fluid pump system) through bench testing against recognized standards and internal specifications. It does not involve AI/ML components, clinical studies for human reader interpretation, or advanced ground truth establishment methods typically seen in AI device submissions. The "acceptance criteria" are implied by the types of tests performed (e.g., dimensional accuracy, functional performance, safety compliance), and the "study" consists of these various bench tests, shelf-life studies, sterilization validation, biocompatibility testing, and electrical/software safety assessments.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

December 17, 2021

Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu Province China

Re: K211172

Trade/Device Name: Single Use Electrosurgical Knife with Fluid Pump System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, FQH Dated: November 3, 2021 Received: November 8, 2021

Dear Sally He:

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/cfpm/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.

{1}------------------------------------------------

Page 2

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 mediation-emitting products, including information about labeling regulations, please see Device (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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211172

Device Name

Single Use Electrosurgical Knife with Fluid Pump System

Indications for Use (Describe)

Single Use Electrosurgical Knife:

Tyne of Use (Select one or hoth, as annlicable)

These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

Fluid Pump System:

The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------	---------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional block font. The letters are interconnected, with the "M" on the left and the "T" on the right. A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo has a clean and modern design.

510K Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K211172

1. Date of Preparation: 2021-10-28

2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC

Establishment Registration Number: 3004837686

Contact Person: Sally He

Position: RA Engineer

Tel: +86-25-58646395

Fax: +86-25-58350006

Email: RA.Micro-Tech@outlook.com

3. Identification of Proposed Device

Product Name: Single Use Electrosurgical Knife with Fluid Pump System

Trade Name: Single Use Electrosurgical Knife, Fluid Pump System

Common Name: Electrosurgical Knife; Jet

Regulatory Information

Classification Name: Electrosurgical cutting and coagulation device and accessories, Jet lavage.

Classification: 2

Product Code: GEI and FQH

Regulation Number: 878.4400 and 880.5475

Review Panel: General & Plastic Surgery, General Hospital

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a sense of unity and strength. A registered trademark symbol is visible in the upper right corner of the logo.

4. Identification of Predicate Device/Reference Device

Predicate Device

510(k) Number: K193601

Product Name: Single Use Electrosurgical Knife

Manufacturer: Micro-Tech (Nanjing) Co., Ltd

Reference Device

510(k) Number: K143306

Product Name: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe

Manufacturer: ERBE USA, Inc

ട്. Indications for Use

Single Use Electrosurgical Knife:

Fluid Pump System:

6. Device Description

The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected and appear to be angled slightly, giving them a dynamic look. A registered trademark symbol is visible in the upper right corner of the logo.

with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa. The Fluid Pump System is included as an accessory to the Single Use Electrosurgical Knife.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the left, giving the logo a dynamic feel. A circled "R" trademark symbol is positioned in the upper right corner of the logo.

maximum flow rate of 100mL/min. When Fluid Pump System used with Single Use Electrosurgical Knife, the recommended Effect is 10-30. The user can control the fluid delivery through the Foot Pedal or the Disposable Control Button, stepping on the Foot Pedal or pressing the Disposable Control Button to start fluid delivery, releasing the Foot Pedal or the Disposable Control Button, and immediately stop the fluid delivery.

The Single Use Electrosurgical Knife are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of one year.

7. Comparison of Technological Characteristics

The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System. The Single Use Electrosurgical Knife is identical to the current Single Use Electrosurgical Knife cleared under K193601. Compared with the predicate device Single Use Electrosurgical Knife cleared under K193601, the only difference of the proposed device is the addition of Fluid Pump System, which is included as accessory of Single Use Electrosurgical Knife.

For the difference, we cited a reference device ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (K143306) to compare with the new added accessory Fluid Pump System.

Characteristics	Fluid Pump System	Reference DeviceERBEJET® 2 System withHybridAPC Probe(K143306)	Remark
Indications for Use	The Fluid Pump System is afluid delivery device that caninject fluid with adjustable flowrate and can be used with the	The ERBEJET 2 is intendedfor lifting mucosal lesions byinjection into the submucosa as wellas the cutting and dissection of soft	The intended useof the proposeddevice FluidPump System is
		Reference Device
Characteristics	Fluid Pump System	ERBEJET® 2 System withHybridAPC Probe(K143306)	Remark
	Single Use ElectrosurgicalKnife for elevation of tissuelayers by injection into thesubmucosa.	tissue in neurosurgery and softtissue such as the liver, kidney, etc.within the abdomen, including TotalMesorectal Excision (TME) in openas well as endoscopic surgery.The HybridAPC probe is indicatedfor the induction of sterile normalsaline into the submucosa to liftmucosal lesions using directvisualization through an endoscopeand for HF ablation of the mucosallesion by Argon Plasma Coagulation(APC).	included in thereference deviceERBEJET® 2System.
Energy Delivered	Pressurized sterile saline forsubmucosa lifting	Pressurized sterile saline for cutting,dissecting and submucosa lifting	The energydelivered isincluded inERBEJET® 2System.
Power Input	100-240 V	100-240 V	Same
Frequency	50/60 Hz	50/60 Hz	Same
Nozzle Diameter	0.15 mm	0.12 mm	Similar
Flow Rate	25~~100 mL/min25~~75 mL/min(Recommend value when usedwith Single UseElectrosurgical Knife)	1~55 mL/min	Similar
Components	Fluid Pump ConsoleConnecting CablesFoot PedalDisposable Pump CartridgeDisposable Pump TubingDisposable Control Button	UnitConnecting CablesFoot SwitchPump CartridgeApplicatorsSuction System	The proposeddevice doesn'tincludeApplicators andSuction System
Main Material	Metal, Glass Display Screen,Plastics, Wiring, InsulationPlastic, Metal	Metal, Glass Display Screen,Plastics, Wiring, Insulation Plastic,Metal	SE
Mucosal LiftPerformance	Deliver flow liquid for mucosallifting	Deliver flow liquid for mucosallifting	SE
Characteristics	Fluid Pump System	Reference DeviceERBEJET® 2 System withHybridAPC Probe(K143306)	Remark
ConnectionPerformance	properly connect and detachfrom designatedequipment/accessory. Onceconnected, there are no waterleaks.	properly connect and detach fromdesignated equipment/accessory.Once connected, there are no waterleaks, argon gas leakages, or leakagecurrents above internationalstandards.	device doesn'tinclude a probesubsystem,without argon gasor currentsdelivered.
ElectricalPerformance	Comply withIEC 60601-1:2012;IEC60601-1-2:2014;IEC 60529 (Foot Pedal Only)	Comply withIEC 60601-1:2012;IEC60601-1-2:2014;IEC 60529 (Foot Pedal Only)	SE
Usability	Comply withIEC 60601-1-6:2013;IEC 62366-1:2015;	Comply withIEC 60601-1-6:2013;IEC 62366-1:2015;	SE
Software	Comply withIEC 62304:2015;	Comply withIEC 62304:2015;	SE
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Shelf Life	Fluid PumpConsole (withconnectingcables), FootPedal	UnitConnectingcables,Foot PedalSuction System	SE
	Reusable	Reusable
	DisposablePump Cartridge,DisposablePump Tubing,DisposableControl Button	Pump Cartridge,Applicators
	1 YearComplywith ASTMF1980-16	3 YearsComply withASTMF1980-16

Sterilization	Fluid PumpConsole (withconnectingcables), FootPedal	UnitConnectingcables,Foot PedalSuction System	SE
	Non-Sterile	Non-Sterile
	DisposablePump Cartridge,DisposableTubing Set,DisposableControl Button:	Pump Cartridge,Applicators
	EOSterilization,SAL: 10-6.	EOSterilization,SAL: 10-6.

	Section 5 510k summary
Characteristics	Fluid Pump System	Reference DeviceERBEJET® 2 System withHybridAPC Probe(K143306)	Remark
	Fluid PumpConsole (withconnectingcables), FootPedalReusable	UnitConnectingcables,Foot PedalSuction SystemReusable
Single Use	DisposablePump Cartridge,DisposablePump Tubing,DisposableControl ButtonSingle Use	Pump Cartridge,ApplicatorsSingle Use	SE
Labeling	Comply with 21 CFR part 801	Comply with 21 CFR part 801	SE

Comparison to Reference Devices

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are primarily white against a blue background, giving them a bold and prominent appearance. A registered trademark symbol '®' is visible in the upper right corner of the logo, indicating that the design is legally protected.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional block font. The letters are white against a blue background, and there is a registered trademark symbol '®' in the upper right corner of the logo. The logo has a simple, modern design.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows a blue, stylized logo. The logo appears to be the letters 'M' and 'T' in a bold, sans-serif font. The letters are designed with a 3D effect, giving them a blocky, isometric appearance. The logo is simple and modern, with a clean design.

Compared with the reference device, the Fluid Pump System incorporates substantially equivalent device materials, design, configuration, packaging, sterilization process and intended use as those featured in the reference device ERBEJET® 2 System.

8. Performance Data

The following bench tests were performed:

Dimension
A Actuation Performance
Compatible Performance
Sealing Performance
Flowing Performance
Mucosa Lift Performance
ア Cutting Performance
Connected Force Performance

Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1:

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows a logo with the letters "MT" in a bold, sans-serif font. The letters are rendered in a dark blue color and have a three-dimensional effect, with the top and right sides appearing to extend back and to the right, creating a sense of depth. A circled "R" symbol, indicating a registered trademark, is positioned in the upper right corner of the logo.

Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One year aging test was performed to demonstrate the stability and support the results of the accelerated aging test.

Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020.

Electromagnetic compatibility, electric safety had been confirmed according to the following standards:

A IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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

Software of Fluid Pump System had been confirmed according to FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "IEC 62304:2015 Medical device software - Software life cycle processes".

The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Single Use Electrosurgical Knife (K193601).

9. Animal Study

No animal study is included in this submission.

10. Clinical Study

No clinical study is included in this submission.

{11}------------------------------------------------

K211172

Image /page/11/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are primarily white, with a blue outline and shading that gives them a sense of depth. The 'M' is positioned to the left and slightly behind the 'T', creating an overlapping effect. The overall design is simple yet modern, with a clean and professional appearance.

11. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Single Use Electrosurgical Knife with Fluid Pump System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Single Use Electrosurgical Knife (K193601).

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.