The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.

Device Description

The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode.

The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.

The Irreversible Electroporation Ablation Generator has three working modes:

A Mode 1: Monopolar steep pulse mode;
A Mode 2: Bipolar steep pulse mode;
A Mode 3: Needle Track Coagulation.

Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system.

The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis.

Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.

AI/ML Overview

This document is a 510(k) summary for a medical device and does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically presented for AI/ML performance. The information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

However, based on the information provided, we can infer some "acceptance criteria" through the comparative non-clinical studies.

Here's an analysis based on your request, adapting to the provided document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative performance acceptance criteria in a dedicated table for the device's efficacy. Instead, it describes non-clinical tests designed to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing the subject device's effects to those of the predicate and reference devices in specific animal and ex-vivo models.

Metric/Criteria (Inferred from Non-clinical Tests)	Acceptance (Inferred)	Reported Device Performance
Ex-vivo tissue testing (swine muscle, liver, kidney): Ablation effect and ablation zones	Substantially equivalent to predicate and reference devices.	"The result showed the ablation effect and ablation zones of the subject device is substantial equivalent to the predicate device and the reference device."
ECG synchronization trigger mode testing: Comparison to predicate device.	Performance is comparable to predicate device.	"ECG trigger mode testing was conducted to compare ECG synchronization trigger mode of subject to that of the predicate device." (Implies comparable performance was observed)
In-vivo animal testing (swine): Blood routine, blood biochemistry, myocardial enzymes, and diameter of ablation (compared to predicate device).	No significant adverse differences in blood parameters between groups. Ablation diameters are comparable.	"The long ablation diameter and short ablation diameter of subject device group was compared to those of predicate device." (Implies comparable results were found to support substantial equivalence).
Compliance with recognized standards:	Device complies with all relevant standards.	The device passed specific IEC, ISO, and ASTM standards (listed in the document).

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

Test Set Sample Size:
- Ex-vivo tissue testing: Swine muscle, liver, and kidney tissue. The specific number of tissue samples or experiments is not provided.
- In-vivo animal testing: Swine. The specific number of animals used in the subject device group and predicate device group is not provided.
Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer being based in China. The studies are non-clinical (ex-vivo and in-vivo animal), not human clinical.

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

This information is not provided as the studies are non-clinical. The assessment of "ablation effect and ablation zones" or "blood parameters" would typically be performed by trained lab personnel, veterinarians, or pathologists, but specific details on their qualifications or number are not available in this regulatory summary.

4. Adjudication Method for the Test Set

This information is not provided. Given that these are non-clinical studies evaluating physical effects and physiological parameters, typical clinical adjudication methods (like 2+1 or 3+1 consensus) are not directly applicable. The "ground truth" is derived from direct measurements and observations in the experimental setup.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes a medical device, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

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

Not applicable. This device is an Irreversible Electroporation Ablation Generator and Probe, which is a physical medical device used for surgical ablation. It is not an AI algorithm. While it has embedded software, its performance is assessed as part of the overall device system, not as a standalone AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical studies mentioned:

Ex-vivo and in-vivo tests: The "ground truth" for evaluating ablation effect and ablation zones, blood parameters, etc., would be based on direct measurement, observation, and analysis by laboratory techniques (e.g., macroscopic and microscopic examination of tissue, blood tests). It's a form of objective measurement/pathology from the experimental models.

8. The Sample Size for the Training Set

Not Applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. The "development" of the device would involve engineering design, prototyping, and iterative testing, not machine learning model training.

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

Not Applicable. As explained above, there is no AI/ML training set for this device.

Summary

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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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.

June 8. 2023

Zhejiang CuraWay Medical Technology Co., Ltd. Xiaoyu Guan Regulatory Affairs Manager Building 1, No.600, 21st street, Qiantang New Area Hangzhou, Zhejiang 310018 China

Re: K222001

Trade/Device Name: Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OAB Dated: May 8, 2023 Received: May 8, 2023

Dear Xiaoyu Guan:

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 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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.06.08 11:40:14 -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)

Device Name

Irreversible Electroporation Ablation Generator Irreversible Electroporation Probe

Indications for Use (Describe)

The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.

The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K222001 510(K) Summary

Company Name/Owner	Zhejiang CuraWay Medical Technology Co., Ltd.
Contact person/Author	Xiaoyu Guan(Miss)
Date prepared	06/06/2023
Contact details Address	Room 106, Building 1, No. 600, 21st Avenue, BaiyangSub-district, Qiantang New District, 310018, HangzhouCity, Zhejiang Province, China
Trade name	Irreversible Electroporation Ablation GeneratorIrreversible Electroporation Probe
Common name	Low energy direct current ablation device
Classification name	Low Energy Direct Current Thermal Ablation System
Review panel	General & Plastic Surgery (SU)
Regulation number	878.4400
Product code	OAB
Predicate device	Nanoknife system (K183385)
Reference device	The VIVA combo RF System (K163450)

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Device Description

The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.

The Irreversible Electroporation Ablation Generator has three working modes:

A Mode 1: Monopolar steep pulse mode;
A Mode 2: Bipolar steep pulse mode;
A Mode 3: Needle Track Coagulation.

Indications for use

The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissues.

The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation Ablation Generator of CuraWay indicated for the surgical ablation of soft tissue.

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Substantial equivalence comparison with predicate device

Detailed substantial comparison was made between subject device and predicate device. Please refer to below tables for details.

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Substantial equivalence Comparison table

Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
Classification Regulation	878.4400	878.4400	878.4400	Identical
Product Code	OAB, GEI	OAB	GEI	Identical
510(k) Number	-	K183385	K163450	Identical
Indications for use	The IrreversibleElectroporation AblationGenerator is indicated for thesurgical ablation of softtissues.	The NanoKnife System withsix outputs is indicated forthe surgical ablation of softtissue.	The VIVA combo RFSystem is intendedfor use inpercutaneous andintraoperativecoagulation andablation of tissue.	Identical
Principle	The IrreversibleElectroporation AblationGenerator has three workingmodes: Monopolar steeppulse mode (Mode 1), Bipolarsteep pulse mode (Mode 2)and Needle Track Coagulation(Mode 3).Mode 1 and Mode 2 are used	The Nanoknife System usesa series of microsecondelectrical pulses to open"pores" in the cellmembranes. The electricalpulses are deliveredthrough several needle-likeprobes placed into oraround the ablation zoneunder CT or ultrasound	The RF generatorworks at 500kHz.The frequency flowsto the electrode'stip and then isapplied to thetissue. Frictionalheat occurs andcauses the ions tomove from the	Identical
Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
	for soft tissue ablation, theworking principle is that thegenerator transfersnon-thermal energy toelectrodes which are placed atthe target area, it will releasehigh-voltage electrical pulsesforming nano-scalepermanent perforations onthe soft tissues to disrupt theintracellular balance andinduce cell apoptosis. The cellsdie and are removed by thehuman body's own lymphaticsystem.	guidance. By applyingenough high voltageenergy, the open porescause irreversible damageto the cells. The cells dieand are removed by thehuman body's ownlymphatic system.	negative pole to thepositive pole andfrom the positivepole to the negativepole forty tofifty thousand timesper second. Tissuenecrosis is theprinciple thatoccurs by usingheat generatedfrom the tissueimpedance.
	The Mode 3 is used for thesoft tissue coagulation duringthe process when the probe ispulled out. This module worksat 480kHZ, the high frequencyflows to the probe's tip andthen is applied to the tissue.Frictional heat occurs and
	Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
		causes the ions to move fromthe negative pole to thepositive pole and from thepositive pole to the negativepole 40,000 to 50,000 timesper second. Tissue necrosis isthe principle that occurs byusing heat generated from thetissue impedance.
	Working mode	Mode 1: Monopolar steeppulse modeMode 2: Bipolar steep pulsemodeMode 3: Needle trackcoagulation	Steep pulse mode	Coagulation	Identical
	Prescription or OTC	Prescription	Prescription	Prescription	Identical
	Component	Irreversible ElectroporationAblation Generator,electroporation probes,neutral electrode, foot switch	NanoKnife Generator,Electrode Probes, FootPedal	Electrosurgical unit,active electrode,grounding pad,peristaltic pumpand footpedal
ESU	Bipolar or monopolar	Bipolar and Monopolar	Bipolar	Monopolar	Different. Thesubject device has
	Comparison Elements		Subject Device	Predicate Device	Reference Device	Comment
						twoconfigurations. Itdoes not impactdevice safety andeffectiveness
	Pulse Amplitude/Voltageoutput		500 ~ 3000V	500 ~ 3000V	N/A, no pulse mode	Identical
		Pulse amplitude precision	$\pm$ 5%	$\pm$ 5%	N/A, no pulse mode	Identical
		Pulse mode	~50A	~50A	N/A, no pulse mode	Identical
	MaximumOutputCurrent	NeedleTrackCoagulationMode	1A	N/A	2A	Different. Theworking current isless than that ofthe Referencedevice.
	Pulse width	monophasicpulse mode	20 ~ 120μs	20 ~ 100μs	N/A, no pulse mode	Different. Thepulse width ofmonopolar modeis wider than thatof predicate
		biphasicpulse mode	5 ~ 40μs	N/A, no biphasicconfiguration	N/A, no pulse mode	device. Animaltest resultsprovided to

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Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
				demonstrateequivalence.
Pulse width precision	±2µs or ±2%(whichever islarger)	±2µs or ±2% (whichever islarger)	N/A,no pulse mode	Identical
Number of pulse(s)	1 ~ 200	10 ~ 100	N/A, no pulse mode	Different. Thedifference isbetweenallowableadjustment range
Volts/cm	500 ~ 3000	500 ~ 3000	N/A, no pulse mode	Identical
Maximum probes	6	6	N/A, no pulse mode	Identical
Pulse frequency, Un-sync	30~ 240PPM/every 10 pulse	240PPM/every 10 pulse90PPM/every 10 pulse	N/A, no pulse mode	Different. Thehighest pulsefrequency ofsubject device issame as that ofpredicate device.
Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
Pulse frequency, Sync	ECG, frequency variesdepending on heart rate,<120PPM	ECG, frequency variesdepending on heart rate	N/A, no pulse mode	Different. Forsubject device,frequency variesdepending onheart rate below120PPM
ECG synchronizationtriggering	Yes	Yes	N/A, no pulse mode	Identical
Temperature sensors	None	None	yes	Identical toPredicate.
Impedance monitor	Yes	Yes	Yes	Identical
Continuity monitor	Yes	Yes	Yes	Identical
RF Output frequency	480kHZ± 10 %	N/A (refer to Pulsefrequency)	480kHZ± 10 %	Identical toReference
Waveform	monophasic	Square wave with steep edge(one direction)	Square wave with steepedge (one direction)	Square wave withsteep edge (onedirection)	Different, both thepredicate deviceand reference
	biphasic	Square wave with steep edge(alternative direction)	N/A, no bipolarconfiguration	N/A, no bipolarconfiguration	device have nobiphasic waveform.Animal tissueablation testing
Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
				demonstrate safetyand effectiveness
	Maximum Energy perPulse (normal)	Up to 40 watts at 50Ω (18J)	15J	Up to 200 watts at50 ohm	Different.The maximumpower output isalmost the samewith thepredicate device.
	Drive on time	It will stop working when theimpedance is up to 800Ω	N/A, no needle trackcoagulation	Up to 30 minutes,and will stopworking when theimpedance is up to800Ω	Identical to thereference device
	Crest factor	1.414	1.414	1.414	Identical
	Physical dimension	460mm(L)×410mm (W)×200mm (H)	680mm(L) x 560 mm(W) x1490 mm(H)	193mm (W) x60mm(H) x 135mm(D)	Different. Sizedifference doesnot impact safetyand effectiveness.
ActiveAccessory	Monopolar or bipolar	Monopolar or Bipolar	Monopolar	Monopolar	Different.The subjectdevice has twoconfigurations, it

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				does not impactsafety andeffectiveness
Physical dimension	The following lengths ofMonopolar Probe areavailable: 13cm, 15cm, 18cm,25cm. Working length isadjustable in 0.5 cmincrements from 0 – 4 cm viathe thumbslide. Probe needlesize: 19GBipolar Probe lengths: 15cm,25cm. Working length is 1cm,2cm, 3cm and 4cm. Probeneedle size: 18G, 15G.	Monopolar length: 15 cm,25cm, working length isadjustable in 0.5 cmincrements from 0 – 4 cmvia the thumbslide. Probeneedle size: 19GBipolar: not available.	Monopolar length:15 cm, 20cm,working length0.5cm, 1cm, 1.5cm,2cm, 2.5cm and3cm. Probe needlesize: 15G and 17G.Bipolar: notavailable.	Different. Moreavailable probedimensions aredesigned fordifferent clinicalapplication. Noimpact safety andeffectiveness.
Connector type	6 pin	6 pin	1 pin	Different.Connector type isdependent ondesignspecifications.The differencedoes not impactsafety andeffectiveness.

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Comparison Elements	Subject Device	Predicate Device	Reference Device	Comment
PatientcontactMaterials	monopolarStainless steel, PI	Stainless steel, PI	Stainless steel, PI	Different.All materials meetISO 10993-1
	bipolarStainless steel, PI,PTFE	N/A, no bipolarconfiguration	N/A,no bipolarconfiguration	biocompatibilityrequirement.
Neutraelectrodes	Conductiveor capacitive	Conductive	Conductive	Identical to
	Materials	Hydrogel	N/A, no neutral electrodes	Hydrogel	Reference
	Functions	Control the starting and stopping of theenergy output.	Control the starting andstopping of the energyoutput.	Control the startingand stopping of theenergy output.	Identical
FootSwitch	Performancespecification	Single trigger, IPX 8	Double trigger, IPX 8	Single trigger, IPX 8	Different. Thedifference doesnot impact safetyand effectiveness.

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Software description

The software is a built-in(embedded) software. The main function of it is to support Irreversible Electroporation Ablation Generator to achieve its intended use. It comprises of 11 submodules including user interface, IRE process control, coagulation process control, sensor measurement, button control, warning judgement, data storage, power output calibration, preoperative plan, postoperative analysis, and ECG synchronization. IEC62304:2015 and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued on May 11,2005) were used as reference documents during software design verification/validation.

Non-Clinical Tests

Non-clinical tests were conducted to verify that the subject devices met all design specifications and is substantially equivalent to the predicate.

Ex-vivo tissue testing using swine muscle tissue, liver tissue and kidney tissue was performed. The result showed the ablation effect and ablation zones of the subject device is substantial equivalent to the predicate device and the reference device. ECG trigger mode testing was conducted to compare ECG synchronization trigger mode of subject to that of the predicate device.

In-vivo animal (swine) testing was conducted to compare the subject device group and predicate device group in following aspects: blood routine, blood biochemistry, myocardial enzymes and the diameter of ablation. The long ablation diameter and short ablation diameter of subject device group was compared to those of predicate device.

The test results demonstrated that the proposed device complies with the following standards:

A ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
A IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
A IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
A IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
A ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization

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A ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices-Part 11: Test for systemic toxicity--Pyrogen test
A Chinese Pharmacopoeia (2020 version) Bacteria Endotoxins Test
A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
A ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
A ISO 11137-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Clinical data

No clinical data was provided.

Conclusion

The indications for use of subject device are equivalent to the predicate device. The standards testing and nonclinical performance testing demonstrates the subject device technological characteristics are equivalent to the predicate device for general soft tissue electroporation. In conclusion, the subject device is 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.