PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue. After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc. This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and an associated 510(k) summary for the PLAXPOT™ MULTI PLASMA device. This documentation primarily focuses on establishing "substantial equivalence" of the device to legally marketed predicate devices, rather than a detailed study proving the device's clinical performance against specific acceptance criteria for a novel AI/ML device.

Therefore, the document does not contain information regarding acceptance criteria for an AI/ML device, nor does it describe a study that proves the device meets such criteria. The device in question, an electrosurgical device, is not an AI/ML product.

The 510(k) summary (specifically sections 5.8 and Table 2) outlines performance bench tests designed to demonstrate the device's functional requirements and safety as an electrosurgical device, but these are not the type of studies (e.g., MRMC, standalone AI performance) you've inquired about for AI/ML device validation.

Here's an explanation of why the requested information is not present based on the provided text:

Acceptance Criteria for AI/ML Performance: The document does not mention any AI/ML components. The device operates on the principle of generating plasma through high-frequency current to remove/destroy skin lesions and coagulate tissue. Its "Performance Testing" relates to electrical safety, EMC, and thermal effects, which are standard for electrosurgical devices, not AI/ML performance metrics like sensitivity, specificity, AUC, or F1-score.
Study Proving Device Meets Acceptance Criteria: No study in the document describes the formal validation of an AI/ML algorithm against specified performance thresholds. The "Performance Testing" section mentions "bench tests" and "functional requirements," which are engineering and electrical safety checks, not clinical performance studies for an AI/ML diagnostic or therapeutic aid.
Table of Acceptance Criteria and Reported Performance: No such table exists for AI/ML performance. The table (Table 2) lists "Performance Testing Summary" for bench tests with "Pass" results, indicating compliance with electrical safety and other engineering standards.
Sample Size for Test Set and Data Provenance: Not applicable as there's no AI/ML test set defined.
Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no AI/ML ground truth generation process described.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, as it's not an AI/ML device requiring human-in-the-loop performance evaluation.
Standalone (Algorithm Only) Performance: Not applicable, as there's no standalone algorithm.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document details the FDA clearance process for an electrosurgical device (PLAXPOT™ MULTI PLASMA) based on substantial equivalence to existing predicate devices. It covers safety, electrical standards, and intended use as an electrosurgical device, but it does not contain any information about an AI/ML component or studies related to AI/ML device performance.

Summary

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October 27, 2023

GCS Co. Limited % Su Kyung Park Director Compliance Insight 497 Circle Freeway Dr. Unit 230 West Chester, Ohio 45246

Re: K220493

Trade/Device Name: Plaxpot Multi Plasma Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: QVJ Dated: [NOTE: Use date of most recent supplement] Received: September 29, 2023

Dear Su Kyung Park:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.10.27
16:19:00 -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) K220493

Device Name PLAXPOT™ MULTI PLASMA

Indications for Use (Describe) PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of 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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PLAXPOT™ MULTI PLASMA

510(k) Summary

General Information 5.1

18 February 2022 Preparation Date:

26 October 2023 Revision Date:

Submitter/Holder

Su Kyung, Park

Director

GCS Co., Ltd. #1008, 555, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea Tel: 82-2-555-1536 Fax : 82-2-3142-7670 Email: kara21c(@gcsgroup.co.kr

Website: http://www.bestgcs.com/

Primary Contact

Cynthia Ipach President/CEO

Email: cipach@compliance-insight.com

Office +1 513-860-3512 ext. 306 Compliance Insight 497 Circle Freeway Dr Suite 230. Cincinnati, OH 45246

5.2 Regulatory Information

Subject Device Trade Name	PLAXPOT TM MULTI PLASMA
Classification Name	Low Power Electrosurgical Devices For Skin LesionDestruction
Device Classification	II
Regulation Description	Electrosurgical cutting and coagulation device andaccessories
FDA Product Code	QVJ
CFR References	21 CFR 878.4400
Review Panel	General & Plastic Surgery

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5.3 Identification of Predicate Devices

The primary predicate device for PLAXPOT™ MULTI PLASMA is the SubNovii Advanced Plasma Technology (K201738) and the reference device is Plasma IQ (K192813).

5.4 Subject Device Description

After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc.

This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.

ર્સ્ટ Indications for Use

PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.

Substantial Equivalence Discussion 5.6

In Table 1 on the following page please find a characteristics comparison summary. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that PLAXPOT™ MULTI PLASMA is substantially equivalent to the primary predicate device, the SubNovii Advanced Plasma Technology K201738.

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DeviceCharacteristics	ProposedDevice	PrimaryPredicate	ReferenceDevice
Product Name	PLAXPOTTMMULTI PLASMA	SubNoviiAdvancedPlasmaTechnology	Plasma IQ
510(k)	K220493	K201738	K192813
Manufacturer	GCS Co. Ltd.	CartessaAesthetics	Neauvia NorthAmerica
FDA ProductCode	QVJ	GEI	GEI
CFR Reference	878.4400	878.4400	878.4400
Device Class	II	II	II
Prescription orOTC	Prescription	Prescription	Prescription
ImplantedDevice	No	No	No
Indications forUse Statement	PLAXPOT™MULTI PLASMAis intended for theremoval anddestruction of skinlesions andcoagulation oftissue.	The SubNovii isintended for theremoval anddestruction ofskin lesions andcoagulation oftissue.	Plasma IQ isused in theremoval anddestruction ofskin lesions andcoagulation oftissue.
Mode ofOperation	Plasma highfrequency currentionizing the aircreating a plasmastream.	Plasmaradiofrequencyenergy ionizesthe air creating aplasma stream.	Plasmaradiofrequencyenergy ionizesthe air creatinga plasmastream.
Output Mode	Continuous	Continuous	Continuous
Energy Type	High Frequency	High Frequency	High Frequency
Power Level	3 modes at 0.7W,1W, 2W	Max 5W	Max 5W
Reusable orSingle Use	Reusable	Reusable	Reusable
Output	Monopolar	Monopolar	Monopolar
Max PowerOutput	3W	5W	5W
Power Supply	InternalRechargeableLithium IonBattery 7.4 VDC1000mAh	InternalRechargeableLithium IonBattery 11.1VDC	InternalRechargeableLithium IonBattery 11.1VDC
Frequency	70 kHz	40kHz	40kHz
SystemComponents	A handpiece thatincorporates theelectrosurgicalgenerator unit,OLED display,software, anddocking station.	A handpiece thatincorporates theelectrosurgicalgenerator unit,docking stationand an activeelectrode.	A handpiecethatincorporates theelectrosurgicalgenerator unit,docking stationand an activeelectrode.
ElectricalSafetyStandards	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2
Software	Yes	No	No
SoftwareCompliance	IEC 62304	N/A	N/A

Table 1. Summary Comparison of Characteristics

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PLAXPOT™ MULTI PLASMA

5.7 Sterilization and Shelf Life

The PLAXPOT™ MULTI PLASMA is sold non-sterile.

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Shelf-life is not applicable because of low likelihood of time-dependent product degradation.

Performance Testing - Bench 5.8

Performance bench tests of PLAXPOT™ MULTI PLASMA have been performed, see Table 2. The results from the performance bench testing demonstrate that PLAXPOT™ MULTI PLASMA has met the functional requirements and is substantially equivalent to the predicate device. Performance bench testing is provided in detail.

Study	Attachment	Test Method	Results
Basic Safety andEssential Performance	18-3	EN 60601-1:2006+A1:2013 or EN60601-1:2006+A12:2014 andtest reportIEC60601_1K	Pass
ManufacturerTechnical File	18-5	N/A	Pass
EMC Test	18-6	IEC 60601-1-2:2014	Pass
EMC Test	18-7	IEC 60601-1-2:2014	Pass
Thermal Effects Test	NA	FDA Submissions forElectrosurgical Devicesfor General Surgery	Pass

Table 2. Performance Testing Summary

5.9 Conclusion

The subject device PLAXPOT™ MULTI PLASMA has the same technology, principle of operation, indications for use and technical specifications as the primary predicate device Subnovii and the reference device Plasma IQ. PLAXPOT™ MULTI PLASMA shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) as the predicate device and no new elements pertaining to safety or effectiveness have been identified. Performance test results demonstrate that the subject device can perform the same intended use as safely as the predicate and reference devices. Therefore, the subject device is substantially equivalent to the predicate.

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.