The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

Device Description

The PlaDuo System is an electro-surgical device for use in dermatological applications. The device utilizes nitrogen and argon gas to be used separately to generate the desired power level to patients. The effect of the device is achieved by heating the outer layer of the skin so that part or all of it becomes non-viable and there is controlled damage to the underlying skin.

The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the ShenB Co Ltd's PlaDuo System. The system is an electrosurgical device that uses nitrogen and argon gas to generate plasma for dermatological and general surgical procedures.

Based on the provided text, the device meets acceptance criteria through various performance tests, including:

IEC 60601-1:2005 + A1:2012: 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.
IEC 60601-2-2:2017: 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.
IEC 62304:2006+A1:2015: Medical Device Software Life Cycle Processes.
EN ISO 14971:2012: Medical Devices - Application Of Risk Management To Medical Devices.
Biocompatibility testing (cytotoxicity, irritation, and sensitization) per ISO 10993-1:2018 for patient-contacting materials (space guides).
Software verification and validation testing in accordance with FDA's guidance.
Thermal testing on ex vivo tissue specimens to verify the performance of the argon gas.

Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety & Performance	Compliance with relevant IEC standards (60601-1, 60601-1-2, 60601-2-2) for basic safety and essential performance of electrosurgical equipment.	"Verification and validation activities were successfully completed and establish that the PlaDuo System control unit performs as intended. Testing included the following: IEC 60601-1:2005 + A1:2012; IEC 60601-1-2:2014; IEC 60601-2-2:2017;"
Software Safety & Performance	Compliance with IEC 62304 for medical device software life cycle processes and FDA's software guidance.	"IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes;" and "Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices."
Risk Management	Compliance with ISO 14971 for application of risk management to medical devices.	"EN ISO 14971:2012; Medical Devices - Application Of Risk Management To Medical Devices"
Biocompatibility	All patient-contacting materials must be biocompatible (non-cytotoxic, non-irritating, non-sensitizing).	"Biocompatibility –The only patient contacting material in the device are the space guides attached to each handpiece. Biocompatibility testing for cytotoxicity, irritation, and sensitization per ISO 10993-1:2018 are included with the submission and show no concern for patient contacting materials."
Thermal Performance (Argon Handpiece)	The argon handpiece should achieve consistent and desirable thermal damage profiles comparable to predicate/reference devices for the intended clinical effect.	"In addition, thermal testing on ex vivo tissue specimens was conducted to verify the performance of the argon gas used with the device. The Test device at stacked pulses produced measurable thermal damage in skin and in liver models and traceable thermal effect in muscle. The study demonstrated the ability of the device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate and reference devices. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect."
Substantial Equivalence (Overall)	The modified PlaDuo System (with Argon handpiece) must be substantially equivalent to the predicate device(s) for the proposed indications for use.	"The PlaDuo System that is the subject of this application is a next-generation of the currently cleared PlaDuo with Nitrogen only. Besides the addition of the gas and handpiece tip for use with Argon, there have been no changes to the device. Performance testing shows that the newly added argon feature produces consistent thermal damage profiles similar to predicate and reference devices. The subject device is substantially equivalent to the predicate device for the requested indications for use."

Study Details:

Sample sizes used for the test set and data provenance:
- The document mentions "thermal testing on ex vivo tissue specimens." It specifies "skin and in liver models" and "muscle" as the tissue types. However, the exact sample size (number of specimens or tests) is not provided.
- Data provenance: "ex vivo tissue specimens." The country of origin is not specified. The study's nature is likely prospective as it involves new testing for the modified device.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish ground truth or interpret the thermal testing results. The conclusion about "desirable clinical treatment effect" based on thermal damage profiles implies expert assessment, but details are absent.
Adjudication method for the test set:
- Since the thermal testing is described as direct measurement of physical effects ("measurable thermal damage," "traceable thermal effect"), a human adjudication method in the sense of consensus reading (2+1, 3+1) is not applicable in the same way it would be for image interpretation. The method of assessing "consistent thermal damage profiles" and comparability to predicate devices would likely rely on quantitative measurements and engineering/biomedical expertise, but no specific adjudication method is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is an electrosurgical tool, not an AI interpreting medical images. The evaluation focuses on the safety and performance of the electrosurgical function itself, particularly its thermal effects, rather than how it assists human interpretation or decision-making in a diagnostic context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a piece of hardware with integrated software for control, not an AI algorithm to be evaluated in a standalone diagnostic capacity. The "software verification and validation testing" confirms the software's functional performance, which is a component of the device's overall standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the thermal testing, the ground truth was observed thermal damage profiles on ex vivo tissue, measured directly. The comparison was made against profiles produced by predicate and reference devices, implying their established effectiveness provides a benchmark. It's a physical/biophysical ground truth.
The sample size for the training set:
- The document describes a 510(k) submission for a physical medical device, not an AI/machine learning model that typically has a "training set." Therefore, the concept of a training set sample size does not apply in this context.
How the ground truth for the training set was established:
- As this is not an AI/ML device, the question of establishing ground truth for a training set is not applicable.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 24, 2023

ShenB Co Ltd % Aubrey Thompson Regulatory Consultant Hoy and Associates Regulatory Consultants 1830 Bonnie Way Sacramento, California 95825

Re: K232223

Trade/Device Name: PlaDuo System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 26, 2023 Received: July 26, 2023

Dear Aubrey Thompson:

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"

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(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).

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.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.24
15:45:03 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K232223

Device Name PlaDuo System

Indications for Use (Describe)

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

Research Use (Part 21 CFR 361.1 Subject to Review)
Therapeutic Goods Use (21 CFR part 312)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K232223

This 510(K) Summary of safety and effectiveness for the PlaDuo System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

ApplicantAddress	ShenB Co., Ltd.Shenb Bldg 148, Seongsui-roSeongdong-Gu, Seoul, 04796Republic of Korea
Contact Person	Aubrey Thompson, Regulatory Consultant
Contact Information	aubreythompson@hoyregulatory.com(323)533-8994
Preparation Date	July 26, 2023
Device Trade Name	PlaDuo System
510(k) number	K232223
Classification Name	Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number	878.4400
Product Code	GEI
Regulatory Class	II
Legally Marketed Predicate Device	Pladuo System (K201735)

Legally Marketed Reference Device Subnovii Advanced Plasma Technology (K201738)

Device Description:

The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.

Indications for use:

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	Proposed DevicePlaDuo	Predicate DevicePlaDuo	Reference DeviceSubNovii	Comparison
Indicationsfor Use	The PlaDuo is intendedfor use in dermatologicand general surgicalprocedures forelectrocoagulation andhemostasis. The Argonhandpiece is intendedfor the removal anddestruction of skinlesions and thecoagulation of tissue.	The PlaDuo isintended for use indermatologic andgeneral surgicalprocedures forelectrocoagulationand hemostasis.	The SubNovii isused in theremoval anddestruction of skinlesions and thecoagulation oftissue.	The proposed PlaDuodevice shares theindications for usewith its previousgeneration device.The addition of theargon handpiece addsthe indications thatare identical to theSubnovii device.

Substantial Equivalence –Technical Specifications Comparison:

	Proposed DeviceShenB PlaDuo	Predicate DeviceShenB PlaDuo	Reference DeviceSubnovii	Comparison
Mode ofoperation	Plasma Radiofrequencyenergy ionizes the aircreating a Plasmastream	PlasmaRadiofrequencyenergy ionizes the aircreating a Plasmastream	PlasmaRadiofrequencyenergy ionizes theair creating aPlasma stream	Same
ElectricalVoltage	AC 100-230V/ 50/60Hz	AC 100-230V/50/60Hz	110-250 VAC50/60 Hz	Same
OutputEnergy	Nitrogen Gas: 0.5 – 4JArgon Gas: 0.12J - 0.7J	Nitrogen Gas: 0.5 – 4J	5J	Same for Nitrogen,No argon option onpredicate. Seediscussion below forReference devicepower leveldifference.
PowerConsumption	1000 VA	1000 VA	Not listed	Same for Predicate 1
RepetitionRate	1 – 3 Hz	1 – 3 Hz	N/A	Same for Predicate 1
Emitting Time	Nitrogen:5 - 40ms +/- 20%Argon: 4-18ms	Nitrogen: 5-40ms	N/A	Same for Predicate 1.The pulse width islower with the Argonbecause of the lowdischarge efficiency

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				of argon and thepotential for the buildup of heat in thedevice with a longerpulse width.
GasRequirement	Medical Grade Argon andMedical Grade Nitrogen	Medical GradeNitrogen	Air	Different. Thepredicate device usesNitrogen gasexclusively. Thesubject device addsargon. The referencedevice does not use amedical grade gas forplasma generation.

Performance Testing

Verification and validation activities were successfully completed and establish that the PlaDuo System control unit performs as intended. Testing included the following:

IEC 60601-1:2005 + A1:2012; 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;
IEC 60601-2-2:2017; 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;
IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes; ●
EN ISO 14971:2012; Medical Devices - Application Of Risk Management To Medical Devices

Biocompatibility –The only patient contacting material in the device are the space guides attached to each handpiece. Biocompatibility testing for cytotoxicity, irritation, and sensitization per ISO 10993-1:2018 are included with the submission and show now concern for patient contacting materials.

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

In addition, thermal testing on ex vivo tissue specimens was conducted to verify the performance of the argon gas used with the device. The Test device at stacked pulses produced measurable thermal damage in skin and in liver models and traceable thermal effect in muscle. The study demonstrated the ability of the device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate and reference devices. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect.

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Conclusion

The PlaDuo System that is the subject of this application is a next-generation of the currently cleared PlaDuo with Nitrogen only. Besides the addition of the gas and handpiece tip for use with Argon, there have been no changes to the device. Performance testing shows that the newly added argon feature produces consistent thermal damage profiles similar to predicate and reference devices. The subject device is substantially equivalent to the predicate device for the requested indications for use.

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.