The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis.

The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides.

AI/ML Overview

The provided text is a 510(k) summary for the PlaDuo System, an electrosurgical device. It outlines non-clinical tests conducted to support its substantial equivalence to predicate devices, but no clinical studies or acceptance criteria based on clinical performance are mentioned. Therefore, I cannot provide details on acceptance criteria or studies that prove the device meets them in the context of clinical performance.

However, based on the non-clinical tests performed, I can infer acceptance criteria for those tests and describe the study that proves the device met them.

Here's a summary of the non-clinical acceptance criteria and the studies performed:

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

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-05:2009)	Device components (electrode tips) must show no cytotoxic effects in vitro.	Pass
	Sensitization (ISO 10993-10:2010, Guinea Pig Maximization Test)	Device components (electrode tips) must not induce sensitization (allergic reaction).	Pass
	Irritation or Intracutaneous Reactivity (ISO 10993-10:2010, Animal Intracutaneous Test)	Device components (electrode tips) must not cause irritation or intracutaneous reactivity.	Pass
Electrical Safety & EMC	IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12 (General requirements for basic safety and essential performance)	Device must meet general requirements for basic safety and essential performance for medical electrical equipment.	Not explicitly stated as "Pass" but implied by submission to standards.
	IEC 60101-2-2:2017 (Particular requirements for the basic safety and essential performance of high-frequency surgical equipment)	Device must meet particular requirements for basic safety and essential performance of high-frequency surgical equipment.	Not explicitly stated as "Pass" but implied by submission to standards.
	IEC 60601-1-2:2014 (General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and Tests)	Device must meet electromagnetic compatibility (EMC) requirements and relevant tests for medical electrical equipment.	Not explicitly stated as "Pass" but implied by submission to standards.
Software Verification & Validation	FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005 (moderate level of concern)	Software must be verified and validated according to FDA guidance for a moderate level of concern, ensuring proper functionality and safety.	Documentation provided. Not explicitly stated as "Pass" but implied by submission and acceptance of documentation.
Bench Testing	Output Energy	Output energy must be within predefined design specifications.	Operates safely and within predefined design specifications.
	Durability of the tip	Tip must demonstrate adequate durability according to predefined design specifications.	Operates safely and within predefined design specifications.
	Thermal testing (in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”)	Thermal effects must be within acceptable limits as outlined by FDA guidance to ensure patient safety and device efficacy.	Operates safely and within predefined design specifications.

Important Note: The document explicitly states "No Clinical study was conducted as part of this submission." Therefore, the following points address the questions in the context of the available non-clinical information.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Biocompatibility: The sample sizes for these tests are specific to the biological assay standards (e.g., number of cells for cytotoxicity, number of guinea pigs for sensitization, number of animals for intracutaneous reactivity). These specific numbers are not detailed in the provided summary, but the tests were performed in accordance with international ISO standards.
Electrical Safety & EMC: These are typically laboratory tests performed on a single or a few units of the device. The specific number of units tested is not stated.
Software Verification & Validation: This involves reviewing and testing the software, often through simulated scenarios or on development units. Sample size for actual "test cases" within software testing is not specified.
Bench Testing: This involved testing of the device and its components (e.g., tips). The specific number of devices or tips tested is not provided.

The provenance of this non-clinical data is from the manufacturer, ShenB Co. Ltd., which is based in South Korea (Seongdong-Gu, Seoul). These were prospective tests conducted to demonstrate compliance with the relevant standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not directly applicable as the studies were non-clinical, involving engineering, materials science, and software experts.

Biocompatibility: The "ground truth" (i.e., whether a material is biocompatible) is established by the results of standardized laboratory tests interpreted by trained toxicologists/biocompatibility specialists.
Electrical Safety & EMC: The "ground truth" (i.e., whether the device meets electrical safety and EMC standards) is established by measurements against predefined limits by qualified electrical engineers and testing laboratories.
Software Verification & Validation: The "ground truth" (i.e., whether the software functions as intended and is safe) is established by software engineers and quality assurance specialists comparing software behavior against its requirements and design specifications.
Bench Testing: The "ground truth" (i.e., performance against specifications) is established by engineers performing measurements and observations against design requirements.

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

This concept is primarily relevant for clinical studies involving human interpretation or subjective endpoints. For these non-clinical tests, adjudication methods like 2+1 or 3+1 are not typically used. The results of these tests are objectively measured against established standards and specifications. If there were any ambiguous results, internal quality processes or re-testing would be employed.

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

No MRMC study was performed as no clinical studies were conducted, and the device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

This question is not applicable as the PlaDuo System is an electrosurgical device, not an algorithm. The "standalone" performance relates to the device's functional integrity as an electrosurgical unit, which was assessed through bench testing and compliance with electrical safety standards.

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

For the non-clinical tests:

Biocompatibility: The ground truth is established by standardized laboratory test results (e.g., cell viability, immune response observed in animal models) compared against established safety thresholds defined by ISO standards.
Electrical Safety & EMC: The ground truth is established by objective measurements of electrical characteristics (e.g., leakage current, electromagnetic emissions) against the limits defined in IEC standards.
Software Verification & Validation: The ground truth is established by the software requirements specification and design documents, against which the functionality and performance of the software are tested.
Bench Testing: The ground truth is established by the device's predefined design specifications and engineering requirements for parameters like output energy, tip durability, and thermal effects.

8. The sample size for the training set

This question is not applicable as there is no mention of an algorithm or AI model in the submission that would require a training set.

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

Not applicable, as no training set for an AI/algorithm was mentioned.

Summary

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December 14, 2020

ShenB Co. Ltd. % Connie Hoy Consultant Hoy and Associates 3916 N. Potsdam Ave #4676 Sioux Falls, South Dakota 57104

Re: K201735

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: November 29, 2020 Received: December 1, 2020

Dear Connie Hoy:

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 Actinclude 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-devices/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 (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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201735

Device Name

PlaDuo System

Indications for Use (Describe)

The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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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510k SUMMARY

A summary of 510k safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

K201735

	807.92(a)(1) - Submitter Information
Name	ShenB Co Ltd.
Address	Shenb Bldg 148Seongsui-roSeongdong-Gu, Seoul , KR 04796
Phone number	82 70.4912.2702
Email	oskar@shenb.com
Establishment Registration Number	3010226575
Name of contact person	Mr. Oskar Lee
Date prepared	June 15, 2020
	807.92(a)(2) - Name of device
Trade or proprietary name	PlaDuo System
Common or usual name	Electrosurgical, cutting and coagulation device and accessories
Classification name	Electrosurgical, cutting and coagulation device and accessories
Classification panel	General and Plastic Surgery
Regulation	21 CFR 878.4400
Product Code(s)	GEI
Regulatory Class	Class II Prescription Use
	807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
Predicate device	Potenza (K)192545
Reference device	Rhytec Portrait PSR (K)060948
	807.92(a)(4) - Device description
	The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis.The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides.
	807.92(a)(5) Intended use of the device
Indications for use	The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis

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807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
Characteristic	Proposed DevicePlaDuo System	Predicate DevicePotenza (K)192545	Reference DeviceRhytec Portrait PSR3(K)060948
Mode of Operation	Nitrogen Gas	Radio Frequency	Nitrogen Gas
Principal ofOperation	Plasma energy is delivered to theskin and energy is rapidlytransferred to the skin surface.As the plasma energy passesthrough the tissue it generates anelectrothermal reaction which iscapable of coagulating tissue.	RF energy is delivered throughthe skin into the target tissue viaa handpiece equipped with anelectrode tip. As the RF energypasses through the tissue, itgenerates an electrothermalreaction which is capable ofcoagulating the tissue.	Plasma energy is delivered to theskin and energy is rapidlytransferred to the skin surface.As the plasma energy passesthrough the tissue it generates anelectrothermal reaction which iscapable of coagulating tissue.
Frequency	2.45Ghz	1mHz and 2mHz	2.45Ghz
Max Power (w)	100W	50W	100W
Output Energy	0.5 – 4J	Up to 2J	1 – 4J
Repetition Rate	1 – 3 Hz	N/A	1 – 4 Hz
Emitting Time	5 – 40ms	N/A	5 – 40ms
Depth of thermaleffect	up to 400 microns	Up to 4mm	Unknown
Gas Requirement	Medical Grade Nitrogen	N/A	Medical Grade Nitrogen
Electrical Voltage	AC 100-230V/ 50/60Hz	AC 100-230V/ 50/60Hz	AC 100-240V/ 50/60Hz
807.92(b)(1) NONCLINICAL TESTS SUBMITTED
Discussion ofnonclinical tests:	BiocompatibilityShenB performed biocompatibility testing for the electrode tips according to FDA's "Use of InternationalStandard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within arisk management process". June 6. 2016. Of the PlaDuo components, only the handpiece guide

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table below:
Test Type	Standard	Results
Cytotoxicity	ISO 10993-05:2009, Biologicalevaluation of medical devices- Part 5: Tests for in vitrocytotoxicity	Pass
Sensitization: Guinea PigMaximization Test (GPMT)	ISO 10993-10:2010, Biologicalevaluation of medical devices- Part 10: Tests for irritationand skin sensitization	Pass
Irritation or IntracutaneousReactivity [AnimalIntracutaneous (Intradermal)Reactivity Test	ISO 10993-10:2010, Biologicalevaluation of medical devices- Part 10: Tests for irritationand skin sensitization	Pass

Electrical Safety and electromagnetic compatibility (EMC)

Electrical safety, EMC and device-related electrical safety for high frequency were conducted on the PlaDuo system according to the following consensus standards:

IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12, . Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance
IEC 60101-2-2:2017, 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 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 Verification and Validation Testing

Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern.

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	Bench TestingShenB conducted bench testing to assure that the PlaDuo operates safely and within thepredefined design specifications. Tested parameters included:• Output Energy• Durability of the tip• Thermal testing in accordance with FDA's “Guidance for Industry and FDA Staff:Premarket Notification (510(k)) Submissions for Electrosurgical Devices for GeneralSurgery”
807.92(b)(2) CLINICAL TESTS SUBMITTED
	No Clinical study was conducted as part of this submission.
807.92(b)(3) Conclusion
	The substantial equivalence of the PlaDuo is demonstrated through performance testing.The PlaDuo has equivalent intended use, indication for use and thermal characteristics to the predicate device.

No new questions of safety and/or effectiveness are raised as a result of the differences when compared to predicate device based on the data provided in the submission. Therefore, the PlaDuo is substantially equivalent to the legally marketed 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.