The AGNES MEDICAL CO.,LTD PlazMagik 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 to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis.

The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.

AI/ML Overview

This document describes the regulatory clearance for the PlazMagik electrosurgical device. It outlines the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device, but it does not include acceptance criteria or a study proving that specific performance metrics are met against those criteria.

Here's a breakdown of the information provided, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing from the document. The document lists various tests performed (Biocompatibility, Electrical Safety, Software Verification, Bench Testing, Ex Vivo Study), but it does not provide specific acceptance criteria for these tests nor does it report the precise performance metrics of the PlazMagik device against such criteria. For example, for "Output Energy" in bench testing, it states "Tested parameters included: Output Energy" but doesn't provide what the acceptable range for output energy was or what the device's actual output energy was.

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

Biocompatibility: Not specified.
Electrical Safety & EMC: Not specified.
Software Verification and Validation: Not specified.
Bench Testing: Not specified.
Ex Vivo Study:
- Sample Size: "Ex Vivo testing conducted on three types of tissue - Liver, skin and Muscle." The number of samples within each tissue type is not specified.
- Data Provenance: Not explicitly stated, but Ex Vivo studies are generally conducted in a laboratory setting. It's not retrospective or prospective in the clinical trial sense.

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

Not applicable. The document describes non-clinical testing. There is no mention of human-established ground truth or experts for these tests.

4. Adjudication Method for the Test Set:

Not applicable. The document describes non-clinical testing. There is no mention of an adjudication method as would be used in a clinical study with human readers/assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC study was not done. The document explicitly states: "Clinical testing is not a requirement and has not been performed."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI/algorithm-based diagnostic or therapeutic software. The "Software Verification and Validation Testing" refers to the control software within the device, not a standalone AI algorithm for medical image analysis or similar.

7. The Type of Ground Truth Used:

Biocompatibility: Based on compliance with ISO standards (e.g., cell viability, presence/absence of irritation).
Electrical Safety & EMC: Based on compliance with IEC standards (e.g., meeting specified limits for electrical leakage, electromagnetic emissions/immunity).
Software Verification and Validation: Based on meeting design specifications and requirements.
Bench Testing: Based on predefined design specifications (e.g., output energy within a certain range, tip integrity after use).
Ex Vivo Study: Based on GLP Thermal testing in accordance with FDA guidance, likely assessing tissue effects (e.g., coagulation depth, thermal spread) against expected outcomes or safety limits.

8. The Sample Size for the Training Set:

Not applicable. This device is hardware with embedded control software; it does not involve machine learning or a "training set" in the context of AI.

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

Not applicable. (See point 8).

Summary of what is present vs. missing:

The document provides evidence of various non-clinical tests conducted to support the safety and substantial equivalence of the PlazMagik device. It lists the types of tests and the standards followed, and generally reports "Pass" for biocompatibility and indicates that electrical safety/EMC and software testing were "conducted" and "shows that the device is safe and meets requirement." However, it does not provide the specific quantitative acceptance criteria or the measured performance values that would allow for a direct comparison in a table as requested. It also explicitly states that no clinical (human) testing was performed, which means no human reader studies, ground truth experts, or training sets in the AI context were involved.

Summary

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February 29, 2024

Agnes Medical Co., Ltd % Sanghwa Myung Regulatory Affair Consultant E&m D-1474, 230, Simin-daero, Dongan-gu Gyeonggi-do, Gyeonggi-do 14067 Korea. South

Re: K230837

Trade/Device Name: PlazMagik Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 2, 2024 Received: February 2, 2024

Dear Sanghwa Myung:

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: 2024.02.29
14:11:05 -05'00'

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name PlazMagik

Indications for Use (Describe)

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

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

X 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."

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6. 510(k) Summary - Traditional 510(K)

The assigned 510(k) Number: K230837

01. Date of Submission: 2024.02.02

02. Applicant / Submitter

AGNES MEDICAL CO.,LTD #401-402, 24 Dunchon-Daero 388beon-Gil, Jungwon-Gu, Seongnam-Si Gyeonggi, KR 13403 TEL: +82-31-8020-9716 Email: rnd@agnesmedical.com

03. Submission Correspondent

Terry Myung E&M. D-1474, 230, Simin-daero, Dongan-gu TEL: +82-70-7807-0550 Email: mshenmc@agnesmedical.com

04. Proposed Device Identification

Device Identification and Regulatory information

Proprietary Name: PlazMagik Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulation Number: 21 CFR 878.4400 Device Class: Class II Product Code: GEI Review Panel: General & Plastic Surgery

Indication for use: PlazMaqik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

05. Predicate Device Identification

Predicate device 510(k) Number: K201735 Device Name: Pladuo System Manufacturer: ShenB Co. Ltd.

06. Device Description

The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.

07. Summary of Technological Characteristics Comparison

1) Predicate

	Subject Device	Predicate Device
Manufacturer	AGNES MEDICAL CO.,LTD	ShenB
Product Name	PlazMagik	PlaDuo System
510(k) Number	Not assigned	K201735
Product code /	GEI	GEI
Regulation	21 CFR 878.4400	21 CFR 878.4400
Classification	Class II	Class II
Indication foruse	The PlazMagik is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.	The Pladuo is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.
Mode of	Helium gas	Nitrogen gas
operationPrincipal ofoperation	Argon gasPlasma energy is delivered to the skinand energy is rapidly transferred tothe skin surface. As the plasmaenergy passes through the tissue itgenerates an electrothermal reactionwhich is capable of coagulating tissue	Plasma energy is delivered to the skinand energy is rapidly transferred to theskin surface. As the plasma energypasses through the tissue it generatesan electrothermal reaction which iscapable of coagulating tissue
Frequency	24KHz	2.54GHz
Max Power (w)	Single H/P: 53.3WTriple H/P 34.13W	100 W
Repetition Rate	0.67Hz - 3Hz	1 - 3Hz
Emitting Time	100ms, 150ms, 166ms, 200ms,250ms, 300ms, 400ms, 500ms,1500ms	5 - 40ms
Gasrequirement	Medical grade Helium / Medical gradeArgon	Medical grade Nitrogen
Electricalvoltage	AC 100-240V 50/60Hz	AC 100-230V 50/60Hz

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The subject devices are substantially equivalent to the predicate and reference devices with respect to indications for use, technology and construction. The differences between the predicate devices and the subject devices are minor and any risks have been mitigated through testing. The PlazMagik and the predicate device have same indication for use, Technology, mechanism of actions, operational principles and performance for the proposed indications for use.

The non-clinical data for proposed device, including biocompatibility, bench testing, hardware, and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe

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to use and meets requirement.

There are no significant differences between Subject device and the predicate devices (K201735) that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics standards. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this

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Image /page/7/Picture/2 description: The image shows the logo for AGNES MEDICAL. The word "AGNES" is in a sans-serif font and is in a light blue color. Below the word "AGNES" is the word "MEDICAL" in a smaller sans-serif font and is also in a light blue color. There is a horizontal line separating the two words.

08. Non-clinical Testing Data

(1) Biocompatibility

Test type	Standard	Results
Cytotoxicity	ISO 10993-05:2009,Biological evaluation ofmedical devices - Part 5:Tests for in vitro cytotoxicity	Pass
Sensitization	ISO 10993-10:2010,Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization	Pass
Irritation or IntracutaneousReactivity	ISO 10993-10:2010,Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization	Pass

(2) Electrical Safety and electromagnetic compatibility (EMC)

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

· IEC 60601-1:2005, AMD1:2012, Medical Electrical Equipment - Part 1: 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 surqical equipment and high frequency surgical accessories

· IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic

(3) 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.

(4) Bench Testing

AGNES MEDICAL conducted bench testing to assure that the PlazMagik operates safely and within the predefined design specifications. Tested parameters included:

· Output Energy
· Durability of the tip
(5) Ex Vivo Study

Ex Vivo testing conducted on three types of tissue - Liver, skin and Muscle under GLP Thermal testing in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", August 15, 2014

09. Clinical Testing

Clinical testing is not a requirement and has not been performed.

10. Substantial Equivalence Conclusion

The comparison between the subject devices and the predicate devices shows that the general information, some technical and material information are the same. Although there are some differences, the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the

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subject devices. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject devices are substantially equivalent to the predicate devices.

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.