AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, single use needle type RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).

AI/ML Overview

This document, K203013, is a 510(k) summary for a medical device called AGNES, an RF electrosurgical device. It's a submission to the FDA to demonstrate substantial equivalence to a previously cleared device (K192728).

The document details changes made to the device and the testing performed to ensure safety and effectiveness. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of human clinical performance or AI algorithm performance. This is because K203013 is for an electrosurgical device, not an AI or imaging device that would typically have performance metrics like sensitivity, specificity, or reader improvement.

The tests performed are primarily bench tests, animal studies, and biocompatibility tests related to the physical changes made to the device (e.g., power input, connector color, and a new type of RF electrode). Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving performance in the way you've outlined for an AI/imaging device.

To directly address your specific points, based on the provided document:

A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) because it's not evaluating an AI or diagnostic imaging device in that manner. The "performance" discussed relates to electrical safety, electromagnetic compatibility, and thermal effects, for which the acceptance is successful compliance with recognized standards.
Sample size used for the test set and the data provenance:
- Bench Testing (Electrical Safety, EMC): These tests are typically performed on a sample of the manufactured device and new accessories. Sample size is not specified but would follow standard engineering testing practices for medical devices, often a small number of units.
- Biocompatibility Testing: Tested on materials of manufacture and the final device. Sample size not specified.
- Animal Testing: Conducted on tissues from 3 mini pigs for thermal tissue damage/spread, and skin from 1 mini pig for histopathological analysis.
- Data Provenance: Not explicitly stated for specific test data, but the submitter is Agnes Medical CO., LTD in South Korea.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by compliance with engineering and biological safety standards (e.g., IEC standards, ISO standards for biocompatibility), not through expert consensus on diagnostic interpretations. For the animal study, histopathological analysis would be performed by a qualified pathologist, but the number and qualifications are not specified.
Adjudication method for the test set: Not applicable. There's no human interpretation or diagnostic decision-making being assessed by multiple readers that would require adjudication.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI or diagnostic imaging device; therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used:
- Bench Testing: Engineering specifications and compliance with international standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2).
- Biocompatibility: Compliance with ISO 10993 series standards.
- Animal Testing: Histopathological analysis of tissue and thermal imaging measurements.
The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of an electrosurgical device based on engineering and biological safety standards, not an AI or diagnostic imaging device involving clinical performance metrics and reader studies.

Summary

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July 14, 2022

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health and Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Agnes Medical CO., LTD % DongHa Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375 Korea. South

Re: K203013

Trade/Device Name: Agnes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 13, 2022 Received: July 13, 2022

Dear DongHa Lee:

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 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 (OS) 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 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,

Colin Keijing Chen, Ph.D. Acting 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) K203013

Device Name AGNES

Indications for Use (Describe)

AGNES is indicated for use in dermatological 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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K203013 510(k) Summary

This summary of 510(K) – safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 6, 2022

1. Applicant / Submitter

AGNES MEDICAL CO., LTD

Address: (Seohyeon-dong, 4, 5F Cocoplaza), 20, Seohyeon-ro 210beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea (Postal code: 13591) Tel : +82-31-8020-9702 Fax : +82-31-701-5162

2. Submission Contact Person

DongHa Lee (RA Consultant / KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, Korea Fax : +82-2-2672-0579 Tel : +82-70-8965-5554 Email: dhlee@kmcerti.com

3. Device Information

Trade Name: AGNES
Common Name: RF Electrosurgical Device
Classification Name: Electrosurgical cutting and coagulation device and accessories
Classification Product Code and Regulation: GEI, 21CFR 878.4400
Subsequent Product Code and Regulation: KCW, 21CFR 878.5350
Device Class: 2

4. Legally Marketed (Existing) Device

Trade Name: AGNES (K192728)

5. Description

6. Indication for use

AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

7. Comparison of the modified device to the cleared device

The following comparison table is presented to demonstrate substantial equivalence.

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Descriptive Information		Cleared Device	Modified Device
Manufacturer		AGNES MEDICAL CO., LTD	AGNES MEDICAL CO., LTD
Device Name		AGNES	The same (No change)
510(k) number		K192728
Classification Product Code /Regulatory Number		GEI / 878.4400	The same (No change)
Subsequent Product Code		KCW / 878.5350	The same (No change)
Regulatory Class		2	The same (No change)
Indications for Use		AGNES is indicated for use indermatological and generalsurgical procedures forelectrocoagulation andhemostasis.	The same (No change)
Prescription or OTC		Prescription	The same (No change)
Operation		The device uses RF energydelivered through micro needleelectrode to apply heat to targettissue for coagulating.	The same (No change)
ElectrosurgicalUnit (ESU)	Monopolar orBipolar	Monopolar	The same (No change)
	Temperaturesensors	None	The same (No change)
	Impedancemonitor	None	The same (No change)
	Continuitymonitor	Checking the connection betweenthe neutral electrode and theelectrosurgical unit.	The same (No change)
	Electrodemonitor	Provide a camera to monitor theelectrode coating condition andshape before using by the user.	The same (No change)
	Waveform	Oscillating rectangular wave	The same (No change)
	Outputfrequency	1MHz	The same (No change)
	Outputoperating time	Min 50ms / Max 2,000ms	The same (No change)
	Output powerlevels	25 levels(2 to 46 W)	The same (No change)
	Max. outputpower	46 W at 200 ohm	The same (No change)
	Max. outputvoltage	104V	The same (No change)
	Dimensions	290mm(W)x455mm(L)x271.7mm(H)	The same (No change)
	Weight	5.8Kg	The same (No change)
	Power Input	100-250VAC, 50-60Hz, 280VA	100-240VAC, 50-60Hz, 420VA
	RF Handpiecefor the needle	It is connected with theelectrosurgical unit.	Connector color changed fromyellow to green
	type RFelectrode	It transfers the radiofrequencyenergy through the Single use RFelectrode (Needle type)
	RF Handpiecefor the roundedelectrode typeRF electrode	No existed	New addition
Activeaccessory(RF Electrode)	Needle type	510(k) cleared by FDA(K171707)	The same (No change)
	Roundedelectrode type	No existed	New addition(Models: AG-CN-23G)
Neutralelectrode pad	FDA Approval	510(k) cleared by FDA(K102372)	The same (No change)
Miscellaneousaccessory(Foot switch)	Functions	For emitting RF energy intoelectrode.	The same (No change)
	PerformanceSpecifications	Single pole, single throw	The same (No change)
	PhysicalSpecification	Single pedal, IPX6	Single pedal, IPX8

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Justification of the Changes

1. Electrosurgical Unit (ESU) Power Input Specification
- : The power input specification of the Electrosurgical Unit (ESU) is changed.
  - Existed specification: 100-250VAC, 50-60Hz, 280VA ।
  - Changed specification: 100-240VAC, 50-60Hz, 420VA -

The change was tested for the electrical safety and electromagnetic according to the FDA recognized standards, IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-2.

1. Active accessory (RF Electrode) Connector Color
  : The connector color of the RF electrode is changed.
Existed connector color of the RF electrode: yellow ।
Changed connector color of the RF electrode: Green ।
1. New additional type RF electrode and RF Handpiece

: Rounded electrode type RF electrode and RF Handpiece for it are added.

Existed device: Only micro needle type RF electrode and handpiece. -
-Modified device: Addition of rounded electrode type RF electrode and handpiece

The new additional type RF electrode and RF Handpiece was tested with the main body for the electrical safety and electromagnetic compatibility according to the FDA recognized standards.

1. AAMI/ANSI ES60601-1:2005+A1:2012 (IEC 60601-1:2005+A1:2012), Medical Electrical Equipment - part 1: General requirements for basic safety and essential performance
1. 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
1. IEC 60601-1-2:2014. Medical electrical equipment part 1-2: General requirements for

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basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests.

8. Biocompatibility

The new additional type RF electrode can be touched with a patient. Biocompatibility tests were conducted to ensure that no risks arise from biological hazards associated with materials of manufacture and the final device.

1. ISO 10993-1: 2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
1. ISO 10993-10:2010. Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.

9. Sterilization

The EO gas sterilization method of the new additional type RF electrode was validated according to the FDA recognized standards. In the validation, SAL (10th) and EO gas residuals also was verified.

1. ISO 11135:2014 + A1:2018, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
1. ISO 10993-7: 2008+A1:2019, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals

10. Performance Testing - Bench Testing

The RF output power testing was performed in accordance with the FDA recognized standard, 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.

11. Performance Testing - Animal Testing

Animal study was performed to assess thermal tissue damage/spread using mini pig tissues. The skin, liver, kidney, and femoral muscle dissected from 3 mini pigs were used for thermal tissue spread experiment. The skin from 1 mini pig was used in the histopathological analysis for thermal tissue damage experiment. Thermal imaging area analysis, the maximum temperature, the time to reach basal temperature, and histopathological analysis were evaluated.

12. Conclusion

The major consideration such as intended use and principle of operation is not changed. The changes (modifications) of the device were verified and validated relevant to electrical safety and electromagnetic compatibility and biocompatibility. Animal test also performed to assess thermal effect. The test results are supported that the device still maintain safety and effectiveness.

We conclude that the modified device is substantially equivalent to the legally marketed (existed) 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.