Agnes by Agnes Medical Co., Ltd | FDA 510(k) Summary

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 RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).

AI/ML Overview

The provided text describes a 510(k) summary for the AGNES RF electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device, particularly for newly added electrode models. However, it does not explicitly detail acceptance criteria or a comprehensive study proving the device meets specific performance thresholds in a clinical or AI-assisted context.

The document is a K223805 510(k) submission for an electrosurgical cutting and coagulation device. The key information is about the device's technical specifications and the comparison of the subject device (AGNES with additional electrode models) to its predicate device (AGNES with a previously cleared electrode model).

Based on the provided text, a robust study proving the device meets acceptance criteria, especially in the context of an AI/human-in-the-loop diagnostic accuracy study, is NOT present. The document describes a bench testing and an animal testing study to demonstrate the safety and effectiveness of the device as an electrosurgical tool, but not a study designed to evaluate diagnostic performance or human reader improvement with AI assistance.

Therefore, many of the requested sections regarding acceptance criteria and performance in a diagnostic or AI-assisted context cannot be directly answered from the provided text.

Here's an analysis of what CAN be extracted or inferred from the document regarding its performance in the context of a 510(k) submission, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred from the comparison table demonstrating substantial equivalence to the predicate device and the results of the bench and animal testing.

Acceptance Criterion (Inferred from Substantial Equivalence and Testing)	Reported Device Performance (Subject Device: AGNES with new electrode models)
Intended Use Equivalence:	AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. (Same as predicate)
Principle of Operation Equivalence:	Uses RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. (Same as predicate)
Output Frequency:	1MHz (Same as predicate)
Output Operating Time:	Min 50ms / Max 2,000ms (Same as predicate)
Output Power Levels:	25 levels (2 to 46 W) (Same as predicate)
Max. Output Power:	46 W at 200 ohm (Same as predicate)
Max. Output Voltage:	104V (Same as predicate)
Electrode Functionality:	Transfers RF energy through single-use RF electrodes (Needle type and Rounded type). Expanded to include new rounded electrode models (AG-CN21G, AG-CN20G, AG-CN19G, AG-CN18G) with varying diameters.
Biocompatibility:	All materials for the additional models RF electrodes were tested according to ISO 10993-1, ISO 10993-5, and ISO 10993-10, ensuring no risks from biological hazards. (Presumed to meet standard requirements)
Sterilization:	EO gas sterilization method of the additional models RF electrode validated according to ISO 11135:2014 + A1:2018. SAL (10^-6) and EO gas residuals verified according to ISO 10993-7:2008+A1:2019. (Presumed to meet standard requirements)
RF Output Power (Bench Test):	Performed in accordance with IEC 60601-2-2:2017. (Presumed to meet standard requirements)
Thermal Tissue Damage/Spread (Animal Test):	Evaluated in mini pig tissues (skin, liver, kidney, femoral muscle). Thermal imaging area analysis, max temperature, time to reach basal temperature, and histopathological analysis were evaluated. (Study performed, implied to show acceptable performance for electrosurgical use)

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

Test Set (for performance validation of the electrosurgical function):
- Bench Testing: Not explicitly stated as a "sample size" of devices, but implies testing of the subject device and its new accessories against electrical safety and performance standards (IEC 60601-2-2:2017).
- Animal Testing: Tissues from 3 mini pigs were used for thermal tissue spread experiment (skin, liver, kidney, femoral muscle). Skin from 1 mini pig was used for histopathological analysis. This is not a "test set" in the context of an AI/diagnostic study, but for evaluating the physical tissue effects of the electrosurgical device.
Data Provenance: The studies were conducted by AGNES Medical Co., Ltd, based in Korea. The provenance of the specific test data for the animal study is "mini pig tissues." It would be considered prospective for the device's validation.

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

This question is not applicable to the provided document. The document describes a medical device (electrosurgical unit), not a diagnostic AI system requiring expert consensus for ground truth establishment. The "ground truth" in this context relates to the physical and biological effects of the electrosurgical energy, evaluated through standard engineering tests and pre-clinical animal studies. Histopathological analysis for the animal study would typically involve a veterinary pathologist, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

Not applicable in the context of diagnostic AI. For the animal study, the evaluation methods were "Thermal imaging area analysis, the maximum temperature, the time to reach basal temperature, and histopathological analysis." Adjudication among human readers is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC study was NOT done. This type of study is relevant for diagnostic AI devices where human readers interpret medical images. The AGNES device is an electrosurgical cutting and coagulation device, not an image interpretation or diagnostic AI tool.

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

Not applicable. The AGNES device is not an algorithm or AI system. It's a hardware medical device used by a human operator. Its performance is inherent in its electrosurgical capabilities, not in an independent software algorithm.

7. The Type of Ground Truth Used:

Bench Testing: Engineering measurements against established performance standards (e.g., output power, frequency, safety parameters).
Animal Testing: Direct measurement of physical effects on biological tissues (thermal imaging, temperature readings, histopathological analysis). This is a form of direct biophysical ground truth.

8. The Sample Size for the Training Set:

Not applicable. The AGNES device is not an AI/ML device, so there is no "training set" in the context of machine learning. Its design and efficacy are based on established electrosurgical principles and engineering/biological validation, not on learned patterns from a dataset.

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

Not applicable, as there is no training set.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of an electrosurgical device, particularly regarding the addition of new electrode models, to its predicate. The "studies" mentioned (bench and animal testing) are for validating the physical and biological safety and performance of the electrosurgical function, not for evaluating diagnostic accuracy or AI-assisted human performance, which are the typical contexts for the detailed questions about acceptance criteria and ground truth in your prompt.

Summary

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May 4, 2023

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: K223805

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, KCW Dated: April 3, 2023 Received: April 3, 2023

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 (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

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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 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-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: 2023.05.04 13:42:12 -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

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Indications for Use

510(k) Number (if known) K223805

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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.

AGNES MEDICAL CO., LTD. Submitter: (Seohyeon-Donq, 5f Cocoplaza), 20, Seohyeon-Ro 210beon-Gil, Bundang-Gu, Seongnam-Si, Gyeonqgido, Korea (ZIP code: 13591) Telephone: +82-31-8020-9702 Fax: +82-31-701-5162 E-mail: jks@aqnesmedical.com

E&M Contact: Requlatory Affair/Terri Myung Telephone: +82-70-7807-0550 FAX: +82-31-388-9263 Cellphone: +82-10-4952-6638 E-mail: mshenmc@gmail.com Primary Contact: Terri Myung

Date 510(k) summary prepared: May 4, 2023

1. 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: II

2. Predicate Device

Agnes, K203013
1. Description

4. Indication for use

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

5. Comparison of the modified device to the cleared device

The following comparison table is presented to demonstrate substantial equivalence.

Descriptive Information		Predicated Device	Subject Device
Manufacturer		AGNES MEDICAL CO., LTD	AGNES MEDICAL CO., LTD
Device Name		AGNES	AGNES
510(k) number		K203013	K223805
Classification Product Code /Regulatory Number		GEI / 878.4400	GEI / 878.4400
Subsequent Product Code		KCW / 878.5350	KCW / 878.5350
Regulatory Class		II	II
Indications for Use		AGNES is indicated for usein dermatological andgeneral surgical proceduresfor electrocoagulation andhemostasis.	AGNES is indicated for use indermatological and generalsurgical procedures forelectrocoagulation andhemostasis.
Prescription or OTC		Prescription	Prescription
Operation		The device uses RF energydelivered through microneedle electrode to applyheat to target tissue forcoagulating.	The device uses RF energydelivered through micro needleelectrode to apply heat to targettissue for coagulating.
	Monopolar orBipolar	Monopolar	Monopolar
	Temperaturesensors	None	None
	Impedancemonitor	None	None
Electrosurgical Unit(ESU)	Continuitymonitor	Checking the connectionbetween the neutralelectrode and theelectrosurgical unit.	Checking the connectionbetween the neutral electrodeand the electrosurgical unit.
	Electrodemonitor	Provide a camera to monitorthe electrode coatingcondition and shape beforeusing by the user.	Provide a camera to monitor theelectrode coating condition andshape before using by the user.
	Waveform	Oscillating rectangular wave	Oscillating rectangular wave
	Outputfrequency	1MHz	1MHz
	Outputoperating time	Min 50ms / Max 2,000ms	Min 50ms / Max 2,000ms
	Output powerlevels	25 levels(2 to 46 W)	25 levels(2 to 46 W)
	Max. output	46 W at 200 ohm	46 W at 200 ohm
	power
	Max. outputvoltage	104V	104V
	Dimensions	290mm(W)x455mm(L)x271.7mm(H)	290mm(W)x455mm(L)x271.7m(H)
	Weight	5.8Kg	5.8Kg
	Power Input	100-240VAC, 50-60Hz, 420VA	100-240VAC, 50-60Hz, 420VA
	RF Handpiecefor the needletype RFelectrode	It is connected with theelectrosurgical unit.It transfers theradiofrequency energythrough the Single use RFelectrode (Needle type)	It is connected with theelectrosurgical unit.It transfers the radiofrequencyenergy through the Single useRF electrode (Needle type)
	RF Handpiecefor theroundedelectrode typeRF electrode	It is connected with theelectrosurgical unit.It transfers theradiofrequency energythrough the Single use RFelectrode (Rounded type)	It is connected with theelectrosurgical unit.It transfers the radiofrequencyenergy through the Single useRF electrode (Rounded type)
Active accessory(RF Electrode)	Needle type	510(k) cleared by FDA(K171707)	510(k) cleared by FDA(K171707)
	Roundedelectrode type	Models: AG-CN-23G	Add models (AG-CN21G,AG-CN20G, AG-CN19G,AG-CN18G)
	Neutral electrode pad	510(k) cleared by FDA(K102372)	510(k) cleared by FDA(K102372)
	FDA Approval
	Functions	For emitting RF energy intoelectrode.	For emitting RF energy intoelectrode.
Miscellaneous accessory(Foot switch)	PerformanceSpecifications	Single pole, single throw	Single pole, single throw
	PhysicalSpecification	Single pedal, IPX8	Single pedal, IPX8

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Model	AG-CN-23G	AG-CN21G	AG-CN20G	AG-CN19G	AG-CN18G
Diameter (ø)	0.64	0.84	0.90	1.09	1.28
Rounded ElectrodeLength	40mm ± 5%		40mm ± 5%
Rounded Electrodematerial	SUS 304		SUS 304
Cover tip length	38mm ± 5%		38mm ± 5%
Cover tipthickness	9.14mm ± 5%		9.14mm ± 5%
Cover tip material	Polycarbonate		Polycarbonate
Total length	77.5mm ± 5%		77.5mm ± 5%

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Sterility	E.O gasSterilization	E.O gas Sterilization
Single Use	Single Use	Single Use

- Differences between Subject and Predicates Device

Predicate device's electrode is AG-CN23G. Modified to add electrode AG-CN21G, AG-CN20G, AG-CN19G, AG-CN18G. The each of model's difference is diameter of electrode. Among the same products, the product with the smallest diameter was added to the previous submission, and the remaining electrodes are added this time.

Discussion

The modifications expressed in this 510(k) Premarket Notification do not change the intended use, nor alter the fundamental scientific technology of the device. The modified devices are as safe and as effective as the predicate device.

6. Biocompatibility

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.

7. Sterilization

The EO gas sterilization method of the additional models 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

Performance Testing - Bench Testing 8.

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.

9. Performance Testing - Animal Testing

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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.

Conclusion

The major consideration such as intended use and principle of operation is not changed. Also, it is only adding more models of rounded electrode. The changes (modifications) of the device were verified and validated with biocompatibility of material. 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.