AGNES

• K Number: K203013
• Device Name: AGNES
• Manufacturer: Agnes Medical CO., LTD
• Date Cleared: 2022-07-14 ( 651 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

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

Device Description

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).

Predicate Devices

K192728

Reference Devices

K102372

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard RF electrosurgical device with no mention of AI or ML capabilities, image processing, or data training/testing.

Therapeutic

Yes
The device is used for electrocoagulation and hemostasis in dermatological and general surgical procedures, which are therapeutic interventions.

Diagnostic

No
The device description states its purpose is for "electrocoagulation and hemostasis" in "dermatological and general surgical procedures," which are therapeutic actions, not diagnostic ones. It generates radiofrequency energy for these procedures, indicating a treatment function.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an LCD screen, radiofrequency generator, SMPS, footswitch, hand-piece, and electrodes.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "electrocoagulation and hemostasis in dermatological and general surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
• Device Description: The description details an RF electrosurgical device with components like a generator, hand-piece, and electrodes. These are tools used for surgical procedures, not for analyzing biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to perform a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GEI, KCW

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192728

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 ([e-mail]) or phone [phone] 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 : [phone] Fax : [phone]

2. Submission Contact Person

DongHa Lee (RA Consultant / KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, Korea Fax : [phone] Tel : [phone] Email: [e-mail]

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

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).

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 in
dermatological and general
surgical procedures for
electrocoagulation and
hemostasis.	The same (No change)
Prescription or OTC		Prescription	The same (No change)
Operation		The device uses RF energy
delivered through micro needle
electrode to apply heat to target
tissue for coagulating.	The same (No change)
Electrosurgical
Unit (ESU)	Monopolar or
Bipolar	Monopolar	The same (No change)
	Temperature
sensors	None	The same (No change)
	Impedance
monitor	None	The same (No change)
	Continuity
monitor	Checking the connection between
the neutral electrode and the
electrosurgical unit.	The same (No change)
	Electrode
monitor	Provide a camera to monitor the
electrode coating condition and
shape before using by the user.	The same (No change)
	Waveform	Oscillating rectangular wave	The same (No change)
	Output
frequency	1MHz	The same (No change)
	Output
operating time	Min 50ms / Max 2,000ms	The same (No change)
	Output power
levels	25 levels
(2 to 46 W)	The same (No change)
	Max. output
power	46 W at 200 ohm	The same (No change)
	Max. output
voltage	104V	The same (No change)
	Dimensions	290mm(W)x455mm(L)x271.7m
m(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 Handpiece
for the needle	It is connected with the
electrosurgical unit.	Connector color changed from
yellow to green
	type RF
electrode	It transfers the radiofrequency
energy through the Single use RF
electrode (Needle type)
	RF Handpiece
for the rounded
electrode type
RF electrode	No existed	New addition
Active
accessory
(RF Electrode)	Needle type	510(k) cleared by FDA
(K171707)	The same (No change)
	Rounded
electrode type	No existed	New addition
(Models: AG-CN-23G)
Neutral
electrode pad	FDA Approval	510(k) cleared by FDA
(K102372)	The same (No change)
Miscellaneous
accessory
(Foot switch)	Functions	For emitting RF energy into
electrode.	The same (No change)
	Performance
Specifications	Single pole, single throw	The same (No change)
	Physical
Specification	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.

• 2. 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 ।

• 3. 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
• 2. 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
• 3. 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
• 2. ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
• 3. 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
• 2. 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.