Agnes

• K Number: K223805
• Device Name: Agnes
• Manufacturer: Agnes Medical Co., Ltd
• Date Cleared: 2023-05-04 ( 136 days)
• Product Code: GEI KCW
• 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 RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).

Predicate Devices

K203013

Reference Devices

K102372, K171707

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

No.
The device is used for electrocoagulation and hemostasis in surgical procedures, which are interventional rather than therapeutic.

Diagnostic

No
The device is described as an RF electrosurgical device for electrocoagulation and hemostasis, which are therapeutic procedures, not diagnostic ones.

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's tissue, not a test performed on a sample taken from the body to diagnose a condition.
• Device Description: The description details an "RF electrosurgical device" with components like a generator, hand-piece, and electrodes. These are typical components of surgical devices, not IVD devices which usually involve reagents, analyzers, or test kits.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

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 directly treat tissue through electrocoagulation and hemostasis.

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 (comma separated list FDA assigned to the subject device)

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 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K203013

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K102372, K171707

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

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)

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 [e-mail]

"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."

3

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: [phone] Fax: [phone] E-mail: [e-mail]

E&M Contact: Requlatory Affair/Terri Myung Telephone: [phone] FAX: [phone] Cellphone: [phone] E-mail: [e-mail] 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
• 3. 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 RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).

4. Indication for use

4

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 use
in dermatological and
general surgical procedures
for electrocoagulation and
hemostasis.	AGNES is indicated for use in
dermatological and general
surgical procedures for
electrocoagulation and
hemostasis.
Prescription or OTC		Prescription	Prescription
Operation		The device uses RF energy
delivered through micro
needle electrode to apply
heat to target tissue for
coagulating.	The device uses RF energy
delivered through micro needle
electrode to apply heat to target
tissue for coagulating.
	Monopolar or
Bipolar	Monopolar	Monopolar
	Temperature
sensors	None	None
	Impedance
monitor	None	None
Electrosurgical Unit
(ESU)	Continuity
monitor	Checking the connection
between the neutral
electrode and the
electrosurgical unit.	Checking the connection
between the neutral electrode
and the electrosurgical unit.
	Electrode
monitor	Provide a camera to monitor
the electrode coating
condition and shape before
using by the user.	Provide a camera to monitor the
electrode coating condition and
shape before using by the user.
	Waveform	Oscillating rectangular wave	Oscillating rectangular wave
	Output
frequency	1MHz	1MHz
	Output
operating time	Min 50ms / Max 2,000ms	Min 50ms / Max 2,000ms
	Output power
levels	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. output
voltage	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 Handpiece
for the needle
type RF
electrode	It is connected with the
electrosurgical unit.
It transfers the
radiofrequency energy
through the Single use RF
electrode (Needle type)	It is connected with the
electrosurgical unit.
It transfers the radiofrequency
energy through the Single use
RF electrode (Needle type)
	RF Handpiece
for the
rounded
electrode type
RF electrode	It is connected with the
electrosurgical unit.
It transfers the
radiofrequency energy
through the Single use RF
electrode (Rounded type)	It is connected with the
electrosurgical unit.
It transfers the radiofrequency
energy through the Single use
RF electrode (Rounded type)
Active accessory
(RF Electrode)	Needle type	510(k) cleared by FDA
(K171707)	510(k) cleared by FDA
(K171707)
	Rounded
electrode 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 into
electrode.	For emitting RF energy into
electrode.
Miscellaneous accessory
(Foot switch)	Performance
Specifications	Single pole, single throw	Single pole, single throw
	Physical
Specification	Single pedal, IPX8	Single pedal, IPX8

5

| Rounded
electrode type | 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 Electrode
Length | 40mm ± 5% | | 40mm ± 5% | | |
| | Rounded Electrode
material | SUS 304 | | SUS 304 | | |
| | Cover tip length | 38mm ± 5% | | 38mm ± 5% | | |
| | Cover tip
thickness | 9.14mm ± 5% | | 9.14mm ± 5% | | |
| | Cover tip material | Polycarbonate | | Polycarbonate | | |
| | Total length | 77.5mm ± 5% | | 77.5mm ± 5% | | |

6

| Sterility | E.O gas
Sterilization | 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
• 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.

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
• 2. 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

7

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.