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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the AGNES device.

It's important to note that the provided document is a 510(k) Summary, which establishes substantial equivalence to a predicate device. It demonstrates that the new device is as safe and effective as a legally marketed device and does not necessarily involve establishing new acceptance criteria or conducting a comprehensive "study that proves the device meets the acceptance criteria" in the same way a PMA (Premarket Approval) submission would. Instead, the focus is on showing equivalence through comparing specifications, adherence to recognized standards, and preclinical/animal testing to address differences.

Therefore, some of the requested information (like human reader MRMC studies or specific acceptance criteria for a novel AI algorithm's performance) is not applicable or present in this type of FDA submission.

Acceptance Criteria and Device Performance for AGNES (K160469)

The "acceptance criteria" for this 510(k) submission are primarily rooted in demonstrating that the AGNES device is substantially equivalent to its predicate devices (HR-5000 and INTRAcel Premium Fractional RF Micro Needle System) and that any differences do not raise new questions of safety or effectiveness. This is achieved by conforming to recognized electrical safety and performance standards, and, for specific functional aspects, through preclinical and animal studies.

The document does not present a table of quantitative acceptance criteria for its overall performance and compare it to reported device performance in a clinical efficacy context. Instead, it demonstrates compliance with safety and engineering standards and addresses the biological effects of its differences through testing.

1. Table of Acceptance Criteria and Reported Device Performance

Category / Aspect	Acceptance Criteria (from recognized standards or equivalence to predicate)	Reported Device Performance (as demonstrated by studies)
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2 standards.	Device passed all tests for electrical safety and electromagnetic compatibility according to the specified standards.
RF Output Power	Compliance with IEC 60601-2-2, Clause 201.11 & 201.12. Output power range (2-46 W) shown not to raise safety/effectiveness concerns compared to predicate (12.5-50W at 200 ohm).	Tests demonstrated compliance with IEC 60601-2-2. The output power range was shown to be safe and effective, analogous to predicate.
Active Component (RF Electrode)	Compliance with IEC 60601-2-2 (Clause 201.8, 201.13, 201.15) for mechanical, electrical, and insulation integrity.	Mechanical, electrical performance, and insulation integrity tests were performed and complied with IEC 60601-2-2.
Biocompatibility	Compliance with ISO 10993-1, -5, -10 standards.	Tests demonstrated biological compatibility according to ISO 10993 series.
Sterility & Packaging	Compliance with ISO 11135, ISO 11138-2, ISO 10993-7, ISO 11607-1, ASTM F1980-07.	Sterility and packaging validation confirmed compliance with the specified ISO and ASTM standards.
Neutral Electrode Pad (K102372)	Compliance with IEC 60601-2-2, Sub-clause 201.15.101 for thermal performance, contact impedance, and adhesion.	Tests confirmed compliance with IEC 60601-2-2 for thermal performance, contact impedance, and adhesion. (Note: Pad itself has prior 510(k) clearance K102372).
Foot Switch	Compliance with IEC 60601-2-2, Sub-clause 201.8.10.4, 201.11.6.5, and 201.12.2.	Tests confirmed compliance with IEC 60601-2-2.
Thermal Effect/Penetration Depth (Animal Study)	Demonstration that differences in electrode dimensions and output power do not raise new safety concerns and achieve intended effect (electrocoagulation and hemostasis).	Macroscopic Assessment (Dermatologist): Damage and safety on skin surface/corium, reduction of acne lesions observed. Microscopic Assessment (Histological): Accurate penetration depth, distinct coagulation in mini pigs; destruction of sebaceous glands, reduction of inflammatory cells, papule, and pustule in rabbit acne model. "Valid method to prevent reoccurrence" of acne.

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

Engineering/Safety Tests (Electrical, Biocompatibility, Sterility): The document refers to compliance with recognized standards (IEC, ISO, ASTM). These standards typically define the sample sizes and procedures for testing components and the overall device. For example, biocompatibility tests (ISO 10993) would involve specific numbers of cell cultures, animals, or material samples. The exact sample sizes for each specific engineering test are not detailed in this 510(k) summary but are inherent to the standard methods. Data provenance is implied to be laboratory testing by the manufacturer or accredited labs.
Animal Study: The study used "mini pigs" for penetration depth and coagulation assessment, and a "rabbit's ear model" for acne treatment. Specific numbers of animals are not provided in the summary. The provenance is preclinical testing, likely conducted by or for the manufacturer.

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

Engineering/Safety Tests: "Experts" in this context are the qualified personnel in test laboratories who perform and interpret the results of the standard tests (e.g., electrical engineers for IEC 60601, toxicologists/biologists for ISO 10993, microbiologists for sterility tests). Their specific number and qualifications are not detailed in the summary but are presumed to meet the requirements of the standards.
Animal Study (Macroscopic Assessment): A "dermatologist" performed macroscopic assessment on damage and safety. The number of dermatologists and their specific years of experience are not specified.
Animal Study (Histological Assessment): The histological assessments would typically be performed by a veterinary pathologist or a pathologist with experience in animal tissue, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Engineering/Safety Tests: Adjudication is generally not applicable in the same way as clinical imaging studies. Compliance is determined by whether the device's performance meets the quantitative thresholds defined by each standard (e.g., leakage current within limits, tensile strength exceeding a value).
Animal Study:
- Macroscopic Assessment: A "dermatologist" assessed damage and safety. It's unclear if this was a single dermatologist, or if a consensus/adjudication process was used if multiple assessors were involved.
- Microscopic Assessment: The histological assessment involves objective staining and observation. While interpretation requires expertise, a formal adjudication process between multiple experts for "ground truth" establishment in this specific context is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission. This type of study is more common for diagnostic devices (e.g., AI for radiology reading) to compare human performance with and without AI assistance. The AGNES device is a therapeutic electrosurgical device; its primary function is to perform a physical action (electrocoagulation and hemostasis) and treat conditions like acne, not to provide diagnostic readings. The "effectiveness" is shown through its functional performance and biological effect, not by improving human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. The AGNES device is a physical electrosurgical device operated by a human. It is not an AI algorithm designed to operate autonomously or provide outputs without human interaction.

7. Type of Ground Truth Used

Engineering/Safety Tests: The "ground truth" is defined by the objective pass/fail criteria established by the international and national standards (IEC, ISO, ASTM).
Animal Study: The "ground truth" for the animal study was based on:
- Clinical Assessment (Photo Assessment): Macroscopic observations by a dermatologist and photographic evidence.
- Histological Pathology Analyses: Microscopic examination of tissue samples stained with hematoxylin & eosin, assessing sebaceous gland destruction, inflammatory cells, etc. This is considered objective biological evidence.
- 3D Measuring Instrument (PRIMOS Pico): For assessing reduction of acne lesions, providing quantitative data.

8. Sample Size for the Training Set

Not applicable / Not disclosed. This is a medical device approval that primarily relies on engineering specifications, safety standards, and preclinical (animal) performance, not machine learning or AI models that require a "training set" in the conventional sense. The device itself is designed and tested, not "trained" on data.

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

Not applicable. As there is no "training set" in the AI/machine learning sense, no ground truth was established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 5, 2017

GOWOONSESANG Cosmetics Co., Ltd % DongHa Lee Regulatory Affairs Consultant KMC. Inc. Room No. 409, ACE Technotower 1-Cha, 38-9, Digital-ro 31-gil, Guro-gu Seoul, Korea 152-766 KR

Re: K160469

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: November 4, 2016 Received: November 8, 2016

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160469

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 (K160469)

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

Date: January 3, 2017

1. Applicant / Submitter

GOWOONSESANG COSMETICS CO., LTD Address: (Seohyeon-dong, 4, 5F Cocoplaza), 20, Seohyeon-ro 210beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea (Postal code: 13591) Tel : +82-31-724-9009 Fax : +82-31-724-9093

2. Submission Contact Person

DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, Korea Tel: +82-70-8965-5554 Fax: +82-2-2672-0579 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, 21CFR878.5350
Device Class: 2

4. Predicate Device

	Predicate Device(1)	Predicate Device(2)
Manufacturer	Jeisys Medical Incorporated	IME Co., Ltd.
Device Name	INTRAcel Premium FractionalRF Micro Needle (FRM) System	HR-5000
510(k) number	K153727	K881276

5. Description

AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable

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neutral electrode pad and a footswitch.

6. Indication for use

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

7. Substantial Equivalence

AGNES is substantially equivalent to the predicate device, HR-5000 (K881276) by IME Co., Ltd. The following comparison table is presented to demonstrate substantial equivalence.

Descriptive Information	Subject Device	Predicate Device (1)	Predicate Device (2)
Manufacturer	GowoonsesangCosmetics Co., Ltd.	Jeisys MedicalIncorporated	IME Co., Ltd.
Device Name	AGNES	INTRAcel PremiumFractional RF MicroNeedle (FRM) System	HR-5000
510(k) number	K160469	K153727	K881276
Classification Product Code /Regulatory Number	GEI / 878.4400	GEI / 878.4400	KCW / 878.5350
Subsequent Product Code	KCW / 878.5350	-	-
Regulatory Class	2	2	1
Indications for Use	AGNES is indicatedfor use indermatological andgeneral surgicalprocedures forelectrocoagulation andhemostasis.	INTRAcel PremiumFractional RF MicroNeedle (FRM) Systemdevice is indicated foruse in dermatologicaland general surgicalprocedures forelectrocoagulation andhemostasis.	Epilation.Dermatologicindications,specifically:telangiectasia, portwine stain, adenomasebaceum,angiokeratoma,angioma, nevus cellnevi, syringoma, acne,rosacea, senile ectasia,rhinophyma, andlymphangiomas.
Prescription or OTC	Prescription	Prescription	Prescription
Operation	The device uses RFenergy deliveredthrough micro needleelectrode to apply heatto target tissue forcoagulating.	The device uses RFenergy deliveredthrough micro needleelectrode to apply heatto target tissue forcoagulating.	The device uses RFenergy deliveredthrough micro needleelectrode to apply heatto target tissue forcoagulating.
ElectrosurgicalUnit (ESU)	Monopolaror Bipolar	Monopolar	Bipolar
	Temperaturesensors	None	None
	Impedancemonitor	None	None	None
	Continuitymonitor	Checking theconnection between theneutral electrode andthe electrosurgical unit.	None	Unknown
	Electrodemonitor	Provide a camera tomonitor the electrodecoating condition andshape before using bythe user.	None	None
	Outputfrequency	1MHz	1MHz	1MHz
	Waveform	Oscillating rectangularwave	Unknown	Oscillating rectangularwave
	Poweroutput	2 to 46 W at 200 ohm	12.5 to 50W at 200ohm	5 to 50W at 200 ohm
	Voltageoutput	25 to 104V	Unknown	10 to 90V
	Dimensions	290mm(W)x455mm(L)x271.7mm(H)	350mm(W)x405mm(L)x1080mm(H)	247mm(W)x270mm(L)x127mm(H)
	Weight	5.8Kg	63Kg	5.2kg
	Power Input	100-250VAC, 50-60Hz	120VAC, 50/60 Hz	100-240VAC,
	FDAApproval	None	None	None
	Monopolaror Bipolar	Monopolar	Bipolar	Monopolar
	Electrodetype	Micro Needle type	Micro Needle type	Micro Needle type
Activeaccessory(RF Electrode)	PhysicalDimensions	Needle length :0.8/1.25/1.5/ 2.0 mmThickness : 0.2mm	Needle length :0.5/0.8/1.5/2.0mmThickness : 0.25mm	Needle length: 1.5mm
	Materials	Electrode: STS 304,Insulating Coating: p-xylylene dimer C	ABS + SUS304	Material: STS 304,Insulating Coating:Teflon PTFE
	Single Useor Reusable	Single Use	Single Use	Single Use
	Sterilization	EO gas	EO gas	EO gas
Neutralelectrode pad	Approval	510(k) cleared by FDA(Κ102372).	None	Unknown
	ConductiveOrCapacitive	Conductive area:132cm²	None	Unknown
	Single Useor Reusable	Single Use	None	Unknown
	PhysicalSpecification	Mono-polar	None	Mono-polar
	Materials	Conductive material:Metal foilBacking material:Foam backing	None	Metal plate
Miscellaneousaccessory(Foot switch)	Functions	For emitting RF energyinto electrode.	For emitting RF energyinto electrode.	For emitting RF energyinto electrode.
	PerformanceSpecifications	Single pole, singlethrow	Single pole, singlethrow	Single pole, singlethrow
	PhysicalSpecification	Single pedal, IP68	Single pedal, IPX8	Single pedal, Unknown
	Materials	Plastic, SPCC	Unknown	Plastic, SPCC

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7.1 The same between the subject device and the predicates device.

1. Product Code
  : The proposed product code of the subject device is GEI for electrosurgical function. It is the same product code as the predicate device in K153727. The proposed product also has subsequent product code as KCW for epilation function. It is the same product code as the predicate device in K881276.

2) Regulatory number and classification

: The proposed regulatory number of the subject device is 878.4400 and the classification is 2. It is the same regulatory number and classification as the predicate device in K153727.

3) Indications for Use

: The subject device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. It is the same as the predicate device in K153727.

4) Prescription Use

: The subject device is a prescription use device. It is the same as the predicate devices in K153727 and K881276.

5) Operation

: The principle of operation of the subject device is using RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. It is the same as the predicate devices in K153727 and K881276.

6) Technical characteristic

: The subject device is monopolar function. It is the same as the predicate device in K881276. The subject device has 1MHz frequency output. It is the same as the predicate devices in K153727 and K881276.

7) Electrode

: The subject device uses disposable sterilized needle type electrode to delivery RF energy to the

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target tissue. It is the same as the predicate devices. For monopolar function, the subject device uses a neutral electrode to be attached the patient back. It is the same as the predicate device in K881276.

8) Miscellaneous accessory

: The subject device uses a footswitch (Single pole, single throw) to emit RF energy into electrode. It is the same as the predicate devices.

7.2 Differences between Subject and Predicates Devices

: The subject device has different RF output power (2 to 46 W). The range of output power is within the predicate devices and the output was also evaluated by safety and performance tests according to IEC 60601-1, IEC 60601-2-2 and animal testing. The results show that these difference does not raise any problems in the safety and effectiveness.

2) Electrode

: The subject device has different electrode physical dimensions (Needle length: 0.8/1.25/1.5/ 2.0 mm, Thickness: 0.2mm). The target tissue is located in dermis (average depth from 0.5mm to 2.0mm). The predicate devices (needle length 0.5/0.8/1.5/2.0mm in K153727, 0.5 to 2.0 mm in K12336 and 1.5mm in K881276) also has target tissue located in dermis. The electrode is coated by different insulating coating material p-xylylene dimer C. Thermal effect was evaluated by animal testing. The results show that these difference does not raise any problems in the safety and effectiveness.

8. Electrical Safety and Electromagnetic compatibility

The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards.

-IEC 60601-1: 2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-2: 2009, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

9. Performance Testing - Nonclinical

9.1 Electrosurgical Unit
1. RF output power testing

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The tests were performed in accordance with the FDA recognized standard, IEC 60601-2-2:2009, Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Clause 201.11 and 201.12

9.2 Active Component - Disposable RF electrode (Needle type)

Mechanical testing (mechanical failure and short circuiting)
Electrical performance (insulation integrity)

The tests were performed with the RF surgical unit in accordance with the FDA recognized standard,

-IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Clause 201.8, 201.13 and 201.15
1. Biocompatibility

The tests were performed in accordance with the FDA recognized standards,

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

The sterilization and packing is verified and validated in in accordance with the FDA recognized standards

ISO 11135: 2014, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11138-2: 2006, Sterilization of health care products Biological indicators Part 2: -Biological indicators for ethylene oxide sterilization processes
ISO 10993-7: 2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ASTM F1980-07: 2011, Standard guide for accelerated aging of sterile barrier systems for medical devices.
9.3 Disposable Neutral Electrode Pad

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The disposable neutral electrode pad is received prior 510(k) clearance by FDA (K102372).

Thermal performance, contact impedance, and adhesion testing

The tests were performed with the RF electrosurgical unit in accordance with the FDA recognized standard,

IEC 60601-2-2:2009, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Sub-clause 201.15.101.
9.4 Miscellaneous component - Foot Switch

Design specification and performance test.

The tests were performed with the RF electrosurgical unit in accordance with the FDA recognized standard,

-IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Sub-clause 201.8.10.4. 201.11.6.5 and 201.12.2

10. Performance Testing - Animal

This animal study was conducted to measure the penetration depth and do a macroscopic check on the improvement of acne and histological pathology analyses on the animal model of acne through clinical assessment (photo assessment) and histological evaluation.

1) Microscopic assessment

Macroscopic assessment by dermatologist on damage and safety on the skin surface and inside the corium
Photo taking with a camera (EOS D3000, Cannon, Tokyo, Japan)
Check the skin conditions using a folliscope magnifying glass (LeedM. Seoul, Korea)
Assess reduction of acne lesion using 3 dimensional measuring instrument PRIMOS Pico (GFM, Germany)

2) Historical assessment

Extract skin on the rabbit's ear at the end of the test and fix with a 4% paraformaldehyde. Dehydrate with alcohol and xylene by stage and embed with paraffin. Make a fragment of 5 m or smaller using a microtome, and remove paraffin with alcohol and xylene again. Dye with hematoxylin & eosin and check the condition of the epidermis and dispersion of sebaceous glands.

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This animal study results as the below.

We checked the depth of skin penetration and discovered that the penetration depth was relatively accurate. For mini pigs, we found distinct coagulation of skin on the area applied with RF.
In order to make the rabbit's ear model, we conducted intradermal injection of acne bacteria P. acnes and induced oleic acid for 4 weeks. As a result, we found acne lesions such as closed comedos and papules or pustules.
We selected groups by each grade and conducted the Agnes treatment, and discovered that the sebaceous glands were destroyed and inflammatory cells, papule and pustule on the lesion area were greatly reduced.
The destruction of sebaceous glands by Agnes killed acne bacteria and induced fast relief of inflammation, and helped quick treatment that it is considered as a valid method to prevent reoccurrence.

11. Conclusion

In comparing between the subject device and the predicate devices, there are indications for use, the operating principle and technological characteristics (monopolar function, output frequency). Although there are some differences as output power, electrode physical dimensions and electrode insulating coating material, the safety and performance test reports are supported to the safety and effectiveness of the subject device. The result of animal study is also supported to thermal effects on tissue and the intended use of the subject device.

In this regard, we conclude that the subject device is 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.