The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body. Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer). The INTRAgen consists of the following components: INTRAgen (Main Frame), Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece, Miscellaneous Accessories : Foot Switch and Power Cable.

AI/ML Overview

The provided document describes the INTRAgen, an electrosurgical cutting and coagulation device and its accessories. The document focuses on demonstrating its substantial equivalence to a predicate device (Thermage ThermaCool System) for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed as a separate table but are implied by the types of tests performed and the statement "The INTRAgen met all the acceptance criteria." The performance is reported in the summary tables and discussed in the text.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety & EMC Testing	Compliance with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2.	Met all acceptance criteria in accordance with IEC 60601-1:2009, IEC 60601-2-2:2009, and IEC 60601-1-2:2007.
Biocompatibility Testing	Compliance with ISO 10993-1 for patient-contacting parts.	The active electrodes (made of PCB and ABS) are biocompatible, as per cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogen tests.
Bench Data (Performance Testing)	Accurate dimensional measurements, impedance, energy output, current density, on/off time, output waveform, and skin temperature control.	Met all acceptance criteria for dimensional inspection, accuracy of measurement (impedance), energy output, current density, on/off time, and output waveform. Demonstrated that skin surface temperature does not cause damage even without a cooling system.
Pre-Clinical Trial	Demonstrate substantial equivalence to the predicate device in terms of biological effects (wound healing, neocollagenesis, neoelastogenesis).	Evaluated effects on porcine tissue using different joule energy levels and active electrodes. Showed vigorous wound healing, progressive inflammatory cell infiltration, profound neocollagenesis, and neoelastogenesis up to 10 weeks post-treatment. Concluded substantial equivalence to the predicate device.
Sterilization	Compliance with ISO 11135-1:2007 for EtO sterilization.	Met all acceptance criteria in accordance with ISO 11135-1:2007 for the EtO sterilization of active electrodes (KT-07 and KT-15).

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

Test Set Sample Size:
- Pre-clinical Study: "a porcine tissue model." The exact number of animals or tissue samples is not specified.
- For Electrical Safety, Biocompatibility, Bench Data, and Sterilization, the "sample size" refers to the tested device units/materials. The document states "The tests were performed on the INTRAgen" and "The active electrodes... Biocompatibility test has been conducted..." without indicating the number of units.
Data Provenance: The document does not specify the country of origin for the data collection, but the manufacturing company is based in Korea. The studies are described as "pre-clinical" and "bench tests", implying controlled laboratory settings rather than patient data.

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

Pre-clinical Study:
- Number of Experts: Not specified.
- Qualifications: "Histology evaluation" and "immune histochemical and PCR studies" would imply evaluation by qualified scientists or pathologists. However, specific qualifications (e.g., "radiologist with X years of experience") are not provided.
For other tests (Electrical Safety, Biocompatibility, Bench Data, Sterilization), ground truth is established by meeting recognized standards (e.g., IEC, ISO) and internal specifications, which are assessed by qualified engineers/testers rather than external domain experts in the clinical sense.

4. Adjudication Method for the Test Set

No adjudication method is described. For the pre-clinical study, the evaluation was stated as "histologically and by RT-PCR," implying objective lab analyses rather than expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. The study primarily focuses on the device's technical specifications and biological effects in a pre-clinical model.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The INTRAgen is a hardware electrosurgical device, not an algorithm or AI. Its performance is inherent to its physical operation, not an algorithm's output.

7. The Type of Ground Truth Used

Pre-clinical Trial: The ground truth was based on objective biological markers and histological evaluations:
- Histological evaluation of wound healing response.
- Immune histochemical and PCR studies for neocollagenesis and neoelastogenesis.
Other Tests: Ground truth was based on established industry standards (IEC, ISO), internal engineering specifications, and measurement accuracy.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for traditional medical devices like electrosurgical units.

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

Not applicable. As a traditional medical device, there is no training set for which ground truth would be established.

Summary

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

June 4, 2015

Jeisys Medical Incorporated % Ms. Priscilla Chung LK Consulting Group USA Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K142833

Trade/Device Name: INTRAgen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OUH GEI Dated: April 28, 2015 Received: April 30, 2015

Dear Ms. Chung:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in 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" (21CFR 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 -S

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) K142833

Device Name

INTRAgen

Indications for Use (Describe)

INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation 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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510(k) Summary

[As required by 21 CRF 807.92] (K142833)

1. Date Prepared

June 3, 2015

2. Submitter's Information

Name of 510K Applicant / Manufacturer:
Jeisys Medical Inc.

307, Daeryung Techno Town 8th, 481-11, Gasan-dong, Geumcheon-gu, Seoul, 153-775, Korea,

Contact Name: KyungWon Hwang (Mr.) / RA Manager .
- -Telephone No. : +82 2 2603 6417
- -Fax No. :

●

+82 2 2603 6447 Email Address : lhs1436@jeisys.com
Registration Number: 3006985163 .

Trade Name, Common Name, and Classification 3.

. Trade Name: INTRAgen
Common Name: Electrosurgical Unit .
Classification Name: Electrosurgical cutting and . coagulation device and accessories.
- Classification Panel: General & Plastic Surgery
Classification Regulation: 21 CFR 878.4400 •
Primary Product Code: ойн • Secondary Product Code: GEI

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. Device Class: ll

4. Identification of Predicate Device(s)

The identified predicate devices within this submission are shown as follow;

510(k) Number: K023365 .
Applicant: ●
Common Name: .

Thermage Inc. Electrosurgical Unit

Device Name:
Thermage ThermaCool System

5. Description of the Device

The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body.

Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer).

The INTRAgen consists of the following components:

INTRAgen (Main Frame) .
. Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece
. Miscellaneous Accessories

: Foot Switch and Power Cable

6. Intended Use

The INTRAgen is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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7. Technological Characteristics

Based on a technical feature comparison, the subject device was found to have the same output frequency as the predicate devices. The design and the components of the INTRAgen including the RF generator and the handpiece applicator are similar to the predicate.

However, the subject device has a different power output, tip energy and electrode size from the predicate device. The power output of the subject device is 5 W - 136 W while that of the predicate device is 330 W. The tip energy of the subject device is 10 J – 136 J while that of the predicate device is 52 J - 220 J. The subject device has two types of tip size (7 mm x 7 mm and 15 mm x 15 mm) whereas the predicate device has three types of tip size (25 mm x 25 mm, 15 mm x 15 mm and 30 mm x 30 mm).The differences are insignificant and do not influence the safety or efficacy of the device as shown in the performance tests provided in section 9.

Description	INTRAgen
510(K) Number	K142833
Indications for Use	Dermatologic and general surgical procedures for electro coagulation and hemostasis.
Electrosurgical Unit	Major Functions	1. Monopolar
		2. Impedance monitor
	Performance Specifications	Output Frequency
		Power Output

		Tip Energy

		Fluence

Physical Specifications	1. Dimensions: 365.0 * 454.8 * 795.5 ( mm)
	2. Weight: 28 kg

The detailed information on INTRAgen's specifications is shown in the following table:

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Active Accessory	Monopolar or Bipolar	Monopolar
	PhysicalDimensions andDesign	KT-07:31 * 30.4 * 30.3 (mm)(width * length * height)KT-15:31 * 30.4 * 29.4 (mm)(width * length *height)
	Effective Area	KT-07: 7 * 7 (mm)
		KT-15: 15 * 15 (mm)
	Materials(Patient contact)	PCB(polychlorinated biphenyl)ABS (Acrylonitrile-Butadiene-Styrene Copolymer)
	Foot Pedal	Physical Specification	1) Dimensions: 130 * 150 * 134.6 (mm) (width * length *height)2) Cable length: 2 (m)3) Weight: 1 kg
Power adjustment increment	Level Joules (J) T 5 1 45 2 60 3 75 4 91 5 105 6 134 7 136
On/Off Time	KT-07 On: 2 secOff: 0 sec KT-15 On: 1 secOff: 0 sec
	Use or Non-use of Coupling gels		Use
Skin Cooling Methods		Not use
Ointment and/or Drug Product Use		Not use

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8. Substantial Equivalence

Substantial equivalence to the following predicate devices is claimed:

Description		Proposed[INTRAgen]	Predicate[ThermageThermaCoolSystem]	Remark
510(K) Number		K142833	K053365	-
Indications for Use		The INTRAgen isindicated for use indermatologic andgeneral surgicalprocedures forelectrocoagulationand hemostasis.	The ThermageThermaCool Systemis indicated for use inDermatologic andGeneral Surgicalprocedures forelectrocoagulationand hemostasis".	Same
ElectrosurgicalUnit	Major Functions	1. Monopolar2. Impedancemonitor	1. Monopolar2. Impedancemonitor3. Temperaturemonitor	PerformanceTesting
	PerformanceSpecifications	OutputFrequency	6 MHz	6 MHz	Same
		PowerOutput	KT-07:5 W - 35 WKT-15:5 W - 136 W	330 W	ElectricalSafetyTesting(IEC60601-2-2) andAnimalStudy
		Tip Energy	KT-07:10 J - 70 JKT-15:20 J - 136 J	52 J - 220 J	Performa-nceTestingand
					AnimalStudy
		Fluence	KT-07:20 – 144 J/cm²KT-15:2 – 60 J/cm²	225 J/cm²	Performa-nceTestingandAnimalStudy
	Physical Specifications		1. Dimensions:365.0 * 454.8 *795.5 (mm)2. Weight: 28 kg	Not known	-
ActiveAccessory	Monopolar or Bipolar		Monopolar	Monopolar	Same
	PhysicalDimensionsand Design	Dimensions	KT-07:31 * 30.4 * 30.3(mm)(width * length height)KT-15:31 30.4 * 29.4(mm)(width * length *height)	2.5 * 2.5 (mm),15 * 15 (mm),30 * 30 (mm)	Performa-nceTesting
		EffectiveArea	KT-07: 7 * 7 (mm)KT-15: 15 * 15(mm)	15 * 15 (mm),2.5 * 2.5 (mm),30 * 30 (mm)
		Materials(Patient contact)	PCB(polychlorinatedbiphenyl)ABS (Acrylonitrile-Butadiene-StyreneCopolymer)	Polymid film	BiocompatibilityTesting
FootPedal	Physical Specification		1) Dimensions:130 * 150 134.6 (mm)(width length *height)2) Cable length: 2(m)3) Weight: 1 kg	Not known	-
Power adjustment increment	Level	Joules (J)	Level	Joules (J)	Performa-
	T	5	10.5	52	nceTestingandAnimalStudy
	1	45	11.0	58
	2	60	11.5	65
	3	75	12.0	72
	4	91	12.5	79
	5	105	13.0	87
	6	134	13.5	95
	7	136	14.0	103
			14.5	112
			15.0	121
			15.5	131
			16.0	140
			16.5	151
			17.0	161
			17.5	172
			18.0	184
			18.5	195
			19.0	207
			19.5	220
On/Off Time	KT-07	On: 2 secOff: 0 sec	Not Known		Performa-nceTestingandAnimalStudy
	KT-15	On: 1 secOff: 0 sec
Use or Non-use of Coupling gels	Use		Use		Same
Skin Cooling Methods	Not use		Uses a bio-safecryogenTetrafluoroethane		Performa-nceTesting
Ointment and/or Drug Product Use	Not use		Not known

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The indications for use and technological characteristics of the INTRAgen device are substantially equivalent to theThermageThermaCool System. The key technological characteristics of the INTRAgen, such as energy type and operating principle, are equivalent to the predicate device.The design and components in the INTRAgen device, including the RF generator and the hand piece applicator are also similar to the design and components found in the predicate ThermageThermaCool System.

The major differences between the subject device and the predicate device are power output, tip energy and electrode size from the predicate device. However, the preclinical study using the porcine model demonstrated the subject device would perform as well as the predicate devices in the market. The INTRAgen device also underwent performance testing, including software validation testing (provided in Section 4) and electrical and mechanical safety testing according to IEC 60601-1 and

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electromagnetic compatibility testing according to IEC 60601-1-2 (provided in Section 10) and bench tests (provided in Section 9). These performance tests demonstrated that the differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the INTRAgen is substantially equivalent to the predicate ThermageThermaCool System, cleared under 510(k) K053365.

9. Summary of Non-Clinical Performance Data

. Electrical Safety and Electromagnetic Compatibility
The tests were performed on the INTRAgen to confirm electrical safety and electromagnetic compatibility in accordance with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2. The results were acceptable.
Biocompatibility .
The patient contacting part of the INTRAgen is the active electrode and it is made of PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Stvrene Copolymer). Biocompatibility test has been conducted according to the ISO 10993-1 standards, and the test results support that it is biocompatible.
. Bench Data
Bench tests were performed to evaluate the dimensional accuracy, the accuracy of measurement for impedance, the accuracy of the active electrode output and output waveform. The test results were acceptable. An additional bench test was performed to demonstrate that the temperature of the skin surface does not go up to the point where it can cause damage to the skin tissue even when the cooling system is not used. The results demonstrated that the temperature of the skin surface did not go up to the point where it could cause damage to the skin tissue.
. Pre-Clinical
A pre-clinical trial was performed to evaluate performance of the subject device. The test was performed on a porcine tissue model using different joule energy levels and active electrodes.
Study purpose: The study was designed to evaluate the effects of the novel grid fractional RF treatment on skin structure and collagen in vivo.

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Follow up periods/days: The wound healing response was evaluated histologically and by RT-PCR up to 10 weeks post-RF treatment. - Animal type: Porcine
Treatment applied: The INTRAgen RF device was used to deliver RF energy to skin.
Histology evaluation: The study results showed that vigorous wound healing response was initiated post-treatment with progressive increase in inflammatory cell infiltration from day 2 through 10 weeks. Furthermore, through both immune histochemical and PCR studies, it was found that profound neocollagenesis and neoelastogenesis following RF treatment of micropigskin occurred.

In conclusion, the test results of the pre-clinical study demonstrated that the subject device is substantially equivalent to the predicate device.

· Sterilization
The active electrodes (KT-07 and KT-15) are sterilized in its final packaging using 20% Ethylene Oxide (EtO) and 80% CO2. The EtO sterilization process has been validated in accordance with ISO 11135-1:2007.

· INTRAgen complies with the following recognized standards. The following table lists the non-clinical testing performed.

Testing Type	Test Description	Test Result
Electrical Safety andElectromagneticCompatibility Testing	• IEC 60601-1:2012• IEC 60601-2-2:2009• IEC 60601-1-2:2007	The INTRAgen met allThe acceptancecriteria in accordancewith IEC 606011:2009, IEC 60601-2-2:2009 and IEC60601-1-2:2007.
BiocompatibilityTesting	• Cytotoxicity• Sensitization• Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogen	The active electrodesare biocompatible.
Performance Testing	• Dimensional Inspection• Accuracy of Measurement• Energy Output• Current Density• On/off time• Output Waveform• Skin Temperature	The INTRAgen met allthe acceptancecriteria.

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Pre-clinical Trial	• Tissue Analysis• Total RNA isolation andreal-time RT-PCR· Statistical analysis	The test resultsdemonstrated that thesubject device issubstantially equivalentto the predicate device.
Sterilization	• ISO 11135-1:2007	The INTRAgen met allthe acceptancecriteria in accordancewith ISO 11135-1:2007.

10. Summary of Clinical Test

No clinical studies were considered necessary and performed.

11. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807, FDA's "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" and based on the information provided in this premarket notification, Jeisys Medical Inc. concludes that INTRAgen is safe, effective and substantially equivalent to predicate devices for dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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.