INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin in monopolar and bipolar mode.

Device Description

The INTRAcel RF Microneedle System comprises of two primary components; an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the INTRAcel RF Microneedle System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test Description	Reported Device Performance
Electrical Safety & EMC	IEC 60601-1:2012 (Medical electrical equipment - General requirements for basic safety and essential performance)	Met all acceptance criteria in accordance with IEC 60601-1:2012.
	IEC 60601-1-6:2010, AMD1:2013 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability)	Met all acceptance criteria in accordance with IEC 60601-1-6:2010, AMD1:2013.
	IEC 60601-2-2:2009 (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)	Met all acceptance criteria in accordance with IEC 60601-2-2:2009.
Performance Testing	Performance Test Report for ESU (Electrosurgical Unit)	Met the acceptance criteria.
	INTRAcel Tip Count Test	Met the acceptance criteria.
	Verification Performance of INTRAcel Tip	Met the acceptance criteria.
Biocompatibility Testing	Cytotoxicity	Microneedle electrodes are biocompatible.
	Sensitization	Microneedle electrodes are biocompatible.
	Intracutaneous Reactivity	Microneedle electrodes are biocompatible.
Sterilization & Shelf Life	Ethylene Oxide Sterilization Residuals	Met the acceptance criteria.
	Accelerated aging test	Met the acceptance criteria.
Software Verification & Validation	Software tested against established Software Design Specifications to assure performance as intended; Device Hazard Analysis completed, risk control implemented; acceptance criteria of each module and interaction of processes met.	The software for this device was considered a "moderate" level of concern. All acceptance criteria for software development, verification, and validation were met, and the device performs as intended, supporting substantial equivalence and safe operation.

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

The document does not explicitly state a "test set" in the context of clinical images or patient data that would require sample sizes and data provenance like country of origin or retrospective/prospective nature. The studies described are primarily non-clinical, focusing on device performance, electrical safety, biocompatibility, and software validation.

Animal Performance Testing (Wound Healing): The "study was conducted to see the wound healing response following FRM treatment for both human and porcine skin." While human skin is mentioned, the detailed procedural description (biopsy time points, H&E, HSP47, RT-PCR) is for "Micro-pig covering 10 weeks." The specific number of human or porcine subjects is not provided. The study appears to be prospective as it involves active treatment and observation over time.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies detailed are technical (electrical, biocompatibility, software) or animal studies for wound healing, which do not typically involve human expert adjudication for ground truth establishing in the sense of medical image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided for the types of studies performed (technical bench testing, software validation, animal studies). There's no indication of a test set requiring adjudication in the context of expert consensus.

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

A MRMC comparative effectiveness study was not performed or reported in this document. The device is an electrocoagulation and microneedling system; therefore, its performance is assessed directly through physical and electrical properties, biological safety, and tissue response, rather than as an aid to human interpretation like an AI diagnostic tool.

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

This concept is not applicable to the INTRAcel RF Microneedle System in the way it's usually applied to AI diagnostic algorithms. The device itself is an active treatment device, not a diagnostic algorithm. The software validation mentioned is for the control and functionality of the device, implying a "standalone" software performance in terms of controlling the hardware as intended, rather than interpreting medical data.

7. Type of Ground Truth Used

For Electrical Safety & EMC: Ground truth would be defined by the specifications and pass/fail criteria of the referenced international standards (IEC 60601 series).
For Performance Testing: Ground truth would be defined by the device's design specifications and expected functional outputs (e.g., specific power output, tip count accuracy).
For Biocompatibility Testing: Ground truth is established by the results of standardized biological tests (cytotoxicity, sensitization, intracutaneous reactivity) against acceptance criteria for biocompatible materials.
For Sterilization & Shelf Life: Ground truth is established by the ability to achieve sterility (e.g., meeting sterility assurance levels) and maintain device integrity/functionality over time via accelerated aging.
For Software Verification & Validation: Ground truth is the established "Software Design Specifications" — the software's ability to operate the device as programmed and safely (per the "moderate" level of concern).
For Animal Performance Testing (Wound Healing): Ground truth is established through histological examination (H&E, HSP47 stain) and molecular analysis (RT-PCR for mRNA changes in collagen, HSPs, MMPs) of biopsied tissue, documenting physiological wound healing responses at different time points and energy levels.

8. Sample Size for the Training Set

This information is not provided and is specifically irrelevant as the document describes a physical medical device, not an AI/ML algorithm that requires a training set of data. The software mentioned handles device control, not predictive modeling or classification.

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

This information is not applicable as there is no "training set" in the context of an AI/ML model for this device.

Summary

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January 15, 2020

Jeisys Medical Inc. % Parul Chansoria Regulatory Consultant Elexes Medical Consulting 6494 Tralee Village Dr Dublin, California 94568

Re: K183284

Trade/Device Name: INTRAcel RF Microneedle System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 16, 2019 Received: December 16, 2019

Dear Parul Chansoria:

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.

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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 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.

Long Chen, 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

Enclosure

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Indications for Use

510(k) Number (if known) K183284

Device Name INTRAcel RF Microneedle System

Indications for Use (Describe)

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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I. SUBMITTER

Jeisys Medical Inc. 307, Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul, Republic of Korea Contact Person: Parul Chansoria Elexes Medical Consulting 6494 Tralee Village Dr Dublin, CA 94568, USA Telephone: 650-528-2445, 408-475-8091 E-mail: parul@elexes.com Summary Prepared: January 15, 2020 FDA Establishment Number: 3006985163

II. DEVICE

Common/Usual Name: Electrosurgical coagulation device and accessories Trade Name: INTRAcel RF Microneedle System Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Classification Panel: General and Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400

III. PREDICATE DEVICE

The INTRAcel RF Microneedle System is substantially equivalent to the following cleared device:

Company	PredicatePriority	Product	510(k) Number
JeisysMedicalInc.	Primary Predicate	INTRAcel PremiumFractionalRF Micro needle (FRM)System	K153727

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IV. DEVICE DESCRIPTION

The INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures. INTRAcel RF Microneedle System comprises of two primary components; an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable.

RF Generator: RF energy is delivered from the RF Generator through the electrodes into the target tissue. Treatment is provided in bipolar mode and monopolar mode. In the monopolar mode, RF energy flows from the main unit and a patient loop is formed by pairing the active electrode (microneedle electrode) with the neutral electrode pad. Heat is not generated in a neutral electrode plate which has a low contact resistance but heat is generated in an active electrode which has a relatively large contact resistance and this heat momentarily causes tissue to heat up to cause coagulation. The bipolar RF energy is delivered between independent adjacent electrode pairs. The RF Generator is not disposable.

Electrode Insertion Device: The insertion device is a hand-held mechanical device that is used to insert the electrodes into the target tissue. It is supplied sterile, is for single patient use only and cannot be resterilized. The device has forty-nine electrodes. The device has a mechanism to deploy and retract the electrodes when actuated by the operator.

Cable: There is a cable with a connector that connects to the RF Generator. The RF Generator is the energy source for the system.

Accessories: Cables, neutral electrode pad, neutral electrode pad cable, footswitch, and power cord are also supplied with the system.

V. INDICATIONS FOR USE

INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and percutaneous fractional treatment of the skin in monopolar and bipolar mode.

TECHNOLOGICAL CHARACTERISTICS W.R.T. THE PREDICATE DEVICE VI.

The Indications for Use, key technological characteristics of the Electrosurgical Unit (ESU) and operating principle of the Subject Device are equivalent to those of the Predicate Device.

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Comparison with Primary Predicate
Parameter		Subject Device	Predicate Device	Comments
Device Name		INTRAcel RF Microneedle System	INTRAcel Premium Fractional RF Micro needle (FRM) system
Electrosurgical Unit(ESU)	Monopolar or Bipolar	Monopolar and Bipolar	Bipolar	Different. Addition of Monopolar mode.
	Output frequency	1MHz	1MHz	Same as predicate
	Power Output	50W	50W	Same as predicate
	Voltage Output	90V	90V	Same as predicate
	Dimensions	350mm(W)x405mm(D)x1080mm(H)	350mm(W)xx400mm(D)x1080mm(H)	Same as predicate
	Weight	63Kg	63Kg	Same as predicate
	Power Source/Input	AC 120V,50-60Hz	AC 120V,50/60Hz	Same as predicate
Activeaccessory(RFElectrode)	Monopolar orBipolar	Monopolar andBipolar	Bipolar	Different. Additionof Monopolar Mode
	ElectrodeType	Micro Needle	MicroNeedle	Same as predicate
	PhysicalDimensions	Depth of skinAblation:0.5/0.8/2.0mmThickness:0.25mm (Tip of theneedle:22")	Depth ofskinablation:0.5/0.8/2.0mmThickness:0.25mm	Same as predicate
	Materials	Tip:ABS(sr-0300)Needles:SUS304	Tip:ABS(sr-0300)Needles:SUS304	Same as predicate
	Single-Use orReusable	Single-Use	Single-Use	Same as predicate
	Sterilization	EO gas	EO gas	Same as predicate
Neutralelectrode pad	Conductive orCapacitive	Conductivearea:250mmx140mmcontact on theskin	Not afeature ofthis device	Different. Additionin the subject devicefor the monopolarmode.
	Single-Use orReusable	Single-Use
	PhysicalSpecification	250mm(W)x 140mm(L)x0.5mm(H)
	Materials	ABS HighdensityPolyethene(material that ispatientcontacting)
Miscellaneousaccessory(Footswitch)	Functions	For emitting RFenergy intoelectrode	ForemittingRFenergy intoelectrode	Same as predicate
	Performance	Single pole,singlethrow	Singlepole, singlethrow	Same as predicate
	PhysicalSpecification	Single pedal,IPX8	Singlepedal,IPX8	Same as predicate
	Materials	Steel and plastic	Steel andplastic	Same as predicate

Comparison with Primary Predicate

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The following differences exist between the Subject Device and Predicate Device:

The Subject Device operates in both monopolar and bipolar mode but the primary predicate operates only in bipolar mode.
The Neutral Electrode Pad is an addition to the Subject Device.

VII. NON-CLINICAL STUDY

1.1. Non-Clinical Performance Data
The device's hardware and software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure that the device performs as intended. The Device Hazard Analysis was completed and risk control was

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implemented to mitigate identified hazards. The test results demonstrate that all the acceptance criteria of each module and interaction of processes have been met. The Subject Device passed all testing which supports substantial equivalence and safe operation. The INTRAcel RF Microneedle System complies with the applicable voluntary standards for Electromagnetic Compatibility and Safety. The device passed all the electrical and safety testing according to national and international standards.

Testing Type	Test Description	Test Result
Electrical SafetyandElectromagneticCompatibilityTesting	• IEC 60601-1:2012• IEC 60601-1-6:2010,AMD1:2013• IEC 60601-2-2:2009	The INTRAcel RFMicroneedleSystem met allacceptance criteria inaccordance with IEC60601-1:2012,IEC 60601-1-6:2010,AMDA1:2013and IEC60601-2-2:2009.
PerformanceTesting	• Performance TestReport for ESU• INTRAcel TipCount Test• VerificationPerformance ofINTRAcel Tip	The INTRAcel RFMicroneedle hasmet the acceptancecriteria.
BiocompatibilityTesting	• Cytotoxicity• Sensitization• IntracutaneousReactivity	The microneedleelectrodes arebiocompatible.
Sterilization andShelf Life Testing	• Ethylene OxideSterilization	The INTRAcel RFMicroneedle has
	Residuals Accelerated aging test	met the acceptance criteria.

Tests Performed

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VIII. SOFTWARE VERIFICATION AND VALIDATION TESTING

Software Verification and Validation Testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as "moderate" level of concern, since a failure or latent flaw in the software would not directly or indirectly result in serious injury or death to the patient or operator.

ANIMAL PERFORMANCE TESTING IX.

A study was conducted to see the wound healing response following FRM treatment for both human and porcine skin. Healing responses were observed by the time after Fractional Radiofrequency Microneedling (FRM) treatment at various energy levels. Biopsy was conducted to see the wound healing process immediately after the treatment, 2days, 14days, 28days, and 10 weeks post the treatment. H&E stain and HSP47 stain were conducted to see the changes in inflammatory cell, collagen. Also, the study has conducted RT-PCR (Reverse Transcription - Polymerase Chain Reaction) with the tissue biopsied from Micro-pig covering 10 weeks to see mRNA change of collagen, Heat Shock Proteins (HSPs), and matrix metalloproteinase (MMPs).

CONCLUSION X.

The INTRAcel RF Microneedle System is substantially equivalent to the Predicate Device in Indications for Use, key technological characteristics of the Electrosurgical Unit (ESU) and operating principle. Safety and performance testing was performed and Jeisys Medical Inc. has concluded that the Subject Device does not raise any new questions of safety and efficacy and is substantially equivalent to the predicate 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.