INTRAcel Premium Fractional RF Micro Needle (FRM) System

K153727 · Jeisys Medical, Inc. · GEI · Jul 21, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153727
• Device Name: INTRAcel Premium Fractional RF Micro Needle (FRM) System
• Applicant: Jeisys Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The INTRAcel Premium device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Device Story

INTRAcel Premium is an electrosurgical system using bipolar radiofrequency (RF) energy delivered via micro-needle electrodes. The device consists of a main frame, handpiece, and disposable tips. It is operated by a clinician in a clinical setting. The user programs treatment parameters (energy levels, depth) via a touch-screen interface. The device delivers RF energy to the skin to induce thermal coagulation of collagen, facilitating hemostasis and tissue remodeling. The clinician monitors the procedure via the display and manual interface. The system includes safety features such as emergency switches, key switches, and audible/visual indicators. Benefits include controlled tissue coagulation for dermatological and surgical applications.

Clinical Evidence

No clinical testing was required for the 510(k) clearance. Evidence includes bench testing (electrical safety, EMC, dimensional accuracy), biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity), and sterilization validation. Preclinical performance was supported by an in-vivo porcine model evaluating wound healing and collagen response, and an ex-vivo animal tissue study comparing the subject device to the predicate, demonstrating similar conical diamond-shaped tissue coagulation columns.

Technological Characteristics

Bipolar RF electrosurgical system; 1 MHz frequency; 50W max power. Components: main frame, handpiece, micro-needle tips (SUS304/ABS). Interface: touch screen. Safety: emergency/key switches, interlocks. Connectivity: standalone. Sterilization: Ethylene Oxide. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 62304.

Indications for Use

Indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Regulatory Classification

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.

Predicate Devices

• Lutronic — INFINI (K121481)

Submission Summary (Full Text)

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

July 21, 2016

Jeisys Medical Incorporated c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste 110 Fullerton. CA 92831

Re: K153727

Trade/Device Name: INTRAcel Premium Fractional RF Micro Needle (FRM) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, cutting and coagulation device & accessories Regulatory Class: Class II Product Code: GEI Dated: June 7, 2016 Received: June 17, 2016

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

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Christopher J. Ronk -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K153727

Device Name

INTRAcel Premium Fractional RF Micro Needle (FRM) System

Indications for Use (Describe)

The INTRAcel Premium Fractional RF Micro Needle is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

| Type of Use (Select one or both, as applicable) | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|

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# 510(k) Summary (K153727)

#### 1. Submission Sponsor

Jeisys Medical, Inc. 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul 153-775 Korea Phone: [phone] Fax: [phone] Contact: Hyo Seok Lee, RA Manager

#### 2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Tel: [phone] Email: [e-mail]

#### 3. Date Prepared

July 19, 2016

#### 4. Device Identification

| Trade/Proprietary Name: | INTRAcel Premium Fractional RF Micro Needle (FRM) System |
|----------------------------|----------------------------------------------------------------|
| Common/Usual Name: | Electrosurgical coagulation device and accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 878.4400 |
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |

#### 5. Predicate Devices

Lutronic — INFINI, K121481

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#### 6. Device Description

The INTRAcel Premium consists of the following components:

- INTRAcel Premium (Main Frame)
- Active Accessory
- : 10xINTRAcelTip 1011 1x Power cable 1x Foot switch 1xHandpiece 1xHandpiece hanger 1x User's manual

#### 7. Intended Use

The INTRAcel Premium device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

#### 8. Comparison of Technological Characteristics

The INTRAcel Premium device shares the same or similar indications for use, device operation, overalltechnical and functional capabilities, and therefore is substantially equivalent to the predicate devices. The INTRAcel Premium device is similar in design and function to the predicate devices for the modes of operation and use.

The devices have a control unit that can be programmed utilized for the patient parameters. The devices are equipped with an input device either a stylus or touch screen to program the parameters. In addition, they are equipped with manual interface, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. During operation the devices have an applicator instrument attached to the main unit.

These devices all have the same intended use and indications for use as the INTRAcel Premium device. Devices use RF energy delivered through micro needle electrodes to provide treatment controlled by a user controlled interface.

#### 9. Substantial Equivalence Discussion

The following table compares the INTRAcel Premium device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

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| | | | | Table 5A - Comparison of Characteristics |
|--|--|--|--|------------------------------------------|
|--|--|--|--|------------------------------------------|

| | Manufacturer<br>Trade Name | Lutronic<br>Predicate Device<br>INFINI | Jeisys Medical, Inc.<br>Subject Device<br>INTRAcel Premium |
|-----------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K121481 | K153727 |
| Intended Use | | The device is intended for use in<br>dermatologic and general surgical<br>procedures for electrocoagulation<br>and hemostasis and the<br>percutaneous treatment of facial<br>wrinkles. | The INTRAcel Premium is<br>intended for use in dermatologic<br>and general surgical procedures<br>for electrocoagulation and<br>hemostasis. |
| Design | | The device uses Bipolar<br>radiofrequency to apply heat therapy<br>to the skin, resulting skin resurfacing<br>and collagen remodeling for<br>treatment of wrinkles. | The device uses Bipolar radio<br>frequency to apply therapy for<br>use in Dermatologic and General<br>Surgical procedures<br>electrocoagulation and<br>hemostasis. |
| Materials | | Plastic and metal enclosure with<br>hand-piece for application | Plastic and metal enclosure with<br>hand-piece for application |
| Construction | | Constructed of materials that<br>conform to safety standards and<br>requirements | Constructed of materials that<br>conform to safety standards and<br>requirements |
| Interface | | Touch screen user applied interface<br>to program and setthe controls for<br>the patient application; there is a<br>hand-piece utilized to deliver the<br>treatment | Touch screen user applied<br>interface to program and set the<br>controls for the patient<br>application; there is a hand-piece<br>utilized to deliver the treatment |
| Electr<br>osurgical<br>Unit | Energy Source<br>Mode of Operation<br>Power Source<br>Frequency<br>Nominal Operating<br>Power | Radio Frequency<br>Bipolar<br>Unknown<br>1 MHz<br>50W (Up to 20 Level) | Radio Frequency<br>Bipolar<br>120 VAC, 50/60 Hz<br>1 MHz<br>12.5W (Level 1 -4),<br>32W (Level 5)<br>40.5 W(Level 6)<br>50 W(Level 7) |
| | Maximum power<br>delivered to the<br>patient | 50W | 50W |
| | Maximum power of<br>per pin delivered to<br>the patient | 50W | 50W |
| | Impedance | | 200 ohm |
| | Treatment<br>temperature range | 36 - 43°C | 39°C - 42°C |
| | Treatment levels | 20 Level | 1 – 7 levels (1 low, 7 high) |
| | Dimensions | 362 mm (W) x 40 mm (L) x 108 mm<br>(H) | 350 mm (W) x 400 mm (L) x 108<br>mm (H) |
| | Weight | 28 kg | 63 kg |

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| | Safety features | | Safety interlocks, removable key<br>switches, hand-piece triggering,<br>visual and audible indicators, cut-off<br>temperature switches, emergency<br>off button. | There are an emergency switch<br>and a key switch so that the<br>operator can control by touch<br>screen based on window O/S<br>program. |
|-------------------------|-------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Active<br>Access<br>ory | Dimensions | Depth of<br>skin ablation | 0.5-3.5mm | 0.5/0.8/1.5/2.0mm |
| | | Pin<br>thickness | 0.25mm | 0.25mm |
| | | Needle<br>Quantity | 49ea | 49ea |
| | | Pin<br>length | 7.6mm | 11mm |
| | | The<br>distance<br>between<br>the pin | 1.3mm | 1.3mm |
| | Material | | Unknown+SUS304 | ABS+SUS304 |
| | RF treatment area | | Spot Size (Treated area) : 1cm X 1cm | Spot Size (Treated area) : 1cm X<br>1cm |
| | Recommended<br>Treatment Time | | 10 min | 10min~15min |

#### 10. 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 the deviceperforms as intended. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing result supports that all the hardware specifications and software specifications have met the acceptance criteria of each module and interaction of processes. The INTRAcel Premium device passed all testing and supports the claims of substantial equivalence and safe operation.

The INTRAcel Premium device complies with the applicable voluntary standards for Electromagnetic Compatibility and Safety. The device passed all the electrical and safety testing according tonational and international standards.

| Testing Type | Test Description | Test Result |
|-------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety and<br>Electromagnetic<br>Compatibility Testing | • IEC 60601-1:2012<br>• IEC 60601-2-2:2009<br>• IEC 60601-1-2:2007 | The INTRAcel Premium met<br>all acceptance criteria in<br>accordance with IEC 60601-<br>1:2009, IEC 60601-2-2:2009<br>and IEC 60601-1-2:2007. |
| Performance Testing | • Dimensional Inspection<br>• Accuracy of Measurement | The INTRAcel Premium met<br>all acceptance criteria. |

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| Biocompatibility Testing | Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity | The active electrodes are<br>biocompatible. |
|-----------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Sterilization and Shelf<br>Life Testing | Ethylene Oxide Residues Bioburden Sterility Bacteriostasis/Fungistasis Shelf Life | The INTRAcel Premium met<br>all acceptance criteria. |
| Software design Testing | IEC62304:2006 | The INTRAcel Premium met<br>all acceptance criteria in<br>accordance with IEC<br>62304:2006 |

The preclinical performance test by in-vivo micropig model was performed to investigate the wound healing response in porcine subjects after the Fractional RF Micro Needle (FRM) treatment using histopathological examination.The treatment was performed at the energy level, 0.5J, 1.25J and 3.0J and in depth ofmicroneedling0.5mm, 0.8mm, 1.5mm and 2.0mm. Histologic evaluation was done by H&E and Trichrome for immediately after, 7 days after, 14 days after, 28 days after and 10 weeks after procedure.Histologically, the thermally coagulated collagen after treatment was replaced by new collagen.

Additional preclinical performance test was performed to investigate ex-vivo animal tissue testing comparing the subject device and predicate device power delivery characteristics effect on tissue.The treatment was performed at the energy level, 0.5J, 1.25J and 3.0J in depth of microneedling0.5mmand 2.0mm. Histologic evaluation was done by H&E and Trichrome for immediately after procedure. Histologically, both Subject device and predicate device created conical diamond shaped tissue coagulation inthe dermis and show similar coagulated column. The INTRAcel Premium Fractional RF Micro Needle (FRM) System was found to be substantially equivalent to the predicate device foruseindermatological and general surgical procedures for electrocoagulation and hemostasis.

### 11. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. However, we did clinical testing to validate safety and efficacy. It was published in the surgical corner of Journal of Drugs in Dermatology. The verification and validation testing of the device software and electrical safety and EMC testing of the device was found to acceptable and supports the claims of substantial equivalence.

#### 12. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the difference between the INTRAcel Premium system and the predicate device do not raise any questions regarding its safety and effectiveness. The INTRAcel Premium system, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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#### 13. Conclusion

The INTRAcel Premium device has similar intended use and technological characteristics as the predicate devices.

The information provided in this submission supports the substantial equivalence to the predicate device.