(206 days)
The INTRAcel Premium Fractional RF Micro Needle is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
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
This document is a 510(k) Premarket Notification for the INTRAcel Premium Fractional RF Micro Needle (FRM) System. It demonstrates the device's substantial equivalence to a legally marketed predicate device (Lutronic – INFINI, K121481) for electrocoagulation and hemostasis in dermatological and general surgical procedures.
Based on the provided text, here is a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "performance" often refers to meeting these standards during testing.
| Acceptance Criteria (What was tested for) | Reported Device Performance (Did it pass?) | Comments |
|---|---|---|
| Electrical Safety (IEC 60601-1:2012, IEC 60601-2-2:2009) | Met all acceptance criteria. | Device is electrically safe. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2007) | Met all acceptance criteria. | Device operates without electromagnetic interference and is not susceptible to it. |
| Performance Testing (Dimensional Inspection, Accuracy of Measurement) | Met all acceptance criteria. | Physical dimensions and measurement accuracy are within specifications. |
| Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity) | Active electrodes are biocompatible. | Materials in contact with the patient are safe. |
| Sterilization & Shelf Life Testing (Ethylene Oxide Residues, Bioburden, Sterility, Bacteriostasis/Fungistasis, Shelf Life) | Met all acceptance criteria. | Device can be safely sterilized and maintains sterility over its shelf life. |
| Software Design Testing (IEC 62304:2006) | Met all acceptance criteria. | Software functions as intended and safely; development adhered to standards. |
| Preclinical Performance (In-vivo Micropig Model) - Wound Healing Response | Histologically, thermally coagulated collagen after treatment was replaced by new collagen. | Demonstrates biological effect of the treatment (tissue remodeling). |
| Preclinical Performance (Ex-vivo Animal Tissue) - Power Delivery Characteristics Effect on Tissue | Both subject device and predicate device created conical diamond-shaped tissue coagulation in the dermis and show similar coagulated columns. | Demonstrates similar biological effect and mechanism of action to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Preclinical In-vivo Study: The text mentions "in-vivo micropig model" and "porcine subjects" but does not specify the number of subjects (i.e., the sample size).
- Sample Size for Preclinical Ex-vivo Study: The text mentions "ex-vivo animal tissue testing" but does not specify the number of tissue samples or animals from which they were derived.
- Data Provenance: Not explicitly stated in terms of country of origin for the preclinical studies. However, the manufacturer is in Korea (Jeisys Medical, Inc., Seoul, Korea), and the submission correspondent is in the USA (LK Consulting Group USA, Inc., Fullerton, CA), suggesting international collaboration or trials conducted in either location.
- Retrospective or Prospective: The preclinical studies described (in-vivo micropig model, ex-vivo animal tissue testing) are inherently prospective as they involve conducting new experiments to gather data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not specify the number or qualifications of experts used to establish ground truth for the preclinical studies. "Histologic evaluation was done by H&E and Trichrome" implies a histopathologist, but no details are provided.
- For the non-clinical testing (Electrical Safety, EMC, Software, etc.), these are typically assessed against pre-defined engineering standards by qualified test engineers/laboratories, but expert details are not provided.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the preclinical test sets. Histological evaluation is typically performed by a pathologist, and sometimes a second review is done for quality control, but this is not mentioned.
- For the non-clinical (engineering) tests, adjudication is usually not applicable; rather, the results are objectively measured against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done.
- This device is an electrocoagulation and hemostasis system, not an AI-assisted diagnostic or therapeutic device that involves human readers interpreting medical images or data. Therefore, this type of study is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a medical instrument for electrocoagulation and hemostasis, not an AI algorithm. Its performance is evaluated through physical and electrical characteristics, and its effect on tissue.
7. The Type of Ground Truth Used
- Preclinical In-vivo Study: The ground truth for the wound healing response was histopathological examination (H&E and Trichrome staining) after varying time points. This is a direct biological and histological ground truth.
- Preclinical Ex-vivo Study: The ground truth for comparing power delivery characteristics was also histopathological examination (H&E and Trichrome staining) of the tissue after immediate treatment. This serves as a direct, objective measure of the device's effect on tissue.
- Non-Clinical (Engineering) Testing: The "ground truth" for these tests is adherence to established international and national standards (e.g., IEC 60601 series for electrical safety and EMC, IEC 62304 for software).
8. The Sample Size for the Training Set
- This device is not an AI/machine learning device that requires a "training set." Therefore, this concept is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As the device does not employ AI/machine learning requiring a training set, this concept is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping profiles of human faces, creating a sense of community and connection. The logo is presented in black and white.
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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
EF
PSC Publishing Services (301) 443-6740
{3}------------------------------------------------
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: (82) 2.2603.6417 Fax: (82) 2.2603.6447 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: 714-202-5789 Email: juhee.c@LKconsultinggroup.com
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
{4}------------------------------------------------
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.
{5}------------------------------------------------
| Table 5A - Comparison of Characteristics | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------ |
| ManufacturerTrade Name | LutronicPredicate DeviceINFINI | Jeisys Medical, Inc.Subject DeviceINTRAcel Premium | |
|---|---|---|---|
| 510(k) Number | K121481 | K153727 | |
| Intended Use | The device is intended for use indermatologic and general surgicalprocedures for electrocoagulationand hemostasis and thepercutaneous treatment of facialwrinkles. | The INTRAcel Premium isintended for use in dermatologicand general surgical proceduresfor electrocoagulation andhemostasis. | |
| Design | The device uses Bipolarradiofrequency to apply heat therapyto the skin, resulting skin resurfacingand collagen remodeling fortreatment of wrinkles. | The device uses Bipolar radiofrequency to apply therapy foruse in Dermatologic and GeneralSurgical procedureselectrocoagulation andhemostasis. | |
| Materials | Plastic and metal enclosure withhand-piece for application | Plastic and metal enclosure withhand-piece for application | |
| Construction | Constructed of materials thatconform to safety standards andrequirements | Constructed of materials thatconform to safety standards andrequirements | |
| Interface | Touch screen user applied interfaceto program and setthe controls forthe patient application; there is ahand-piece utilized to deliver thetreatment | Touch screen user appliedinterface to program and set thecontrols for the patientapplication; there is a hand-pieceutilized to deliver the treatment | |
| ElectrosurgicalUnit | Energy SourceMode of OperationPower SourceFrequencyNominal OperatingPower | Radio FrequencyBipolarUnknown1 MHz50W (Up to 20 Level) | Radio FrequencyBipolar120 VAC, 50/60 Hz1 MHz12.5W (Level 1 -4),32W (Level 5)40.5 W(Level 6)50 W(Level 7) |
| Maximum powerdelivered to thepatient | 50W | 50W | |
| Maximum power ofper pin delivered tothe patient | 50W | 50W | |
| Impedance | 200 ohm | ||
| Treatmenttemperature 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(H) | 350 mm (W) x 400 mm (L) x 108mm (H) | |
| Weight | 28 kg | 63 kg |
{6}------------------------------------------------
| Safety features | Safety interlocks, removable keyswitches, hand-piece triggering,visual and audible indicators, cut-offtemperature switches, emergencyoff button. | There are an emergency switchand a key switch so that theoperator can control by touchscreen based on window O/Sprogram. | ||
|---|---|---|---|---|
| ActiveAccessory | Dimensions | Depth ofskin ablation | 0.5-3.5mm | 0.5/0.8/1.5/2.0mm |
| Pinthickness | 0.25mm | 0.25mm | ||
| NeedleQuantity | 49ea | 49ea | ||
| Pinlength | 7.6mm | 11mm | ||
| Thedistancebetweenthe 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 X1cm | ||
| RecommendedTreatment 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 andElectromagneticCompatibility Testing | • IEC 60601-1:2012• IEC 60601-2-2:2009• IEC 60601-1-2:2007 | The INTRAcel Premium metall acceptance criteria inaccordance with IEC 60601-1:2009, IEC 60601-2-2:2009and IEC 60601-1-2:2007. |
| Performance Testing | • Dimensional Inspection• Accuracy of Measurement | The INTRAcel Premium metall acceptance criteria. |
{7}------------------------------------------------
| Biocompatibility Testing | Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity | The active electrodes arebiocompatible. |
|---|---|---|
| Sterilization and ShelfLife Testing | Ethylene Oxide Residues Bioburden Sterility Bacteriostasis/Fungistasis Shelf Life | The INTRAcel Premium metall acceptance criteria. |
| Software design Testing | IEC62304:2006 | The INTRAcel Premium metall acceptance criteria inaccordance with IEC62304:2006 |
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.
{8}------------------------------------------------
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.
§ 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.