(206 days)
Not Found
No
The summary describes a fractional RF micro-needling device for electrocoagulation and hemostasis. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on tissue response to the RF energy and micro-needling depth, not on algorithmic performance.
No.
The device is indicated for "electrocoagulation and hemostasis" in "dermatological and general surgical procedures," which are not considered therapeutic but rather procedural.
No
The device is indicated for "electrocoagulation and hemostasis" in "dermatological and general surgical procedures," which are therapeutic functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a main frame, active accessory, power cable, foot switch, handpiece, and handpiece hanger.
Based on the provided information, the INTRAcel Premium Fractional RF Micro Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "dermatological and general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The components listed are typical of a surgical or dermatological device used for energy delivery and tissue modification. There are no components mentioned that would be used for analyzing biological samples.
- Performance Studies: The performance studies described involve in-vivo (on living subjects) and ex-vivo (on tissue outside the body) testing of the device's effect on tissue, specifically wound healing and coagulation. This is consistent with a device used for surgical or dermatological procedures, not for diagnostic testing of samples.
In summary, the INTRAcel Premium Fractional RF Micro Needle is a device used for treating tissue directly, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The INTRAcel Premium Fractional RF Micro Needle is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Electrical Safety and Electromagnetic Compatibility Testing: IEC 60601-1:2012, IEC 60601-2-2:2009, IEC 60601-1-2:2007. Results: The INTRAcel Premium met all acceptance criteria.
- Performance Testing: Dimensional Inspection, Accuracy of Measurement. Results: The INTRAcel Premium met all acceptance criteria.
- Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity. Results: The active electrodes are biocompatible.
- Sterilization and Shelf Life Testing: Ethylene Oxide Residues, Bioburden, Sterility, Bacteriostasis/Fungistasis, Shelf Life. Results: The INTRAcel Premium met all acceptance criteria.
- Software design Testing: IEC62304:2006. Results: The INTRAcel Premium met all acceptance criteria.
Additional Preclinical Performance Tests:
- In-vivo micropig model: Investigated wound healing response after Fractional RF Micro Needle (FRM) treatment using histopathological examination. Treatment performed at energy levels 0.5J, 1.25J, and 3.0J and microneedling depths of 0.5mm, 0.8mm, 1.5mm, and 2.0mm. Histologic evaluation (H&E and Trichrome) done immediately after, 7, 14, 28 days after, and 10 weeks after procedure. Result: Thermally coagulated collagen was replaced by new collagen.
- Ex-vivo animal tissue testing: Compared subject device and predicate device power delivery characteristics effect on tissue. Treatment performed at energy levels 0.5J, 1.25J, and 3.0J in microneedling depths of 0.5mm and 2.0mm. Histologic evaluation (H&E and Trichrome) immediately after procedure. Result: Both devices created conical diamond shaped tissue coagulation in the dermis and showed similar coagulated column.
Clinical Testing:
- No clinical testing was required for substantial equivalence.
- Clinical testing was performed to validate safety and efficacy and was published in the surgical corner of Journal of Drugs in Dermatology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
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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 | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------ |
| | Manufacturer
Trade Name | Lutronic
Predicate Device
INFINI | Jeisys Medical, Inc.
Subject Device
INTRAcel Premium |
|-----------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K121481 | K153727 |
| Intended Use | | The device is intended for use in
dermatologic and general surgical
procedures for electrocoagulation
and hemostasis and the
percutaneous treatment of facial
wrinkles. | The INTRAcel Premium is
intended for use in dermatologic
and general surgical procedures
for electrocoagulation and
hemostasis. |
| Design | | The device uses Bipolar
radiofrequency to apply heat therapy
to the skin, resulting skin resurfacing
and collagen remodeling for
treatment of wrinkles. | The device uses Bipolar radio
frequency to apply therapy for
use in Dermatologic and General
Surgical procedures
electrocoagulation and
hemostasis. |
| Materials | | Plastic and metal enclosure with
hand-piece for application | Plastic and metal enclosure with
hand-piece for application |
| Construction | | Constructed of materials that
conform to safety standards and
requirements | Constructed of materials that
conform to safety standards and
requirements |
| Interface | | Touch screen user applied interface
to program and setthe controls for
the patient application; there is a
hand-piece utilized to deliver the
treatment | Touch screen user applied
interface to program and set the
controls for the patient
application; there is a hand-piece
utilized to deliver the treatment |
| Electr
osurgical
Unit | Energy Source
Mode of Operation
Power Source
Frequency
Nominal Operating
Power | Radio Frequency
Bipolar
Unknown
1 MHz
50W (Up to 20 Level) | Radio Frequency
Bipolar
120 VAC, 50/60 Hz
1 MHz
12.5W (Level 1 -4),
32W (Level 5)
40.5 W(Level 6)
50 W(Level 7) |
| | Maximum power
delivered to the
patient | 50W | 50W |
| | Maximum power of
per pin delivered to
the patient | 50W | 50W |
| | Impedance | | 200 ohm |
| | Treatment
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
(H) | 350 mm (W) x 400 mm (L) x 108
mm (H) |
| | Weight | 28 kg | 63 kg |
6
| | Safety features | | Safety interlocks, removable key
switches, hand-piece triggering,
visual and audible indicators, cut-off
temperature switches, emergency
off button. | There are an emergency switch
and a key switch so that the
operator can control by touch
screen based on window O/S
program. |
|-------------------------|-------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Active
Access
ory | Dimensions | Depth of
skin ablation | 0.5-3.5mm | 0.5/0.8/1.5/2.0mm |
| | | Pin
thickness | 0.25mm | 0.25mm |
| | | Needle
Quantity | 49ea | 49ea |
| | | Pin
length | 7.6mm | 11mm |
| | | The
distance
between
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
1cm |
| | Recommended
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 | ||
| Electromagnetic | ||
| Compatibility Testing | • IEC 60601-1:2012 | |
| • IEC 60601-2-2:2009 | ||
| • IEC 60601-1-2:2007 | The INTRAcel Premium met | |
| all acceptance criteria in | ||
| accordance with IEC 60601- | ||
| 1:2009, IEC 60601-2-2:2009 | ||
| and IEC 60601-1-2:2007. | ||
| Performance Testing | • Dimensional Inspection | |
| • Accuracy of Measurement | The INTRAcel Premium met | |
| all acceptance criteria. |
7
| Biocompatibility Testing | Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity | The active electrodes are
biocompatible. |
|-----------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Sterilization and Shelf
Life Testing | Ethylene Oxide Residues Bioburden Sterility Bacteriostasis/Fungistasis Shelf Life | The INTRAcel Premium met
all acceptance criteria. |
| Software design Testing | IEC62304:2006 | The INTRAcel Premium met
all acceptance criteria in
accordance with IEC
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.
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.