(415 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts. The performance studies focus on hardware/software validation and biological responses to the treatment, not on algorithmic performance.
No.
The device is used for electrocoagulation, hemostasis, and fractional treatment of the skin in dermatological and general surgical procedures, which are considered aesthetic or surgical functions rather than therapeutic.
No
The device is indicated for "electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin," which are all therapeutic procedures. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it comprises an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable, indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin". This describes a therapeutic or surgical intervention performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description of the components (RF Generator, User Interface Software, disposable Electrode Insertion Device) aligns with a device used for delivering energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to treat the skin directly.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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: 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 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.
Electrical Safety and Electromagnetic Compatibility Testing (IEC 60601-1:2012, IEC 60601-1-6:2010, AMD1:2013, IEC 60601-2-2:2009): The INTRAcel RF Microneedle System met all acceptance criteria.
Performance Testing (Performance Test Report for ESU, INTRAcel Tip Count Test, Verification Performance of INTRAcel Tip): The INTRAcel RF Microneedle has met the acceptance criteria.
Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity): The microneedle electrodes are biocompatible.
Sterilization and Shelf Life Testing (Ethylene Oxide Sterilization, Residuals, Accelerated aging test): The INTRAcel RF Microneedle has met the acceptance criteria.
Software Verification and Validation Testing: Conducted and documentation 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.
Animal Performance Testing: 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, 2 days, 14 days, 28 days, 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).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K183284
Device Name INTRAcel RF Microneedle System
Indications for Use (Describe)
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.
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
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 | Predicate
Priority | Product | 510(k) Number |
|---------------------------|-----------------------|-------------------------------------------------------------------|---------------|
| Jeisys
Medical
Inc. | Primary Predicate | INTRAcel Premium
Fractional
RF Micro needle (FRM)
System | K153727 |
4
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.
5
| 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)x | |||
| 405mm(D)x | ||||
| 1080mm(H) | 350mm(W)x | |||
| x400mm(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 | |||
| Active | ||||
| accessory | ||||
| (RF | ||||
| Electrode) | Monopolar or | |||
| Bipolar | Monopolar and | |||
| Bipolar | Bipolar | Different. Addition | ||
| of Monopolar Mode | ||||
| Electrode | ||||
| Type | Micro Needle | Micro | ||
| Needle | Same as predicate | |||
| Physical | ||||
| Dimensions | Depth of skin | |||
| Ablation: | ||||
| 0.5/0.8/2.0mm | ||||
| Thickness:0.25 | ||||
| mm (Tip of the | ||||
| needle:22") | Depth of | |||
| skin | ||||
| ablation:0.5 | ||||
| /0.8/2. | ||||
| 0mm | ||||
| Thickness: | ||||
| 0.25mm | Same as predicate | |||
| Materials | Tip:ABS(sr-030 | |||
| 0)Needles: | ||||
| SUS304 | Tip:ABS(sr | |||
| -0300) | ||||
| Needles:S | ||||
| US304 | Same as predicate | |||
| Single-Use or | ||||
| Reusable | Single-Use | Single-Use | Same as predicate | |
| Sterilization | EO gas | EO gas | Same as predicate | |
| Neutral | ||||
| electrode pad | Conductive or | |||
| Capacitive | Conductive | |||
| area: | ||||
| 250mm | ||||
| x140mm | ||||
| contact on the | ||||
| skin | Not a | |||
| feature of | ||||
| this device | Different. Addition | |||
| in the subject device | ||||
| for the monopolar | ||||
| mode. | ||||
| Single-Use or | ||||
| Reusable | Single-Use | |||
| Physical | ||||
| Specification | 250mm(W) | |||
| x 140mm(L) | ||||
| x0.5mm(H) | ||||
| Materials | ABS High | |||
| density | ||||
| Polyethene | ||||
| (material that is | ||||
| patient | ||||
| contacting) | ||||
| Miscellaneous | ||||
| accessory | ||||
| (Footswitch) | Functions | For emitting RF | ||
| energy into | ||||
| electrode | For | |||
| emitting | ||||
| RF | ||||
| energy into | ||||
| electrode | Same as predicate | |||
| Performance | Single pole, | |||
| single | ||||
| throw | Single | |||
| pole, single | ||||
| throw | Same as predicate | |||
| Physical | ||||
| Specification | Single pedal, | |||
| IPX8 | Single | |||
| pedal, | ||||
| IPX8 | Same as predicate | |||
| Materials | Steel and plastic | Steel and | ||
| plastic | Same as predicate |
Comparison with Primary Predicate
6
7
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
8
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 Safety | ||
| and | ||
| Electromagnetic | ||
| Compatibility | ||
| Testing | • IEC 60601-1:2012 | |
| • IEC 60601-1-6:2010,A | ||
| MD1:2013 | ||
| • IEC 60601-2-2:2009 | The INTRAcel RF | |
| Microneedle | ||
| System met all | ||
| acceptance criteria in | ||
| accordance with IEC | ||
| 60601-1:2012, | ||
| IEC 60601-1-6:2010, | ||
| AMDA1:2013 | ||
| and IEC | ||
| 60601-2-2:2009. | ||
| Performance | ||
| Testing | • Performance Test | |
| Report for ESU | ||
| • INTRAcel Tip | ||
| Count Test | ||
| • Verification | ||
| Performance of | ||
| INTRAcel Tip | The INTRAcel RF | |
| Microneedle has | ||
| met the acceptance | ||
| criteria. | ||
| Biocompatibility | ||
| Testing | • Cytotoxicity | |
| • Sensitization | ||
| • Intracutaneous | ||
| Reactivity | The microneedle | |
| electrodes are | ||
| biocompatible. | ||
| Sterilization and | ||
| Shelf Life Testing | • Ethylene Oxide | |
| Sterilization | The INTRAcel RF | |
| Microneedle has | ||
| Residuals Accelerated aging test | met the acceptance criteria. |
Tests Performed
9
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.