(210 days)
INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727)
No
The device description focuses on the delivery of RF energy and user-controlled parameters, with no mention of AI or ML for analysis, control, or optimization.
Yes.
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin and for the non-invasive treatment of mild to moderate facial wrinkles and rhytides, which are considered therapeutic interventions.
No
The device is described as being for "dermatological procedures requiring ablation and resurfacing of the skin" and "non-invasive treatment of mild to moderate facial wrinkles and rhytides." These are treatment procedures, not diagnostic ones.
No
The device description clearly lists multiple hardware components including a Main Unit, Control Panel, RF Generator, various applicators, a foot switch, and a patient-controlled manual switch. It generates and applies RF energy to the skin, which is a physical interaction requiring hardware.
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 procedures requiring ablation and resurfacing of the skin, and for the non-invasive treatment of mild to moderate facial wrinkles and rhytides. These are therapeutic and aesthetic procedures performed directly on the patient's skin.
- Device Description: The device description details how the system delivers radiofrequency energy to the skin surface to achieve these therapeutic effects. It describes applicators that are applied to the skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
- Anatomical Site: The anatomical site is the skin and facial areas, which are treated directly by the device.
- Performance Studies: The performance study described is an animal study evaluating the effects of the device on tissue in vivo (in a living organism), not the analysis of in vitro samples.
In summary, the Pollogen Legend+™ System is a therapeutic device used for dermatological procedures directly on the patient's skin, not an IVD device used for analyzing specimens outside the body.
N/A
Intended Use / Indications for Use
The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).
It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).
Product codes
GEI
Device Description
Pollogen Ltd's modified Legend™ system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of:
- Main Unit (includes the Controller); -
- Control Panel (User Interface); -
- RF Generator; -
- VO (VoluDerm) Treatment Applicator -
- Disposable tips; gen12, gen36 & gen36L -
- Treatment Applicators 1-3 (TriPollar); -
- Foot Switch; -
- Patient-Controlled Manual Switch. -
The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.
The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (for dermatological procedures, facial area for wrinkles)
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)
Pollogen conducted several performance tests to demonstrate that the modified Legend™ system complies with the following standards and that it functions as intended.
- IEC/EN 60601-1 Edition 3.1 Medical Electrical Equipment Part 1: General . requirements for safety (2005/AMD:2012).
- IEC/EN 60601-2-2 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 (2009)
- IEC 60601-1-2 Medical Electrical Equipment Part 2. Collateral standard: . Electromagnetic compatibility - Requirements and tests (2007, Ed. 3).
- IEC 60601-2-2 Medical electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (2006); clauses 36.201 (Emission) & 36.202 (Immunity)
- IEC 62304 Medical device software Software life cycle processes . (2006/AMD2015)
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: ● Evaluation and testing
- ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: ● Ethylene oxide sterilization residuals
Animal Study: An animal study was conducted, 3 pigs underwent treatment for ablation and resurfacing of the skin with the modified Legend ""system while using the gen36L tip. There were no procedure related complications or premature deaths in this study, for all follow-up evaluation time points up to two weeks.
The safety and effectiveness of the modified Legend+"system was evaluated by macroscopic and histological evaluation of the tissue in the treatment areas. These studies demonstrated that the modified Legend*™system can safely perform ablation and resurfacing of the skin for dermatological procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pollogen Legend+™ System (K171359)
Reference Device(s)
INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
June 11, 2018
Pollogen Ltd. % Elissa Burg Regulatory Consultant BioVision Ltd Had Nes 183 Had Nes, 1295000 Israel
Re: K173503
Trade/Device Name: Pollogen Legend System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 8, 2018 Received: April 11, 2018
Dear Elissa Burg:
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, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -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
Section 6 - Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K173503 |
|---|---|
| Device Name | Pollogen Legend+™ System |
| Indications for Use (Describe) | The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). |
| It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3). |
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:
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Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
3
Section 7 - 510(k) Summary
Pollogen Ltd's Legend+™ System
| Applicant's name: | Pollogen Ltd. |
|---|---|
| 6 Kaufman St. | |
| Gibor House, P.O.B. 50320 | |
| Tel Aviv | |
| ISRAEL 6801298 | |
| Tel. (972)3-510-4110 | |
| Fax (972)3-510-4112 |
- Contact Person: Elissa Burg Regulatory Consultant BioVision Ltd. Had Nes 183 Israel 1295000 Tel. (972) 526633572 Fax (972) 4-6827312
- Date Prepared: June 6, 2018
- Pollogen Ltd's Legend+™ system Name of Device:
Common or Usual Name: Electrosurgical cutting and coagulation device and accessories
- Classification: Product Code: GEI Regulation No: 21 C.F.R. §878.4400 Class: II Classification Panel: General & Plastic Surgery
- Pollogen Legend+™ System (K171359) Predicate Device:
- Reference Device: INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727)
4
Intended Use / Indications for Use
The Modified Legend*™ system is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).
It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).
Modified Device Description
Pollogen Ltd's modified Legend*"system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of:
- Main Unit (includes the Controller); -
- Control Panel (User Interface); -
- RF Generator; -
- VO (VoluDerm) Treatment Applicator -
- Disposable tips; gen12, gen36 & gen36L -
- Treatment Applicators 1-3 (TriPollar); -
- Foot Switch; -
- Patient-Controlled Manual Switch. -
The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.
The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.
Technological Characteristics
Pollogen's modified Legend*™ system has similar technological characteristics as the Pollogen Legendt" system that was previously cleared under K171359. The primary purpose of this
5
submission is to add an optional disposable tip, gen36L, to the cleared Legend+"" System's VO applicator.
Pollogen Ltd's modified Legend+"system consists of a console, Applicators 1-3 (TriPollar) and VO (VoluDerm) hand held applicators, and disposable tips. It is designed to deliver bipolar radiofrequency electrical current to the skin.
Performance Data
Pollogen conducted several performance tests to demonstrate that the modified Legend™ system complies with the following standards and that it functions as intended.
- IEC/EN 60601-1 Edition 3.1 Medical Electrical Equipment Part 1: General . requirements for safety (2005/AMD:2012).
- IEC/EN 60601-2-2 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 (2009)
- IEC 60601-1-2 Medical Electrical Equipment Part 2. Collateral standard: . Electromagnetic compatibility - Requirements and tests (2007, Ed. 3).
- IEC 60601-2-2 Medical electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (2006); clauses 36.201 (Emission) & 36.202 (Immunity)
- IEC 62304 Medical device software Software life cycle processes . (2006/AMD2015)
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: ● Evaluation and testing
- ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: ● Ethylene oxide sterilization residuals
6
Animal Study
An animal study was conducted, 3 pigs underwent treatment for ablation and resurfacing of the skin with the modified Legend ""system while using the gen36L tip. There were no procedure related complications or premature deaths in this study, for all follow-up evaluation time points up to two weeks.
The safety and effectiveness of the modified Legend+"system was evaluated by macroscopic and histological evaluation of the tissue in the treatment areas. These studies demonstrated that the modified Legend*™system can safely perform ablation and resurfacing of the skin for dermatological procedures.
Substantial Equivalence
The following table compares the modified Legend+™system to the predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| | Subject Device: | Predicate Device: | Applicator Weight | A1- 0.78 Kg
A2- 0.66 Kg
A3- 0.6 Kg
VO- 0.47 Kg | A1- 0.78 Kg
A2- 0.66 Kg
A3- 0.6 Kg
VO- 0.47 Kg |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Modified Pollogen Ltd.
Legend+™ system – Applicator VO
and Applicators 1-3
(K173503) | Pollogen Ltd.
Legend+ system – Applicator VO
and Applicators 1-3
(K171359) | System Dimensions:
h•w•d | 110cm x 45cm x 45cm
43.3" x 17.72" x 17.72" | 110cm x 45cm x 45cm
43.3" x 17.72" x 17.72" |
| Device Class | Class II | Class II | Number of
Applicators | 4 | 4 |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery | Applicator Type | VO: Fractional Bi Polar RF
A1: Bi Polar RF
A2: Bi Polar RF
A3: Bi Polar RF | VO: Fractional Bi Polar RF
A1: Bi Polar RF
A2: Bi Polar RF
A3: Bi Polar RF |
| Product Code | GEI | GEI | Comparison of
disposable tips | gen 12, gen 36, gen 36L | gen 12, gen 36 |
| Regulation
Description | Device, electrosurgical, cutting and
coagulation device and accessories. | Device, electrosurgical, cutting and
coagulation device and accessories. | Number of electrode
pins | gen 12: 6x2
gen 36: 6x6
gen 36L: 6x6 | gen 12: 6x2
gen 36: 6x6 |
| Regulation Number | 21 C.F.R. §878.4400 | 21 C.F.R. §878.4400 | The distance between
the electrode pins | gen 12: 2.2mm
gen 36: 2.2mm
gen 36L: 2.2mm | gen 12: 2.2mm
gen 36: 2.2mm |
| Intended Use and
clinical indication | The Modified Pollogen Legend+™
system is intended for dermatological
procedures requiring ablation and
resurfacing of the skin when using
VoluDerm Energy (Applicator VO).
It is also intended for use in
dermatologic and general surgical
procedures for the non-invasive
treatment of mild to moderate facial
wrinkles and rhytides when using
TriPollar RF Energy (Applicators 1-3). | The Pollogen Legend+™ system is
intended for dermatological procedures
requiring ablation and resurfacing of
the skin when using VoluDerm Energy
(Applicator VO).
It is also intended for use in
dermatologic and general surgical
procedures for the non-invasive
treatment of mild to moderate facial
wrinkles and rhytides when using
TriPollar RF Energy (Applicators 1-3). | Treatment area size | gen 12: 11x2.2mm
gen 36: 11x11mm
gen 36L: 11x11mm | gen 12: 11x2.2mm
gen 36: 11x11mm |
| Device Description | The Modified Pollogen Legend+™ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and Patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area. | The Pollogen Legend+™ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and Patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area. | Electrode pin's
diameter | gen 12: 150 microns
gen 36: 150 microns
gen 36L: 150 microns | gen 12: 150 microns
gen 36: 150 microns |
| Principles of Operation: | The Modified Pollogen Legend+™ VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. | The Pollogen Legend+™ VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. | Electrode pin's
length | gen 12: ~600 microns
gen 36: ~600 microns
gen 36L: ~1000 microns | gen 12: ~600 microns
gen 36: ~600 microns |
| Energy Source: | RF (Bipolar) | RF (Bipolar) | RF energy per pin | up to 62mJ/pin | up to 62mJ/pin |
| Frequency: | 1 MHz | 1 MHz | Maximum number of
pulses | 800 | 800 |
| Maximum Output Power | 44 Watts on 300 ohm for VO applicator. | 44 Watts on 300 ohm for VO applicator. | Modes of Operation
(Treatment
programs): | VO: Low, Medium, High
A1: A1-A; A1-B
A2: A2-A; A2-B
A3: A3-A; A3-B | VO: Low, Medium, High
A1: A1-A; A1-B
A2: A2-A; A2-B
A3: A3-A; A3-B |
| | 50 Watts on 200 ohm for applicators no. 1 and no.2.
15 Watts on 200 ohm for applicator no. 3. | 50 Watts on 200 ohm for applicators no. 1 and no.2.
15 Watts on 200 ohm for applicator no. 3. | Biocompatibility | All parts that are in contact with
patient comply with the requirements
of ISO 10993-1 | All parts that are in contact with patient
comply with the requirements of ISO
10993-1 |
| Electrical Requirements | 100-240 Volt, max 2.2A, 50- 60Hz | 100-240 Volt, max 2.2A, 50-60Hz | Software | Verified and validated according to
the FDA guidance | Verified and validated according to the
FDA guidance |
| System Weight | ~30 Kgs/66.14 lb | ~30 Kgs/66.14 lb | | | |
7
Attachment 1 - Interactive Additional Information for K173503/S002
Pollogen Legend+™ System
8
9
Pollogen's modified Legend*™ system has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate device. No technological differences exist between the modified Legend*" system and its predicate device, except for the addition of an optional disposable tip gen36L that can be used with the VO applicator.
The minor difference in the length of the electrode pins of the gen36L has been demonstrated via the reference predicate device, INTRAcel Premium (K153727), an RF energy device for electrocoagulation procedures that has the same or longer length pins and therefore, the minor increase in pin length does not raise new or different questions of safety or effectiveness. Furthermore, performance data and a pre-clinical study both demonstrate that the modified Legend+™ system is as safe and effective as its predicate device.
Thus, Pollogen's modified Legend™ system is substantially equivalent to its predicate device.