(127 days)
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).
The Pollogen 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;
- -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.
This document is a 510(k) summary for the Pollogen Legend+™ System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission does not typically include detailed clinical studies or rigorous acceptance criteria as might be found for a PMA (Premarket Approval) submission for a novel device. Instead, the focus is on demonstrating equivalence through performance testing against established standards and comparison to predicate devices.
Based on the provided text, a table of acceptance criteria and reported device performance directly related to clinical effectiveness or diagnostic accuracy is not available. The document primarily details engineering performance tests to ensure safety and functionality.
Here's an analysis of the provided information, addressing your points where data is available:
1. A table of acceptance criteria and the reported device performance
As mentioned, a table of acceptance criteria and reported device performance in the context of clinical efficacy (e.g., specific wrinkle reduction percentages, ablation effectiveness metrics) is not provided in this 510(k) summary. The performance data section focuses on engineering and safety verifications.
| Acceptance Criterion (Type of Test) | Reported Device Performance (Outcome) |
|---|---|
| TriPollar RF Energy (Accuracy test) | Validated system's power control and accuracy in reference to the user's input (Applicators 1-3). Functioned as intended. |
| VoluDerm Energy Electrical Verification | Validated system power control and accuracy; verified maximum energy per pin not higher than 62 mJ (VO Applicator). Functioned as intended. |
| VO disposable tip drop test Verification | Validated disposable tip packages durability after drop tests. Functioned as intended. |
| Performance testing of VoluDerm Applicator Tips | Validated VO tips (gen 12 and gen 36) capable of performing 800 pulses while electrode pins and return remained intact. Functioned as intended. |
| VO disposable tip electrode pins mechanical strength Verification | Validated disposable tip electrode pins withstand the specified applied force. Functioned as intended. |
| Electrical safety and compatibility testing | Validated power control and accuracy in reference to the user's input. Functioned as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests performed. These appear to be bench tests or engineering verifications, not clinical studies involving human subjects with a "test set" in the context of diagnostic performance. There is no information on data provenance concerning geographic origin or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The performance tests described are engineering validations of device functionality and adherence to technical specifications, not clinical assessments requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "test set" in the clinical sense, or human expert adjudication mentioned for the performance tests.
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
This is not applicable. The Pollogen Legend+™ System is an electrosurgical device for dermatological procedures, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical electrosurgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described, the "ground truth" would be the engineering specifications and performance standards (e.g., maximum energy per pin not higher than 62 mJ, ability to perform 800 pulses, withstand specified force, adherence to IEC/EN standards). This is a technical or engineering ground truth, not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
This is not applicable. The device is not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2017
Pollogen Ltd. % Ms. Elissa Burg Regulatory Consultant BioVision Ltd. Had Nes 183 Had Nes. Israel 1295000
Re: K171359
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: August 22, 2017 Received: August 29, 2017
Dear Ms. 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 Actinclude 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 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education (DICE) 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. 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 Industry and Consumer Education (DICE) 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.
Sincerelv.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171359
Device Name Pollogen Legend+TM 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 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) |
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510(k) SUMMARY
Pollogen Ltd.'s Pollogen 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 |
- Elissa Burg Contact Person: Regulatory Consultant BioVision Ltd. Had Nes 183 Israel 1295000 Tel. (972) 526633572 Fax (972) 4-6827312 Email: elissa@biovision.co.il
| Date Prepared: | April 27, 2017 |
|---|---|
| Name of Device: | Pollogen Legend+™ system |
| Common or Usual Name: Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Product Code: GEIRegulation No: 21 C.F.R. §878.4400Class: IIClassification Panel: General & Plastic Surgery |
Predicate Devices:
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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).
Device Description
The Pollogen 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;
- -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
The Pollogen 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.
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Performance Data
Pollogen conducted several performance tests to demonstrate that the Pollogen Legend™ system complies with performance standards and that it functions as intended.
- Tripollar RF Energy (Accuracy test) was performed to validate Pollogen Legend+"" system's power control and accuracy in reference to the user's input (Applicators 1-3).
- VoluDerm Energy Electrical Verification was performed to validate the Pollogen Legend+"" system power control and accuracy in reference to the user's input, and verify the maximum energy per pin is not higher than 62 mJ (VO Applicator).
- VO disposable tip drop test Verification was performed to validate disposable tip packages durability after drop tests.
- -Performance testing of the Voluderm Applicator Tips was done to validate that the VO tips, gen 12 and gen 36, are capable of performing 800 pulses while electrode pins and return were not affected and remain fully intact.
- VO disposable tip electrode pins mechanical strength Verification was performed to validate disposable tip electrode pins withstand the specified applied force.
Electrical safety and compatibility testing was done to validate the Pollogen Legend™ system's power control and accuracy in reference to the user's input.
In all instances, the Pollogen Legend"" system functioned as intended and observations were as expected.
Performance Standards
The Pollogen Legend+" system complies with the following performance standards:
- 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).
Traditional 510(k) Submission - Pollogen Legend+™ System
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- 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
Substantial Equivalence
The Pollogen Legend*""system is as safe and effective as Pollogen's apollo device (K111026) for applicators 1-3 (TriPollar) and as safe and effective as Pollogen's Surgen U device (K131758) for the VO (VoluDerm) applicator. The Pollogen Legend*" system has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate devices per each applicator. No technological differences exist between the Pollogen Legend+"" system and its predicate device per each applicator. Performance data demonstrate that the Pollogen Legend™ system is as safe and effective as its predicate devices. Thus, the Pollogen Legend*™ system is substantially equivalent to its predicate devices.
§ 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.