The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

Device Description

The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.

AI/ML Overview

This FDA 510(k) summary describes the Pollogen STOP U Model UXV Device, which is intended for the non-invasive treatment of mild to moderate facial wrinkles. The document details the device's technical specifications, performance tests, and comparison to a predicate device to demonstrate substantial equivalence for clearance.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. Instead, compliance is reported against various performance standards and general functional expectations.

Acceptance Criteria / Performance Standard	Reported Device Performance
System's Technical Specification for Max RF Power Output	Verification test demonstrated that the STOP U Model UXV meets the system's technical specification for the max RF power output. (Implicitly, the device delivers 5.7W (+/- 10%) RF power as stated in the technological characteristics).
Electrical Safety and Compatibility (referencing power control & accuracy related to user's input)	Electrical safety and compatibility testing was performed to validate that the STOP U Model UXV's power control and accuracy is in reference to the user's input. (Implicitly, it passed these tests).
Software Validation Requirements	The STOP U Model UXV software was validated as required. (Implicitly, it passed validation).
General Functionality as Intended	In all instances, the STOP U Model UXV device functioned as intended and observations were as expected. (This is a general statement of success for the performance tests conducted).
Usability for Self-Selection (Correct self-selection rate for potential device users)	The Self-Selection study using the final packaging and design produced a correct self-selection rate that met Pollogen's goal. (Specific percentage not provided, but deemed successful).
Human Factors Validation (Users can safely and effectively self-select, set up, and deliver treatment)	61 subjects participated in the Human Factors validation with a 100% success rate. These results indicated that the design facilitated safe use.
Clinical Efficacy and Safety for Mild to Moderate Facial Wrinkles (Indirectly, through the TriPollar technology)	A clinical study was conducted demonstrating the effect of the TriPollar technology for mild to moderate facial wrinkles and rhytides while using the FDA-cleared STOP U device for prescription use (K140255). This substantiated the safety and effectiveness of the technology.
Compliance with Specific Performance Standards:- IEC/EN 60601-1 Ed 3.1 & A1:2012 (Medical Electrical Equipment: General safety)- IEC 60601-1-6 (Usability)- IEC 60601-1-11:2015 (Home healthcare environment)- IEC/EN 60601-2-2 (High frequency surgical equipment)- IEC 62304 (Software life cycle processes)- IEC 60601-1-2 (Electromagnetic disturbances)- ISO 15223-1:2016 (Symbols on labels)- ISO 14971:2007 (Risk management)	The STOP U Model UXV device complies with all listed performance standards. (Implicitly, the device met the requirements of these standards).
Biocompatibility (Cytotoxicity, Sensitization)	The body contact materials are biocompatible per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization).

2. Sample Size Used for the Test Set and Data Provenance

Self-Selection Study:
- Sample Size: Not explicitly stated for the "test set" demonstrating the correct self-selection rate, but the study "produced a correct self-selection rate that met Pollogen's goal."
- Data Provenance: Not specified (e.g., country of origin). The study was likely prospective, conducted by Pollogen Ltd.
Human Factors Validation:
- Sample Size: 61 subjects.
- Data Provenance: Not specified (e.g., country of origin). The study was prospective, conducted by Pollogen Ltd.
Clinical Study (for TriPollar Technology):
- Sample Size: Not specified.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective, though "a clinical study was conducted" generally implies a prospective study. It refers to a previously cleared device (K140255), suggesting this data predates the current submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Self-Selection Study & Human Factors Validation: The document does not describe the use of experts to establish a "ground truth" in the traditional sense. These studies evaluated user interaction and self-selection by users, not by expert interpretation of clinical outcomes.
Clinical Study (for TriPollar Technology): The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study that demonstrated the effect on wrinkles. It only states that the study "demonstrating the effect... for mild to moderate facial wrinkles and rhytides."

4. Adjudication Method for the Test Set

Self-Selection Study & Human Factors Validation: Adjudication methods are not described as these studies focused on user performance with the device/packaging, not expert consensus on specific findings.
Clinical Study (for TriPollar Technology): The adjudication method for assessing wrinkle reduction in the clinical study is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device in question is a medical aesthetic device, not an AI diagnostic or assistance tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical electrosurgical device for aesthetic use, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant.

7. The Type of Ground Truth Used

Self-Selection Study & Human Factors Validation: The ground truth was based on the outcome of user tasks (e.g., correct self-selection, successful setup and treatment delivery). There wasn't a "ground truth" in terms of a clinical diagnosis or objective measurement adjudicated by experts.
Clinical Study (for TriPollar Technology): The ground truth for this study was the effect on mild to moderate facial wrinkles and rhytides. The specific methodology for measuring and verifying this effect (e.g., blinded assessments, imaging, standardized scales) is not detailed.

8. The Sample Size for the Training Set

Not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set. The clinical study mentioned would be considered for validation/performance, not for training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI algorithm.

Summary

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May 4, 2023

Pollogen Ltd. % Elissa Burg Regulatory Consultant BioVision Ltd. Had Nes 183 Had Nes. 1295000 Israel

Re: K220322

Trade/Device Name: Pollogen STOP U Model UXV Device Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device For Over-The-Counter Aesthetic Use Regulatory Class: Class II Product Code: PAY Dated: April 3, 2023 Received: April 3, 2023

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. 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.

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

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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 medical devices and radiation-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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.05.04 09:04:30 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220322

Device Name STOP U Model UXV Device

Indications for Use (Describe)

The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K220322 - 510(k) SUMMARY

Pollogen Ltd.'s STOP U Model UXV Device

Applicant's name: Pollogen Ltd. 6 Kaufman St. 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: April 3, 2023

Name of Device: STOP U Model UXV

Common or Usual Name: Electrosurgical device for over-the-counter aesthetic use

Classification: Product Code: PAY

Regulation No: 21 C.F.R. §878.4420

Class: II

Classification Panel: General & Plastic Surgery

Predicate Device: Pollogen Ltd., STOP U Model UXV (K203665)

Intended Use / Indications for Use

The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

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Device Description

Technological Characteristics

The TriPollar™ STOP U Model UXV device delivers RF energy at a frequency of 1 MHz (+/-10%) and a maximum output RMS power of 5.7 watts (+/- 10%) into the skin through its electrodes. The device generates heat through electrical impedance in the dermis and subcutaneous layers. The temperature sensor located in the electrodes area constantly momitors the skin temperature and disables/reduces RF transmission once the maximal skin temperature is obtained.

Performance Data

Pollogen conducted several performance tests to demonstrate that the STOP U Model UXV device complies with performance standards and that it functions as intended.

Verification test demonstrating that the STOP U Model UXV meets the system's technical specification for the max RF power output.
Electrical safety and compatibility testing was performed to validate that the STOP U Model UXV's power control and accuracy is in reference to the user's input.
The STOP U Model UXV software was validated as required.
In all instances, the STOP U Model UXV device functioned as intended and observations were as expected.

Performance Standards

The STOP U Model UXV device complies with the following performance standards:

· IEC/EN 60601-1 Edition 3.1 Medical Electrical Equipment Part 1: General requirements for safety (2005) and A1:2012.
· IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (2010/AMD2013).
· IEC 60601-1-11:2015 (2nd edition), Medical electrical equipment Part 1-11 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

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· 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 (Edition 6.0 2017-03).
· IEC 62304 Medical device software Software life cycle processes (2006. Ed. 1/AMD A1:2015).
· IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (2014, Ed. 4).
· ISO 15223-1:2016- Medical devices -- Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirement.
· ISO 14971:2007 Medical devices Application of risk management to medical devices.

8. Cleaning / Disinfection, Shelf Life and Biocompatibility

The STOP U Model UXV is a reusable device which is required to be cleaned following each use according to a validated cleaning procedure.

The device's cleaning instructions are based on the cleaning instructions of the predicate device due to the fact that both devices are made from the same materials and used similarly.

The shelf-life expectancy of the device is 7 years, similar to the predicate device.

The biocompatibility evaluation for the STOP U Model UXV device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1:

"Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Pollogen has categorized its STOP U Model UXV device as: "Surface device, Skin Contact for limited contact duration", with contact duration of less than 24h.

Therefore, the battery of testing included the following tests: cytotoxicity, sensitization tests.

The body contact materials are biocompatible per:

· ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.

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Clinical performance data

Safety & Effectiveness

A Self-Selection study and Human Factors validation were conducted to demonstrate that users can safely and effectively self-select, set up and deliver treatment with the previously cleared STOP U (K182774).

The Self -Selection study using the final packaging and design produced a correct self-selection rate that met Pollogen's goal. The final packaging design promotes correct self-selection and adequately explains user eligibility to potential users in the real world.

61 subjects which had successfully identified themselves as potential device users participated in the Human Factors validation with a 100% success rate. These results indicated that the design of the STOP U (K182774) which is similar to the subject STOP U Model UXV and its associated instructional materials facilitated safe use of the device.

Additionally, a clinical study was conducted demonstrating the effect of the TriPollar technology for mild to moderate facial wrinkles and rhytides while using the FDA-cleared STOP U device for prescription use (K140255). This study substantiates the safety and effectiveness of the TriPollar Technology for wrinkle reduction incorporated into the subject STOP U Model UXV and thus substantiates the safety and effectiveness of the subject STOP U Model UXV.

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Substantial Equivalence

The following table compares the modified STOP U Model UXV device 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.

	Proposed Device:ModifiedSTOP U Model UXV	Predicate Device:STOP U Model UXV(K203665)
Manufacturer	Pollogen® Ltd.	Pollogen® Ltd.
Device Class	Class II	Class II
Regulation Description	Electrosurgical device for overthe-counter aesthetic use	Electrosurgical device forover the-counter aestheticuse
Regulation Number	21 C.F.R. 878.4420	21 C.F.R. 878.4420
Product Code	PAY	PAY
Intended Use /Indications for Use	The STOP U Model UXVdevice is intended for use in thenon-invasive treatment of mildto moderate facial wrinkles foradult users who haveFitzpatrick Skin Types I-IV	The STOP U Model UXV deviceis intended for use in the non-invasive treatment of mild tomoderate facial wrinkles for adultusers who have Fitzpatrick SkinTypes II-IV
Deep tissueHeatingElectromagneticEnergy	RF	RF
Modes of Operation	RF Bipolar Energy	RF Bipolar Energy
Nominal OperatingRF Power (200Ohms)	5.7W (+/- 10%)	5.7W (+/- 10%)
RF Carrier Frequency	1MHz (+/- 10%)	1MHz (+/- 10%)
	Proposed Device:ModifiedSTOP U Model UXV	Predicate Device:STOP U Model UXV(K203665)
Waveform	Sinusoid	Sinusoid
ApplicatorEffective Area	1 cm²	1 cm²
Total PowerDensity (fluence)	5.7 W/cm² (+/- 10%)	5.7 W/cm² (+/- 10%)
Output Voltage	8V DC	8V DC
Output Current	1.5A	1.5A
Dimensions	H=134mm; L=51mm;W=32mm	H=134mm; L=51mm; W=32mm
Weight	85 gr	85 gr
RF Energy EmissionIndicator	Yes (Temp. sensor)	Yes (Temp. sensor)
Energy Source	100-240V, 50-60Hz, 0.4A	100-240V, 50-60Hz, 0.4A
Heating Levels	1	1
Electrodes	4	4
Electrodes Diameter	6mm	6mm
Biocompatibility	All parts that are in contactwith patient comply withthe requirements of ISO10993-1	All parts that are in contactwith patient comply withthe requirements of ISO10993-1
Software	Verified and validated.according to the FDAguidance	Verified and validated.according to the FDAguidance
	Proposed Device:ModifiedSTOP U Model UXV	Predicate Device:STOP U Model UXV(K203665)
Intended OperatingEnvironment	Home Use Device	Home Use Device
Intended Operator	Lay Person	Lay Person
Testing	Electrical safety & EMC,& Usability Study	Electrical safety, EMC,& Usability Study

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Conclusion:

The modified STOP U Model UXV device is as safe and effective as its predicate, Pollogen's STOP U Model UXV device (K203665). The modified STOP U Model UXV device has the same intended use and identical technological characteristics and principles of operation as its predicate. Clinical and Performance data demonstrated that the minor difference in the indications for use of the STOP U Model UXV device does not raise any issues of safety or effectiveness in comparison to the predicate device. Thus, the STOP U Model UXV device is substantially equivalent to its predicate, Pollogen's STOP U Model UXV device (K203665).

Regulation Number and Section

§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.

(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.