Who is the manufacturer of Pollogen STOP U Model UXV Device?

Pollogen, Ltd. filed the 510(k) submission for Pollogen STOP U Model UXV Device (K220322).

What is the FDA product code for Pollogen STOP U Model UXV Device?

PAY. It is classified under 21 CFR 878.4420 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Pollogen STOP U Model UXV Device?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Pollogen STOP U Model UXV Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Pollogen STOP U Model UXV Device

Q: What are the predicate devices for Pollogen STOP U Model UXV Device?

Pollogen Ltd., STOP U Model UXV (K203665).

K220322 · Pollogen, Ltd. · PAY · May 4, 2023 · General, Plastic Surgery

Device Facts

Record ID	K220322
Device Name	Pollogen STOP U Model UXV Device
Applicant	Pollogen, Ltd.
Product Code	PAY · General, Plastic Surgery
Decision Date	May 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4420
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

The STOP U Model UXV is a home-use electrosurgical device for aesthetic wrinkle reduction. It delivers bipolar RF energy (1 MHz) to the skin via four electrodes. A temperature sensor monitors skin temperature, automatically disabling or reducing RF transmission when a maximum threshold is reached to prevent thermal injury. The device is operated by lay persons in a home environment. It requires the use of a preparation gel to facilitate energy delivery. By generating heat through electrical impedance in the dermis and subcutaneous layers, the device aims to reduce facial wrinkles. The healthcare provider or user assesses the output via the device's thermal feedback mechanism, which ensures safe operation within specified temperature limits.

Clinical Evidence

No new clinical trials were conducted for this specific submission. Safety and effectiveness were substantiated by previous clinical studies on the TriPollar technology (K140255) and human factors/self-selection studies (K182774) demonstrating that lay users can safely and effectively operate the device. Bench testing confirmed compliance with electrical safety (IEC 60601-1 series) and performance specifications.

Technological Characteristics

Bipolar RF electrosurgical device; 1 MHz (+/- 10%) frequency; 5.7W (+/- 10%) RMS power; 4 electrodes (6mm diameter). Materials are biocompatible per ISO 10993-1, -5, and -10. Features integrated temperature sensor for thermal feedback/safety. Powered by 100-240V AC. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, and 60601-2-2.

Indications for Use

Indicated for non-invasive treatment of mild to moderate facial wrinkles in adults with Fitzpatrick Skin Types I-IV.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Pollogen Ltd., STOP U Model UXV (K203665)

Reference Devices

STOP U (K182774)
STOP U (K140255)

Related Devices

K203665 — STOP U Model UXV Device · Pollogen, Ltd. · Feb 25, 2021
K182774 — STOP U (Packed Black USA), STOP U (Packed White USA) · Pollogen, Ltd. · Jun 19, 2019
K170499 — sensiLift · El Global Trade, Ltd. · Jun 15, 2017
K140255 — STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) · Pollogen, Ltd. · May 14, 2014
K232424 — CurrentBody Skin RF · El Global Trade, Ltd. · Mar 6, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X 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: > Department of Health and Human Services Food and Drug Administration 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." {3}------------------------------------------------ #### 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. {4}------------------------------------------------ ## 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. ## 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. {5}------------------------------------------------ - · 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. {6}------------------------------------------------ ## 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. {7}------------------------------------------------ ## 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: Modified STOP 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 over the-counter aesthetic use | Electrosurgical device for over the-counter aesthetic use | | 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 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 | 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 II-IV | | Deep tissue Heating Electromagnetic Energy | RF | RF | | Modes of Operation | RF Bipolar Energy | RF Bipolar Energy | | Nominal Operating RF Power (200 Ohms) | 5.7W (+/- 10%) | 5.7W (+/- 10%) | | RF Carrier Frequency | 1MHz (+/- 10%) | 1MHz (+/- 10%) | | | Proposed Device: Modified STOP U Model UXV | Predicate Device: STOP U Model UXV (K203665) | | Waveform | Sinusoid | Sinusoid | | Applicator Effective Area | 1 cm² | 1 cm² | | Total Power Density (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 Emission Indicator | 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 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 | | Software | Verified and validated. according to the FDA guidance | Verified and validated. according to the FDA guidance | | | Proposed Device: Modified STOP U Model UXV | Predicate Device: STOP U Model UXV (K203665) | | Intended Operating Environment | Home Use Device | Home Use Device | | Intended Operator | Lay Person | Lay Person | | Testing | Electrical safety & EMC, & Usability Study | Electrical safety, EMC, & Usability Study | {8}------------------------------------------------ {9}------------------------------------------------ ## 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).