(455 days)
No
The summary describes a radiofrequency device for wrinkle treatment and mentions software validation and performance testing, but there is no indication of AI or ML being used for image processing, data analysis, or any other function. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the non-invasive treatment of mild to moderate facial wrinkles". Treatment implies a therapeutic purpose.
No
The device is intended for non-invasive treatment of facial wrinkles, not for diagnosing any condition.
No
The device description explicitly lists hardware components: the applicator unit and the power supply. It also mentions delivering RF current, which is a physical modality requiring hardware.
Based on the provided information, the STOP U Model UXV device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "non-invasive treatment of mild to moderate facial wrinkles." This describes a therapeutic or cosmetic purpose, not a diagnostic one.
- Device Description: The device delivers RF current to generate heat in the skin. This is a physical treatment mechanism, not a method for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Anatomical Site: The device is used on the "facial" area, which is a direct application to the body, not a sample collection site.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The STOP U Model UXV device does not fit this description.
N/A
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.
Product codes
PAY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
adult users
Intended User / Care Setting
Intended Operator: Lay Person
Intended Operating Environment: Home Use Device
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pollogen Ltd., STOP U Model UXV (K203665)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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.
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.
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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:
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).