(261 days)
The STOP U 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.
The STOP U 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 device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.
The provided text describes the acceptance criteria and a clinical study conducted for the Pollogen Ltd. STOP U device (K182774), intended for non-invasive treatment of mild to moderate facial wrinkles.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Clinical Study Findings) |
|---|---|
| Safety | No incidences of adverse effects or complications. Mild to moderate erythema and mild edema detected immediately after treatment, resolving within a few hours without treatment. Treatment was well tolerated with minimal to no pain. |
| Effectiveness (Improvement in facial wrinkles) | Over 80% of subjects showed at least one grade improvement in Fitzpatrick wrinkle score at three months follow-up post-treatment. |
| Usability/Self-Selection | Correct self-selection rate met Pollogen's goal (study with final packaging design). The packaging adequately explains user eligibility. |
| Human Factors Validation | 100% success rate in human factors validation (design and instructional materials facilitated safe use). |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Clinical Efficacy and Safety): 40 subjects (37 female, 3 male)
- Sample Size (Usability/Self-Selection Study): Not explicitly stated, but the text mentions "using the final STOP U packaging design produced a correct self-selection rate that met Pollogen's goal."
- Sample Size (Human Factors Validation): 61 subjects (39 female, 22 male)
- Data Provenance: The clinical trial "was conducted to support the clearance of the prescription version of the STOP U device (K140255)." This implies it was a prospective clinical study. The country of origin for the clinical study is not explicitly stated in the provided text.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three uninvolved physicians.
- Qualifications of Experts: Not explicitly stated beyond "uninvolved physicians." It is implied they are qualified to evaluate facial wrinkles and elastosis using the Fitzpatrick scale.
4. Adjudication Method for the Test Set
The adjudication method for evaluating treatment efficacy was blinded evaluation by three uninvolved physicians based on the Fitzpatrick Wrinkle and Elastosis scale using pre and post-treatment photos. A specific method like "2+1" or "3+1" is not detailed, but the use of three independent evaluators suggests a consensus-based approach would likely have been employed if there were disagreements.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a direct-to-consumer medical device, not an AI-powered diagnostic or assistive tool for clinicians.
6. Standalone Performance Study
The clinical trial described (40 subjects) assessed the standalone performance of the STOP U device regarding its safety and effectiveness in treating facial wrinkles. It measured the device's effect directly on subjects without human-in-the-loop assistance for the core treatment, though a human user operates the device. The evaluation of results, however, involved human experts (physicians) reviewing images.
7. Type of Ground Truth Used
The ground truth for effectiveness was established by expert consensus/evaluation using the Fitzpatrick Wrinkle and Elastosis scale based on pre and post-treatment photographs. Safety was assessed by monitoring adverse events.
8. Sample Size for the Training Set
The provided document describes performance testing and clinical trials for validation. It does not mention a "training set" as would be relevant for machine learning models. The studies described are for verifying the device's physical and clinical performance.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for a machine learning model, this question is not applicable based on the provided text. The studies validate the device itself, not an algorithm that would require a training set.
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June 19, 2019
Pollogen Ltd. % Elissa Burg Regulatory Consultant BioVision Ltd Had Nes 183 Had Nes, Israel 1295000
Re: K182774
Trade/Device Name: STOP U (Packed Black USA), STOP U (Packed White USA) Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device for Over-The-Counter Aesthetic Use Regulatory Class: Class II Product Code: PAY Dated: May 8, 2019 Received: May 9, 2019
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/cfpmp/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.
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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) 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 mediation-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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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V. INDICATIONS FOR USE STATEMENT
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number ( if known ) | K182774 |
|---|---|
| Device Name | STOP U |
Indications for Use (Describe)
The STOP U 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.
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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FORM FDA 3881 (7/17)
Page 1 of 1
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Traditional 510(k) Submission - STOP U - Pollogen Ltd.
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VI.
510(k) SUMMARY
Pollogen Ltd.'s STOP U Device
| Applicant's name: | Pollogen Ltd.6 Kaufman St.Gibor House, P.O.B. 50320Tel AvivISRAEL 6801298Tel. (972)3-510-4110Fax (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: September 25, 2018
- Name of Device: STOP U
Common or Usual Name: Electrosurgical device for over-the-counter aesthetic use
- Product Code: PAY Classification: Regulation No: 21 C.F.R. §878.4420 Class: II Classification Panel: General & Plastic Surgery
Predicate Devices
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Intended Use / Indications for Use
The STOP U 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.
Device Description
The STOP U 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 device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.
Technological Characteristics
The STOP U device delivers RF energy at a frequency of 1 MHz and a maximum output RMS power of 5.7 watts into the skin through its electrodes. The device generates heat through electrical impedance in the dermis and subcutaneous layers. The temperature sensor, located between the electrodes constantly monitors the skin temperature and disables RF transmission once the desired skin temperature is obtained.
Performance Data
Pollogen conducted several performance tests to demonstrate that the STOP U device complies with performance standards and that it functions as intended.
- STOP U Electrical safety and compatibility testing was performed to validate the STOP U power control and accuracy in reference to the user's input.
- STOP U over-heating safety testing was performed to validate the conformity with the STOPU's design requirements and specifications for its temperature sensor and profile in reference to the user's input.
- -The STOP U software was validated as required.
In all instances, the STOP U device functioned as intended and observations were as expected.
Performance Standards
The STOP U 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.
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- IEC 62304 Medical device software Software life cycle processes (2006, ● Ed. 1/AMD A1:2015)
- 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 Ed.5) sections 202.6.1 (Emission) & 202.6.2 (Immunity).
- 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).
- 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
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for ● basic safety and essential performance – Collateral standard: Usability (2010/AMD2013)
- ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing
- 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 14971:2012 Medical devices Application of risk management to medical ● devices
Clinical performance data
Safety & Effectiveness
The effect of treatment of mild to moderate facial wrinkles using the STOP U was tested in a clinical trial that was conducted to support the clearance of the prescription version of the STOP U device (K140255). Since the over-the-counter (OTC) version of the STOP U device is identical to the prescription version, this data is also applicable to support the safety and effectiveness of the OTC device.
Altogether, 40 subjects (37 female and 3 male) were enrolled in the study. Subjects were treated for improvement of facial wrinkles appearance and were followed for 3 months post last
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K182774
treatment. In order to assess safety, adverse events occurrence was monitored before and after each treatment and at follow up visits. In order to evaluate treatment efficacy, pre and post treatment photos were introduced to three uninvolved physicians for blinded evaluation based on Fitzpatrick Wrinkle and Elastosis scale.
Over 80% of the subjects showed at least one grade improvement in Fitzpatrick wrinkle score at three months follow-up post treatment based on objective evaluations of the baseline and three months follow-up photographs. There were no incidences of adverse effects or complications. As expected, mild to moderate erythema and mild edema were detected at the site of treatment immediately after treatment. All cases resolved without treatment within a few hours. Treatment was well tolerated with minimal to no pain in the majority of study subjects. The data reported in this study clearly indicates that the Stop U provides a safe and effective treatment for facial wrinkles.
Usability, Self-selection & Labeling Comprehension
Furthermore, Pollogen conducted a usability study for the STOP U device which was divided into two stages:
- Stage one Self-Selection Study of the STOP U Device; 1.
-
- Stage two - Human Factors Validation of the Pollogen STOP U Device.
The Self -Selection study using the final STOP U packaging 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 (39 female and 22 male) which had successfully identified themselves as potential device users participated in the Human Factors validation with 100% success rate. These results indicated that the design of the STOP U and its associated instructional materials facilitated safe use of the device.
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K182774
Substantial Equivalence
The following table compares the STOP U device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| STOP UProposed Device | STOP U(K140255) | Newa(DEN150005) | |
|---|---|---|---|
| Manufacturer | Pollogen® Ltd. | Pollogen® Ltd. | Endymed™ |
| Device Class | Class II | Class II | Class II |
| Regulation Description | Electrosurgical device forover-the-counter aestheticuse | Electrosurgical cuttingand coagulation deviceand accessories | Electrosurgical devicefor over-the-counteraesthetic use |
| Regulation Number | 21 C.F.R. 878.4420 | 21 C.F.R. §878.4400 | 21 C.F.R. 878.4420 |
| Product Code | PAY | GEI | PAY |
| IntendedUse/Indications for Use | The STOP U device isintended for use in thenon-invasive treatment ofmild to moderate facialwrinkles for adult userswho have Fitzpatrick SkinTypes II-IV. | The STOP U device isintended for use in thenon-invasive treatmentof mild to moderatefacial wrinkles andrhytides. | The EndyMed Newa™is an over-the-counterhome use deviceintended for non-invasive treatment ofmild to moderate facialwrinkles for adultwomen with FitzpatrickSkin Types I-IV |
| Deep tissueHeatingElectromagneticEnergy | RF | RF | RF |
| Modes of Operation | RF Bipolar Energy | RF Bipolar Energy | RF Bipolar Energy |
| Nominal OperatingRF Power (200 Ohms) | 5.7W | 5.7W | 10W |
| RF CarrierFrequency | 1 MHz | 1 MHz | 675 KHz |
| STOP UProposed Device | STOP U(K140255) | Newa(DEN150005) | |
| Waveform | Sinusoid | Sinusoid | Square |
| Applicator EffectiveArea | 1 cm² | 1 cm² | $0.9 X 1.5 = 1.35 cm²$ |
| Total Power Density(fluence) | 5.7 W/cm² | 5.7 W/cm² | 10 W/cm² |
| Output Voltage | 8V DC | 8V DC | 9V DC |
| Dimensions | H=134mm; L=51mm;W=32mm | H=134mm;L=51mm; W=32mm | 120mm X 73mm X37mm |
| Weight | 85 gr | 85 gr | 70 gr |
| RF Energy EmissionIndicator | Yes (Temp. sensor) | Yes (Temp. sensor) | Yes (Temp. sensor &motion sensor) |
| Energy Source | 100-240V, 50-60Hz,600mA | 100-240V, 50-60Hz,600mA | 100-240V, 50-60Hz,800mA |
| Heating Levels | 1 | 1 | 2 |
| Electrodes | 4 | 4 | 6 |
| Biocompatibility | All parts that are incontact with patientcomply with therequirements of ISO10993-1 | All parts that are incontact with patientcomply with therequirements of ISO10993-1 | All parts that are incontact with patientcomply with therequirements of ISO10993-1 |
| Software | Verified and validatedaccording to the FDAguidance | Verified and validatedaccording to the FDAguidance | Verified and validatedaccording to the FDAguidance |
| Intended OperatingEnvironment | Home Use Device | Prescription UseDevice | Home Use Device |
| Intended Operator | Lay Person | Healthcareprofessionals | Lay Person |
| Testing | Electrical safety, EMC,& Usability Study | Electrical safety, EMC& Clinical Study | Electrical safety,EMC, Clinical &Usability Study |
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K182774
The subject STOP U device is as safe and effective as Pollogen's STOP U device (K140225) and Endymed's NEWA (DEN150005). The Pollogen STOP U device has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate devices. Performance data demonstrate that the STOP U device is as safe and effective as its predicate devices. Thus, the STOP U device is substantially equivalent to its predicate devices.
§ 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.