(103 days)
Not Found
No
The summary describes a radiofrequency device for wrinkle treatment and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for the "non-invasive treatment of mild to moderate facial wrinkles and rhytides," indicating a therapeutic purpose.
No.
The device is described as a treatment device for wrinkles, not a diagnostic device.
No
The device description explicitly lists hardware components: the applicator unit, power supply, and preparation gel. This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "non-invasive treatment of mild to moderate facial wrinkles and rhytides." This describes a therapeutic or cosmetic treatment applied directly to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device delivers RF current to generate heat in the skin. This is a physical treatment method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Pollogen STOP U device does not fit this description.
N/A
Intended Use / Indications for Use
Pollogen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
A study was conducted in order to evaluate the safety and efficacy of the STOP U device for treatment of wrinkles and rhytides. Altogether, 40 subjects were enrolled in the study. Subjects were treated for improvement of facial wrinkles appearance and were followed for 3 months post last 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 erytherna and mild edema were detected at the site of treatment immediately after treatment. All cases resolved without treatment within 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.
Key Metrics
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(k) SUMMARY
Pollogen Ltd.'s STOP U System
MAY 1 4 2014
Pollogen Ltd. Applicant's name: 6 Kaufman St. Gibor House, P.O.B. 50320 Tel Aviv ISRAEL 6801298 Tel. (972)3-510-4110 Fax (972)3-510-4112
- Contact Person: Jonathan S. Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 Tel. (202) 637-5794 Fax (202) 637-5910
Date Prepared: May 13, 2014
STOP U device Name of Device:
Electrosurgical cutting and coagulation device and accessories Common or Usual Name:
- Classification: Product Code: GEI Regulation No: 21 C.F.R. §878.4400 Class: Il Classification Panel: General & Plastic Surgery
Predicate Devices
Pollogen Ltd., apollo (K111026)
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.
1
Intended Use / Indications for Use
Pollogen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Technological Characteristics
The TriPollar™ 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 system complies with performance standards and that it functions as intended:
- . STOP U Electrical Verification was done to validate the STOP U power control and accuracy in reference to the user's input.
- The STOP U software was validated as required. .
In all instances, the STOP U system functioned as intended and observations were as expected..
Performance Standards
The STOP U system complies with the following performance standards:
- EN/IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for . Safety, Collateral Standard: Safety Requirements for Medical Electrical Systems.
- EN/IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: . Electromagnetic Compatibility - Requirements and Tests.
- EN/IEC 60601-2-2 Safety of high frequency surgical equipment. .
Clinical performance data
A study was conducted in order to evaluate the safety and efficacy of the STOP U device for treatment of wrinkles and rhytides. Altogether, 40 subjects were enrolled in the study. Subjects were treated for improvement of facial wrinkles appearance and were followed for 3 months post last 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.
2
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 erytherna and mild edema were detected at the site of treatment immediately after treatment. All cases resolved without treatment within 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.
Substantial Equivalence
The STOP U system is as safe and effective as Pollogen Ltd.'s apollo device (K111026). The STOP U system has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the STOP U system and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the STOP U system is as safe and effective as its predicate device. Thus, STOP U is substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WQ66-G609 Silver Spring, MD 20993-0002
May 14, 2014
Pollogen Ltd. % Mr. Jonathan S. Kahan Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: KI40255
Trade/Device Name: STOP U Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 28, 2014 Received: March 28, 2014
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the 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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Jonathan S. Kahan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
1
Indications for Use
510(k) Number (if known) K140255
Device Name
STOP U
Indications for Use (Describe)
Pollogen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Type of Use (Select one or both, as applicable)
� Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Joshua CONipper-S
FORM FDA 3881 (1/14)
Page 1 of 2
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