(184 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts. The device description focuses on RF energy delivery and user control, and the performance studies describe standard bench and pre-clinical testing.
No
The device is used for dermatological procedures requiring ablation and resurfacing of the skin, which is typically considered a cosmetic or aesthetic procedure rather than a therapeutic one for treating a disease or medical condition.
No
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which are treatment procedures, not diagnostic.
No
The device description and performance studies clearly indicate the device is a hardware system (delivers bipolar radiofrequency electrical current) with associated hardware testing (electrical and mechanical verification, drop tests, pre-clinical study on animal skin).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin." This is a therapeutic and aesthetic procedure performed directly on the patient's skin.
- Device Description: The device delivers "bipolar radiofrequency (RF) electrical current to the skin surface." This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The Surgen U system is a therapeutic device used for skin treatment, not a diagnostic device used to analyze biological samples.
N/A
Intended Use / Indications for Use
Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Product codes
GEI
Device Description
The Surgen™ U system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface.
The Surgen U system consists of a console, Hybrid Energy (HE) hand held Applicator, Disposable tips, Footswitch and a Patient—Controlled Manual Switch. The disposable tips attach to the distal end of the applicator and are placed on the patient's skin for treatment. The tips contain a matrix of bi-polar electrode pins. The disposable tips are provided sterile and in two size options. The applicator and tips are connected to the main console unit by a cable containing electrical wiring and a connector. A Footswitch controls activation of the RF current for delivery through the applicator tips. The physician can control the parameters of the treatment through a touch-screen user interface on the main console control panel. The system also includes a Patient-Controlled Manual Switch for the patient to stop treatment in case of discomfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pollogen conducted several performance tests to demonstrate that the Surgen U system complies with performance standards and that it functions as intended. In this submission bench testing performance data as well as histology data presented.
- Several bench tests were done to support the device performance, HE Electrical . Verification was done to validate the Surgen U power control and accuracy in reference to the user's input, and verify the maximum energy per pin is not higher than 62 mJ.
- HE Mechanical verification was done to validate Applicator pins mechanical interface . with disposable tip and to validate Applicator HE drop test.
- . HE disposable tip drop test Verification was done to validate disposable tip packages durability after drop tests.
- Performance testing of the Hybrid Energy Applicator Tips was done to validate that . the HE tips, gen 12 and gen 36, are capable of performing 800 pulses while electrode pins and return were not affected and remain fully intact.
- A pre-clinical study was performed in order to evaluate the safety of Pollogen's HE . applicator for fractional skin ablation treatment. For four time points, treatment was applied on animal (pig) skin for each disposable tip. Study results demonstrate that the treatment induces the expected fractional pattern at the treatment site, surrounded by normal healthy tissue. The results of this study support the conclusion that fractional ablation treatment using Pollogen's HE Applicator is safe and effective.
In all instances, the Surgen U system functioned as intended and observations were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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510(k) SUMMARY Pollogen Ltd.'s Surgen U System
| Applicant's name: | Pollogen Ltd.
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: | December 18, 2013 |
| Name of Device: | Surgen U system |
| Common or Usual Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Product Code: GEI
Regulation No: 21 C.F.R. §878.4400
Class: II
Classification Panel: General & Plastic Surgery |
Predicate Devices
Invasix Ltd., Fractora (K102461)
Device Description
The Surgen™ U system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface.
Intended Use / Indications for Use
Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Technological Characteristics
The Surgen U system consists of a console, Hybrid Energy (HE) hand held Applicator, Disposable tips, Footswitch and a Patient—Controlled Manual Switch. The disposable tips
DEC 18 2013
1
attach to the distal end of the applicator and are placed on the patient's skin for treatment. The tips contain a matrix of bi-polar electrode pins. The disposable tips are provided sterile and in two size options. The applicator and tips are connected to the main console unit by a cable containing electrical wiring and a connector. A Footswitch controls activation of the RF current for delivery through the applicator tips. The physician can control the parameters of the treatment through a touch-screen user interface on the main console control panel. The system also includes a Patient-Controlled Manual Switch for the patient to stop treatment in case of discomfort.
Performance Data
Pollogen conducted several performance tests to demonstrate that the Surgen U system complies with performance standards and that it functions as intended. In this submission bench testing performance data as well as histology data presented.
- Several bench tests were done to support the device performance, HE Electrical . Verification was done to validate the Surgen U power control and accuracy in reference to the user's input, and verify the maximum energy per pin is not higher than 62 mJ.
- HE Mechanical verification was done to validate Applicator pins mechanical interface . with disposable tip and to validate Applicator HE drop test.
- . HE disposable tip drop test Verification was done to validate disposable tip packages durability after drop tests.
- Performance testing of the Hybrid Energy Applicator Tips was done to validate that . the HE tips, gen 12 and gen 36, are capable of performing 800 pulses while electrode pins and return were not affected and remain fully intact.
- A pre-clinical study was performed in order to evaluate the safety of Pollogen's HE . applicator for fractional skin ablation treatment. For four time points, treatment was applied on animal (pig) skin for each disposable tip. Study results demonstrate that the treatment induces the expected fractional pattern at the treatment site, surrounded by normal healthy tissue. The results of this study support the conclusion that fractional ablation treatment using Pollogen's HE Applicator is safe and effective.
In all instances, the Surgen U system functioned as intended and observations were as expected.
Performance Standards
The Surgen 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.
2
- 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. .
Substantial Equivalence
The Surgen U system is as safe and effective as Invasix Ltd.'s Fractora device (K102461). The Surgen U system has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate device. The main output parameter that determines the ablative and coagulative effects is the energy per pin, which is identical for the Surgen U and the predicate device. Minor differences in the number of pins, and array dimensions, may slightly affect the number of pulses required to cover the treatment area.
The minor technological differences between the Surgen U system and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Surgen U system is as safe and effective as its predicate device. Thus, Surgen U is substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, representing the department's mission of protecting the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pollogen Ltd % Mr. Jonathan S. Kahan Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K131758
Trade/Device Name: Surgen U System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 8, 2013 Received: November 12, 2013
December 18, 2013
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 (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 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 Kahan
. . . . .
2007 - 1
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K131758
··· משפחת הייתה היישוב של המועד המועד המועד המועד המועד המועד המו
.
Indications for Use Statement
| 510(k) Number (if known): | K131758 |
|---|---|
| Device Name: | Surgen U |
| Indications for Use: | Pollogen's Surgen U system is intended for dermatological procedures requiring ablation and resurfacing of the skin. |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Long H. Chen -A | Digitally signed by Long H. Chen - A DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen-A 0.9.2342.19200300.100.1.1=1300369056 Date: 2013.12.18 13:11:10 -05'00' |
|---|---|
| ----------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
for BSA
(Division Sign-off)
Division of Surgical Devices
510(k) Number: K131758
Page ___ of ___
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