(217 days)
Not Found
No
The description focuses on the RF energy delivery mechanism and user-controlled parameters, with no mention of AI/ML terms or functionalities like image processing, data analysis for treatment optimization, or automated decision-making based on patient data.
Yes
The device is intended for the "non-invasive treatment of mild to moderate facial wrinkles and rhytides," which describes a therapeutic purpose.
No
The device is intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides, not for diagnosis.
No
The device description clearly outlines multiple hardware components including a Main Unit, Control Panel, RF Generator, Treatment Applicators, Foot Switch, and Patient-Controlled Manual Switch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the non-invasive treatment of facial wrinkles and rhytides in dermatologic and general surgical procedures. This is a therapeutic use, not a diagnostic one.
- Device Description: The device delivers RF current to generate heat in the skin for treatment. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, sample handling, or analysis of biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a condition on the body.
N/A
Intended Use / Indications for Use
The apollo™ is a non-invasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Product codes
GEI
Device Description
The apollo™ system delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The system consists of:
- Main Unit (includes the Controller)
- Control Panel (User Interface)
- RF Generator
- Three Treatment Applicators
- Foot Switch
- Patient-Controlled Manual Switch
The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with low pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.
The RF power module provides RF energy to the selected applicator at a frequency of 1 MHz and a maximum output RMS power of 50 watts for applicators No. 1 and 2 and a maximum RMS power of 15 watts for applicator No. 3.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1 MHz and power of up to 50 W is well established in scientific research and clinical studies. Multiple studies with similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides.
Due to the comprehensive animal and clinical study performed in scientific research and published in the literature, and since the power and frequency of the apollo™ are well within the previously cleared values, Pollogen believes that animal and clinical studies are not required to determine the safety and efficacy of the device.
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
Pollogen™
Page 1 of 3
NOV 1 6 2011
510(K) Summary
apollo™ system
510(k) Number K_11 026
| Applicant's Name: | Pollogen Ltd. |
|---|---|
| 6 Kaufman St. | |
| Gibor House, P.O.B. 50320 | |
| Tel Aviv | |
| ISRAEL 68012 | |
| Tel. (972)3-510-4110 | |
| Fax (972)3-510-4112 |
Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Trade Name: apollo™M
Summarv Preparation Date: April 14, 2011
Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878 4400 Class: II Panel: General and Plastic Surgery
Device Description:
The apollo™ system delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The system consists of:
- Main Unit (includes the Controller) ﮯ
- Control Panel (User Interface) -
- RF Generator -
- Three Treatment Applicators -
- Foot Switch
- Patient-Controlled Manual Switch
apollo™ - 510k submission
1
Page 2 of 3
Image /page/1/Picture/1 description: The image shows the word "Pollogen" in a simple, sans-serif font. The letters are evenly spaced and have a consistent line weight. The word appears to be slightly pixelated, suggesting it may be a digital rendering or a low-resolution scan.
K 111 026
The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with low pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.
The RF power module provides RF energy to the selected applicator at a frequency of 1 MHz and a maximum output RMS power of 50 watts for applicators No. 1 and 2 and a maximum RMS power of 15 watts for applicator No. 3.
Intended Use Statement:
The apollo"M is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Venus Concept Ltd. Venus | ||
| Freeze | K100586 | Nov 29, 2010 |
| EndyMed Imagine TC Skin | ||
| Treatment System | K083461 | Jul 24, 2009 |
Performance Standards
apollo™ complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following standards:
- 60601-1 Electrical Equipment-Part General . EN ﺳﮯ Requirements for Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral � Standard: Electromagnetic Compatibility - Requirements and Tests.
- . ANSI AAMI 60601-2-2 - safety of high frequency surgical equipment
A detailed description appears in Section 14.
:
Summary of Clinical performance data
apollo131 - 510k submission
2
K 111 026
Pollogen
Page 3 of ③
The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1 MHz and power of up to 50 W is well established in scientific research and clinical studies. Multiple studies with similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides.
Due to the comprehensive animal and clinical study performed in scientific research and published in the literature, and since the power and frequency of the apolloTM are well within the previously cleared values, Pollogen believes that animal and clinical studies are not required to determine the safety and efficacy of the device.
2-4 apollo" - 510k submission
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
NOV .1 6 2011
Pollogen Ltd. % Osite Mr. Yoram Levy 31 Haavoda Street Binyamina. Israel 30500
Re: K111026
Trade/Device Name: apollo™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 01, 2011 Received: November 04, 2011
Dear Mr. Levy:
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
4
Page 2 - Mr. Yoram Levy
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/ResourcesforYou/Industry/default.htm
http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.
Sincerely yours,
Sincerely, yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the word "Pollogen" in a simple, sans-serif font. The letters are evenly spaced and have a consistent line weight. The word appears to be handwritten or drawn, as the lines are not perfectly smooth and have a slightly irregular quality.
K i 11026
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
apollo™M
Indications for Use:
The apollo"M is a non-invasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General and Plastic Surgery Devices 510(k) Number
Neil R.P. Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111026
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apollo™ - 510k Notification