(245 days)
The Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides
The Imagine Skin Treatment System is a noninvasive, non-ablative device consisting of: User interface Programmable Logic controller (PLC) RF power module Thermoelectric cooling (TEC) module Two treatment handpieces (small and large) The interface allows the selection of treatment parameters by pressing on the treatment buttons; LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. Handpieces incorporating: Treatment handpieces with thermoelectric cooling (TEC) that maintains electrodes at ambient temperature. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 1000 kHz frequency
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical performance study with specific metrics, sample sizes, and expert adjudication.
Instead, the document states:
- Reliance on Predicate Devices: "Substantial equivalence to the following predicate devices is claimed."
- Established Safety and Efficacy: "The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1000 KHz with power of 10 to 100 W is well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides."
- No New Animal or Clinical Studies: "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 Imagine TC Skin Treatment System are well within the previously cleared values, EndyMion believes that animal and clinical studies are not required to determine the safety and efficacy of the device."
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a specific study conducted for this particular device as requested in the input prompt. The FDA clearance was based on substantial equivalence to existing predicate devices and the generally established safety and efficacy of similar technology.
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Section 2- 510(k) Summary
510(K) SUMMARY
JUL 2 4 2009
Imagine TC Skin Treatment System 510(k) Number K 08346)
Applicant's Name:
EndyMion Ltd 7 Bareket Street, North Industrial Park, Caesarea, 38900 Israel Tel: (972)4-630-9100 Fax: (972)4-630-9101
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:
Imagine TC Skin Treatment System
Classification: & accessories
Name: Electrosurgical, cutting & coagulation device
Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General & Plastic Surgery
Device Description:
The Imagine Skin Treatment System is a noninvasive, non-ablative device consisting of:
User interface
Programmable Logic controller (PLC)
RF power module
Thermoelectric cooling (TEC) module
Two treatment handpieces (small and large)
The interface allows the selection of treatment parameters by pressing on the treatment buttons;
IMAGINE Skin Treatment System - 510k submission
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LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. Handpieces incorporating:
Treatment handpieces with thermoelectric cooling (TEC) that maintains electrodes at ambient temperature.
The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 1000 kHz frequency
Intended Use Statement:
The Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides
Substantial equivalence to the following predicate devices is claimed: Predicate Devices:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Lumenis Aluma | K051214 | Oct 24 2005 |
| Alma Lasers Accent | K070004 | Jan 18 2006 |
| Thermage ThermaCool | K053365 | Aug 30 2001 |
| Syneron Polaris | K031671 | Apr 07 2006 |
Performance Standards
Imagine TC Skin Treatment System complies with ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment.
In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:
EN 60601-1 (Medical Electrical Equipment-Part 1: General 1. Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
IEC 60601-1-2 (Electromagnetic compatibility (EMC) ●
A detailed description appears in Section 14.
Summary of Clinical performance data
The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1000 KHz with power of 10 to 100 W is well established in scientific rescarch and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides.
IMAGINE Skin Treatment System - 510k Notification
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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 Imagine TC Skin Treatment System are well within the previously cleared values, EndyMion believes that animal and clinical studies are not required to determine the safety and efficacy of the device.
IMAGINE Skin Treatment System – 510k Notification
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EndyMion Ltd. % Yoram Levy 31 Haavoda Street Binyamina 30500 Israel
Re: K083461
Trade/Device Name: Imagine TC Skin Treatment System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 6, 2009 Received: July 9, 2009
JUL 2 4 2009
Dear Yoram 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.
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
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Page 2 - Yoram Levy
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Charlara Bucku
Mark N. Melkerson
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 083461
Device Name:
Imagine TC Skin Treatment System
Indications for Use:
The Imagine TC Skin Treatment System is a noninvasive 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, Restorative and Neurological Devices 510(k) Number
Nilre Gal formin
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083461
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IMAGINE Skin Treatment System - 510k submission
§ 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.