FLEXI-LUME LED SYSTEM

{0}------------------------------------------------ # K140281 ## JUL 2 4 2014 ### 510(k) Summary In response to the Safe Medical Devices Act of 1990 and as required by 21 CFR 807.87, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based for the Flexi-Lume 510(K) premarket notification. | Owner/Operator: | Epic Medical Concepts & Innovations<br>6950 Squibb Rd, Suite 300<br>Mission, KS, 66202<br>913-432-5321 | |-----------------|--------------------------------------------------------------------------------------------------------| |-----------------|--------------------------------------------------------------------------------------------------------| - Contact Person: Alex Waller Director of Engineering 6950 Squibb Rd, Suite 300 Mission, KS, 66202 913-515-2271 Email: awaller@emci.co Date of Submission: 25 April 2014 Trade Name: Flexi-Lume LED System Common Name: Flexi-Lume 21 CFR 872.7060 Class II Activator. Ultraviolet, for Polymerization Classification: EBZ Product code: Predicate Device: K121093: D1 LED Curing Light Device Description: The Flexi-Lume LED System is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is a device intended for the photo-polymerization of light-cured dental materials. The Flexi-Lume contains a multifunction LED that directs light via a fiber optic gooseneck to the patient's mouth. The LED light has several modes: Daylight white (color temperature 5500K), Fluorescent white (color temperature 3500K), Transdental Illumination, Bleaching Light, Non-Curing light (all visible wavelengths excluding blue wavelengths), and Curing Light. The Curing Light mode produces visible blue light in the 430-490nm waveband of the light spectrum with a power density of 1,500mW/cm2. This power density is sufficient for the product intended uses, generally the photo-polymerization of visible light cured dental materials, restorative composite materials, orthodontic brackets and orthodontic bonding and sealing materials. Page 13 of 50 - {1}------------------------------------------------ The different lighting modes can be selected with touch controls on the housing. The touch controls also include a dimmer which allows the selection of light intensity in all modes except Curing and Bleaching, which have pre-set intensity levels. The Flexi-Lume runs on 12VDC, powered by a certified AC/DC adapter that can be hidden inside the dental chair. Indication for Use: The Flexi-Lume LED System is intended to polymerize dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials that are photo-polymerized in the 430~490nm waveband of visible light. It is also intended to illuminate the patient's oral structures. It is also intended for bleaching procedures to apply light to a tooth after it is treated with a bleaching agent. Discussion of Nonclinical Tests Performed for Determination of Substantial Equivalence: To establish substantial equivalence to the predicate, testing was conducted in accordance with IEC 60601-1. Software validation was performed in accordance with IEC 62304. acon-clinical bench testing included (in accordance with FDA Guidance Document 1591): - Verification of Spectral Irradiance Output "Exitance" . - Verification of Irradiance Intensity (at peak wavelength) . - Depth of Cure . - Verification of Case Temperature Rise . #### Substantial similarities to predicate | Description | Submission Device<br>(Device Name) | Predicate Device<br>(Device Name & K#) | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Intended use | The Flexi-Lume LED System is<br>intended to polymerize<br>resinous dental materials,<br>restorative composite<br>materials, orthodontic brackets<br>bonding and sealing materials<br>that are photo-polymerized in<br>the 430~490nm waveband of<br>visible light. | Same | | Device Design | - Light source is an LED<br>- Powered by standard<br>AC 120V power<br>- Light emitter tip can be<br>removed and sterilized | - Light source is<br>an LED<br>- Powered by<br>Standard AC<br>120V power<br>- Light emitter tip<br>can be removed | Page 14 of 50 {2}------------------------------------------------ | | | and sterilized | |-----------------------------------|------------------------------------------------------------------|------------------------| | Curing Light Intensity | 1,500 mW/cm² | 1,500 mW/cm² | | Curing Depth | At least 2.5mm | At least 2.5mm | | Curing Light Wavelength | 430-490nm (460 peak) | 430-490nm | | FDA recognized standards followed | IEC 60601-1, ISO 10993, IEC 62304, ANSI/ADA Specification No. 48 | IEC 60601-1, ISO 10993 | Conclusion: The Flexi-Lume is substantially similar to the predicate in intended use, operation, and function. It is substantially equivalent to the predicate in safety and effectiveness. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 24, 2014 Epic Medical Concepts & Innovations Mr. Alex Waller Director of Engineering 6950 Squibb Road, Suite 300 Mission. KS 66202 Re: K140281 Trade/Device Name: Flexi-Lume LED System Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ, EEG, EAY Dated: April 25, 2014 Received: April 28, 2014 Dear Mr. Waller: 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. > :: ..: , {4}------------------------------------------------ Page 2 - Mr. Waller 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm. : .. Sincerely yours, Mary Bumner -S Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K140281 Device Name: Flexi-Lume LED System Indications for Use: The Flexi-Lume LED System is intended to polymerize dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials, restorative composite materials, enneded of visible light. It is matenals that are process poympatient's oral structures. It is also intended for bleaching arocedures to apply light to a tooth after it is treated with a bleaching agent. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sheena A. Green's 2014.07.23 11:40:59 -04'00' Page 12 of 50