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.

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. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Flexi-Lume LED System (K140281), based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Curing Light Intensity	1,500 mW/cm²
Curing Depth	At least 2.5mm
Curing Light Wavelength	430-490nm (460nm peak)
Predicate Device (K121093):	Predicate Device (K121093):
Curing Light Intensity	1,500 mW/cm²
Curing Depth	At least 2.5mm
Curing Light Wavelength	430-490nm

Note: The provided document details substantial equivalence based on meeting the same performance metrics as the predicate device.

Study Information

The provided document describes non-clinical bench testing to establish substantial equivalence, rather than clinical studies involving human subjects or algorithm-only performance.

Sample size used for the test set and the data provenance: Not applicable. This was non-clinical bench testing. The "test set" would refer to the physical device and its components undergoing specific measurements. The document does not specify a "sample size" in the context of a dataset, nor does it refer to data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical bench testing typically relies on standardized measurement techniques and established engineering principles, not expert human interpretation of data in the same way a diagnostic study would.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical bench testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental curing light, not an AI-powered diagnostic tool, so MRMC studies involving human readers are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing, the "ground truth" would be established by validated measurement equipment and standardized testing procedures (e.g., using a radiometer for light intensity, calibrated depths for curing depth measurements).
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary of Nonclinical Tests Performed:

The nonclinical bench testing for the Flexi-Lume LED System included:

Verification of Spectral Irradiance Output "Exitance"
Verification of Irradiance Intensity (at peak wavelength)
Depth of Cure
Verification of Case Temperature Rise

These tests were conducted in accordance with IEC 60601-1 and FDA Guidance Document 1591 to demonstrate substantial equivalence to the predicate device (K121093). Software validation was performed in accordance with IEC 62304.

Summary

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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 & Innovations6950 Squibb Rd, Suite 300Mission, KS, 66202913-432-5321
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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.

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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(Device Name)	Predicate Device(Device Name & K#)
Intended use	The Flexi-Lume LED System isintended to polymerizeresinous dental materials,restorative compositematerials, orthodontic bracketsbonding and sealing materialsthat are photo-polymerized inthe 430~490nm waveband ofvisible light.	Same
Device Design	- Light source is an LED- Powered by standardAC 120V power- Light emitter tip can beremoved and sterilized	- Light source isan LED- Powered byStandard AC120V power- Light emitter tipcan be removed

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		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.

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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.

:: ..:

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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

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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'

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Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.