THE CANARY SYSTEM

K112139 · Quantum Dental Technologies, Inc. · NBL · Oct 26, 2012 · Dental

Device Facts

• Record ID: K112139
• Device Name: THE CANARY SYSTEM
• Applicant: Quantum Dental Technologies, Inc.
• Product Code: NBL · Dental
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

The Canary System is intended to be used by qualified dental professionals as an aid in the detection and monitoring of dental caries, and as an intra-oral camera to record anatomical details.

Device Story

The Canary System uses a 660 nm low-powered laser to examine tooth surfaces. The device emits modulated laser light (2 Hz) onto the tooth, which is absorbed and scattered; this generates thermal infrared signals (Photothermal Radiometry, PTR) and optically converted light (Luminescence, LUM). These signals provide information on tooth health and subsurface defects up to 5 mm deep. The system combines PTR and LUM signals into a 'Canary Number' (0-100 scale) to indicate the presence or progression of caries. The device includes a CMOS camera for capturing and displaying images of the tooth surface. Used in dental offices by professionals, the system provides chair-side visual feedback, numeric data, and reports to assist in clinical decision-making regarding treatment and monitoring of remineralization. The device benefits patients by enabling early detection of caries and monitoring of lesion changes over time.

Clinical Evidence

Bench testing only. Evidence includes in vitro studies evaluating the device's ability to detect caries and subsurface lesions compared to predicate technologies. No clinical trial data provided.

Technological Characteristics

Core technology: Photothermal Radiometry (PTR) and modulated luminescence (LUM). Light source: 660 nm laser, <50 mW, sinusoidally modulated at 2 Hz. Detectors: Photodiode for LUM, mid-IR detector for PTR, and CMOS camera (640x480) for imaging. Power: 100-240V, 50/60Hz. Sterilization: Disposable plastic sleeves/tips; unit disinfected with alcohol-based solutions. Output: Canary Number (0-100) and visual images.

Indications for Use

Indicated for qualified dental professionals as an aid in the detection and monitoring of dental caries and as an intraoral camera to visualize and record anatomical details.

Regulatory Classification

Identification

A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

Special Controls

*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter; (2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and (3) The labeling must include detailed use instructions with precautions that urge users to: (i) Read and understand all directions before using the device, (ii) Store probe tips under proper conditions, (iii) Properly sterilize the emitter-detector handpick before each use, and (iv) Properly maintain and handle the instrument in the specified manner and condition.

Predicate Devices

• DIAGNOdent (K983658)
• SOPRO Life (K092583)

Submission Summary (Full Text)

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# 510(k) Summary

#### A. Submitter Information

Quantum Dental Technologies Inc. 748 Briar Hill Avenue Toronto. Ontano M6B 1L3, Canada

### Contact Person:

Josh Silvertown, PhD Vice President Quantum Dental Technologies Inc. 748 Briar Hill Avenue Toronto, Ontario M6B 1L3, Canada

Phone: [phone] ext 103 Fax: [phone] [e-mail]

Date Prepared: Tuesday, October 09, 2012

## B. Device Identification:

| Classification Name | Laser fluorescence caries detection device |
|-----------------------|--------------------------------------------|
| Proprietary Name | The Canary System |
| Device Classification | Class II |
| Panel | Dental |
| Device Product Code | NBL |
| Previous FDA Status | The Canary System has no prior FDA Status |
| Basis for Submission | New Device |

## C. Identification of Predicate Device:

| Device | Applicant | 510(k) No. | Date Cleared |
|------------|-----------------|------------|-------------------|
| DIAGNOdent | KAVO DIAGNODENT | K983658 | February 22, 2000 |
| SOPRO Life | SOPRO | K092583 | January 13, 2010 |

#### D. Device Description:

The Canary System™ uses a low powered 660 nm wavelength laser to examine the tooth surface. When this laser light is shone on the tooth the laser light is scattered and absorbed. An absorbed portion of the light is converted into heat and emits thermal infrared (Photothermal Radiometry, PTR) and another part of the light excites the tissue and emits optically converted light (Luminescence; LUM), which shows the difference between what appears to be healthy tooth structure and areas suspected of being carious tooth structure. Compared to a healthy tooth, areas suspected of being canous or possibly having other defects such as micro cracks absorb more light and generate higher PTR signals and lower LUM signals. The Canary System is very safe because the temperature rise on the tooth surface by the laser is only 1 - 2℃, which is much lower temperature than hot beverages.

Modulated laser light hitting the tooth surface generates a thermal diffusion (heat transfer) wave. The depth that this wave can penetrate is determined by the modulation frequency. Even though its sensitivity is lower than PTR, modulated light scattering also gives information from deep inside the enamel by luminescence. The Canary System can detect suspect areas, up to a depth

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K112139

of 5mm because The Canary System uses a 2Hz frequency modulation that penetrates deeper than higher frequencies (100s or 1000s Hz) and the detected PTR/LUM signals deliver integrated information from the surface to the penetration depth.

The measured PTR and LUM signals are combined into a Canary Number. As the suspicion of a carious lesion develops, the Canary Number increases. With remineralization treatment, or lesion reduction in size, the Canary Number appears to decrease.

The Canary System is associated with a photographic image of the tooth surface being The images are displayed on an accompanying monitor for immediate chair-side examined. review with the patient. Images are also shown in Canary Reports incorporating Canary Numbers and color codes for the examined teeth. The Canary software is able to record and store the Canary Numbers, images of the surfaces examined, along with the dentist's treatment recommendation.

# E. Intended Use:

The Canary System is intended to be used by qualified dental professionals as an aid in the detection and monitoring of dental canes, and as an intra-oral camera to record anatomical details.

### F. Indications for use:

The Canary System is indicated as an aid in the detection and monitoring of dental caries and as an intraoral camera to visualize and record anatomical details.

# G. Substantial Equivalence:

Safety and effectiveness comparison to predicate devices:

| COMPARISON OF THE ABILITY TO DETECT AREAS OF SUSPICION BY TOOTH SURFACE | | | |
|----------------------------------------------------------------------------------|-------------------|------------|-------|
| CRITERIA | The Canary System | DIAGNODent | SOPRO |
| Examination of<br>Interproximal Caries<br>Areas | YES | NO | NO |
| Examination of Pit<br>and Fissure Caries | YES | YES | YES |
| Smooth Surface<br>Caries | YES | YES | YES |
| Evaluation of<br>Possible Caries<br>Around Visible<br>Margins of<br>Restorations | YES | NO | NO |
| Evaluation of<br>Possible Subsurface<br>Caries lesions | YES | NO | NO |

| COMPARISON BY FUNCTIONALITY | | | |
|-----------------------------|---------------------|-----------------------|-----------------------|
| CRITERIA | The Canary System | DIAGNOdent | SOPRO |
| Necessary | Removal of pools of | Clean tooth using any | Clean tooth using any |

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| pre-treatment of<br>teeth | saliva using air drying<br>or dabbing with cotton | method and dry | method |
|--------------------------------------------------------------|---------------------------------------------------|-------------------|-------------------|
| Detection of areas of<br>suspect Incipient | YES | YES | YES |
| Target Population | Dentist's Offices | Dentist's Offices | Dentist's Offices |
| Printed / Electronic<br>Report for patients<br>and providers | YES | NO | YES |
| Visual Image | YES | NO | YES |

| TECHNICAL SPECIFICATIONS | | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CRITERIA | The Canary System | DIAGNODent | SOPRO |
| Indications for use | An aid in the detection<br>and monitoring of dental<br>caries and as an intraoral<br>camera to visualize and<br>record anatomical details | Aid in the diagnosis of<br>dental caries | Intended to be used by<br>qualified physicians in<br>dentistry as an aid in the<br>diagnosis of dental caries,<br>and as an intraoral camera<br>to visualize anatomical<br>details invisible to the naked<br>eye or with a mirror. |
| Core Technology | Combined Photothermal<br>radiometry (PTR) and<br>modulated luminescence<br>(LUM) caries detection<br>device | Fluorescence caries<br>detection device | Light-induced fluorescence<br>caries detection device |
| How suspicion of<br>caries are detected | The Canary System<br>shines a 2 Hz pulsed<br>laser light (660nm) on the<br>tooth surface and the<br>device collects the<br>converted and emitted<br>infrared radiation (2-5µm)<br>by heat released from the<br>tooth (1-2 deg. C<br>maximum increase in<br>heat) and luminescence<br>(715-800nm) when the<br>laser modulates. By the<br>interaction of the laser<br>light with the crystalline<br>structure of the enamel<br>and dentin, the emitted<br>luminescence and<br>thermal infrared signal<br>provide information about<br>the health of the tooth<br>and areas that might be<br>suspected of having<br>dental caries . | DIAGNOdent emits<br>red laser light at a<br>wavelength of 655 nm<br>onto a tooth surface.<br>This wavelength<br>causes porphyrins<br>(coloured protein<br>molecules) in carious<br>tissue to fluoresce,<br>resulting in elevated<br>scale readings on the<br>display of the system.<br>The presence of<br>bacterial by-products<br>is an indirect measure<br>that caries are<br>present. | SOPROLIFE emits blue LED<br>(wavelength of 450 nm) onto<br>a tooth surface. This<br>wavelength excites the<br>dentin, which, in response,<br>reflects a light signal called<br>fluorescence. The colour of<br>the fluorescence signal is<br>green when the dentin is<br>healthy and dark red, when<br>the dentin is infected. |
| How suspicion of<br>caries are reported | The Canary Number is a<br>combination of the PTR<br>and LUM amplitude and | Scale of 1 - 100 with<br>readings below 13<br>suggests a healthy | Colour suggests health of<br>dentin. Red suggests caries<br>in the dentin. Green |

Quantum Dental Technologies: 510(k) Summary for K112139

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K112139

| phase readings at a point<br>on a tooth surface. The<br>Canary Number scale is<br>from 0 - 100. Canary<br>Numbers below 20<br>suggest a healthy tooth<br>surface. Canary<br>Numbers above 70<br>suggest the possible<br>presence of advanced<br>decay. Canary Numbers<br>between 21 - 70<br>suggests the presence of<br>an early lesion or decay<br>and treatment depends<br>upon location of these<br>suspect areas and patient<br>risk factors. | tooth surface.<br>Readings over 20<br>suggest presence of<br>caries into the dentin.<br>Readings over 30<br>suggest the presence<br>of caries into dentin<br>requiring restoration. | suggests healthy dentin.<br>The stronger the red colour<br>the larger the suspicious<br>area of caries. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

.

| CRITERIA | The Canary System | DIAGNODent | SOPRO |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------|
| Probe | Lenses and mirrors | Fiber Optic | Fiber Optic |
| Light source | 660 nm <50 mW Laser,<br>sinusoidally modulated at<br>2Hz | 655 nm <1 mw Laser | 450 nm LED |
| Camera | CMOS<br>Resolution: 640 x 480<br>pixels | N/A | 1/2" CCD; Resolution<br>(752x582) PAL; (768x494)<br>NTSC |
| Returned light | AC or modulated<br>Luminescence + thermal<br>infrared<br>Pulsing the laser light<br>allow for measurement of<br>both the luminescence<br>and changes in thermal<br>properties. | Fluorescence<br>(DC luminescence) | Fluorescence<br>(DC luminescence) |
| Detectors for<br>Returned Light | • Photodiode for LUM<br>and or AC<br>Fluorescence<br>• Mid-IR detector for<br>PTR<br>• Visible Range CMOS<br>Camera to track area<br>scanned & visual<br>surface changes | Photodiode for DC<br>fluorescence | Visible range CMOS camera<br>for DC fluorescence |
| Sterilization and<br>Disinfection | Disposable, one-time use<br>plastic sleeve and plastic<br>tip. The Canary System<br>unit and cables can also<br>be disinfected with<br>alcohol-based solutions. | Probe tip only,<br>autoclave | Probe autoclave |
| Medical Device<br>Classification | II | II | II |
| User interface | Graphical, numeric<br>and audible tones | Numeric and audible<br>tones LED numbers | Image with colours |

Quantum Dental Technologies: 510(k) Summary for K112139

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| | Visual image of surface under examination and surface that was examined previously Reports generated for patients. | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------|
| Patient & Dentist<br>Reports | Reports generated for patients and dentists<br>which can be printed or<br>stored on The Canary for<br>later review | No printed reports | Reports stored on dental<br>practice software where<br>bridging is available |
| Power source | 100-120/200-240,<br>50/60Hz | 6- AA Alkaline battery | 115-230V, 50-60Hz |

The Canary System is substantially equivalent to other legally marketed devices in the United States. This conclusion is based on indications for use, bench, in vitro studies, as well as EMC, laser and electrical safety testing. Differences that exist between The Canary System and the nredicate devices relating to technical operation and performance do not affect the safety and effectiveness of the device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
26 2012

Ouantum Dental Technologies, Incorporated Josh Silvertown, Ph.D. M.B.A. Vice President, Corporate Development 748 Briar Hill Avenue Toronto, Ontario Canada M6B 1L3

Re: K112139

Trade/Device Name: The Canary System™ Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: October 9, 2012 Received: October 10, 2012

Dear Dr. Silvertown:

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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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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Luonne

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K112139

Device Name: The Canary System™

# Indications for Use:

The Canary System is intended to be used by qualified dental professionals as an aid in the diagnosis of dental caries, and as an intra-oral camera to visualize and record anatomical details.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-counter Use NO (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Puuri

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

**510(k) Number:**

000010