THE CANARY SYSTEM

• K Number: K112139
• Device Name: THE CANARY SYSTEM
• Manufacturer: QUANTUM DENTAL TECHNOLOGIES INC
• Date Cleared: 2012-10-26 ( 458 days)
• Product Code: NBL
• Regulation Number: 872.1745

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. 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. 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.

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 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 examined. The images are displayed on an accompanying monitor for immediate chair-side 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.

Predicate Devices

K983658, K092583

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical principles of Photothermal Radiometry (PTR) and Luminescence (LUM) to generate a "Canary Number" based on signal analysis. There is no mention of AI or ML algorithms being used for signal processing, image analysis, or decision support. The device appears to rely on direct measurement and calculation based on the physical properties of the tooth.

Therapeutic

No.
The device is described as an "aid in the detection and monitoring of dental caries" and as an "intra-oral camera to record anatomical details," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The Canary System is intended to be used by qualified dental professionals as an aid in the diagnosis of dental caries".

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components, including a laser, sensors for detecting PTR and LUM signals, and a system for generating thermal diffusion waves. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Canary System is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Canary System's Function: The Canary System directly examines the tooth surface using light and thermal properties. It does not analyze a specimen taken from the body.
• Intended Use: The intended use clearly states it's an aid in the detection and monitoring of dental caries and as an intra-oral camera. This is a direct examination of the anatomical site.

Therefore, the Canary System falls under the category of a medical device used for direct examination of the body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.
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.
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.

Product codes

NBL

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CMOS camera; PTR/LUM signals from 660 nm laser light interaction with tooth

Anatomical Site

Tooth surface / dental

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified dental professionals; Dentist's Offices

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K983658, K092583

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.1745 Laser fluorescence caries detection device.

(a)
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.(b)
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.

Summary

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OCT 2 6

KIZZA

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
Interproximal Caries
Areas	YES	NO	NO
Examination of Pit
and Fissure Caries	YES	YES	YES
Smooth Surface
Caries	YES	YES	YES
Evaluation of
Possible Caries
Around Visible
Margins of
Restorations	YES	NO	NO
Evaluation of
Possible Subsurface
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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K112139

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

Quantum Dental Technologies: 510(k) Summary for K112139

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K112139

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

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CRITERIA	The Canary System	DIAGNODent	SOPRO
Probe	Lenses and mirrors	Fiber Optic	Fiber Optic
Light source	660 nm