Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a chemical agent that binds to tooth surfaces for visual detection, with no mention of AI/ML algorithms, image processing, or data analysis typically associated with such technologies.

Therapeutic

No.
The device is described as a diagnostic tool to aid in the visualization of carious lesions, not to treat them.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the device aids in the "visualization of carious lesions." The "Device Description" also explicitly states, "BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "solution containing colored agents" supplied as a "liquid product in single use vials." This indicates a physical, chemical-based product, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "To aid the dental professional in the visualization of carious lesions." This clearly indicates a diagnostic purpose – helping to identify a disease state (caries).
Device Description: The device is a solution applied to tooth surfaces that binds to porosities and causes a visual color change. This is a chemical reaction or interaction that occurs in vitro (outside the living body, on the tooth surface which is considered a biological sample in this context) to provide diagnostic information.
Diagnostic Tool: The description explicitly states that BlueCheck is intended to be used in routine dental examinations as a "diagnostic tool that assists dental professionals to visualize and assess caries."

While the device is applied to a part of the body (teeth), the diagnostic process itself involves a chemical interaction on the tooth surface to reveal information about the presence of caries, which aligns with the definition of an in vitro diagnostic. The tooth surface, in this context, is treated as a biological sample being analyzed.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To aid the dental professional in the visualization of carious lesions.

Product codes (comma separated list FDA assigned to the subject device)

LFC

Device Description

BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Directly visible tooth surfaces

Indicated Patient Age Range

Adults and children

Intended User / Care Setting

Dental professional / Dental Operatory

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)

Non-clinical testing data submitted to demonstrate substantial equivalence included: shelf life testing, biocompatibility evaluation and testing according to ISO 10993-1, and performance testing compared to predicate and reference devices.

Performance studies were conducted to demonstrate that the subject device has been removed from the tooth surface after rinsing, brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva.

Risk assessments and viral inactivation studies were performed according to FDA's guidance Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) issued on March 15, 2019.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K200601

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K955445

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

May 16, 2023

Incisive Technologies Pty Ltd % Melissa Burbage Senior Regulatory Specialist PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130

Re: K222560

Trade/Device Name: BlueCheck™ Caries Detection & Monitoring Regulation Number: 21 CFR 872.1740 Regulation Name: Caries Detection Device Regulatory Class: Class II Product Code: LFC Dated: May 1, 2023 Received: May 3, 2023

Dear Melissa Burbage:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222560

Device Name

BlueCheck™ Caries Detection & Monitoring

Indications for Use (Describe)

To aid the dental professional in the visualization of carious lesions.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K 222560

BlueCheck™ Caries Detection & Monitoring

Incisive Technologies Pty Ltd

May 1, 2023

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Incisive Technologies Pty Ltd
Level 4, 71 Collins Street
Melbourne, Victoria, Australia
Telephone: +61 (0)3 9653 3777 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Kerry A. Hegarty, PhD; CEO |
| Representative/Consultant | Melissa Burbage, Senior Regulatory Specialist
Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Fax: +1 858-792-1236
Email: mburbage@paxmed.com
kthomas@paxmed.com, flarson@paxmed.com |

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	BlueCheck™ Caries Detection & Monitoring
Common Name	Device, Caries Detection
Regulation Number	21 CFR 872.1740
Regulatory Class	Class II
Product Code	LFC
Classification Panel	Dental
Reviewing Office	Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory,
ENT and Dental Devices)
Reviewing Division	Division of Health Technology 1B (Dental and ENT Devices)

PREDICATE DEVICE INFORMATION

Primary Predicate Device: K200601, LumiCare™ Caries Detection Rinse, GreenMark Biomedical, Inc.

Reference Device: K955445, Caries Finder, Danville Engineering, Inc.

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INDICATIONS FOR USE STATEMENT

To aid the dental professional in the visualization of carious lesions.

SUBJECT DEVICE DESCRIPTION

BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).

PERFORMANCE DATA

Non-clinical testing data submitted to demonstrate substantial equivalence included: shelf life testing, biocompatibility evaluation and testing according to ISO 10993-1, and performance testing compared to predicate and reference devices.

Performance studies were conducted to demonstrate that the subject device has been removed from the tooth surface after rinsing, brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva.

Risk assessments and viral inactivation studies were performed according to FDA's guidance Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) issued on March 15, 2019.

EQUIVALENCE TO MARKETED DEVICES

All devices use a stain in a liquid that is able to penetrate the subsurface of caries (active) lesions and bind either to the hydroxyapatite via electrostatic forces (subject device and primary predicate device) or to denatured collagen (reference device). Non-bound product is removed by rinsing with water. The remaining product is visible to the dental professional, as it contains a staining agent bound to a carious lesion. For the subject device, bound product is removed by brushing with a toothpaste containing SLS and by action of saliva.

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Characteristic	Subject Device	Predicate Device	Reference Device
	BlueCheck Caries
Detection and
Monitoring
Incisive
Technologies Pty Ltd	K200601
LumiCare™
Caries Diagnostic
Rinse
GreenMark
Biomedical Inc.	K955445
Caries Finder
Danville Engineering,
Inc.
Reason for
Predicate/Reference	n/a	Similar indications
Performance
comparison	Similar indications
Performance
comparison
Use of color staining
agent
Product Code	LFC	LFC, EAQ	LFC
Regulation Number	872.1740	872.1740	872.1740
Identification	Caries Detection
Device	Caries Detection
Device	Caries Detection Device
Intended Use	Detection of dental
caries	Detection of dental
caries	Detection of dental
caries
Indication for Use
Statement	To aid the dental
professional in the
detection and
monitoring of dental
caries.	To aid the dental
professional in
visualization of
carious lesions	A visual aid for the
detection of carious
dentin.
Indication for
Disease	Dental caries	Dental caries	Dental caries
Indication for
Patient Population	Adults and children	Adults and
children	Not specified
Anatomic Sites	Directly visible tooth
surfaces	Directly visible
tooth surfaces	Directly visible tooth
surfaces
Use Environment	Dental Operatory	Dental Operatory	Dental Operatory
Product Form	Liquid	Liquid	Liquid
Primary Carrier
Fluids	Phosphate Buffered
Saline (PBS)	Water with
Propylene Glycol	Water with Propylene
Glycol
Contains Staining
Agent	Yes	Yes	Yes
Staining Agent	Deep-blue dye
(Amido black)	Fluorescein	Red color: acid red 52
Green color: FD&C
green
Carrier for Staining
Agent	Submicron Protein
(Bovine
Hemoglobin)	Submicron Starch
Particle (cationic)	None
Application	Product is applied to
teeth with an
applicator/brush.	Product is poured
into mouth and
patient instructed
to rigorously swish	Product is applied to
teeth with an
applicator/brush.
Detection Method	Areas of tooth decay
temporarily stain	Areas of tooth
decay temporarily
stain	Areas of tooth decay
temporarily stain
Viewing
Conditions	Ambient light/white
light with the naked
eye or under
magnification	Blue light/orange
filter	Ambient light/white
light with the naked eye
or under magnification
Characteristic	Subject Device	Predicate Device	Reference Device
	BlueCheck Caries
Detection and
Monitoring

Incisive
Technologies Pty Ltd | K200601
LumiCare™
Caries Diagnostic
Rinse

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CONCLUSION

Based on a comparison of the indications for use and technology, BlueCheck is substantially equivalent to LumiCare™ Caries Diagnostic Rinse, K200601.