BlueCheck™ Caries Detection & Monitoring

K222560 · Incisive Technologies Pty, Ltd. · LFC · May 16, 2023 · Dental

Device Facts

• Record ID: K222560
• Device Name: BlueCheck™ Caries Detection & Monitoring
• Applicant: Incisive Technologies Pty, Ltd.
• Product Code: LFC · Dental
• Decision Date: May 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1740
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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

Device Story

BlueCheck™ is a liquid caries detection agent supplied in single-use vials. Used in dental operatory by dental professionals during routine examinations. Following dental prophylaxis, solution is applied to tooth surfaces via applicator/brush. Contains colored agent (Amido black) bound to submicron protein (bovine hemoglobin). Principle of operation: protein component utilizes natural hydroxyapatite-binding chemistry to bind to surface porosities of carious lesions. Non-bound product is removed by rinsing with water. Bound product remains visible as blue stain under ambient/white light (naked eye or magnification). Bound product is subsequently removed by brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva. Provides visual aid for caries assessment; assists clinician in identifying and monitoring carious lesions; facilitates targeted clinical decision-making.

Clinical Evidence

Bench testing only. Included shelf life testing, biocompatibility (ISO 10993-1), and performance testing comparing removal of the agent from tooth surfaces via rinsing, brushing with SLS-containing toothpaste, and saliva action. Risk assessments and viral inactivation studies performed per FDA guidance for animal-derived materials.

Technological Characteristics

Liquid solution in single-use vials. Contains submicron bovine hemoglobin protein and Amido black dye in phosphate buffered saline (PBS). Binding mechanism: hydroxyapatite-binding chemistry. Application: manual applicator/brush. Detection: visual inspection under ambient/white light. Biocompatibility: ISO 10993-1 compliant. Viral inactivation: per FDA 2019 guidance for animal-derived materials.

Indications for Use

Indicated for adults and children to aid dental professionals in the visualization of carious lesions on accessible tooth surfaces.

Regulatory Classification

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.

Predicate Devices

• LumiCare™ Caries Detection Rinse (K200601)

Reference Devices

• Caries Finder (K955445)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 16px;">☑</span> 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<br>Level 4, 71 Collins Street<br>Melbourne, Victoria, Australia<br>Telephone: [phone] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Kerry A. Hegarty, PhD; CEO |
| Representative/Consultant | Melissa Burbage, Senior Regulatory Specialist<br>Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail], [e-mail] |

#### 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,<br>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<br>Detection and<br>Monitoring<br>Incisive<br>Technologies Pty Ltd | K200601<br>LumiCare™<br>Caries Diagnostic<br>Rinse<br>GreenMark<br>Biomedical Inc. | K955445<br>Caries Finder<br>Danville Engineering,<br>Inc. |
| Reason for<br>Predicate/Reference | n/a | Similar indications<br>Performance<br>comparison | Similar indications<br>Performance<br>comparison<br>Use of color staining<br>agent |
| Product Code | LFC | LFC, EAQ | LFC |
| Regulation Number | 872.1740 | 872.1740 | 872.1740 |
| Identification | Caries Detection<br>Device | Caries Detection<br>Device | Caries Detection Device |
| Intended Use | Detection of dental<br>caries | Detection of dental<br>caries | Detection of dental<br>caries |
| Indication for Use<br>Statement | To aid the dental<br>professional in the<br>detection and<br>monitoring of dental<br>caries. | To aid the dental<br>professional in<br>visualization of<br>carious lesions | A visual aid for the<br>detection of carious<br>dentin. |
| Indication for<br>Disease | Dental caries | Dental caries | Dental caries |
| Indication for<br>Patient Population | Adults and children | Adults and<br>children | Not specified |
| Anatomic Sites | Directly visible tooth<br>surfaces | Directly visible<br>tooth surfaces | Directly visible tooth<br>surfaces |
| Use Environment | Dental Operatory | Dental Operatory | Dental Operatory |
| Product Form | Liquid | Liquid | Liquid |
| Primary Carrier<br>Fluids | Phosphate Buffered<br>Saline (PBS) | Water with<br>Propylene Glycol | Water with Propylene<br>Glycol |
| Contains Staining<br>Agent | Yes | Yes | Yes |
| Staining Agent | Deep-blue dye<br>(Amido black) | Fluorescein | Red color: acid red 52<br>Green color: FD&C<br>green |
| Carrier for Staining<br>Agent | Submicron Protein<br>(Bovine<br>Hemoglobin) | Submicron Starch<br>Particle (cationic) | None |
| Application | Product is applied to<br>teeth with an<br>applicator/brush. | Product is poured<br>into mouth and<br>patient instructed<br>to rigorously swish | Product is applied to<br>teeth with an<br>applicator/brush. |
| Detection Method | Areas of tooth decay<br>temporarily stain | Areas of tooth<br>decay temporarily<br>stain | Areas of tooth decay<br>temporarily stain |
| Viewing<br>Conditions | Ambient light/white<br>light with the naked<br>eye or under<br>magnification | Blue light/orange<br>filter | Ambient light/white<br>light with the naked eye<br>or under magnification |
| Characteristic | Subject Device | Predicate Device | Reference Device |
| | BlueCheck Caries<br>Detection and<br>Monitoring<br><br>Incisive<br>Technologies Pty Ltd | K200601<br>LumiCare™<br>Caries Diagnostic<br>Rinse<br><br>GreenMark<br>Biomedical Inc. | K955445<br>Caries Finder<br>Danville Engineering,<br>Inc. |
| Reason for<br>Predicate/Reference | n/a | Similar indications<br>Performance<br>comparison | Similar indications<br>Performance<br>comparison<br>Use of color staining<br>agent |
| Stimulation<br>wavelength | Visible light | Blue light (450-<br>470 nm, peak<br>value) | Visible light |
| Prescription/OTC | Prescription only | Prescription only | Prescription only |
| Usage | Single-patient,<br>single-use | Single-patient,<br>single-use | Single-patient, single-<br>use |

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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.