CARIESCAN PRO

K090598 · Cariescan , Ltd. · NBL · Dec 15, 2009 · Dental

Device Facts

• Record ID: K090598
• Device Name: CARIESCAN PRO
• Applicant: Cariescan , Ltd.
• Product Code: NBL · Dental
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Device Story

CarieScan PRO is a handheld dental caries detection device used in dental surgeries by professionals. It utilizes AC impedance spectroscopy (ACIST) to assess mineral changes in tooth structure. The system consists of a handheld unit connected to single-use disposable sensors. During operation, a sensor is placed on the target tooth site while a metal lip hook is attached to the patient's lip. The device passes a small electrical current (< 10 μA) between the sensor and the lip hook, measuring impedance across multiple frequencies (3kHz - 20kHz). The resulting signals are processed to detect mineral density variations, providing clinicians with data to aid in caries diagnosis and monitoring. This objective measurement helps clinicians make informed treatment decisions, potentially improving diagnostic accuracy compared to traditional methods.

Clinical Evidence

The submission reports performance metrics of 92.5% sensitivity and 92.5% specificity for the CarieScan PRO, compared to 80% sensitivity and 52% specificity for the predicate DIAGNOdent 2095. The device also underwent electrical safety testing to demonstrate conformity with applicable standards.

Technological Characteristics

Handheld device using AC impedance spectroscopy (ACIST). Power source: Lithium Polymer rechargeable battery. Measurement method: Comparison of impedance at multiple frequencies (3kHz - 20kHz). Max applied current: < 10 μA. Connectivity: Single-use disposable sensors. Form factor: Handheld.

Indications for Use

Indicated for dental professionals to aid in the diagnosis and monitoring of dental caries in patients.

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 2095 (K983658)
• Apex NRG XFR, Electronic Apex Locator (K071133)

Submission Summary (Full Text)

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K090598

# CarieScan PRO 510(k) Submission

25 February 2009

### 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitter Details 5.1

CarieScan Ltd Prospect Business Centre The Technology Park Dundee DD2 1SW വി Tel: [phone] Fax: [phone] www.cariescan.com

EC 1 5 2009

### 5.2 Official Contact

Nikola Skelly, Quality & Regulatory Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Submission date: February 25th 2009

#### 5.3 Device Details

| Proprietary / Trade Name: | CarieScan PRO |
|---------------------------|--------------------------------------------|
| Classification Name: | Laser Fluorescence Caries Detection Device |
| Product Codes: | NBL |
| Common / Usual Name: | Dental Caries Detection Device. |

#### 5.4 Equivalent legally marketed devices

| Performance | - DIAGNOdent® 2095 | K983658. |
|-------------|-----------------------------------------|----------|
| Safety | - Apex NRG XFR, Electronic Apex Locator | K071133. |

#### 5.5 Indications for Use (Intended Use)

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

### 5.6 Device Description

This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.

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# CarieScan PRO 510(k) Submission

### Comparison of Technological Characteristics 5.7

### 5.7.1 Performance

. . .

r

With respect to performance, the CarieScan PRO is substantially equivalent to the predicate device, DIAGNOdent 2095. The devices are used in the same way for the same purpose, however the technology used is different. The DIAGNOdent uses laser fluorescence, while the CarieScan PRO uses AC impedance spectroscopy.

### 5.7.2 Safety

A second predicate device has been selected for safety comparison, this is the Apex NRG - Electronic Apex Locator which also uses an impedance technique.

| | Candidate Device | Predicate Devices | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristics | | Performance | Safety |
| | CarieScan PRO | DIAGNOdent | Apex NRG |
| Intended Use /<br>Indications for<br>Use | For use by dental<br>professionals as an aid in<br>the diagnosis and<br>monitoring of dental<br>caries. | For use as an aid in<br>the diagnosis of dental<br>caries. | To measure the length of<br>the root canal for the<br>purpose of performing<br>root canals and related<br>dental procedures for use<br>by a trained professional<br>in general dentistry. |
| Target population | Dental Professionals | SAME | SAME |
| Anatomical Sites | Teeth | SAME | SAME |
| Where Used | Dental Surgery | SAME | SAME |
| Energy used<br>and/or delivered | Electrical Impedance | Laser Fluorescence | Electrical Impedance |
| Power Source | Lithium Polymer<br>Rechargeable Battery | 5- AA Alkaline Battery | 1- AA Battery |
| Measurement<br>Method | Comparison of<br>impedance at multi<br>frequencies | Light fluorescence | Comparison of impedance<br>at multi frequencies |
| Frequencies used<br>for comparison | 3kHz - 20kHz | N/A | 6.5kHz - 1.3 kHz |
| Performance* | 92.5 % sensitivity<br>92.5% specificity | 80% sensitivity<br>52% specificity | N/A |
| Max Applied<br>Current | < 10 μ A | N/A | < 30 μ A |

Predicate Comparison Table

* See Section 12.2, Substantial Equivalence Discussion.

The CarieScan PRO meets all of the medical safety standards that are applicable, tests have been mo ourced and certificates have been achieved to demonstrate conformity. This is further detailed in Declarations of Conformity (Section 9) and Electrical Safety (Section 17).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or bird.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Nikola Skelly Quality & Regulatory Affairs Manager CarieScan Limited Prospect Business Centre, Gemini Crescent The Technology Park Dundee UNITED KINGDOM DD2 1SW

DEC 1 5 2009

Re: K090598

Trade/Device Name: CarieScan PRO Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: November 6, 2009 Received: November 12, 2009

Dear Ms. Skelly:

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.

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- Ms. Skelly

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

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

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K09a598

# CarieScan PRO 510(k) Submission

25 February 2009

### INDICATIONS FOR USE 4

510(k) Number (if known):

Device Name:

CarieScan PRO

Indications For Use:

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Prescription Use (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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A.S. Betz DDS for Dr. K.P. Mulry (Acting)

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

510(k) Number: K0902598

CarieScan Ltd

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