REMOTE VIEW SOFTWARE

K111321 · Cariescan , Ltd. · NBL · May 17, 2011 · Dental

Device Facts

• Record ID: K111321
• Device Name: REMOTE VIEW SOFTWARE
• Applicant: Cariescan , Ltd.
• Product Code: NBL · Dental
• Decision Date: May 17, 2011
• Decision: SESE
• Submission Type: Special
• 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 dental diagnostic device used by professionals to detect and monitor dental caries. It utilizes AC Impedance Spectroscopy (ACIS) technology to measure the electrical properties of tooth structure. The device consists of a handheld probe and a base unit. During operation, the probe tip is placed on the tooth surface; the device applies a low-voltage electrical signal and measures the impedance response. This data is processed to determine the presence and severity of demineralization (caries). The output is displayed to the clinician, providing a quantitative assessment that assists in clinical decision-making regarding treatment planning and longitudinal monitoring of lesion progression. The device benefits patients by enabling early detection of caries, potentially allowing for non-invasive or minimally invasive interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance verification of the modified system.

Technological Characteristics

AC Impedance Spectroscopy (ACIS) sensing principle. Handheld probe with base unit. Device operates via electrical impedance measurement of tooth structure. Software-based signal processing. Sterilization via standard dental practice protocols for probe tips.

Indications for Use

Indicated for use by 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

• CarieScan PRO System (K090598)

Submission Summary (Full Text)

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

Ms. Nikola Skelly Head of Quality & Regulatory Affairs CarieScan Limited Unit 5 Gateway West. Luna Place, Technology Park Dundee, Angus UNITED KINGDOM DD2 1XZ

MAY 1 7 2011

Re: K11321

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: May 6, 2011 Received: May 11, 2011

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

Sincerely yours.

ph. for

Anthony 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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K111321

## Special 510(k): K090598 CarieScan PRO System Modification

06 May 2011

## INDICATIONS FOR USE 4

510(k) Number (if known):

KIII331 、・・・

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

\/

Over The Counter Use AND/OR

(Part 21 CFR 801 Subpart D)

(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)

Susan Pumpe

siology, General Hosnits

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CarieScan Ltd