DIAGNOCAM

K123402 · Kaltenbach & Voigt GmbH · NTK · Sep 24, 2013 · Dental

Device Facts

• Record ID: K123402
• Device Name: DIAGNOCAM
• Applicant: Kaltenbach & Voigt GmbH
• Product Code: NTK · Dental
• Decision Date: Sep 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

The DIAGNOcam 2170 is a diagnostic aid for the detection of open or incipient caries lesions above the gingiva and for monitoring the progress of such lesions. Indications: - Detection of smooth surface caries . - . Detection of occlusal carries - Detection of proximal caries . - . Detection of initial caries - Detection of secondary caries . - Detection of cracks . The device is intended for use in a dentist's office or dental clinic.

Device Story

Handheld laser fluorescence caries detection device; uses Digital Imaging Fiberoptic Transillumination (DIFOTI) principle. Internal laser diode (788 nm) transmits light through tooth structure; carious lesions block light, appearing as dark areas on digital images. CCD sensor captures images; USB connection provides power and data transfer to computer. Used in dentist's office/clinic by dentists. Software displays real-time video (live stream) and static images on monitor; allows image storage. Enables visualization of dental structures without ionizing radiation; assists dentists in identifying and monitoring decay/cracks; facilitates clinical decision-making regarding treatment planning.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, UL 60601-1), electromagnetic compatibility, and biocompatibility studies. Software performance confirmed via validation testing.

Technological Characteristics

Handheld device; internal laser diode (788 nm, 2mW per source, max 21mW/cm2); CCD sensor; USB 5V power. Autoclaveable tips (small/large). Connectivity: USB to PC. Software-controlled image acquisition/display. Standards: IEC 60601-1, UL 60601-1.

Indications for Use

Indicated for detection of open or incipient caries lesions above the gingiva and monitoring lesion progression in dental patients. Specific indications include smooth surface, occlusal, proximal, initial, and secondary caries, and tooth cracks.

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

• DIFOTI USB 2.0 SYSTEM (K043068)
• Transillumination Cable Ti2200 (K071429)

Submission Summary (Full Text)

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K123402/5003

IAI

KaVo. Dental Excellence.

## Section V - 510(k) Summary

Submitter:

Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach/RiB Stefan Trampler - Contact Person 49 (7351) 56 3515 - Phone number [phone] - Facsimile

**SEP 24 2013**

Date Summary Prepared: September, 24th 2013

#### Device Name:

- Trade Name DIAGNOcam 2170 .
- Common Name Caries detector, laser light, transmission ●
- Classification Name Laser fluorescence caries detection device, per 21 CFR § 872.1745 .

#### Devices for Which Substantial Equivalence is Claimed:

- DIFOTI USB 2.0 SYSTEM (K043068) .
- . Transillumination Cable Ti2200 (K071429)

#### Device Description:

The DIAGNOcam 2170 is a handheld laser fluorescence caries detection device which uses the DIFOTI technology (Digital Imaging Fiberoptic Transillumination) as the functional principle. KaVo DIAGNOcam 2170 delivers images, which are reminiscent of X-rays but which are completely radiation free - by means of a light that is especially adapted to this examination method. The tooth structures allow the passage of light from the entry site to the camera. Areas that block light transmission (e.g. carious lesions) show up clearly as well delimited, dark areas. A digital camera captures the actual situation and makes it visible in real-time on the screen. The USB connector provides electric power to the unit. The DIAGNOcam 2170 will be delivered with a firmware (unit) at the handheld device which is responsible for steering of the camera functions and a computer based software (image) which is responsible to show / display the pictures, store / save the pictures and the possibility of a life stream. The internal laser diode generates an exact wavelength being detectable by the CCD sensor. The DIAGNOcam 2170 follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings. The DIAGNOcam 2170 works with a laser wavelength at 788 nm and an output power of 2mW for each laser diode (2 sources). The maximum output power is 21mW/cm2.

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The life stream describes a way how the dentist can use the DIAGNOcam 2170. So it is possible to use the DIAGNOcam 2170 to see life images of the teeth and not only to have the possibility to make single pictures. While using the DIAGNOcam 2170 at the teeth the dentist can see real pictures / a video on his monitor.

The tips of the DIAGNOcam 2170 can be sterilized according to the instructions for use. Two tips (small & large) are supplied with the handheld device. Additionally the DIAGNOcam 2170 will be supplied with a holder for the device. This holder allows the dentist to deposit the DIAGNOcam 2170 in a safe position. The holder is intended to be used outside the treatment for general storage.

#### Intended Use of the Device:

The DIAGNOcam 2170 is a diagnostic aid for the detection of open or incipient caries lesions above the gingiva and for monitoring the progress of such lesions.

Indications:

- Detection of smooth surface caries .
- . Detection of occlusal carries
- Detection of proximal caries .
- . Detection of initial caries
- Detection of secondary caries .
- Detection of cracks .

The device is intended for use in a dentist's office or dental clinic.

#### Substantial Equivalence:

The DIAGNOcam 2170 handheld laser fluorescence caries detection device is substantially equivalent to other legally marketed devices in the United States. The DIAGNOcam 2170 functions in a manner similar to and is intended for the same use as the DIFOTI USB 2.0 SYSTEM marketed by Electro-Optical Sciences, inc. and to the Transillumination Cable Ti2200 marketed by Kerr Corporation. The DIAGNOcam 2170 is similar to all three predicate devices in that it is a handheld laser fluorescence caries detection device which uses the transillumination as the functional principle. As the DIFOTI USB 2.0 SYSTEM an internal light source (laser diode) is used to generate the exact wavelength being detectable by the CCD sensor, a USB connection supplies the DIAGNOcam 2170 with power and additional to that the DIFOTI USB 2.0 SYSTEM works with software consisting of a product firmware and a computer based software, which is responsible to show / display the pictures, to store / save the pictures, for the possibility of a life stream and for steering of the camera function.

The life stream describes a way how the dentist can use the DIAGNOcam 2170. So it is possible to use the DIAGNOcam 2170 to see life images of the teeth and not only to have the possibility to make single pictures. While using the DIAGNOcam 2170 at the teeth the dentist can see real pictures / a video on his monitor.

The DIAGNOcam 2170 differs from the Transillumination Cable Ti2200 in that the DIAGNOcam 2170 uses an internal light source and a USB connection. Furthermore does the Transillumination Cable Ti2200 not have software and it is not a handheld device by itself. The DIAGNOcam 2170 differs from both predicate devices in that the DIAGNOcam 2170 has autoclaveable tips (small & large).

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# Summary of the Technological Characteristics:

| Descriptive<br>Information | DIAGNOcam 2170 | DIFOTI USB 2.0 SYSTEM<br>(K043068) | Transillumination Cable<br>TI2200 (K071429) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The DIAGNOcam 2170 is a<br>diagnostic aid for the detection of<br>open or incipient caries lesions<br>above the gingiva and for monitoring<br>the progress of such lesions.<br>Indications:<br>• Detection of smooth surface caries<br>• Detection of occlusal carries<br>• Detection of proximal caries<br>• Detection of initial caries<br>• Detection of secondary caries<br>• Detection of cracks | The DIFOTI USB 2.0 System<br>(DIFOTI System for Dental<br>Examinations, Model B) is<br>indicated for detection of frank<br>or incipient caries lesions above<br>the gum line, and for monitoring<br>the progression of such lesions. | The Ti2200 Transillumination<br>Cable is a diagnostic aid used to<br>locate decay, calculus, fracture<br>lines, endodontic orifices, cracks<br>and fissures underneath the<br>tooth surface utilizing a fiber<br>optic cable and handle attached<br>to a light source. |
| Design | Handheld device | Identical | Identical |
| Functional Principle | Transillumination<br>(It makes use of the tooth structure<br>which has the ability of light<br>transmission. If the light<br>transmission is interrupted due to<br>caries lesions a dark shadow<br>appears. | Identical | Identical |
| Device Components | Handheld device with USB cable and<br>software | Identical | Handheld device with cable and<br>unit |
| Light Source | An internal laser diode is used to<br>generate the exact wavelength being<br>detectable by the CCD sensor. | Identical | External light source |
| Installation | The computer based installation<br>enables the customer to update the<br>firm and software. | Identical | Independent (no software) |
| Power Source | USB - 5V | Identical | N/A |
| Compatibility | USB connection | Identical | Specific connection |
| Compliance to<br>Standards | IEC 60601-1, UL 60601-1 | Identical | Not specified |
| Autoclaveable | Yes (tip of the product) | No (tip of the product is<br>disposable) | No |
| Portable | No | Identical | Identical |
| Software | The software consists of a product<br>firmware and a computer based<br>software, which is controlling:<br>- Show / display the pictures<br>- Store / save the pictures<br>- Life stream<br>- Steering of camera function | Identical | No software |
| Intended Users | Dentists | identical | identical |
| Laser wavelength | 788 nm | 670 nm | Not specified |
| | ' 2 sources (each ~2mW)<br>1 / 2 >>0 / 2 / 2 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 2 / 2 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 | 2 sources (left side ~1mW, right | |
| · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·<br>STATE A PARTIC PORT STATE | max. 21 mW / cm² | max. 41 mW / cm² | |

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#### Non-Clinical Test Data:

Temperature and energy tests according to the international standards for electrical safety and electromagnetic compatibility have been conducted to determine the conformance to the state of the art. Biocompatibility studies have been completed which demonstrate that the DIAGNOcam 2170 is safe for his intended use.

Additionally, the DIAGNOcam 2170 software has been successfully validated to confirm the performance of the device.

#### Clinical Test Data:

Clinical testing has not been conducted on this product.

#### Conclusion :

Based upon the tests according to the international standards for electrical safety and electromagnetic compatibility, the biocompatibility studies, the similar technological / performance characteristics as compared to the predicate devices, and successful validation of the DIAGNOcam 2170 software, the performance of the DIAGNOcam 2170 is deemed to be substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

September 24, 2013

Kaltenbach & Voigt GmbH Mr. Stefan Trampler Head of Quality Management & Regulatory Affairs Bismarchring 39 Biberach / Riss Germany 88400

Rc: K123402

Trade/Device Name: DIAGNOcam 2170 Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NTK Dated: September 2, 2013 Received: September 6, 2013

Dear Mr. Trampler:

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Richard C.
Chapman

for

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Section IV - Indications for Use

510(k) Number (if known): K123402

Device Name: DIAGNOcam 2170

Indications for Use:

The DIAGNOcam 2170 Is a diagnostic ald for the detection of open or includent carles lesions above the gingiva and for monitoring the progress of such lesions.

Indications:

- Detection of smooth surface caries �
- Detection of occlusal carries .
- Detection of proximal carles 0
- Detection of Initial caries ●
- Detection of secondary caries
- Detection of cracks

#### Andrew I S 2013.09.24 1 -04'00'

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

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K123402 510(k) Number:

Prescription Use 1 (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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