(142 days)
Not Found
No
The description focuses on the hardware (handpiece, camera, light) and basic image processing for visualization. There is no mention of AI/ML algorithms for analysis or interpretation of the images.
No.
The device is described as a "diagnostic aid for the detection of interproximal caries lesions" and explicitly states that it "aids in the detection and diagnosis of proximal caries" by producing images for visualization. There is no indication that it treats or provides therapy for any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a diagnostic aid for the detection of interproximal caries lesions."
No
The device description clearly states it consists of a handpiece, a "Proxi" head, and a USB cable, which are hardware components. While it uses imaging software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CamX Triton HD Proxi Head is a diagnostic aid that uses infrared light transillumination to visualize and detect caries lesions directly on the teeth within the mouth. It does not analyze samples taken from the body.
- Anatomical Site: The device is used on the "interproximal caries lesions above the gingiva," which is an in-vivo application, not an in-vitro one.
Therefore, while it is a diagnostic device, it falls under the category of in-vivo diagnostic devices rather than in-vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
Product codes (comma separated list FDA assigned to the subject device)
NTK
Device Description
The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece.
After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.
Mentions image processing
A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared light (transillumination)
Anatomical Site
Teeth (interproximal caries lesions above the gingiva)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
The purpose of the evaluation was to demonstrate substantial equivalence based on similar performance between the new device, the CamX Triton HD Proxi and latest predicate device, DIAGNOcam 2170. Key performance attributes tested and compared include:
- a. LED Illumination and output
- b. Image Quality
Validation and verification test results showed that new device and the predicate device are equivalent, and that illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and KaVo's DIAGNOcam camera.
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.
DIAGNOcam 2170 (K123402), DIFOTI USB2.0 System (K043068), Transillumination Cable Ti2200 K071429
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.
Not Found
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
§ 872.1745 Laser fluorescence caries detection device.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 22, 2017
Duerr Dental AG % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114
Re: K172007
Trade/Device Name: CamX Triton HD Proxi Head Regulation Number: 21 CFR 872.1745 Regulation Name: Laser fluorescence caries detection device Regulatory Class: Class II Product Code: NTK Dated: October 5, 2017 Received: October 10, 2017
Dear Daniel Kamm:
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.
1
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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172007
Device Name CamX Triton HD Proxi Head
Indications for Use (Describe)
The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary, DUERR DENTAL AG, CamX Triton HD Proxi Head K172007
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
Date Summary Prepared: 1.
September 21, 2017
2. Submitter's Identification:
DUERR DENTAL AG Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Contact:
Oliver Lange Head of Quality Management DUERR Dental AG Höpfigheimer Strasse 17 D-74321 Bietigheim-Bissingen Deutschland / Germany Phone: + 49 (0) 7142 / 705-0 Fax: + 49 (0) 7142 / 705-500 Email: lange.o@duerr.de
U.S. Contact:
Suzanne Lucas Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Tel: 516-214-5514 Email: slucas@airtechniques.com
3. Device:
Trade /Proprietary Name: Device: Regulation Description: Medical Specialty: Product Code: NTK Regulation Number: Device Class: 2
CamX Triton HD Proxi Head Caries Detector, Laser Light, Transmission Laser fluorescence caries detection device. Dental 872.1745
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4. Predicate Devices:
| DIAGNOcam 2170 (K123402); Kaltenbach & Voigt GmbH, | |
|---|---|
| DIFOTI USB2.0 System (K043068), ELECTRO-OPTICAL SCIENCES, INC. | |
| Transillumination Cable Ti2200 K071429), Sybron Dental Specialties, Inc | |
| For all of these predicates: | |
| Device: | Caries Detector, Laser Light, Transmission |
| Regulation Description: | Laser fluorescence caries detection device. |
| Medical Specialty: | Dental |
| Product Code: | NTK |
| Regulation Number: | 872.1745 |
| Device Class: | 2 |
5. Device Description:
The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece.
After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.
6. Indications for use:
The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
7. Summary of the technological characteristics of the device compared to the predicate devices:
Duerr Dental's CamX Triton HD Proxi Head is substantially equivalent in terms of indications for use and the technology to the predicate devices which are currently in commercial distribution.
Table 1 below, summarizes the technological characteristics of CamX Triton HD Proxi Head vs. the predicate devices.
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Summary of the Technological Characteristics
| Descriptive
Information | CamX Triton HD Proxi Head (new
product) | DIAGNOcam 2170
(K123402) | DIFOTI USB 2.0 System
(K043068) | Transillumination
Cable TI2200
(K071429) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The CamX Triton HD Proxi Head is a
diagnostic aid for the detection of
interproximal caries lesions above
the gingiva and for monitoring the
progress of such lesions | 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 caries
- Detection of proximal caries
- Detection of secondary caries
- Detection of cracks | The DIFOTI USB 2.0 System (DIFOTI
System for Dental Examinations,
Model B) is indicated for detection
of frank or incipient caries lesions
above the gum line, and for
monitoring the progression of such
lesions. | The TI2200
Transillumination Cable is a
diagnostic aid used to
locate decay, calculus,
fracture lines, endodontic
orifices, cracks and fissures
underneath the tooth
surface utilizing a fiber
optic cable and handle
attached to a light source |
| Design | Handheld device | Identical | Identical | Identical |
| Functional
Principle | Transillumination
It makes use of the tooth structure
which has the ability of light
transmission. If the light
transmission is interrupted due to
caries lesions a bright area appears
(inverse to e.g.
DIAGNOcam 2170) | Transillumination
It makes use of the tooth structure
which has the ability of light
transmission. If the light
transmission is interrupted due to
caries lesions a dark shadow
appears. | Transillumination
It makes use of the tooth structure
which has the ability of light
transmission. If the light
transmission is interrupted due to
caries lesions a dark shadow
appears. | Transillumination
It makes use of the tooth
structure which has the
ability of light transmission.
If the light transmission is
interrupted due to caries
lesions a dark shadow
appears. |
| Device
Components | Handheld device with USB
cable and software | Identical | Identical | Handheld device with
cable and unit. |
| Descriptive
Information | CamX Triton HD Proxi Head (new
product) | DIAGNOcam 2170
(K123402) | DIFOTI USB 2.0 System
(K043068) | Transillumination
Cable TI2200
(K071429) |
| Light Source | Two LED are used to generate the
exact wavelength being detectable
by the CMOS sensor. | An internal laser diode is used to
generate the exact wavelength
being detectable by the CCD
sensor. | An internal laser diode is used to
generate the exact wavelength
being detectable by the CCD
sensor. | External light source |
| Installation | The computer based
installation enables the
customer to update the
software | The computer based installation
enables the customer to update
the firm- and software | The computer based installation
enables the customer to update
the firm- and software | Independent (no
software) |
| Power Source | USB-5V | Identical | Identical | N/A |
| Compatibility | USB connection | Identical | Identical | Specific connection |
| Compliance to
Standards | IEC 60601-1 | IEC60601-1, UL60601-1 | IEC60601-1, UL60601-1 | Not specified |
| Autoclaveable | Yes (distance spacer of the
product) | Yes (tip of the product) | No (tip of the product is
disposable) | No |
| Portable | No | Identical | Identical | Identical |
| Software | The software is a computer
based software, which is
controlling: - Show / display the pictures
- Store / save the pictures
- Live stream
- Steering of camera function | The software consists of a
product firmware and a
computer based software,
which is controlling: - Show / display the pictures
- Store / save the pictures
- Life stream
- Steering of camera function | The software consists of a
product firmware and a
computer based software,
which is controlling: - Show / display the pictures
- Store / save the pictures
- Life stream
- Steering of camera function | No software |
| Intended Users | Dentist | Identical | Identical | Identical |
| Wavelength | 850 nm | 788 nm | 670 nm | Not specified |
| Output power | 2 sources (together ~4,5mW)
max. 4,1 mW / cm² at a distance
of 7 mm (spacer) | 2 sources (each ~2mW)
max. 21 mW / cm² | 2 sources (left side ~1mW,
right side ~3mW) max. 41
mW/cm² | Not specified |
6
7
8. Discussion of Differences:
- i. Functional Principle: The main function is based on transillumination, same as the predicate devices. The only difference is the image information of the CamX Triton HD Proxi is displayed inverted in comparison to the predicate devices.
- ii. Light source : CamX Triton HD Proxi uses 2 infrared LEDs whereas other devices use a laser light source. The difference has geometrical and constructional/ design reasons. The predicate devices use light guides to bring the laser light to the tooth surface, in contrast to the CamX Triton HD Proxi has a direct illumination by LED in the distal end.
- iii. Wavelength: The wavelength which is used (850 nm) is a little bit higher than the wavelength used by the predicate devices. The wavelength of the CamX Triton HD Proxi is optimized for the ability of light transmission of the sound enamel and for the sensitivity of the used CMOS image sensor.
- iv. Output power: The output power for CamX Triton HD Proxi is 4,5 mW and for DIAGNOcam and DIFOTI the output power is about 4 mW (the two sources in addition, each).
9. Non-Clinical Data and Performance Testing
The purpose of the evaluation was to demonstrate substantial equivalence based on similar performance between the new device, the CamX Triton HD Proxi and latest predicate device, DIAGNOcam 2170. Key performance attributes tested and compared include:
- a. LED Illumination and output
- b. Image Quality
Validation and verification test results showed that new device and the predicate device are equivalent, and that illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and KaVo's DIAGNOcam camera. Duerr Dental AG's CamX Triton HD Proxi complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (edition 3) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 (edition 4) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, and IEC 80601-2-60:2012 (first edition) Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment. Sterilization validation testing was successfully performed according to ANSI/AAMI/ISO 17665-1, Annex D and the validation approach outlined in ANSI/AAMI/ISO 14937, Annex D (Approach 3).
8
10. Biocompatibility Assessment
There are no biocompatibility issues known to be associated with any of the materials used to manufacture the CamX Triton HD Proxi. Patient contact Distance Spacer component was tested and complies with ISO 10993- 10:2002 Standard and Amendment 1, "Biological Evaluation of Medical Devices, Part 10-Tests for Irritation and Delayed-Type Hypersensitivity", and ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. By design, many of the components of the CamX Triton HD Proxi are isolated from patient contact by a camera cover and through a distance spacer. Components that have no patient contact are:
- Hand piece housing ●
- Lens window-
- Handpiece control buttons -
- Umbilical -
Components that contact the patient are:
- Camera cover*
- 8 mm Spacer*
*These materials are currently in use and market distribution with the similar device "Spectra Fluorescence Caries Detection Aid System" device, 510K# K090169.
-
- Clinical Data: Not required for a finding of substantial equivalence.
12. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, Duerr Dental AG concludes that the CamX Triton HD Proxi is substantially equivalent to the predicate device as described herein.
The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.