(317 days)
Not Found
No
The description focuses on fluorescence imaging and image processing software, with no mention of AI or ML algorithms for analysis or interpretation. The performance studies compare the new device to a predicate based on illumination, image quality, and color separation, not on AI/ML-driven diagnostic performance metrics.
No.
The device is used for detection and diagnosis of dental caries, not for treatment.
Yes
The device is described as an aid in "detection and diagnosis of dental caries", directly indicating a diagnostic purpose.
No
The device description explicitly mentions a "toothbrush-sized handpiece," a "Proof" head, and a "USB cable" connecting the handpiece to a computer. These are physical hardware components, not solely software.
Based on the provided information, the VistaCam iX "Proof" is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to be used as an "aid in the detection and diagnosis of dental caries." This clearly indicates a diagnostic purpose.
- Mechanism of Action: The device works by illuminating the tooth surface and detecting the fluorescence of bacteria resident in caries. This process involves analyzing a biological sample (the tooth surface with potential bacterial presence) to provide diagnostic information.
- Output: The device produces an image with color separation to illustrate suspected areas of decay, which is a form of diagnostic output.
While the device interacts with the patient's tooth, the core diagnostic process involves analyzing the light emitted from the tooth surface due to the presence of bacteria, which is an in vitro process (occurring outside the living organism in the sense of analyzing a sample/signal from the tooth).
Therefore, the VistaCam iX "Proof" fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.
Product codes
NBL
Device Description
The VistaCam iX "Proof" aids in the detection and diagnosis of caries. It consists of a toothbrush-sized handpiece and a "Proof" 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 is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the tooth to be examined. The camera functions by illuminating the tooth surface with a light that causes the bacteria resident in carries to fluoresce. The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.
Mentions image processing
The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging
Anatomical Site
Tooth/dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 VistaCam iX "Proof"and the predicate device, Spectra Fluorescence Caries Detection Aid. Key performance attributes tested and compared include:
- a. LED Illumination and output
- b. Image Quality
- c. Color Separation
Validation and verification test results showed that new device and the predicate device are equivalent, and that illumination and fluorescence of potential caries detection products are similar for both Dürr Dental AG's VistaCam iX "Proof" and Air Techniques' Spectra camera.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are simple and abstract, with no facial features, and are rendered in a dark color against a light background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
Durr Dental Ag % Ms. Suzanne Lucas Air Techniques, Inc 1296 Walt Techniques, Inc Melville, New York 11747
Re: K150672
Trade/Device Name: VistaCam iX "Proof" Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: April 24, 2015 Received: May 26, 2015
Dear Ms. Lucas:
This letter corrects our substantially equivalent letter of January 27, 2016
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Susan Runno DDS, mA
Tina Kiang, Ph.D Acting Division Director Science and Policy 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150672
Device Name VistaCam iX "Proof"
Indications for Use (Describe)
The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.
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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This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
1. Date Summary Prepared:
January 21, 2016
2. Submitter's Identification:
DÜRR DENTAL AG Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Telefon: (0 71 42) 70 5-0 Telefax: (0 71 42) 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com
Contact:
Oliver Lange Email: lange.o@@duerr.de Head of Quality Management DÜRR 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: | VistaCam iX "Proof" |
|---|---|
| Common Name: | Intraoral Camera with Fluorescence Caries Detection |
| Aid | |
| Classification: | 21 CFR 872.1745; Laser Fluorescence Caries Detection |
| Aid | |
| Product Code: | NBL |
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Predicate Device: 4.
Spectra Fluorescence Caries Detection Aid Device by Air Techniques, Inc. 510K# K090169
5. Device Description:
The VistaCam iX "Proof" aids in the detection and diagnosis of caries. It consists of a toothbrush-sized handpiece and a "Proof" 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 is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the tooth to be examined. The camera functions by illuminating the tooth surface with a light that causes the bacteria resident in carries to fluoresce. The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.
6. Indications for use:
The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.
7. Summary of the technological characteristics of the device compared to the predicate device:
Dürr Dental's VistaCam iX "Proof" is identical in terms of indications for use and the technology to the Spectra caries detection aid manufactured by Air Techniques'. Whose predicate dental devices are currently in commercial distribution and US-FDA cleared under 510K #K090169.
Table 1 below, summarizes the technological characteristics of VistaCam iX "Proof" vs. the predicate device.
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Table 1: Comparison to the Predicate device:
| Comparison criteria | New device
VistaCam iX "Proof"
510K # K150672 | Predicate device
Air Technique's Spectra
Fluorescence Caries
Detection Device
510K #K090169 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/ Operator | Dürr Dental AG | Dürr Dental AG |
| Manufacturer | Dürr Dental AG | Air Techniques, Inc |
| Similarities | | |
| Intended use | Caries detection aid | Caries detection aid |
| Indications for use | The VistaCam iX "Proof" is
intended to be used as an aid in
the detection and diagnosis of
dental caries. | The Spectra is indicated as an
aid in the detection and
diagnosis of dental caries. |
| Technology | Fluorescence technology to aid
in the detection of carious
lesions | Fluorescence technology to aid
in the detection of carious
lesions |
| Mode of operation | Excites bacteria to fluoresce | Excites bacteria to fluoresce |
| Image evaluation | Same as predicate | Image Color
Relative level
Green: 0 - 1.0
Blue: 1.0 - 1.5
Red 1.5 - 2.0
Orange 2.0 - 2.5
Yellow 2.5 - 3.0
Lighter colors and higher
numbers indicate an increasing
magnitude of the red / green
fluorescence ratio and the
likelihood of poorer tooth
health. |
| Detection wavelength | 495 nm | 495 nm |
| Power Supply | Uses power from PC USB port | Uses power from PC USB port |
| Returned light | Fluorescence | Fluorescence |
| Differences: | | |
| Enclosure | ASA+PC (Acrylonitrile Styrene
Acrylate + Polycarbonate) | ABS (Acrylonitrile Butadiene
Styrene) Plastic |
| Intensity | 3 mW/cm squared at 8mm | 3.5 mW/cm squared at 10mm |
| Light source | Utilizes 4 Violet LEDs with light
collecting lens. | Utilizes 6 Violet LEDs with light
collecting lens. |
| Comparison criteria | New device
VistaCam iX "Proof"
510K # K150672 | Predicate device
Air Technique's Spectra
Fluorescence Caries
Detection Device
510K #K090169 |
| Software: | VistaCam iX "Proof" driver
software and DBSWIN.
VistaCam iX "Proof" can only
be used with DBSWIN imaging
software | ATI Spectra driver software and
Visix. |
| Operating | 10-40 C | 10-40 C |
| environment | 20 to 75% RH non-condensing | 10 to 90% RH non-condensing |
| Length | 7.48 inches | 8.6 inches |
| Width | 1.03 inches | 0.87 inches |
| Height | 1.03 inches | 1.15 inches |
| Spacers | 8 mm | 10 mm |
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Discussion of Differences: 8.
- i. Enclosure: The material of composition for VistaCam iX "Proof" is substantially equivalent to that of Spectra enclosure as both these materials are non-carcinogenic and poses no health hazards as per their MSDSs. The enclosure of the VistaCam iX "Proof" was safety tested by Intertek to IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The enclosure of the Spectra was safety tested by Underwriters Laboratory to IEC 60601-1:1988 +A1:1991 +A2:1995, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- ii. Intensity: The intensity for VistaCam iX is 3 mW/cm squared at 8mm and for Spectra is 3.5 mW/cm squared at 10mm. The difference in intensity of these devices does not impact VistaCam iX "Proof's" performance, safety and effectiveness. VistaCam iX's performance is demonstrated in the document - Executed validation report.
- Light source and Lens: VistaCam iX "Proof" uses 4 violet LEDs and 2 iii. lenses whereas Spectra use 6 violet LEDs and 4 lenses. The difference in the number of lenses and LED's has geometrical and constructional/ design reasons.
The function of lens is to focus the image of an object (surface of a tooth) onto the image sensor (CCD). As the "Proof" spacers are "shorter" (8mm), the camera and thus the image sensor is closer to the surface
7
during image capturing. Therefore less lenses and LED's are needed for gaining a similar picture section and image quality. Most importantly, for both cameras, the recorded object area is nearly the same for the given distance, which is defined by the spacer.This difference in number of LEDs and lenses does not impact device's performance. VistaCam iX "Proof's" performance is demonstrated in the document - Executed validation report.
- iv. Software: VistaCam iX "Proof" works with VistaCam iX "Proof" driver software and Spectra device works with ATI Spectra driver software. Both VistaCam iX "Proof" and Spectra uses same algorithm developed for VistaCam iX by Duerr. VistaCam iX "Proof" can only be used with DBSWIN imaging software as opposed to Visix for Spectra. The compatibility of VistaCam iX "Proof" and DBSWIN is demonstrated by the DBSWIN software documents that are provided.
- Operating environment: The difference in the limits for relative humidity V. for VistaCam iX and Spectra is very minor and has no impact on the substantial equivalence of VistaCam iX.
- vi. Spacers: The 8 mm spacers for VistaCam iX "Proof" are exactly the same as the 10 mm spacers for Spectra in terms of shape and material* of construction. Moreover these are purchased from the same supplier. The 2 mm difference in the size of these spacers is not a significant change in their dimensions and thus has no impact on their performance and/or sterilization characteristics. The Sterilization validation study was performed on the 10 mm Spectra spacers in 2009 per ISO 11134:1994. Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization, by Nelson laboratories. Nelson has provided their rationale dated October 27, 2015 to support the validity of the Sterilization for Spectra Spacers performed to ISO 11134:1994 in 2009 and it's conformance to the requirements of current FDA recognized standard, ISO 17665-1. Sterilization of health care products moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
*Septon plus a UV stabilizer (2-5-chloro-2H-benzotriazole-2-yl)-6-(1,1dimethylethyl)- 4-methylphenol (CAS-No. 3896-11-5) with the restriction SML(T) =30 mg/kg.
8
Non-Clinical Data 9.
The purpose of the evaluation was to demonstrate substantial equivalence based on similar performance between the new device, the VistaCam iX "Proof"and the predicate device, Spectra Fluorescence Caries Detection Aid. Kev performance attributes tested and compared include:
- a. LED Illumination and output
- b. Image Quality
- c. Color Separation
Validation and verification test results showed that new device and the predicate device are equivalent, and that illumination and fluorescence of potential caries detection products are similar for both Dürr Dental AG's VistaCam iX "Proof" and Air Techniques' Spectra camera.
10. Performance Testing
Dürr Dental AG's VistaCam iX "Proof" complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (30 edition) - Medical electrical equipment -Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 (4" edition) - 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.
11. Biocompatibility Assessment
There is no biocompatibility issues known to be associated with any of the materials used to manufacture the VistaCam iX "Proof". 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 VistaCam iX "Proof" are isolated from patient contact by a camera cover or through a distance spacer. Components that have no patient contact are:
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- Hand piece housing ASA+PC (Acrylonitrile Styrene Acrylate + ● Polycarbonate)
- Lens window- Glass* .
- Handpiece control buttons Polyester ●
- Umbilical Silicone .
Components that contact the patient are:
- Camera cover* Ethylene methyl acrylate copolymer and low density polyethylene
- 8 mm Spacer* ●
- Septon plus a UV stabilizer (2-5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)- 4-methylphenol (CAS-No. 3896-11-5) with the restriction SML(T) =30 mg/kg
*These materials are currently in use and market distribution with the predicate device "Spectra Fluorescence Caries Detection Aid System" device, 510K# K090169.
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, Dürr Dental AG concludes that the VistaCam iX "Proof" 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.