(137 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description of the device's functional principle relies on optical scanning and image processing without indicating advanced algorithmic learning.
No.
The device is intended for aid in diagnosis of caries, which is a diagnostic function, not a therapeutic one. It uses optical scanning to collect images and software to process them for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for aid in diagnosis of caries," and the "Device Description" reiterates this, confirming its role in the diagnostic process.
No
The device description explicitly states that the system consists of a scanner and a detachable scanner tip, which are hardware components. While it includes software (ScanSuite TRIOS and TRIOS Patient Monitoring software), it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The L1P-1F intraoral scanner directly scans the teeth in situ (within the mouth). It does not analyze a sample like blood, urine, tissue, etc., that has been removed from the body.
- The intended use is for "aid in diagnosis of caries" by scanning the teeth. This is a direct examination of the anatomical site, not an analysis of a biological specimen.
While the device uses light and fluorescence to gather information that aids in diagnosis, the mechanism is direct imaging of the teeth, not the analysis of a biological sample.
N/A
Intended Use / Indications for Use
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
Product codes (comma separated list FDA assigned to the subject device)
NBL
Device Description
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.
The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user.
The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.
The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence
Anatomical Site
Teeth (occlusal and surface)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The L1P-1F System is to be operated by legally qualified health care professionals in dental clinics.
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)
Key performance attributes tested and compared include:
-
- Fluorescence scanning
-
- Color Separation
-
- In vitro caries detection study
-
- Spatial resolution
The results of the performance testing demonstrates that L1P-1F is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than the predicate device.
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.
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2022
3Shape TRIOS A/S Klaus Hoj Senior Regulatory Affairs Specialist Holmens Kanal 7 Copenhagen K, Dk-1060 DENMARK
Re: K221249
Trade/Device Name: L1P-1F (TRIOS 5) Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: August 12, 2022 Received: August 18, 2022
Dear Klaus Hoj:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221249
Device Name TRIOS 5 (L1P-1F)
Indications for Use (Describe) The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
|__ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) PREMARKET NOTIFICATION 3SHAPE L1P-1F SYSTEM
510(K) SUMMARY - K221249
Date Summary Prepared
15 September 2022
Submitter's Identification
3Shape TRIOS A/S Holmens Kanal 7 DK-1060 Copenhagen K Denmark Phone: +45 7027 2620 E-mail: info@3Shape.com Web: www.3Shape.com
Contact: Klaus Rudbæk Høj Senior Regulatory Affairs Specialist Direct phone: +45 3148 8032 E-mail: Klaus r@3Shape.com
US Agent: F. David Rothkopf MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 Phone: 617-899-3449 E-mail: Drothkopf@MEDIcept.com
Device Identification
| Trade / Proprietary
| Name: | TRIOS 5 |
|---|---|
| Models: | L1P-1F |
| Common Name: | Intraoral optical scanning system including aid in diagnosis of caries, |
| pod with wireless scanner | |
| Requlation number: | |
| Regulation Name: | 21 CFR 872.1745 |
| Laser fluorescence caries detection device. | |
| Product Code: | |
| Classification: | |
| Panel: | NBL |
| Class II | |
| Dental (76) |
4
Predicate Device
DÜRR DENTAL AG – VistaCam iX "Proof" – K150672
Device Description
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.
The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user.
The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.
The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.
Indications for Use
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.
Summary of the technological characteristics of the new device compared to predicate device
The L1P-1F system is substantially equivalent in terms of indications for use and technology to the VistaCam iX "Proof" manufactured by Dürr Dental AG, which currently is in commercial distribution and FDA cleared under 510(k) #K150672.
Table 1 below, summarizes the technological characteristics of the L1P-1F system vs. the predicate device.
5
Table 1 Comparison to the predicate device
| Comparison
criteria | New Device
L1P-1F (TRIOS 5)
#K221249 | Predicate Device
VistaCam iX "Proof" 510(k)
#K150672 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner / Operator | 3Shape TRIOS A/S | Dürr Dental AG |
| Manufacturer | 3Shape TRIOS A/S | Dürr Dental AG |
| | Comparison | |
| Intended Use | The L1P-1F intraoral scanner
(IOS) system is intended to aid
in the detection of tooth decay
by measuring increased laser
induced fluorescence. | Caries detection aid |
| Indications for Use | The L1P-1F intraoral scanner
(IOS) system is intended for aid
in diagnosis of caries. | The VistaCam iX "Proof" is
intended to be used as an aid in
the detection and diagnosis of
dental caries. |
| Intended Users | The L1P-1F System is to be
operated by legally qualified
health care professionals in
dental clinics. | Dentists and dental personnel. |
| Main parts | Scanner
Detachable scanner tip
Communication software
between external operating
system and scanner | Handpiece
Interchangeable head (Proof)
Handpiece holder
USB connection cable
Communication software
between PC and handpiece |
| Accessories and
Components | Scanner holder (pod)
Wireless dongle
Protection tip
Batteries and charger
Software
Body Sleeve | Spacers
Hygienic protective cover |
| Variants | Different packaging
configurations | There are different packaging
configurations including
different heads. |
| Technology | Technology to obtain 3D digital
images based on white light
illumination and fluorescence
technology to aid in diagnosis of
caries. | Fluorescence technology to aid
in the detection of carious
lesions. |
| Mode of Operation | The blue-violet light causes
tooth structures and bacterial
metabolites to fluoresce. | The blue-violet light causes
tooth structures and bacterial
metabolites to fluoresce |
| Light Source | 1 White LED (broad emission
spectrum in the visible) + 2 Blue | 4 LEDs at 405 nm (blue-violet
light) |
| Comparison
criteria | New Device
L1P-1F (TRIOS 5) | Predicate Device
VistaCam iX "Proof" 510(k)
#K150672 |
| | LEDs at 405 nm (blue-violet
light) | |
| Detection
Wavelength | Green to red visible light,
435 nm | Green to red visible light,
495 nm peak wavelength |
| Power Supply | Power from batteries | Uses power from PC USB port |
| Connectivity | Wireless | Wired |
| Software | TRIOS Module (imaging
software)
ScanSuite TRIOS (advanced
driver software)
TRIOS Patient Monitoring (caries
detection aid software) | VistaCam iX "Proof" driver
software and DSBWIN.
VistaCam iX "Proof" can only be
used with DBSWIN imaging
software |
| Image Evaluation | 3D image color indicating caries
stage
Red: Moderate/Extensive
Yellow: Initial
White: Insufficient scan
The colors of the diagnostic
overlay are derived from the
fluorescence texture recorded
from the tooth substance | 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. |
| Spatial Resolution | Obtained from many 2D images
at different focus positions
stitched together | N/A. No publicly available
information on spatial resolution
performance. |
| Returned Light | Reflection for white LED
illumination
Fluorescence for blue LED
illumination | Fluorescence |
| Operating
Environment | Ambient temperature range: 15-
26°C
Relative humidity: 10-85%
(non-condensing)
Atmospheric pressure: 800-1100
hPa
The scanner should be used in
an environment maintaining a
consistent room temperature | Ambient conditions during
operation:
Temperature range: 10-40°C
Relative humidity: 20-75%
(non-condensing)
Air pressure: 800-1060 hPa |
| Materials | Scanner:
Shell: Polycarbonate
Battery inlet: PC/ABS
Scanner tip: | Handpiece housing:
ASA + PC (Acrylonitrile Styrene
Acrylate + Polycarbonate)
Handpiece control buttons: |
| Comparison
criteria | New Device
L1P-1F (TRIOS 5) | Predicate Device
VistaCam iX "Proof" 510(k)
#K150672 |
| | PSU
Scanner tip window:
Sapphire with FDTS and Al2O3
Protection tip:
PSU | Polyester Umbilical – Silicone
Camera cover: Ethylene methyl
Lens window: Glass |
| Components
impacting
reprocessing | Scanner tip
Body Sleeve | Camera cover
Spacer |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 10993-12
ISO 10993-17
ISO 10993-18
ISO 10993-23 | ISO 10993-5
ISO 10993-10 |
| Method of
sterilization | Autoclave (scanner tip) | Autoclave (only spacer) |
| Electrical Safety &
EMC | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2
IEC 80601-2-60 |
6
7
Discussion of Differences
Power Source / Connectivity
The VistaCam iX "Proof" only comes in a wired version whereas the L1P-1F is made in a wireless variant where the power source is batteries.
The batteries are certified and tested according to IEC 62133-2:2017 ('Secondary cells and batteries containing alkaline or other non-acid electrolytes. Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications').
The wireless part complies with 47 CFR, Part 15, and has been tested to comply with IEC 60601-1-2:2014 ('Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances. Requirements and tests').
Light Source
The L1P-1F includes two types of LEDs as the light source: one white LED (for 3D image generation) and two blue LEDs (405 nm) as contrary to the predicate device which has four LEDs with blue-violet light (405 nm). The arrangement with two blue LEDs yields sufficient performance for fluorescence detection.
8
The LEDs have been tested and assessed to be in Risk Group 1 (Low-Risk) according to IEC 62471:2008 ('Photobiological safety of lamps and lamp systems').
Detection wavelength
The L1P-1F and predicate device are detecting similar wavelengths and the images are equivalent.
Detection wavelength is >435 nm for L1P-1F and 495 nm for the predicate device. Both devices detect green to red visible light (in particular, L1P-1P for wavelengths above 435 nm).
It is assumed that the predicate device detection wavelength of 495 nm refers to the wavelength of highest sensitivity.
Software
The software package for the L1P-1F consists of the following parts: TRIOS Module (imaging software), ScanSuite TRIOS (advanced driver software), and TRIOS Patient Monitoring (caries detection aid software).
The software package for the VistaCam iX "Proof" consists of the VistaCam iX "Proof" driver software and DSBWIN. VistaCam iX "Proof" can only be used with DBSWIN imaging software.
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The software has been validated according to EN 62304:2006+A1:2015, Medical Device Software Life-Cycle Processes.
Image Evaluation
The color categories used by the two devices to aid image interpretation are named differently.
The predicate device presents four caries severity categories, while the L1P-1F presents two severity caries categories. Table 2 shows how they correspond to each other.
Table 2 Color categories
| VistaCam iX Proof | L1P-1F |
|---|---|
| Early-stage caries, | |
| incipient enamel caries | Initial |
| Enamel caries up to enamel/dentine junction | Initial |
| Dentin junction already exceeded | Initial |
| Deep dentin caries | Moderate/Extensive |
L1P-1F is following the merged codes of the International Caries Detection and Assessment System (ICDAS) summarizing the first three categories of the VistaCam stages into one.
510(K) SUMMARY
9
With the intended use to aid caries diagnosis, the important clinical performance characteristic is to distinguish between a healthy tooth surface and a surface with initial decay or early-stage lesion. The additional caries severity categories that are provided in the predicate device are not expected to trigger any difference in the equivalent clinical performance and safety of caries assessments. However, these early caries stages would usually receive the same non-operative treatment approach by the dental practitioners and the distinction between them would therefore be of less clinical significance as well as reliability.
Spatial Resolution
The spatial (3D) model is obtained from many 2D images at different focus positions stitched together by the imaging software.
There is no publicly available data on spatial resolution for the predicate device. But a qualitative comparison of obtained shows that the resolution of L1P-1F must be at least as good or better than the predicate device.
Components impacting reprocessing
Both L1P-1F and the predicate device have exchangeable tips for scanning and single-use covers.
The predicate device has a protective cover which covers the entire scanner and thus acts as a microbial barrier. The microbial barrier for L1P-1F consists of a protective cover (Body Sleeve) and an autoclavable tip. The Body Sleeve is designed to cover the body of the scanner as well as the base of the detachable tip, which is closed with a window in the front end.
The Body Sleeve has been evaluated to ensure that requirements for clearance of dental barriers and sleeves requlated under 21 C.F.R §878.4370, FDA product code PEM, are met. This included evaluation of tear resistance, tensile strength, puncture resistance, viral penetration, and synthetic blood penetration.
The microbial barrier functionality of the scanner tip has been tested to show that no viral ingress through the tip window will reach the scanner body as tested using the test organism described in ASTM F1671/F1671M-22.
In conclusion, the microbial barrier properties implemented for the L1P-1F system are equivalent to the predicate device and ensures that cleaning and intermediate-level disinfection can be recommended for the scanner body between patients.
Non-Clinical Data
Key performance attributes tested and compared include:
-
- Fluorescence scanning
-
- Color Separation
-
- In vitro caries detection study
-
- Spatial resolution
10
The results of the performance testing demonstrates that L1P-1F is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than the predicate device.
Performance Testing
Electrical Safety / Electromagnetic Compatibility (EMC)
Testing was performed for the L1P-1F and complies with:
- . IEC 60601-1:2005/AMD1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- . IEC 60601-1-2:2014 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests)
- . IEC 62366-1:2015+ A1:2020 (Medical Devices - Part 1: Application of Usability Engineering to Medical Devices).
Biocompatibility Testing
Patient contact components were evaluated according to relevant recognized standards in the ISO 10993-series. It was concluded that there are no biocompatibility concerns for any of the materials used to manufacture the L1P-1F.
Sterilization
The L1P-1F is not sold as a sterile device.
The Scanner tip is required to be processed prior to first use and between patients. Testing to support recommended methods for reprocessing was performed in accordance with AAMI TIR12:2010 ('Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical manufacturers') and AAMI TIR30:2011+R2016 ('A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices').
Conclusion
The proposed device, the L1P-1F, is substantially equivalent to the predicate device Vistacam iX "Proof".
The differences between the proposed and predicate device do not impact the safety and effectiveness of the proposed device. Performance testing supports that L1P-1F is substantially equivalent to the legally marketed predicate device.