(168 days)
The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.
The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images.
The iTero Lumina Pro consists of the following main components:
- A. Scanning Wand used for intraoral scanning.
- B. Wand Cradle used to hold the Scanning Wand when not in use.
- C. Application Software that includes Graphical User Interface ("GUI").
- D. Computer platform
The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle.
The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export.
The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.
The provided text does not contain detailed information about specific acceptance criteria and a study that comprehensively proves the device meets these criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with specific performance metrics against pre-defined acceptance criteria.
However, I can extract information related to performance data and testing methods mentioned in the "Performance Data" section to infer some aspects of device performance and the types of studies conducted.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for NIRI functionality or specific performance targets. Instead, it states that "All testing showed similar performance to the predicate system." This implies that the acceptance criterion was likely comparable performance to the predicate device across various technical attributes.
| Acceptance Criterion (Inferred from testing performed) | Reported Device Performance (Summary) |
|---|---|
| Field of View (NIRI) | Similar performance to the predicate system |
| Image Sharpness (NIRI) | Similar performance to the predicate system |
| Depth of Field (NIRI) | Similar performance to the predicate system |
| Illumination Power (NIRI) | Similar performance to the predicate system |
| Wavelength and Spectral Bandwidth (NIRI) | Similar performance to the predicate system (uses 850nm, same as predicate) |
| Specular Reflection Suppression (NIRI) | Similar performance to the predicate system |
| Signal to Noise Ratio (NIRI) | Similar performance to the predicate system |
| Wand barrier sleeve material properties | Met requirements for dental barriers (e.g., tensile strength, tear resistance, puncture, penetration) |
| Wand barrier sleeve finished assembly | Met requirements (Microbial Ingress Testing, Pull testing) and showed equivalent performance to predicate |
| Basic Safety (IEC 60601-1, IEC 80601-2-60, etc.) | Complies with relevant standards |
| Electromagnetic Compatibility (IEC 60601-1-2, FDA Gdn) | Complies with relevant standards |
| Usability (IEC 60601-1-6, IEC 62366-1) | Complies with relevant standards |
| Software Life-Cycle (IEC 62304, FDA Gdn) | Designed and developed according to standards |
| Cybersecurity (UL ANSI 2900-1, UL ANSI 2900-2-1, FDA) | Ensured by compliance with requirements |
| Biocompatibility (ISO 10993-series) | Patient contacting components shown to be biocompatible |
| Cleaning/Reprocessing (ANSI/AAMI ST98:2022, FDA Gdn) | Found to be reliably cleaned and validated |
2. Sample size used for the test set and the data provenance
The document explicitly states that the company performed "bench testing" to support substantial equivalence. It does not provide details on sample sizes for the NIRI performance attributes (Field of View, Image Sharpness, etc.). It mentions ASTM standards for material testing of the wand barrier sleeve, which would imply defined sample sizes per those standards, but these are not enumerated in the text. There is no information provided about the origin or nature of the "test set" data in terms of patient population (e.g., country of origin, retrospective or prospective).
The testing described appears to be primarily non-clinical bench testing rather than clinical study data involving patient samples or diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe a process for establishing ground truth using human experts for diagnostic accuracy. The performance data presented focuses on technical and engineering performance characteristics of the device itself (e.g., optical properties, material strength, electrical safety).
4. Adjudication method for the test set
Not applicable, as there is no description of a test set involving human interpretation and adjudication of diagnostic results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any MRMC study or AI assistance. The device is described as a "diagnostic aid" providing NIR images for a dentist's review. The NIRI functionality itself is the diagnostic aid, not an AI component assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance testing. The device's NIRI functionality generates images that are then reviewed by a dentist.
7. The type of ground truth used
For the technical and engineering tests described, the ground truth would be established by the specifications and performance characteristics of the predicate device and relevant international standards (e.g., for electrical safety, biocompatibility, material properties). For the NIRI imagery itself, the comparison is made against the predicate device's image output, not against a clinical "ground truth" like pathology for caries detection in this summary.
8. The sample size for the training set
Not applicable. The document describes a medical device generating images, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2024
Align Technology Ltd. % Kristin Zielinski Duggan Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
Re: K240573
Trade/Device Name: iTero Lumina™ Pro Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NTK, OJK Dated: July 26, 2024 Received: July 26, 2024
Dear Kristin Zielinski Duggan:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
iTero Lumina™ Pro
Indications for Use (Describe)
The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.
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 C)
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510(k) SUMMARY - K240573 Align Technology's iTero Lumina™ Pro System
Submitter
Align Technology Ltd. 1 Yitzhak Rabin Rd., Petach Tikva, 4925110, lsrael
Phone: +972544622662 email: atouati@aligntech.com Contact Person: Aviva Touati Date Prepared: August 14th, 2024
Name of Device: iTero Lumina™ Pro
Common or Usual Name: Caries Detector, Laser Light, Transmission
Classification Name: Laser fluorescence caries detection device
Regulation Number: 872.1745
Regulatory Class: Class II
Product Code: NTK
Predicate Device: iTero Element 5D (K193659), Align Technology Ltd.
Device Description
The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images.
The principles of operation of the three modalities are briefly described hereafter.
1) 3D Optical Impression
During the 3D optical impression scan, 450nm (Blue) and 520nm (Green) laser light dot patterns, are operated to create the 3D model.
-
- 2D Color Imaging
To capture the 2D color image, the intra-oral cameras are operated while the white LEDs are turned ON.
- 2D Color Imaging
-
- NIR Imaging
LEDs with a wavelength of 850nm transmit light through the tooth resulting in an image that translates the teeth structure (enamel and dentin) to different brightness levels. The healthy enamel appears dark and translucent, while dentin or caries lesions appear brighter and opaque.
- NIR Imaging
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The NIR Imaging modality is the focus of this submission.
The iTero Lumina Pro consists of the following main components:
- A. Scanning Wand used for intraoral scanning.
- B. Wand Cradle used to hold the Scanning Wand when not in use.
- C. Application Software that includes Graphical User Interface ("GUI").
- D. Computer platform
The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle.
The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export.
The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.
Intended Use / Indications for Use
The iTero Lumina Pro NIRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.
Summary of Technological Characteristics
NIR imaging is the technological principle for both the subject and predicate devices. For both the predicate and the subject device, the NIR LEDs create an 850nm wavelength illumination that transmits through a tooth and is captured by cameras. The NIR Image translates the teeth structure (enamel and dentin) to different brightness levels. The healthy enamel appears dark and translucent, while dentin or caries lesions appear brighter and opaque.
At a high level, the subject and predicate devices are based on the following same technological elements. The iTero Lumina Pro and the iTero Element 5D systems include similar hardware and software components designed to obtain and display NIR images for a dentist's review.
Both system's scanning wand comprise three different light sources, which are capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. In addition, the light sources operate in a substantially equivalent manner, given that they utilize periodical light source activation (i.e., alternating ON / OFF depending on the required modality: 3D optical impression, 2D color imaging and NIR imaging).
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Both devices employ a similar cross contamination prevention strategy in which the user is required to apply a new disposable wand barrier sleeve before each use. The scanning process is also similar in that the user selects the scanning features, places the wand tip slightly above the subject's teeth, initiates the scan by using the control buttons and moves the scanning wand above the area which is required to be scanned.
The subject and predicate devices differ in the number of cameras and sensors and the optical pathway of the emitted lights. While the predicate device encompasses two (2) NIR LEDs and one (1) camera, the subject device has multiple NIR LEDs and cameras and thus can simultaneously acquire NIR images from several angles. In contrast, the predicate device requires more manipulation during scanning in order to capture images from several angles.
The predicate device displays the NIR images both in real time and offline, while the subject device presents the NIR images only upon completion of the scan. Despite this minor difference, both devices meet the clinical need of evaluating the NIR images to aid in diagnosis and monitoring the progress of potential interproximal caries. Clinicians do not typically evaluate the NIR images for aiding in diagnosis during scanning, but rather the evaluation occurs at the end of the scan, making this difference inconsequential.
Both the subject and predicate devices share the same indications for use.
| iTero Lumina ProK240573(Subject device) | iTero Element 5DK193659(Predicate device) | |
|---|---|---|
| Indications for Use/Intended Use | The iTero Lumina Pro NIRIfunctionality is a diagnosticaid for the detection ofinterproximal carious lesionsabove the gingiva and formonitoring the progress ofsuch lesions. | The iTero Element 5D is adiagnostic aid for thedetection of interproximalcaries lesions above thegingiva and for monitoringthe progress of such lesions. |
| User Population | Dentist | Dentist |
| Design | Hand-held device | Hand-held device |
| Main Device Components | Hand-held device with USB,cable, software andcomputer. | Hand-held device with USB,cable, software andcomputer. Alternatively,software is installed on apersonal computer thatmeets performanceparameters defined by thecompany. |
| iTero Lumina ProK240573(Subject device) | iTero Element 5DK193659(Predicate device) | |
| Functional Principle | Transillumination: Based onthe principle that the toothenamel is translucent to NIRlight hence its image appearsdark, while dentin and carieslesions scatter NIR lighthence their image appearsbright. | Transillumination: Based onthe principle that the toothenamel is translucent to NIRlight hence its image appearsdark, while dentin and carieslesions scatter NIR lighthence their image appearsbright. |
| NIRI Light Source | Infrared light emitting diode(LED)s are used to generateexactly 850nm wavelengthwhich are detected by theCMOS sensor. | Infrared light emitting diode(LED)s are used to generateexactly 850nm wavelengthwhich are detected by theCMOS sensor. |
| Installation | The computer-basedinstallation enables thecustomer to install andupdate the software. | The computer-basedinstallation enables thecustomer to install and updatethe software. |
| Power Source | The power supply of thewand is USB-15V | The power supply of the wandis USB-15V |
| Software | The software consists of aproduct firmware and acomputer-based software,which controls: - Display ofpictures - stores/-saves thepictures - Live streamcontrolling of camerafunctions, such as brightnessand contrast. | The software consists of aproduct firmware and acomputer-based software,which controls: - Display ofpictures - Stores/saves thepictures - Live streamcontrolling of camerafunctions, such as brightnessand contrast. |
| Standards with which theDevice Complies | IEC 60601-1 | IEC 60601-1 |
| Compatibility | USB connection | USB connection |
| Cross contaminationcontrol | A single use, disposable,wand barrier sleeve. | A single use, disposable,wand barrier sleeve. |
| Wavelength | 850 nm | 850 nm |
| iTero Lumina ProK240573(Subject device) | iTero Element 5DK193659(Predicate device) | |
| Illumination Type | Pulsed Illumination - methodof illumination that consistsof periodical light sourceactivation. i.e. alternatingON(pulse)/OFF states. | Pulsed Illumination - methodof illumination that consists ofperiodical light sourceactivation. i.e. alternatingON(pulse)/OFF states. |
The table below provides a comparison of the fundamental technological characteristics of the iTero Lumina Pro System and those of its predicate device.
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align | 兴 invisalign® | iTero
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Image /page/8/Picture/0 description: The image shows the logos for Align Technology and its products. The first logo is for "align" with a blue dot above the letter "i". The second logo is for "invisalign" with a flower-like symbol to the left of the word. The third logo is for "itero".
Performance Data
The company has performed bench testing to support the substantial equivalence of the iTero Lumina Pro to the predicate device.
For the Near Infrared Imaging (NIR) functionality, key performance attributes tested included: Field of View, Image Sharpness and Depth of Field, illumination Power, Wavelength and Spectral Bandwidth, Specular Reflection Suppression, and Signal to Noise Ratio. All testing showed similar performance to the predicate system.
Testing for the Lumina Pro wand barrier sleeve testing met requirements for dental barriers regulated under 21 C.F.R §878.4370 and demonstrated equivalent performance as the predicate device wand barrier sleeve. The testing included the following:
- Material testing of the iTero Lumina Pro wand barrier components was conducted in o accordance with ASTM D882-12 (tensile testing), ASTM D1004-13 (tear resistance), ASTM F1342/F1342M-05 and ASTM D2582-16 (puncture resistance), ASTM F1670/F1670M-17a (penetration resistance), and additional internally derived test protocols.
- Finished assembly testing of the wand barrier sleeve including Microbial Ingress o Testing, Pull testing in accordance with ASTM D3330/D3330M-04(18), and additional internally derived test protocols.
Basic Safety and Electromagnetic Compatibility (EMC) testing confirmed the iTero Lumina Pro complies with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), IEC 80601-2-60 (Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment), IEC 60601-1-6 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability), IEC 62366-1 (Application of Usability Engineering to Medical Devices), IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests), FDA Guidance on Electromagnetic Compatibility (EMC) of Medical Devices issued in June 2022 and, FDA Guidance on Radio Frequency Wireless Technology in Medical Devices issued in August 2013, along with lamps and laser safety standards including IEC 62471, Photobiological safety of lamps and lamp systems and IEC 60825-1, Safety of laser products – Part 1: Equipment classification, requirements and user's guide.
The iTero Lumina Pro software application has been designed and developed according to IEC 62304 (Medical Device Software Life-Cycle Processes) and FDA Guidance on Content of Premarket Submissions for Device Software Functions issued in June 2023.
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Cybersecurity is ensured by compliance with the requirements of UL ANSI 2900-1 (Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements), UL ANSI 2900-2-1 (Standard for Safety Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems), and the FDA Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued in September 2023.
Patient contacting components were shown to be biocompatible for their intended use per the recognized consensus standards in the ISO 10993-series. The device was found to be reliably cleaned through validated cleaning methods, including intermediate disinfection level validation of the wand and cradle, that comply with the requirements of ANSI/AAMI ST98:2022 standard and FDA Guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued in March 2015 and Appendix E which was updated in June 2017.
Conclusions
The iTero Lumina Pro System is as safe and effective as the predicate device, the iTero Element 5D. The iTero Lumina Pro System has the same intended use and indications for use, and similar technological characteristics, and principles of operation as its predicate device. The minor differences in design do not alter the intended clinical use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the iTero Lumina Pro System and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the iTero Lumina Pro System is as safe and effective as the iTero Element 5D. Thus, the iTero Lumina Pro System is substantially equivalent.
§ 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.