(437 days)
rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
rainbow MCT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
This document describes the premarket notification (510(k)) for the Dentium Co., Ltd rainbow MCT (K200270), a computed tomography x-ray system. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study of an AI algorithm. Therefore, many of the requested criteria related to AI performance, such as multi-reader multi-case (MRMC) studies, effect sizes, and specific details about training/test set ground truth establishment for AI, are not applicable or not explicitly detailed in this document, as the device itself is an imaging system and not an AI/ML software.
The document primarily discusses the technical and performance characteristics of the imaging device itself, ensuring it meets standards comparable to existing predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal "acceptance criteria" table in the way one might see for an AI algorithm's performance metrics (e.g., AUC, sensitivity, specificity targets). Instead, it compares the rainbow MCT's technical specifications and imaging performance metrics against those of predicate devices (K181432, ProVecta 3D Prime with VistaSoft; and K102196, PaX-Zenith3D). The "acceptance" is implied by demonstrating similar or better performance compared to these legally marketed devices.
| Metric / Characteristic | Acceptance Target (Implied: Similar/Better than Predicate) | rainbow MCT (K200270) Reported Performance | Predicate (K181432) Reported Performance | Reference (K102196) Reported Performance (where available) |
|---|---|---|---|---|
| Image Acquisition Modes | Panoramic and computed tomography | Panoramic and computed tomography | Panoramic and computed tomography | Not explicitly stated for modes, but is a CT system |
| Tube Voltage | Comparable to predicate | 60-100 kV | 50-99 KV | Not explicitly stated |
| Tube Current | Comparable to predicate | 4-12 mA | 4-16mA | Not explicitly stated |
| Focal Spot Size | Comparable to predicate | 0.5 x 0.5 mm | 0.5 mm | Not explicitly stated |
| Exposure Time | Comparable to predicate | Max. 19 s | Max. 16.4s | Not explicitly stated |
| Slice Width | Comparable to predicate | 0.1 mm min. | 0.1 mm min. | Not explicitly stated |
| Total Filtration | Comparable to predicate | 2.5 mm Al | 2.8 mm Al | Not explicitly stated |
| Software | DICOM 3.0 compatible | Rainbow 3D ImageViewer, DICOM 3.0 compatible | VistaSoft, DICOM 3.0 compatible | Not explicitly stated for software |
| Anatomical Sites | Maxillofacial | Maxillofacial | Maxillofacial | Not explicitly stated |
| Image Receptor (CT & Panoramic) | Similar or better MTF, DQE, Pixel Resolution | DTX3024 | Xmaru1404CF | Xmaru2430CF, Xmaru1524CF, Xmaru1501CF |
| MTF @ 1 lp/mm | Similar or better than predicate | 50% | 53% | 53%, 52%, 50% |
| DQE @ 0.5 lp/mm | Similar or better than predicate | 63% | 64% | 64%, 45%, 60% |
| Size of Imaging Volume (cm) | Comparable to predicate for range of FOVs | DTX3024: Max. 10x8, 23x21 | Xmaru1404CF: Max. 10x8.5 | Xmaru2430CF (FOV 24x19cm), Xmaru1524CF (FOV 15x16cm) |
| Pixel Resolution (CBCT) | Similar or better than predicate | DTX3024: 5 lp/mm (1x1) | 2.5 lp/mm (4x4 binning) | 2.5 lp/mm (4x4 binning) |
| Pixel Resolution (Panoramic) | Similar or better than predicate | DTX3024: 5 lp/mm (1x1) | 2.5 lp/mm (4x4 binning) | 5 lp/mm |
| Pixel Size (CBCT) | Similar or better than predicate | DTX3024: 100 µm | Xmaru1404CF: 99 µm (2x2 binning), 198 µm (4x4 binning) | 200 µm |
| Pixel Size (Panoramic) | Similar or better than predicate | DTX3024: 100 µm | Xmaru1404CF: 99 µm (2x2 binning), 198 µm (4x4 binning) | 100 µm |
Summary of differences and claims: The document states, "The MTF, DQE and pixel resolution of the subject device performed similar or better than those of the predicate and reference device. All test results were satisfactory."
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical testing of the device's physical and technical performance (e.g., electrical, mechanical, environmental safety, EMC, imaging properties per IEC standards). It does not refer to a "test set" in the context of a dataset of patient images used to evaluate an AI algorithm's diagnostic performance. Therefore, sample size and data provenance (country, retrospective/prospective) for a patient image test set are not applicable here.
The tests performed were:
- Electrical, mechanical, environmental safety testing according to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63.
- EMC testing in accordance with IEC 60601-1-2.
- Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices."
- Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5.
All these refer to technical and performance benchmarks, often using test phantoms or controlled environments, not patient data for diagnostic accuracy assessment.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. As this is a 510(k) for an imaging device, not an AI diagnostic algorithm, there's no mention of experts establishing ground truth from patient images for a diagnostic performance study. The ground truth for the performance characteristics (e.g., MTF, DQE) is inherent to the physical properties of the imaging system and measured using standardized methods and phantoms.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic image test set or human interpretation adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done, as the submission is for the imaging device itself, not an AI-assisted interpretation tool. The document explicitly states: "Clinical Data: Not required for a finding of substantial equivalence."
6. Standalone (Algorithm Only) Performance
Not applicable. This submission is for a medical imaging device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is based on technical specifications and measurements obtained through standardized testing procedures using phantoms and controlled setups (e.g., MTF, DQE measurements, electrical safety tests). It is not based on expert consensus, pathology, or outcomes data from patient cases in a diagnostic context.
8. Sample Size for the Training Set
Not applicable. The device is a hardware imaging system; it does not involve machine learning or training on a dataset of patient images.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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April 16, 2021
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Dentium Co., Ltd (ICT Branch) % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 HOUSTON TX 77054
Re: K200270
Trade/Device Name: rainbow MCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: March 10, 2021 Received: March 15, 2021
Dear Mr. Kim:
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.
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
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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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200270
Device Name rainbow MCT
Indications for Use (Describe)
rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K200270
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
| 1. | Date Summary Prepared: | March 10,2021 |
|---|---|---|
| 2. | Submitter's Identification: | |
| Submitter's Name :Submitter's Address: | Dentium Co., Ltd (ICT Branch)76, Changnyong-daero 256beon-gil, Yeongtong-gu,Suwon-si, Gyeonggi-do, 16229Republic of Korea | |
| Submitter's Telephone: | ++82-70-7098-6932 | |
| Contact person: | Mr. Sang Woo Lee (swlee1@dentium.com) | |
| Official Correspondent:(U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) | |
| Address:Telephone: | 7707 Fannin St. Ste 200, Houston, TX 77054+1- 713-467-2607 |
3. Device:
| Trade /Proprietary Name: | rainbow MCT |
|---|---|
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number | 892.1750 |
| Device Class | II |
4. Predicate Device:
| Legally Marketed Predicate Device Information: | |
|---|---|
| 510(k) Number: | K181432 |
| Trade /Proprietary Name: | ProVecta 3D Prime with VistaSoft |
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | II |
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5. Reference Device:
Legally Marketed Predicate Device Information:
| 510(k) Number: | K102196 |
|---|---|
| Trade / Proprietary Name: | PaX-Zenith3D |
| Regulation Description: | Computed tomography x-ray system |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | II |
6. Device Description:
-
rainbow MCT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
-
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
7. Indications for use:
rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
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8. Summary of the technological characteristics of the device compared to the predicate devices:
| Descriptive Information | Rainbow MCTK200270 | K181432, ProVecta 3D Primewith VistaSoft (DÜRR DENTAL) | |
|---|---|---|---|
| Indications for Use | - rainbow MCT is a computedtomography x-ray system intendedto produce 3D and panoramicdiagnostic images of themaxillofacial areas for treatmentplanning for adult and pediatricpatients. The device is operatedand used by physicians, dentists,and x-ray technicians.Rainbow 3D Image Viewer softwarefeatures functions for acquiring,saving, searching, displaying,diagnosing and sending digital X-rayimage data in dental practices andclinics. | ProVecta 3D Prime is computedtomography x-ray unit intended togenerate 3D and panoramic X- rayimages in dental radiography foradult and pediatric patients. Itprovides diagnostic details of themaxillofacial areas for a dentaltreatment. The device is operatedand used by physicians, dentists, andx-ray technicians.Not intended for mammography use.The VistaSoft software featuresfunctions for recording, displaying,analyzing, diagnosing, managing andsending digital or digitized video andX-ray images in dental practices andspecialist dental clinics. Not intendedfor mammography use | |
| Image Acquisition Modes | Panoramic and computedtomography | Panoramic and computedtomography | |
| Input Voltage | AC 100-240 V, 50/60 Hz | AC 200-240V | |
| Tube Voltage | 60~100 kV | 50-99 KV | |
| Tube Current | 4~12 mA | 4~16mA | |
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 mm | |
| Exposure Time | Max. 19 s | Max. 16.4s | |
| Slice Width | 0.1 mm min. | 0.1 mm min. | |
| Total Filtration | 2.5 mm Al | 2.8 mm Al | |
| Chin Rest | Bite block, chin rest and headrest | Bite block, chin rest and headrest | |
| Mechanical | Compact design | Compact design | |
| Electrical | LDCP logic circuit (Low Dark CurrentProcessing) | LDCP logic circuit (Low Dark CurrentProcessing) | |
| Software | Rainbow 3D ImageViewer, DICOM3.0 Format compatible | VistaSoft, DICOM 3.0 compatible | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| ImageReceptorNote: CT and | Panoramic | DTX3024 | Xmaru1404CF |
| CBCT | DTX3024 | Xmaru1404CF | |
| panoramicimageperformanceis identicalbecause thesensors areidentical. | MTF@ 1lp/mm | 50% | 53% |
| DQE @ 0.5lp/mm | 63% | 64% | |
| Size of ImagingVolume (cm) | DTX3024: Max. 10x8, 23x21 | Xmaru1404CF : Max. 10x8.5 | |
| Pixel Resolution | CBCT | DTX3024: 5 lp/mm | 2.5 lp/mm - 4x4 binning |
| Panoramic | DTX3024: 5 lp/mm | 2.5 lp/mm - 4x4 binning | |
| Pixel Size | CBCT | DTX3024 :100 μm | Xmaru1404CF : 99 μm -2x2 binning198 μm- 4x4 binning |
| Panoramic | DTX3024:100 μm | Xmaru1404CF : 99 μm -2x2 binning198 μm- 4x4 binning |
Summary of the Technological Characteristics
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9. Rainbow MCT detectors VS. PaX-Zenith 3D Detectors
| Rainbow MCT(K200270) | Pax-Zenith3D (K102196) | ||||
|---|---|---|---|---|---|
| Imagingdetector forCT andpanoramicmode | CBCT | DTX3024 (10x8, 23x 21cm) | Xmaru2430CF(FOV 24 x 19cm) | Xmaru1524CF(FOV 15 x 16cm) | |
| Panoramic | DTX3024 | Xmaru1501CF | |||
| ImagingPerformance | MTF@ 1lp/mm | 50% | 53% | 52% | 50% |
| DQE @ 0.5lp/mm | 63% | 64% | 45% | 60% | |
| Size of ImagingVolume (cm) | |||||
| Pixel Resolution | CBCT | 5 lp/mm - 1x1 | 2.5 lp/mm - 4x4binning | ||
| Panoramic | 5 lp/mm - 1x1 | 5 lp/mm | |||
| Pixel Size | CBCT | 100 μm | 200 μm- | 200 μm- | |
| Panoramic | 100 μm | 100 μm |
10. Discussion of Similarities and Differences:
Rainbow MCT dental computed tomography X-ray system described in this 510(k) is similar to the predicate device in its indications for use, performance, materials, and safety characteristics.
The differences include the digital X-ray imagers and image viewing software. The subject device offers FOV 10x8 & 23x21 cm whereas the predicate device and the reference device provide FOV 10.8.5 and 24x19 cm, respectively. Performance testing was conducted for the subject device to access whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. The MTF, DQE and pixel resolution of the subject device performed similar or better than those of the predicate and reference device.
All test results were satisfactory.
11. Non-Clinical Data and Performance Testing
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(2005, AMD 1: 2012), IEC 60601-1-3 (2008 + A1: 2013), IEC 60601-2-63 (2012,041: 2017) )were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2 (2014).
rainbow MCT meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
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Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 was performed. All test results were satisfactory.
-
- Clinical Data: Not required for a finding of substantial equivalence.
13. 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, Dentium Co., Ltd concludes that the rainbow MCT is substantially equivalent to ProVecta 3D Prime with VistaSoft (K181432), the predicate device, and Pax-Zenith3D (K102196), the reference 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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.