(253 days)
The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists.
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic images by rotating arm to get the recombination data, X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector, When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense, On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-rav is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
The DENTRIα Series are classified as shown below.
DENTRIa: CT Mode + PANORAMA Mode
DENTRI-Ca: CT Mode + PANORAMA Mode + CEPHALO Mode (ONE-SHOT)
DENTRI-Sa: CT Mode + PANORAMA Mode + CEPHALO Mode (SCAN)
This document is a 510(k) summary for the DENTRIα series of Computed Tomography (CT) X-Ray imaging devices. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the context of a clinical trial for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth establishment, sample sizes, and expert adjudication for an AI device is not explicitly present in the provided text.
However, I can extract the information that is available and indicate where the requested details are not provided due to the nature of this type of submission (a 510(k) for a medical imaging device, not an AI/CAD system).
Here's an attempt to answer based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" for diagnostic performance in the way one would for an AI/CAD system (e.g., sensitivity, specificity thresholds). Instead, it focuses on comparative performance with predicate devices for technical characteristics and demonstrating diagnostic quality through non-clinical and limited clinical data.
The "reported device performance" is primarily presented as technical specifications and compliance with standards, and a general statement about diagnostic quality.
| Category | Acceptance Criteria (Not explicitly stated as such for diagnostic performance, implied by substantial equivalence) | Reported Device Performance (Comparative to Predicate Devices #1 and #2) |
|---|---|---|
| Intended Use | Equivalent to predicate devices | Similar: Diagnosing general dental treatments, orthodontic purposes using Panoramic and Cephalometric images, and Otolaryngology by capturing 360-degree rotation of head and neck areas (ENT and dentomaxillofacial) for 3D X-ray tomographic images in adult and pediatric dentistry. Used by physicians, dentists, and X-ray technologists. |
| Operation Mode | Equivalent to predicate devices | Same: CT, Panorama, Cephalo (One shot type & Scan type) |
| Image Properties | Adequate for diagnostic purposes, comparable to predicate devices for safety and effectiveness. | Detectors: Flat panel for CT/Panorama/One-shot Cephalo, CCD for Scan Cephalo. (Details in Section 5, "Description of the Device," and Section 8, "Substantial Equivalence," comparing specific models, resolution, pixel size, MTF, DQE, and active area to predicate devices. Slight differences in MTF and DQE noted but deemed not to affect safety/effectiveness for diagnosis.) |
| Dose Information | Within acceptable limits and comparable to predicate devices, not exceeding 50% of IEC 60601-2-63 requirements. | CT Mode (CTDIw): 11.12 mGy (Proposed) vs. 8.34 mGy (Predicate #1) and 10.61 mGy (Predicate #2). Panorama (DAP): 198.8 mGy·cm² (Proposed Xineos-1313), 119.0 mGy·cm² (Proposed PaxScan1313DX) vs. 159.0 mGy·cm² (Predicate #2). Cephalo One shot (DAP): 26.7 mGy·cm² (Proposed) vs. 38.4 mGy·cm² (Predicate #2). Cephalo Scan (DAP): 21.3 mGy·cm² (Proposed) vs. 65.8 mGy·cm² (Predicate #2). Differences are within acceptable range and do not exceed 50% of IEC 60601-2-63. |
| Safety Standards | Compliance with relevant international standards. | AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 61223-3-4, and 21 CFR 1020.30, 31, and 33. |
| Software | Designed and developed according to a software development process, verified, and validated (MODERATE level of concern). | Original and OTS software (image viewer) used. Reconstruction type is FBP. Complies with FDA guidance "The content of premarket submissions for software contained in medical devices, on May 11, 2005." |
2. Sample size used for the test set and the data provenance
The document mentions "clinical images of patients are presented as the clinical data including date and signature by a licensed professional." However, it does not specify the sample size (number of patients/cases) for this clinical data, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of this specific clinical image set). Since it's a Korean manufacturer, the images likely originated from Korea, but this is not explicitly stated. The context implies it was likely a retrospective collection given the wording "clinical images...are presented."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "The report concluded that the images taken with the subject device are of good diagnostic quality." It also mentions "clinical data including date and signature by a licensed professional."
- Number of experts: Not specified. It only mentions "a licensed professional" in the singular, but a formal clinical study usually involves multiple experts.
- Qualifications of those experts: "licensed professional" – no specific qualifications (e.g., radiologist, years of experience) are provided.
4. Adjudication method for the test set
Not specified. Given the lack of detail on the number of experts and how ground truth was established, no adjudication method is mentioned.
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
- MRMC study: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This submission is for a conventional medical imaging device, not an AI/CAD system necessitating such a study design.
- Effect size of human readers with/without AI assistance: Not applicable, as this is not an AI/CAD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical imaging device (hardware and software for image acquisition and reconstruction), not a standalone algorithm. The device produces images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "clinical data" is implied to be a subjective assessment by a "licensed professional" that the images are of "good diagnostic quality." This is a general statement rather than a rigorous, objective ground truth established by expert consensus, pathology, or outcomes data typically used for evaluating AI/CAD diagnostic performance.
8. The sample size for the training set
Not applicable. This is a conventional CT X-ray system, not an AI/CAD system, so there is no "training set" in the context of machine learning. The device uses established image reconstruction algorithms (FBP is mentioned).
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/CAD system mentioned.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
HDX WILL CORP. % Mr. Hyung-Suk Oh General Manager #105,201,202,203,204,38 Osongsaengmyeong 4-ro, Osong-eup Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA
Re: K160140
Trade/Device Name: DENTRIa series (DENTRIq, DENTRI-Ca, DENTRI-Sa) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 2, 2016 Received: September 6, 2016
Dear Mr. Oh:
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.
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.
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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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017See PRA Statement below. |
| 510(k) Number (if known) | K160140 |
|---|---|
| Device Name | DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) |
| Indications for Use (Describe) | The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Servios (301) 443-6740 EF
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510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
September 02, 2016
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | HDX WILL CORP. |
|---|---|
| - Address: | #105, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro,Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,28161, Korea |
| - Contact Name: | Hyung-suk Oh/ General Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | wrcohs@iwillmed.com |
| - Registration No.: | In process |
Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3.
| Trade Name | DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) |
|---|---|
| Regulation Name | Computed tomography x-ray system |
| Classification Panel | Radiology |
| Classification Regulation | 21 CFR 892.1750 |
| Product Code | OAS |
| Device Class | II |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate device #1
- 510(k) Number: K093590 -
- Applicant: PLANMECA OY -
- Regulation Name: Extraoral source x-ray system -
- -Product Code: MUH
- Class II Device Class: -
- Device Name: PLANMECA PROMAX 3D MAX -
Predicate device #2
| 510(k) Number: | K142247 |
|---|---|
| Applicant: | RAY Co.,Ltd |
| Regulation Name: | Computed tomography x-ray system |
| Product Code: | OAS |
| Device Class: | Class II |
| Device Name: | RAYSCANα-Expert 3D |
There are no significant differences between the DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sa) and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.
Description of the Device [21 CFR 807.92(a)(4)] 5.
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic images by rotating arm to get the recombination data, X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector, When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense, On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-rav is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
- The DENTRIα Series are classified as shown below.
DENTRIa: CT Mode + PANORAMA Mode DENTRI-Ca: CT Mode + PANORAMA Mode + CEPHALO Mode (ONE-SHOT) DENTRI-Sa: CT Mode + PANORAMA Mode + CEPHALO Mode (SCAN)
General Information
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-
- Description of the image detectors used.
CT detector
| Proposed Device | PredicateDevice #1 | Predicate Device#2 | ||
|---|---|---|---|---|
| Model | DENTRIα, DENTRI-Cα, DENTRI-Sα | PROMAX 3DMAX | RAYSCAN α-Expert3D | |
| Contents | CT detector (option) | 3D detector | CT detector | |
| Detector model | Xineos-1313 | PaxScan1313DX | Not known | C10900D |
| Manufacturer | Teledyne DALSA | Varian MedicalSystems | Not known | Hamamatsu |
| Detector type | Flat paneldetector | Flat paneldetector | Flat paneldetector | Flat paneldetector |
| Resolution(pixels) | 1,316 x 1,312 | 1,024 x 1,024 | Not known | 624 × 624 |
| Pixel size (µm) | 100.1 | 127.0 | 127.0 | 200.0 |
| MTF | 57% at 1 LP/mm | 55% at 1 LP/mm | Not known | 60% at 1 LP/mm |
| DQE | 70% at 0 LP/mm | 58% at 1 LP/mm | Not known | 23% at 1 LP/mm |
| Active area(mm) | 131 x 131 | 130 x 130 | 193 x 242 | 124.8 x 124.8 |
| A/DConversion | 14 bits | 16 bits | Not known | 13 bits |
| FDA 510(k)Number | Not known | Not known | Not known | K122981(System) |
PANORAMA detector -
| Model | Proposed Device | Predicate Device #1 | Predicate Device #2 | |
|---|---|---|---|---|
| DENTRIα, DENTRI-Cα, DENTRI-Sα | PROMAX 3D MAX | RAYSCAN α-Expert3D | ||
| Contents | PANORAMA detector (option) | Smart Pan detector | PANO detector | |
| Detector model | Xineos-1313 | PaxScan1313DX | Not known | C10500D |
| Manufacturer | Teledyne DALSA | Varian Medical Systems | Not known | Hamamatsu |
| Detector type | Flat panel detector | Flat panel detector | Flat panel detector | Flat panel detector |
| Resolution(pixels) | 1,316 x 1,312 | 1,024 x 1,024 | Not known | 60 x 1,512 |
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Image /page/6/Picture/0 description: The image is a logo for HDXWill. The logo features a green and blue design. On the left side of the logo is a green square with a white "W" inside. To the right of the square is the text "HDXWill" in blue.
| Model | Proposed Device | Predicate Device #1 | Predicate Device #2 | |
|---|---|---|---|---|
| DENTRIα, DENTRI-Cα, DENTRI-Sα | PROMAX 3D MAX | RAYSCAN α-Expert3D | ||
| Contents | PANORAMA detector (option) | Smart Pan detector | PANO detector | |
| Pixel size (µm) | 100.1 | 127.0 | 127.0 | 100.0 |
| MTF | 57% at 1 LP/mm | 55% at 1 LP/mm | Not known | 70% at 1 LP/mm |
| DQE | 70% at 0 LP/mm | 58% at 1 LP/mm | Not known | 50% at 1 LP/mm |
| Active area (mm) | 6 x 131 | 3.94 x 128.78 | 13 x 162 | 6 x 148 |
| A/D Conversion | 14 bits | 16 bits | Not known | 14 bits |
| FDA 510(k) Number | Not known | Not known | Not known | K122981 (System) |
CEPHALO detector (ONE-SHOT)
| Model | Proposed Device | Predicate Device #1 | Predicate Device #2 |
|---|---|---|---|
| Contents | DENTRI-Ca | PROMAX 3D MAX | RAYSCAN α-Expert3D |
| Detector model | CEPHALO (ONE-SHOT) | Planmeca ProCeph | Ceph (One shot, LargeSize) detector |
| Manufacturer | FLAATZ 330N | Not known | PaxScan 4336X |
| Detector type | DR Tech | Not known | Varian |
| Resolution(pixels) | Flat panel detector | Flat panel detector | Flat panel detector |
| Pixel size (µm) | 2,048 x 1,536 | Not known | 3,072 x 2,560 |
| MTF | 129.0 | 139.0 | 139.0 |
| DQE | 83.3% at 2 LP/mm | Not known | 54% at 1 LP/mm |
| Active area(mm) | 38.5% at 0 LP/mm | Not known | 20% at 1 LP/mm |
| A/DConversion | 193 x 259 | 302 x 249 | 427 x 356 |
| FDA 510(k)Number | 14 bits | Not known | 16 bits |
| Not known | Not known | K121513 (System) |
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Image /page/7/Picture/0 description: The image shows the logo for HDX Will. The logo features a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is stylized with a slight italicized effect.
CEPHALO detector (SCAN)
| Proposed Device | Predicate Device #1 | Predicate Device #2 | |
|---|---|---|---|
| Model | DENTRI-Ca | PROMAX 3D MAX | RAYSCAN α-Expert3D |
| Contents | CEPHALO (SCAN) | Scanning Ceph | Ceph (Scan) detector |
| Detector model | Argus-Ceph (DM-20-08K10) | Not known | XID-C24DS |
| Manufacturer | Teledyne DALSA | Not known | i3System |
| Detector type | Scanning detector(CCD-TDI) | CCD detector | CdTe (Direct type) |
| Resolution(pixels) | 8160 x 256 | Not known | 48 x 2400 |
| Pixel size (µm) | 27.0 | 48.0 | 100.0 |
| MTF | 70% at 1 LP/mm | Not known | 75% at 1 LP/mm |
| DQE | 50% at 0 LP/mm | Not known | 88% at 1 LP/mm |
| Active area(mm) | 6.9 x 221 | 6 x 292 | 4.8 x 240 |
| A/DConversion | 16 bits | Not known | Not known |
| FDA 510(k)Number | K141130 (System) | Not known | K131695 (System) |
Information for detector own 510(K) number or system in which it was cleared 510(k) number.
| Contents | Model | Own 510(K) number | System in which it was cleared 510(k) number. |
|---|---|---|---|
| CEPHALO detector (SCAN) | Argus-Ceph (DM-20-08K10) | No | 1) System name: ENCOMPASS HF1002) Manufacturer: Panoramic Corp.3) 510(K) Number: K141130 |
The DENTRIα series has been communicated with the Workstation for the transmission of data using Ethernet cable and RS232 Cable. The CBCT system of DENTRIα series has not a wireless option for the transmission of data
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Image /page/8/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font. The logo is simple and modern, and the colors are bright and eye-catching.
-
- Laser
The laser is used for patient positioning and is classified as Class A. This technical characteristic is as follows:
- Laser
-
- Optical output : 1mW or less
-
- Wavelength : 655nm
-
- Line type : Accurate Straight
-
- Form of beam output : Gaussian
6. Intended Use [21 CFR 807.92(a)(5)]
The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas. including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry, and obtains x-ray images from different angles and calculate though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
Non-Clinical Test Summarv
-
- Electrical Safety, Electromagnetic Compatibility and Performance:
The DENTRIα series complies with the electrical safety and electromagnetic compatibility requirements established by the standards AAMI ES60601-1 and IEC 60601-1-2.
- Electrical Safety, Electromagnetic Compatibility and Performance:
Bench testing of the subject devices includes:
- Testing to confirm compliance with the Basic Safety and Essential Performance requirements of AAMI ES60601-1
- Testing to confirm compliance with EMC requirements of IEC 60601-1-2
- Testing to confirm compliance with Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3
- Testing to confirm compliance with Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63
- Testing to confirm compliance with Acceptance Tests Imaging Performance Of Dental ● X-Ray requirements of IEC 61223-3-4
The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.
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Image /page/9/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
-
- Software Validation
The DENTRIα series use original software and OTS software as an image viewer. The DENTRIα series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. The type of reconstruction is FBP.
- Software Validation
Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."
-
- Biocompatibility
A biocompatibility study is not necessary and proper device disinfection is sufficient to address any health concerns.
- Biocompatibility
-
- SSXI Report
Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
- SSXI Report
Clinical Test Summary
The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The report concluded that the images taken with the subject device are of good diagnostic quality.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note | |
|---|---|---|---|---|
| K Number | K160140 | K093590 | K142247 | - |
| Model | DENTRIα series(DENTRIα, DENTRI-Cα, DENTRI-Sα) | PLANMECA PROMAX3D MAX | RAYSCANα-Expert 3D | - |
| Manufacturer | HDX WILL CORP. | PLANMECA OY | RAY Co.,Ltd | - |
| Intended Use | The DENTRIα series isa ComputedTomography X-Rayimaging devicespecialized indiagnosing generaldental treatments andorthodontic purposeusing Panoramic andCephalometric imagesrespectively. In | PLANMECA PROMAX3D MAX is a threedimensional ConeBeam VolumetricTomography (CBVT)x-ray system, whichis intended toproduce three-dimensional imagesof the human teeth,jaw and skull. The | RAYSCAN α-Expert3D, panoramic x-rayimaging system withcephalostat, is anextraoral source x-raysystem, which isintended for dentalradiographicexamination of theteeth, jaw, and oralstructures, specifically | Similar |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note | |
| addition DENTRIα | device uses cone | for panoramic | ||
| series is used in the | shaped x-ray beam | examinations and | ||
| field of Otolaryngology | projected on to a flat | implantology and for | ||
| by capturing 360 | panel detector, and | TMJ studies and | ||
| degree rotation | the examined | cephalometry, and it | ||
| sequence of the head | volume image is | has the capability, | ||
| and neck areas, | reconstructed to be | using the CBCT | ||
| including the ENT and | viewed in 3D | technique, to generate | ||
| dentomaxillofacial | viewing stations. The | dentomaxillofacial 3D | ||
| areas for a dental | device is to be | images. | ||
| treatment in adult and | operated and used | The device uses cone | ||
| pediatric dentistry , | by dentists and other | shaped x-ray beam | ||
| and obtains x-ray | legally qualified | projected on to a flat | ||
| images from different | health care | panel detector, and | ||
| angles and calculate | professionals. | the examined volume | ||
| though computer- | image is | |||
| processed to produce | reconstructed to be | |||
| 3D x-ray tomographic | viewed in 3D viewing | |||
| images. The DENTRIα | stations. | |||
| series is used by | 2D Image is obtained | |||
| physicians, dentists, | using the standard | |||
| and x-ray | narrow beam | |||
| technologists. | technique. | |||
| Operation | 1) CT | 1) 3D | 1) CT | Same |
| Mode | 2) Panorama3) Cephalo | 2) Smart Pan3) Cephalo | 2) Panorama3) Cephalo | |
| · One shot type | · PlanmecaProCeph | · One shot type | ||
| · Scan type | · Scanning Ceph | · Scan type | ||
| X-ray tube assembly | ||||
| X-ray tube | OPX/105 (C.E.I. X-raytube) | Toshiba D-067SB | Not known | |
| Focal spotsize | 0.5 mm | 0.6 mm | 0.5 mm | Same #2 |
| Targetangle | Target angle 5° | Target angle 12° | Target angle 5° | Same #2 |
| Permanentfiltration | 0.5 mmAl (IEC 60522) | Inherent FiltrationAt least 0.8 mm Al at50 kV | Inherent FiltrationAt least 0.8 mm | Similar |
| Totalfiltrationof X-raytubeassembly | > 2.5 mmAl | 1) 3D: > 2.5 mm Al+0.5 mm Cu2) Smart Pan: > 2.5mm Al3) Cephalo: > 2.5 mmAl | > 2.6 mmAl | Similar |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note | |
| Anodematerial | Tungsten | Tungsten | Tungsten | Same |
| range of X-ray tubevoltagesettings | 1) CT:60 - 110 kV± 8 %2) Panorama:60 - 90 kV± 8 %3) Cephalo• One shot type:60 - 110 kV± 8 %• Scan type:60 - 90 kV± 8 % | 1) 3D:60 - 96 kV ± 5 %2) Smart Pan:60 - 84 kV ± 5 %3) Cephalo:60 - 84 kV ± 5 % | 60 - 90kV | Similar |
| range of X-ray tubecurrentsettings | 4 - 10mA ± 10 % | 1 - 16 mA ± 10 % | 4 - 17mA | Similar |
| range ofirradiationtimesettings | 1) CT(Normal):8 s or 24 s ± 10 %2) Panorama:14 s and less ± 10 %3) Cephalo• One shot type:0.5, 1, 1.5, 2 s ±10 %• Scan type:8.2 s and less ±10 % | 1) 3D:3.6 - 24 s ± 10 %2) Smart Pan:10 s ± 10 %3) Cephalo:• PlanmecaProCeph:0.1 - 0.8 s ± 10 %• Scanning Ceph:- Normal: 12 -18.7s ± 10 %- High Speed: 6.4 -9.9s ± 10 % | 1) CT: below 14 s2) Panorama:below 14 s3) Cephalo• One shot type:below 2 s• Scan type:below 18 s | Similar |
| Image properties | ||||
| Detectortype | 1) CT: Flat panel2) Panorama: Flatpanel3) Cephalo• One shot type: Flatpanel• Scan type: CCD | 1) 3D: Flat panel2) Smart Pan: Flatpanel3) Cephalo:• PlanmecaProCeph: Flatpanel• Scanning Ceph:CCD | 1) CT: Flat panel2) Panorama: Flatpanel3) Cephalo• One shot type:Flat panel• Scan type:CdTe (Direct type) | Similar |
| Pixel size | 1) CT:100.1 or 127 µm2) Panorama:100.1 or 127 µm3) Cephalo | 1) 3D:127 µm2) Smart Pan:127 µm3) Cephalo:• Planmeca | 1) CT:200 µm2) Panorama:100 µm3) Cephalo | Similar |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note | |
| 129 μm• Scan type:27 μm | ProCeph: 139 μm• Scanning Ceph:48 μm | 139 μm• Scan type:100 μm | ||
| Active area(mm) | 1) CT:• 131 x 131 mm or• 130 x 130 mm2) Panorama:• 6 x 131 mm or• 3.94 x 128.78 mm3) Cephalo• One shot type:193 x 259 mm• Scan type:6.9 x 221 mm | 1) 3D:193 x 242 mm2) Smart Pan:13 x 162 mm3) Cephalo:• PlanmecaProCeph:302 x 249 mm• Scanning Ceph:6 x 292 mm | 1) CT:124.8 x 124.8 mm2) Panorama:6 x 148 mm3) Cephalo• One shot type:427 x 356 mm• Scan type:4.8 x 240 mm | Similar |
| MTF | 1) CT:• 57% at 1 LP/mmor• 55% at 1 LP/mm2) Panorama:• 57% at 1 LP/mmor• 55% at 1 LP/mm3) Cephalo• One shot type:83.3% at 2 LP/mm• Scan type:70% at 1 LP/mm | Not known | 1) CT:• 60% at 1 LP/mm2) Panorama:• 70% at 1LP/mm3) Cephalo• One shot type:54% at 1LP/mm• Scan type:75% at 1LP/mm | Similar#2 |
| DQE | 1) CT:• 70% at 0 LP/mmor• 58% at 1 LP/mm2) Panorama:• 70% at 0 LP/mmor• 58% at 1 LP/mm3) Cephalo• One shot type:38.5% at 0 LP/mm• Scan type:50% at 0 LP/mm | Not known | 1) CT:• 23% at 1 LP/mm2) Panorama:• 50% at 1LP/mm3) Cephalo• One shot type:20% at 1LP/mm• Scan type:88 % at 1LP/mm | Similar#2 |
| Geometry | ||||
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE note | |
| SourceImageDistance(SID) | 1) CT: 600 mm2) Panorama: 560 mm3) Cephalo:• One shot type:1790 mm• Scan type:1783 mm | 1) 3D: 600 mm2) Smart Pan:600 mm3) Cephalo: 1700 mm | Not known | Similar#1 |
| Formatcompatible | DICOM 3.0 Formatcompatible | DICOM 3.0 Formatcompatible | DICOM 3.0 Formatcompatible | Same |
| Dose Information | ||||
| CT Mode(Xineos-1313 orPaxScan1313DX) | CTDIw = 11.12mGyAt the FOV Ø 10 X 890kV, 10mA | CTDIw = 8.34 mGyAt the FOV Ø 10 X 896kV, 10mA | CTDIw = 10.61 mGyAt the FOV Ø 9 X 990kV, 10mA | Similar |
| Panorama(Xineos-1313) | DAP = 198.8 mGy·cm²At the 80kV, 10mA, 14s | Not known | DAP = 159.0 mGy.cm²At the 80kV, 13mA,14s | Similar#2 |
| Panorama(PaxScan1313DX) | DAP = 119.0 mGy·cm²At the 80kV, 10mA, 14s | Not known | Similar#2 | |
| CephaloOne shottype | DAP = 26.7 mGy·cm²At the 80kV, 10mA,0.5s | Not known | DAP = 38.4 mGy.cm²At the 80kV, 10mA,0.3s | Similar#2 |
| CephaloScan type | DAP = 21.3 mGy.cm²At the 80kV, 10mA,8.2 s | Not known | DAP = 65.8 mGy.cm²At the 80kV, 10mA,8.0 s | Similar#2 |
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Image /page/10/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
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Image /page/11/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.
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Image /page/12/Picture/0 description: The image is a logo for HDX Will. The logo features a green and blue square with a white "W" inside. To the right of the square is the text "HDX Will" in blue, with the "HDX" portion being slightly larger than the "Will" portion. The logo is simple and modern, and the colors are bright and eye-catching.
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There are no significant differences between the DENTRIα series and the predicate device that would adversely affect the use of the product. It is substantially equivalent to predicate device in technological characteristics, output characteristics and operation mode.
The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices
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Image /page/14/Picture/0 description: The image shows the logo for HDX Will. The logo features a green and blue square with a white "W" inside. To the right of the square is the text "HDX Will" in blue, with the "HDX" portion being larger than the "Will" portion. The logo is simple and modern, and the colors are bright and eye-catching.
Justification to Support Substantial Equivalence
Image properties
There is a little difference of image properties including MTF and DQE because the used detectors are different. With respect to the functional aspects, the submitted device is enough to perform each modes. The clinical data clearly shows that the DENTRIα series is effective. The little differences of image properties has no effect for diagnosis of the patients in terms of the safety and effectiveness.
Dose Information
The dose information depends on the technological characteristics of device such as FOV size, filtration of X-ray tube, condition of radiation (kV, mA, time) and Source Image Distance (SID). The DENTRIα series has demonstrated that the data does not exceed 50 % according to requirements of Chapter 203.6.4.5 in IEC 60601-2-63. The submitted device is within the same range at similar settings. The dosage does not affect the display outputs.
There are no significant differences between the DENTRIα series and the predicate device.
When compared to the predicate devices (K093590, K142247), the DENTRIα series in this submission presented the substantial equivalence in terms of:
- Technological characteristics ●
- Output characteristics
- Operation Mode .
9. Conclusion [21 CFR 807.92(b)(3)]
The DENTRIα series has similar intended use and technical characteristics to the predicate device. Based on those information, we conclude that the DENTRIα series is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness.
§ 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.