(267 days)
No
The summary describes standard image processing and reconstruction techniques for CT and panoramic X-ray data, with no mention of AI or ML algorithms.
No
The device is described as producing diagnostic images for "diagnostic support," which indicates it is an imaging device used for diagnosis, not for therapy (treatment).
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides images "as diagnostic support" and the "Device Description" section notes that scanning is performed "for the diagnosis of hard tissue including bones and teeth."
No
The device description explicitly states that the PREXION 3D consists of a scanner and two software components. The scanner is a hardware component that generates X-rays and detects the signals. The software processes the data acquired by the scanner. Therefore, it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PreXion 3D is an X-ray imaging system. It uses X-rays to create images of the dento-maxillo-facial region. This is an in vivo diagnostic method (performed on a living organism), not an in vitro method.
- Intended Use: The intended use is to produce digital X-ray images for diagnostic support of the dento-maxillo-facial regions. This aligns with medical imaging, not in vitro testing.
- Device Description: The description details the components and process of generating and processing X-ray images, which is characteristic of an imaging device.
Therefore, the PreXion 3D is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PREXION 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.
Product codes
OAS
Device Description
The PREXION 3D consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION 3D.
The PREXION 3D uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device.
During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on a computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions for the diagnosis of hard tissue including bones and teeth of the jaw and mouth cavity. The PREXION 3D performs two types of scanning including CT scan generating two (2) and three (3) dimensional images and Panoramic scan generating two (2) dimensional images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxillo-facial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
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)
Bench Testing:
- Laser safety: The laser system of the PREXION3D is identical to that of the PANOURA 18S (K111231). Therefore, the test report for IEC 60825-1 for the PANOURA 18S (K111231) is used as the test report for the PREXION3D.
- Modulation-Transfer Function: In order to evaluate the spatial resolution of the PreXion3D, we measured the MTF in accordance with IEC 61223-3-5. The spatial resolution of all scan modes met the acceptance criteria.
- Artifact Analysis: In order to evaluate the artifact of the image of the PREXION 3D, the images of all scan mode of the PREXION 3D were compared to those of the FineCube (K063622). There was no difference of pattern and strength of the metal artifact between the PREXION 3D and the FineCube(K063622).
Software validation: The software of the PREXION3D has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Safety and EMC: EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 2 1 2012
510(k) Summary
- a. Owner/Company name, address THE YOSHIDA DENTAL MFG CO., LTD. 1-3-6, Kotobashi, Sumida-ku Tokyo 130-8516, Japan
Michizo Yamanaka President
· Contact person Hidenori Watanabe Regulatory Affairs Phone: 011-81-3-3631-2165 Fax: 011-81- 3-3633-9420 Email: hi-watanabe@yoshida-net.co.jp
b. Contact/Application Correspondent
Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
011-81-3-3818-8577 Phone: 011-81-3-3818-8573 Fax: Email: kanaif(@mici.co.jp
- c. Date prepared March 28, 2012
d. Name of device
PREXION 3D Trade Name: Computed tomography x-ray system Common Name: Classification Name: X-ray, tomography, computed, dental Classification Regulation: 21 CFR 892.1750
YOSHIDA DENTAL MFG CO., LTD. NOVEMBER 9, 2012
ATTACHMENT 1 A 1-12 OF A 1-17
1
e. Predicate devices
The PREXION 3D is substantially equivalent to the following legally marketed device: .
| 510(k) Number | Trade name | Product code |
|---|---|---|
| K063622 | FINECUBE | OAS |
| K103659 | CS 9300 | OAS |
The predicate devices are hereinafter called "the FINECUBE (K063622)" or "CS 9300 (K103659)" in this application.
f. Description of the device
The PREXION 3D consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION 3D.
The PREXION 3D uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device.
During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on a computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions for the diagnosis of hard tissue including bones and teeth of the jaw and mouth cavity. The PREXION 3D performs two types of scanning including CT scan generating two (2) and three (3) dimensional images and Panoramic scan generating two (2) dimensional images.
g. Indications for Use
The PREXION 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.
h. Statement of substantial equivalence
The PREXION 3D was developed from the FINECUBE (K063622) by adding panoramic scan function. Accordingly, the characteristics of the PREXION 3D are identical or similar to those of the FINECUBE (K063622) regarding X-ray Generation Device characteristics including tube voltage, tube current, and Focal Spot Size, X-ray image capturing device including type of detector, Pixel size, pixel number. (See Table 6-1 Comparison Table).
The only difference of the PREXION 3D from the FINECUBE (K063622) is addition of panoramic scanning function. The panoramic scanning function of the PREXION 3D is similar to CS 9300 (K103659). Both the PREXION 3D and CS 9300 (K103659) have the panoramic scanning function in addition to CT scan function. The PREXION 3D has the similar characteristics regarding intended use, X-ray Generation Device characteristics
YOSHIDA DENTAL MFG CO., LTD. NOVEMBER 9, 2012
ATTACHMENT 1 A1-13 OF A1-17
2
including tube voltage, tube current, and Focal Spot Size, X-ray image capturing device including type of detector, pixel number as CS 9300 (K103659).
By considering above device characteristics, the intended use of the PREXION 3D is identical to part of intended use of the CS 9300 (K103659), and similar to the intended use of the FINECUBE (K063622).
In order to ensure same performance characteristics as predicate devices, software verification/validation, performance testing, and risk analysis were performed. Such test results and risk analysis indicate that the PREXION 3D meets the requirements of the recognized consensus or voluntary standard. Based on the information presented above we conclude that the PREXION 3D is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness.
Comparison table i.
Table 6-1 compares the characteristics between the PREXION 3D and the predicates.
3
ON 3D (K120948)
ONSE TO FDA LETTER DATED MAY
x 149 mm max (Panoram x 1536 pixels (Panorar PD (TFT ર0 - 90k પ 2 - 15m/ 0.7mm l 4 bits .6mm x 123.2m 608 x 610 0.2mm 200μm l 2bits 90k V 4mA FPD Xion sional pisal managalad to provinsi
Adimensional manakal manakaran para na mana mana mana marka marin
sa of the villaga marka mana mana mana mana mana mana mana mana man 123.2mm x 121.6mm (CT)
mm x 131.6mm (Panoram 616 x 608 (CT)
216 x 72 (Panorami 200μm (CT)
0μm (Panorami 0.2mm 90k V 4bits 4mA FPD Tube Current
Tocal Spot Size Number of B ube Voltag ixel numbe Size of Area
receiving receiving
X-ray le 6-1. Comparison Ts ixel size Detector ications for l X ray Generatic
Device K ray image
capturing devi
SHIDA DENTAL MFG CO.,
VEMBER 9, 2012
ATTACHMENT
A I-15 OF A I-1
4
XION 3D (K120948)
K... SPONSE TO FDA LETTER DATED MAY 16, 2012
| PREXION 3D | FINECUBE (K063622) | CS 9300 (K103659) | ||
|---|---|---|---|---|
| Scanner | SID/SOD | |||
| 700mm/468mm | ||||
| (Hi-Def/Ultra Hi-Def/Rapid Scan) | ||||
| 700mm/322mm | ||||
| (Hi-Res) | 700mm/322mm(Magnification | |||
| imaging) | ||||
| 700mm/468mm(Wide area | ||||
| imaging) | 615mm (SID) | |||
| Dimension | ||||
| (W×D×H) | 1170mm×1530mm×1930mm | 1158mm×1595mm×2378mm | ||
| Weight | 390kg | 390kg | 160kg | |
| Scan mode | CT Scan and Panoramic Scan | CT Scan | CT Scan and Panoramic Scan | |
| Panoramic scan | ||||
| Performance | Scan time | 16.2 sec | 4 - 16 sec | |
| Scan time | 8.6 sec | |||
| (Rapid Scan) | ||||
| 16.8 sec | ||||
| (Hi-Def/Hi-Res) | ||||
| 33.5 sec | ||||
| (Ultra Hi-Def/Ultra Hi-Res) | 19sec. (Standard mode) | |||
| 37sec. (High density mode) | 12 - 20 sec | |||
| 28 sec | ||||
| CT scan | ||||
| Performance | φ81mm/H74mm | |||
| (Hi-Def/Ultra Hi-Def/Rapid Scan) |
φ56mm/H51mm
(Hi-Res/Ultra Hi-Res) | Wide area imaging
φ82.0mm H75.1mm
Magnification imaging
φ56.5mm, H51.7mm | φ170mm/H135mm
(0.090mm - 0.500mm)
φ170mm/H110mm
(0.090mm-0.500mm)
φ170mm/H60mm
(0.090mm - 0.500mm)
φ100mm/H100mm
(0.090mm - 0.500mm)
φ80mm/H80mm
(0.090mm - 0.500mm)
φ100mm/H50mm
(0.090mm - 0.500mm)
φ50mm/H50mm
(0.090mm-0.500mm) |
| | FOV
(voxel size) | | | |
ATTACHMENT ]
A1-16 OF A1-17
YOSHIDA DENTAL MFG CO., LTD
NOVEMBER 9, 2012
5
j. Risk Analysis
The PREXION3D was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory.
k. Bench Testing
THE YOSHIDA DENTAL MFG CO., LTD has performed bench tests to ensure safety and effectiveness as follows;
1. Laser safety
The laser system of the PREXION3D is identical to that of the PANOURA 18S (K111231). Therefore, the test report for IEC 60825-1 for the PANOURA 18S (K111231) is used as the test report for the PREXION3D.
2. Modulation-Transfer Function
In order to evaluate the spatial resolution of the PreXion3D, we measured the MTF in accordance with IEC 61223-3-5. The spatial resolution of all scan modes met the acceptance criteria.
3. Artifact Analysis
In order to evaluate the artifact of the image of the PREXION 3D, the images of all scan mode of the PREXION 3D were compared to those of the FineCube (K063622). There was no difference of pattern and strength of the metal artifact between the PREXION 3D and the FineCube(K063622).
The software of the PREXION3D has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32.
I. Conclusion
The PREXION 3D has similar intended use and technical characteristics as the predicate devices including the FINECUBE (K063622) and CS 9300 (K103659). A number of test results and risk analysis indicate that the PREXION 3D meets the requirements of the recognized consensus or voluntary standard. Based on those information, we conclude that the PREXION 3D is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness.
YOSHIDA DENTAL MFG CO., LTD. NOVEMBER 9, 2012
· ATTACHMENT 1 A1-17 OF A1-17
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 21, 2012
The Yoshida Dental MFG Co., LTD. % Dr. Fumiaki Kanai President and CEO MIC international 4-1-17 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN
Re: K120948
Trade/Device Name:PREXION 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: OAS Dated: November, 09, 2012 Received: November 13, 2012
Dear Dr. Kanai:
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.
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
7
Page 2 - Dr. Kanai
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris -S
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K120948
Device Name: PreXion 3d
Indications For Use:
PreXion 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial regions at the direction of healthcare professionals as diagnostic support.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Janine M. Morris -S 2012.12.21 10:48:57 -05'00'
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