(49 days)
Not Found
No
The summary describes standard image processing and reconstruction techniques for X-ray and CT data. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on standard medical device testing and clinical image validation, not AI/ML performance metrics.
No
The device is described as producing digital x-ray images for diagnostic support and image analysis, which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic support".
No
The device description explicitly states it consists of a scanner (hardware for generating and detecting X-rays) and a console (hardware for operating the scanner and managing data), in addition to software for image analysis.
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 PreXion3D Expedition is an X-ray imaging device. It generates X-rays that pass through the patient's body to create images for diagnostic support. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use clearly states it produces digital x-ray images of various anatomical regions for diagnostic support. This is consistent with medical imaging, not in vitro diagnostics.
Therefore, the PreXion3D Expedition falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height: these height and weight measurements approximately correspond to that of an average 5 year old.
Product codes
OAS
Device Description
PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
The operating principle of the device is as follows.
X-rays are generated by the conversion of electron kinetic energy.
Part of the kinetic energy which is generated when electrons moving at high speed are decelerated inside matter becomes the conversion source.
Use a high-voltage transformer to boost the commercial voltage (100 to 240 V) to direct current high voltage (several tens of kV) and apply it to the X-ray tube to accelerate the X-ray tube's thermal electrons, and then the X-ray will be generated.
The change in the voltage (tube voltage) and current (tube current) applied to the X-ray tube brings the following features.
• The higher the X-ray tube voltage is, the greater the penetration strength of X-rays is.
· The higher the current (tube current) is, the more the X-ray dose is.
With the consideration of the above features, X-ray devices are designed to be able to control the X-ray dose and strength according to the intended use.
X-ray photography is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, Panoramic scan).
PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region, hand and wrist
Indicated Patient Age Range
Adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height: these height and weight measurements approximately correspond to that of an average 5 year old.
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)
Non-Clinical and/or Clinical Tests Summary & Conclusions:
As part of demonstrating safety and effectiveness of PreXion and in showing substantial equivalence to the predicate device, PreXion Corporation completed a number of nonclinical performance tests. The PreXion3D Expedition meets all the requirements for overall design, biocompatibility, performance, and electrical safety results confirming that the the design inputs and specifications for the device.
The PreXion3D Expedition passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device.
The PreXion3D Expedition passed all the testing in accordance with internal requirements, and international standards shown below to support substantial equivalence of the subject device:
-Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
- Electrical safety testing per ANSI/AAMI ES 60601-1, IEC 60601-1-3 and IEC 60601-1-6
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
- Dental extra-oral X-ray equipment testing per IEC 60601-2-63
- Software verification and validation IEC 62304
- Acceptance testing of X-ray equipment per IEC 61223-3-4 and IEC 61223-3-5
- Storage and Transport Testing per ISO 4180
- IEC 62366-1:2015,AMD1:2020 Usability engineering to medical devices
- Software Documentation per: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Establish the substantial equivalence of an SSXI to a previously cleared conventional radiographic SSXI per: "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
- Cybersecurity Activities per: "Cybersecurity-for-Networked-Medical-Devices-Containing-Off the-Shelf-(OTS)-Software-Gor Industry", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
We conducted the clinical image validation and as a result, it was confirmed that they are clinically valid.
The results of the above non-clinical studies indicate that the device is substantially equivalent to the predicate device in safety, efficacy, and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
September 8, 2023
Image /page/0/Picture/1 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.
PreXion Corporation % Mr. Kenji Tanaka Manager 1-14-1. Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN
Re: K232166
Trade/Device Name: PreXion3D Expedition Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 21, 2023 Received: July 21, 2023
Dear Mr. Tanaka:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
PreXion3D Expedition
Indications for Use (Describe)
PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height: these height and weight measurements approximately correspond to that of an average 5 year old.
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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3
| K232166 | 510(k) Summary | Prepared on: 2023-09-08 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | PreXion Corporation | |
| Applicant Address | 1-14-1, Kandasuda-cho Chiyoda-ku Tokyo 101-0041 Japan | |
| Applicant Contact Telephone | +81-3-5297-7553 | |
| Applicant Contact | Mr. Kenji Tanaka | |
| Applicant Contact Email | px-ra@prexion.co.jp | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | PreXion3D Expedition | |
| Common Name | X-ray, Tomography, Computed, Dental | |
| Classification Name | Computed tomography x-ray system | |
| Regulation Number | 21 CFR 892.1750 | |
| Product Code | OAS | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K222150 | PreXion3D Expedition | OAS |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
| PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting | ||
| image data, and a console, which is used for operating the scanner and managing the data. The |
scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
The operating principle of the device is as follows.
X-rays are generated by the conversion of electron kinetic energy.
Part of the kinetic energy which is generated when electrons moving at high speed are
decelerated inside matter becomes the conversion source.
Use a high-voltage transformer to boost the commercial voltage (100 to 240 V) to direct current
high voltage (several tens of kV) and apply it to the X-ray tube to accelerate the X-ray tube's
thermal electrons, and then the X-ray will be generated.
The change in the voltage (tube voltage) and current (tube current) applied to the X-ray tube brings the following features.
• The higher the X-ray tube voltage is, the greater the penetration strength of X-rays is.
· The higher the current (tube current) is, the more the X-ray dose is.
4
With the consideration of the above features, X-ray devices are designed to be able to control the X-ray dose and strength according to the intended use.
X-ray photography is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, Panoramic scan).
PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed.
X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
Intended Use/Indications for Use
PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric maging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
The device has the same indications for use in comparison to the predition/P04A). The subject device of PreXion3D Expedition is intended to produce two digital panoramic and cephalometric images, and three dimensional digital x-ray images of the dental(oral), maxillofacial, and Throat) region at the direction of healthcare professionals as diagnostic support for adult
and pediatric patients.
Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Technological Comparison
The different technological characteristics are summarized in the points. The difference is in the FPD, part of the software, and the maximum X-ray field. First, we have confirmed that there are no problems with the FPD according to SSXI guidance, and the report is available as an attachment to this application. Second, the software only changes the protocol of the interface due to the change in the FPD, and we have confirmed that there are no problems with the software in the system test. Finally, the maximum X-ray irradiation field has been confirmed in the IEC 60601-2-63 test report. Other than the above, the intended use/ appearance/design/materials/ labeling for precautions and warnings/operating principle/energy source/manufacturer, etc. are all the same. Based on these points, we claim the substantial equivalence of this device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
As part of demonstrating safety and effectiveness of PreXion and in showing substantial equivalence to the predicate device, PreXion Corporation completed a number of nonclinical performance tests. The PreXion3D Expedition meets all the requirements for overall design, biocompatibility, performance, and electrical safety results confirming that the the design inputs and specifications for the device.
21 CFR 807.92(a)(6)
5
The PreXion3D Expedition passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device.
The PreXion3D Expedition passed all the testing in accordance with internal requirements, and international standards shown below to support substantial equivalence of the subject device:
-Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
-
-Electrical safety testing per ANSI/AAMI ES 60601-1, IEC 60601-1-3 and IEC 60601-1-6
-
Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2
-
Dental extra-oral X-ray equipment testing per IEC 60601-2-63
-
Software verification and validation IEC 62304
-
Acceptance testing of X-ray equipment per IEC 61223-3-4 and IEC 61223-3-5
-
Storage and Transport Testing per ISO 4180
-
IEC 62366-1:2015,AMD1:2020 Usability engineering to medical devices
-
Software Documentation per: "Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices
-
Establish the substantial equivalence of an SSXI to a previously cleared conventional
-
radiographic SSXI per: "Guidance for the Submission of 510(k)'s for Solid State X-ray
Imaging Devices" -
Cybersecurity Activities per: "Cybersecurity-for-Networked-Medical-Devices-Containing-Offthe-Shelf-(OTS)-Software-Gor Industry", "Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices"
We conducted the clinical image validation and as a result, it was confirmed that they are clinically valid.
The results of the above non-clinical studies indicate that the device is substantially equivalent to the predicate device in safety, efficacy, and performance.