(176 days)
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.
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 FDA 510(k) summary for the PreXion3D Expedition describes the device and its claimed substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer the questions about acceptance criteria and the study that proves the device meets them. This document is a regulatory filing, primarily focused on demonstrating substantial equivalence based on technical characteristics and intended use, rather than providing a detailed performance study with specific acceptance criteria and outcome metrics for AI/ML components.
Specifically, the document states: "No clinical testing was performed and that the non-clinical testing provided in this submission supports the substantial equivalence of the device." This confirms that there was no performance study of the kind typically used to evaluate AI model performance (e.g., assessing diagnostic accuracy against ground truth).
Therefore, I cannot extract the requested information from the provided text. The tables and sections related to "Technological Characteristics and Performance" are comparing device specifications (e.g., X-ray generation, detector types, physical dimensions) to predicate devices, not reporting on the performance of an AI component against specific diagnostic acceptance criteria.
To answer your questions, one would typically need access to a detailed clinical validation study report for an AI-powered diagnostic device, which is not present in this 510(k) summary.
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January 12, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
PreXion Corporation % Kenji Tanaka Quality Assurance and Regulatory Affairs Division 1-14-1. Kandasuda-cho Chivoda-ku. Tokyo 101-0041 JAPAN
Re: K222150
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: December 1, 2022 Received: December 15, 2022
Dear Kenji 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
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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,
2023.01.12
09:13:16
-05'00'
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
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Indications for Use
510(k) Number (if known) K222150
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a stylized font, with the "Pre" in a lighter gray and the "Xion" in a darker gray. Below the company name is the tagline "make IT visible" in a smaller font. Above and behind the company name is a swooping graphic in blue and gray, adding a modern and dynamic element to the logo.
510(k) Summary
PreXion3D Expedition
K222150
1. Submission Sponsor
PreXion Corporation 1-14-1, Kandasuda-cho, Chiyoda-ku, Tokyo 101-0041 Japan Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division Email: px-ra@prexion.co.jp Office number: +81-3-5297-7551
2. Submission Correspondent
Same as above
3. Date Prepared
July 13th, 2022
4. Device Identification
Trade/Proprietary Name: PreXion3D Expedition
| Common/Usual Name: | OAS: Computed Tomography X-Ray System |
|---|---|
| Regulation Number: | OAS: 21 CFR 892.1750 |
| Product Code: | OAS |
| Device Class: | Class II |
| Classification Panel: | Radiology |
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Image /page/4/Picture/1 description: The image shows the logo for PreXion. The logo features the word "PreXion" in a light gray, sans-serif font. Below the name is the phrase "make IT visible" in a smaller font, with the "IT" in blue. Above and behind the name is a blue arc with a gray shadow, giving the logo a modern and technological feel.
5. Legally Marketed Predicate Device(s) and Reference Device
Predicate Device: K203784. PreXion3D Explorer PRO. PreXion Corporation Reference Device: K181983, PreXion3D Excelsior, PreXion Corporation
6. Indication for Use Statement
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.
7. 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 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.
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Image /page/5/Picture/1 description: The image shows the logo for PreXion. The logo features the company name in a light gray, elegant font, with the tagline "make IT visible" underneath in a smaller font. Above and to the right of the name is a stylized, curved graphic in blue and gray, adding a modern touch to the overall design.
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 chanqe 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).
Cephalometric Exposure ।
Based on cephalometric radiography, a plain radiographic image of the properly positioned "patient's head" between X-ray generator and flat panel detector with stable magnification ratio, can be acquired. Also, the image of "patient's hand" can be obtained.
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 imaqe 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.
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Image /page/6/Picture/1 description: The image shows the logo for Prexion. The logo features the name "PreXion" in a light gray, elegant font, with the tagline "make IT visible" underneath in a smaller, blue font. Above and behind the name is a stylized graphic of two curved lines, one in blue and one in gray, creating a sense of movement or technology.
For CT and Panoramic scan, the detected data is reconstructed using filtered-back-projection method. In the case of Cephalometric scan, the acquired 2D data is output as it is.
The software is unchanged from the predicates in terms of function.
- Software Level of Concern -
The software level of concern for the PreXion3D Expedition is Moderate. The rationale is as follows:
Even prior to mitigation of hazards, there is no risk of serious injury or death associated with this software. Excessive X-ray irradiation can be considered as a risk of serious injury, but it is limited in scope by a hardware timer. A hardware activated buzzer indicating exposure and an emergency switch are also provided. As such, there is a risk of injury associated with the software, but not serious injury.
8. Substantial Equivalence Discussion
The following table compares the PreXion to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Subject Device | Predicate Device | Reference Device | |||
|---|---|---|---|---|---|
| Manufacturer | PreXionCorporation | PreXionCorporation | PreXionCorporation | Comparisonto Predicate | |
| Trade Name | PreXion3DExpedition | PreXion3DExplorer PRO | PreXion3DExcelsior | ||
| 510(k) Number | K222150 | K203784 | K181983 | N/A | |
| Product Code | OAS | Same | Same | Same | |
| Regulation Number | OAS: 21 CFR892.1750 | Same | Same | Same | |
| Regulation Name | OAS: Computedtomography x-raysystem | Same | Same | Same | |
| Device ClassificationName | X-Ray, Tomography,Computed, Dental | Same | Same | Same | |
| PreXion3D Expeditionis intended toproduce two-dimensional digital x-ray images includingpanoramic andcephalometric image,and three-dimensional digital x-ray images of thedental, oral,maxillofacial region,ENT (Ear, Nose andThroat) and neckregion at thedirection ofhealthcareprofessionals asdiagnostic support foradult and pediatricpatients.Cephalometricimaging also includesthe hand and wrist toobtain carpus imagesfor growth andmaturity assessment.This device is notintended for use onpatients less thanapproximately 21 kg(46 lb) in weight and113 cm (44.5 in) inheight; these heightand weightmeasurementsapproximatelycorrespond to that ofan average 5 yearold. | PreXion3D ExplorerPRO is intended toproduce twodimensional digitalpanoramic andcephalometricimages, and three-dimensional digitalx-ray images of themaxillofacial, andENT (Ear, Nose andThroat) and neckregion at thedirection ofhealthcareprofessionals asdiagnostic supportfor adult andpediatric patients.Cephalometricimaging alsoincludes the handand wrist to obtaincarpus images forgrowth andmaturityassessment.This device is notintended for use onpatients less thanapproximately 21kg (46 lb) in weightand 113 cm (44.5in) in height; theseheight and weightmeasurementsapproximatelycorrespond to thatof an average 5year old. | PreXion3D Excelsioris intended toproduce two-dimensional digital x-ray images includingpanoramic andcephalometricimages, and three-dimensional digital x-ray images of thedental (oral),maxillofacial, andENT (Ear, Nose andThroat) region at thedirection ofhealthcareprofessionals asdiagnostic support foradult and pediatricpatients.Cephalometricimaging also includesthe hand and wrist toobtain carpus imagesfor growth andmaturity assessment.This device is notintended for use onpatients less thanapproximately 21 kg(46 lb) in weight and113 cm (44.5 in) inheight; these heightand weightmeasurementsapproximatelycorrespond to that ofan average 5 year old. | Same | ||
| Indications for use: | Patient/User Characteristics | ||||
| Target Population | Children aged 6(except infants) toelderly | Same | Same | Same | |
| Anatomical Site | The dental, oral,maxillofacial regionENT (Ear, Nose andThroat) and neckregion | Same | Same | Same | |
| Users | Health careprofessionals | Same | Same | Same | |
| Technological Characteristics and Performance | |||||
| Patient ContactMaterial | CHIN REST:polycarbonateForehead Holder:silicone rubberHANDLE GRIP:silicone rubber | Same | CHINREST:polycarbonateForehead Holder:silicone rubber | Same | |
| Sterility | Non-sterile | Same | Same | Same | |
| X-rayGenerationDevice | TubeVoltage | 90-110KV | Same | 60-110KV | Same |
| PulseExposurefunction | Yes | Same | Same | Same | |
| TubeCurrent | 1-5.3mA | Same | 1-6mA | Same | |
| FocalSpot Size | 0.3mm x 0.3mm | Same | Same | Same | |
| X-rayImageCapturing Device(CT,Panorama) | Detector | FPD (TFT) | Same | Same | Same |
| PhotoDiode | IGZO TFT matrix | TFT:a-Si(AmorphousSilicon) | TFT:a-Si | Different | |
| scintillator | Csl:Tl | Same | Same | Same | |
| Manufacturer | PreXion Corporation | Vieworks Co. Ltd., | Same | Different | |
| PixelSize | 248 μm x248μm(With binning)(CT, CT-Panoramic,Panoramic) | Same | 125 μmx125μm,125μmx250μm (CT) | Same | |
| 124 μm x124μm(Without binning)(CT, CT-Panoramic,Panoramic) | Same | 125 um x 125pm(Panoramic) | Same | ||
| 640 x 768 (Withbinning)(CT, CT-Panoramic) | 1024x1280(Withbinning)(CT, CT-Panoramic) | 1024x1280(CT, CT-Panoramic) | RegardingСТ, СТ-Panoramic,smaller | ||
| PixelNumber | 1280 x 1536 (Withoutbinning)(CT, CT-Panoramic) | 2048 x 2560(Without binning)(CT, CT-Panoramic,Ceph) | |||
| 120 x 1280(Panoramic) | 120 x 2560(Panoramic) | 192 x 1280(Panoramic) | Similar | ||
| Size ofArea | 158mm x 190mm(CT, CT-Panoramic) | 253.95mm x317.44mm(CT, CT-Panoramic) | 128mm x 160mm(CT) | Smaller thanpredicatedevice | |
| Receiving X-ray | 158mm x 15mm (Panoramic) | 317.44mm x 15mm (Panoramic) | 160mm x 24mm (Panoramic) | ||
| Number of Bits | 16bits (CT, Panorama) | Same | 16bits (CT, Panorama) | Same | |
| Detector | FPD (TFT) | Same | Same | Same | |
| Photo Diode | IGZO TFT matrix | TFT:a-Si(Amorphous Silicon) | TFT:a-Si | Different | |
| scintillator | GOS | Csl:TI | Same | Different | |
| X-rayImageCapturing Device(Cephalo | Manufacturer | PreXion Corporation | Vieworks Co. Ltd., | Same | Different |
| metric) | Pixel Size | 124 μm x 124μm (Ceph) | Same | 140 μm x 140μm (Ceph) | Same |
| Pixel Number | 2560 x 2048 (Cephalometric) | Same | 2112x1754 (Cephalometric) | Same | |
| Size of Area Receiving X-ray | 253.95mm x 317.44mm (Ceph) | Same | 295.68 x 245.56mm (Ceph) | Same | |
| Number of Bits | 16bits (Ceph) | Same | 14bits (Ceph) | Same | |
| Scanner | SID/SOD | 700mm/ 470mm (CT, Panoramic)1735mm / 15000mm (Ceph) | 700mm/ 420mm (CT, Panoramic)1000mm / 840mm (Ceph) | Same (CT, Panoramic)Same (Ceph) | Similar |
| Similar | |||||
| Dimension (WxDxH) | 1160 mm x 1207 mm x 2330 mm (CT, CT-Panoramic, Panoramic)1833 mm x 1207 mm x 2330 mm ( Ceph) | 1112 mm x 1267 mm x 2330 mm (CT, CT-Panoramic, Panoramic, Ceph) | 930 mm x 1230 mm x 2220 mm (CT, Panoramic)1747 mm x 1230 mm x2220 mm (with Ceph) | ||
| Similar | |||||
| Weight | 170 kg (CT, Panoramic)198kg (Ceph) | 230 kg (CT, Panoramic, Ceph) | 165 kg (CT, Panoramic)200kg (Ceph) | ||
| Imaging Mode | CT scan, Panoramic scan, Cephalometric radiography | Same | Same | Same | |
| Panoramic Scan Performance (Scan Time) | 8-16sec | 8-16sec | 8-16sec | Same | |
| CephalometricRadiography (ScanTime) | 0.16 sec | 0.16sec | 0.5-0.8sec | Same | |
| CT ScanPerformance | ScanTime | 8-25sec | 10-20sec | 5.2-25.6sec | Similar |
| FOV(VoxelSize) | Diameter 140mm xH150mm (0.100 -0.200mm) | Diameter 150mm xH156mm (0.100 -0.200mm) | Diameter 150mm xH130mm(0.100 -0.200mm) | ||
| Diameter 125mm xH100mm (0.100 -0.200mm) | Diameter 150mm xH100mm (0.100 -0.200mm) | Diameter 100mm xH81mm(0.100 - 0.200mm) | Similar | ||
| Diameter 80mm xH80mm (0.100 -0.200mm) | Diameter 100mm xH100mm (0.100 -0.200mm) | Diameter 100mm xH50mm(0.100 - 0.200mm) | |||
| Diameter 50mm xH50mm(0.100 - 0.200mm) | Diameter 50mm xH50mm(0.100 - 0.200mm) | Diameter 50mm xH50mm(0.100 - 0.200mm) | |||
| Applied Standard | |||||
| Electrical SafetyStandard | ANSI/AAMI ES60601-1 | Same | Same | Same | |
| ElectromagneticCompatibilityStandard | IEC 60601-1-2 | ||||
| Radiation SafetyStandard | IEC 60601-1-3 | ||||
| Electrical EquipmentUsability SafetyStandard | IEC 60601-1-6 | ||||
| UsabilityEngineeringStandard | IEC 62366 | ||||
| Software LifecycleProcess StandardEssential | IEC 62304 | ||||
| performance ofdental extra-oral X-ray equipmentStandard | IEC 60601-2-63 | ||||
| Acceptance tests ofImagingperformance ofdental X-ray | IEC 61223-3-4 | ||||
| equipment StandardAcceptance tests ofImagingperformance ofcomputed | IEC 61223-3-5 |
Table 5A - Comparison of Characteristics
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Image /page/7/Picture/1 description: The image shows the logo for PreXion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with "Pre" in a darker shade and "Xion" in a lighter shade. Below the name is the tagline "make IT visible," with "IT" in blue. Above the company name is a curved, swooping graphic in shades of blue and gray, adding a modern and dynamic element to the logo.
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PreXion Corporation PreXion3D Expedition
Image /page/8/Picture/1 description: The image shows the logo for Prexion. The logo features the word "PreXion" in a light gray, serif font. Below the name is the tagline "make IT visible" in a smaller, sans-serif font. Above and to the right of the name is a blue, curved shape that resembles a wave or swoosh, with a gray shadow effect behind it.
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PreXion Corporation PreXion3D Expedition
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PreXion Corporation PreXion3D Expedition
Image /page/10/Picture/1 description: The image shows the logo for PreXion, a company that aims to make IT visible. The logo features the company name in a stylized font, with the "Pre" in a light gray color and the "Xion" in a slightly darker gray. Below the company name is the tagline "make IT visible," with the "IT" in a blue color. Above and behind the company name is a blue swoosh design that adds a modern and dynamic element to the logo.
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| PreXion CorporationPreXion3D Expedition | |
|---|---|
| tomography X-rayequipment StandardLaser SafetyStandardRisk ManagementStandardDICOM StandardBiocompatibilityStandardComplianceBiocompatibilityStandardComplianceBiocompatibilityStandardCompliance | IEC 60825-1ISO 14971NEMA PS 3.1 - 3.20ISO 10993-1ISO 10993-5ISO 10993-10 |
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of PreXion3D Expedition and in showing substantial equivalence to the predicate device, PreXion 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 design output meets 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 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 60601-1-3 and 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 Usability engineering to medical devices
- Software Documentation per: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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Image /page/12/Picture/1 description: The image contains the logo for Prexion. The logo features the word "PreXion" in a light gray, sans-serif font. Below the name is the tagline "make IT visible" in a smaller font. Above and to the right of the name is a curved graphic element in blue and gray, suggesting movement or a technological concept.
- . 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---Guidance-for-Industry", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
10.Clinical Performance Data
No clinical testing was performed and that the non-clinical testing provided in this submission supports the substantial equivalence of the device.
11.Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).
The PreXon3D Expedition, as designed and manufactured, is determined to be substantially equivalent to the referenced 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.