(54 days)
The x-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistic dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures.
The proposed Axeos is a dental cone-beam CT system (CBCT), which comprises sensor units for 2D cephalometric exposures. 2D panoramic radiograph and 3D volume exposure. The combination of sensors varies depending on the installed device configuration. In the proposed device, the 2D sensor, as well as the 2D cephalometric sensor, are identical to the corresponding sensors utilized in the predicate device (K150217). However, with respect to the 3D CBCT exposures, the proposed Axeos device utilizes a new version of the flat panel sensor with a larger field of view compared to the flat panel version utilized within the predicate Orthophos SL (K150217).
The proposed Axeos device uses an x-ray beam that rotates around the patient's head. Detectors acquire two-dimensional x-ray images at varying radiographic angles. An enhanced software algorithm generates the 2D panoramic and 2D cephalometric images and the reconstruction algorithm reconstructs the 3D volumetric image from the raw image data.
The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the sensor/x-ray source movement. Furthermore, the radiation dose can be adapted by various parameters such as program types and exposure technique factors. These functions are available for CBCT, cephalometric and panoramic exposures.
A Class I laser beam is utilized to define reference lines for the correct patient position. The patient is stabilized through different bite blocks and the motor-driven forehead and temple supports.
The obtained digital image data are processed to provide a reconstructed image to the operator/user. The reconstructed images are transferred to the currently marketed SIDEXIS 4 image processing software (K132773) and stored in the SIDEXIS 4 software database. The proposed Axeos device uses the same Sidexis 4 image processing software (K132773) as does the predicate device (K150217) and there are no changes to the SIDEXIS 4 software (K132773) introduced in this premarket notification.
The proposed Axeos device includes metal artifact reduction software feature which automatically reduces image artifacts caused by radiopaque objects. This identical software feature is also included in the predicate Orthophos SL (K150217) device and remains unchanged in the proposed device.
A user control panel allows user actions as: height adjustment, selection of programs, and exposure parameters and delivers information about the unit status.
For 3D imaging, the proposed Axeos allows the user to select volume sizes within which multiple fields of view, anatomic positions, and collimation may be selected. This is intended to allow the clinician to select the field of view based on the diagnostic need and to minimize the dose exposed to the patient.
The main components of the proposed Axeos device are:
- . X-ray source
- . X-ray detector (flat panel and/or PAN sensor)
- Operator panel
- . Laser locator
- Cephalometric arm with detector (Ceph sensor)
- Remote control (only by wire).
- . Test phantoms: Exposure phantom, Constancy test phantom, Contrast element, and Ceph test phantom.
The provided text describes the Dentsply Sirona Axeos, a dental cone-beam CT system, and its substantial equivalence to a predicate device (Orthophos SL, K150217). The document focuses on regulatory approval rather than clinical studies to establish diagnostic performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment cannot be extracted directly from this document.
However, I can provide information on what is present in the document that relates to performance and equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, or image quality metrics for specific pathologies). Instead, it relies on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical performance testing.
The "performance" reported primarily relates to technical specifications and the conclusion that the device's design outputs meet design input requirements and conform to intended user needs.
| Category | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (Orthophos SL, K150217) | Identical: "The x-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and and carpus exposures." (Page 6) |
| Indications for Use | Same as predicate device (Orthophos SL, K150217) | Identical (Page 6) |
| Functional Imaging Cap. | Same as predicate device | Identical: "2D panoramic, 2D cephalometric, and 3D volumetric imaging" (Page 6) |
| Operating Principles | Same as predicate device | Identical (Page 6) |
| Patient Fixation | Same as predicate device | Identical (Page 6) |
| Workflow | Same as predicate device | Identical (Page 6) |
| 3D Flat Panel Sensor Size | Larger than predicate (demonstrated as a difference, not a specific criterion) | Proposed: 3D Hamamatsu 23x16 Flatpanel with active sensor area 230 mm x 160 mm. Predicate: 3D Hamamatsu 16x16 Flatpanel with active sensor area 160 mm x 160 mm. This results in a larger max FOV for the proposed device (17 cm diameter, 13 cm height vs. 11 cm diameter, 10 cm height). (Page 7) |
| Image Visualization | May differ from predicate | Proposed device does not include lingual-buccal exploration, while predicate does. (Page 6) |
| Metal Artifact Reduction | Identical to predicate | Identical software feature also included in the predicate. (Page 5) |
| IEC Standards | Conformity to relevant IEC standards | Testing performed to verify conformity with various IEC standards including general safety, EMC, radiation protection, usability, and software lifecycle. (Page 11) |
| Image Quality | Substantially equivalent to predicate device | "Verification activities for confirmation of the image quality of the proposed device has been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device." (Page 11) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set with a specific sample size. The performance evaluation was primarily non-clinical, focusing on technological characteristics and conformity to standards.
Consequently, there is no information on:
- Sample size used for a test set.
- Country of origin of data.
- Whether data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set requiring ground truth established by experts is described in this document.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
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
Not applicable. This document is for a medical imaging device (CT system), not an AI diagnostic algorithm, and thus no MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a CT imaging system, not a standalone AI algorithm. It produces images for interpretation by a human.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the non-clinical performance, "ground truth" would be engineering specifications and measurements against physical phantoms (e.g., for resolution, dose, etc.), or compliance with regulatory standards. The document mentions "Test phantoms: Exposure phantom, Constancy test phantom, Contrast element, and Ceph test phantom" (Page 5) which are used for technical assessments.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical imaging device, not a machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning model described here.
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Image /page/0/Picture/0 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 and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in two lines.
June 22, 2020
Dentsply Sirona % Mr. Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W YORK PA 17401
Re: K201140
Trade/Device Name: Axeos Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 24, 2020 Received: April 29, 2020
Dear Mr. Nittinger:
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/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
{1}------------------------------------------------
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201140
Device Name Axeos
Indications for Use (Describe)
The x-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistic dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures.
| 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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Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized, abstract symbol on the left, followed by the text "Dentsply" on the first line and "Sirona" on the second line. The text is in a simple, sans-serif font and is aligned to the right of the symbol.
510(k) SUMMARY
K201140
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
| Email Address: | karl.nittinger@dentsplysirona.com |
Date Prepared: May 21, 2020
-
- Device Name:
| Proprietary Name: | Axeos |
|---|---|
| Classification Name: | Computed Tomography X-ray system |
| CFR Number: | 21 CFR 892.1750 |
| Device Class: | Class II |
| Product Code: | OAS |
-
- Predicate Device:
The predicate and reference devices identified relating to the substantial equivalence of the Axeos are:
- Predicate Device:
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| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Orthophos SL | K150217 | Sirona Dental Systems GmbH(Owner Operator: DentsplySirona, Inc.) |
Classification Name: Computed Tomography X-ray system CFR Number: 21 CFR 892.1750 Device Class: Class II Product Code: OAS
| Reference Device | 510(k) | Company Name |
|---|---|---|
| SIDEXIS 4 | K132773 | Sirona Dental Systems GmbH(Owner Operator: DentsplySirona, Inc.) |
Classification Name: Picture archiving and communication system
CFR Number: 21 CFR 892.2050 Device Class: Class II Product Code: LLZ
-
- Description of Device
The proposed Axeos is a dental cone-beam CT system (CBCT), which comprises sensor units for 2D cephalometric exposures. 2D panoramic radiograph and 3D volume exposure. The combination of sensors varies depending on the installed device configuration. In the proposed device, the 2D sensor, as well as the 2D cephalometric sensor, are identical to the corresponding sensors utilized in the predicate device (K150217). However, with respect to the 3D CBCT exposures, the proposed Axeos device utilizes a new version of the flat panel sensor with a larger field of view compared to the flat panel version utilized within the predicate Orthophos SL (K150217).
- Description of Device
The proposed Axeos device uses an x-ray beam that rotates around the patient's head. Detectors acquire two-dimensional x-ray images at varying radiographic angles. An enhanced software algorithm generates the 2D panoramic and 2D cephalometric images and the reconstruction algorithm reconstructs the 3D volumetric image from the raw image data.
The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the sensor/x-ray source movement. Furthermore, the radiation dose can be adapted by various parameters such as program types and exposure technique factors. These functions are available for CBCT, cephalometric and panoramic exposures.
A Class I laser beam is utilized to define reference lines for the correct patient position. The patient is stabilized through different bite blocks and the motor-driven forehead and temple supports.
{5}------------------------------------------------
The obtained digital image data are processed to provide a reconstructed image to the operator/user. The reconstructed images are transferred to the currently marketed SIDEXIS 4 image processing software (K132773) and stored in the SIDEXIS 4 software database. The proposed Axeos device uses the same Sidexis 4 image processing software (K132773) as does the predicate device (K150217) and there are no changes to the SIDEXIS 4 software (K132773) introduced in this premarket notification.
The proposed Axeos device includes metal artifact reduction software feature which automatically reduces image artifacts caused by radiopaque objects. This identical software feature is also included in the predicate Orthophos SL (K150217) device and remains unchanged in the proposed device.
A user control panel allows user actions as: height adjustment, selection of programs, and exposure parameters and delivers information about the unit status.
For 3D imaging, the proposed Axeos allows the user to select volume sizes within which multiple fields of view, anatomic positions, and collimation may be selected. This is intended to allow the clinician to select the field of view based on the diagnostic need and to minimize the dose exposed to the patient. The table below summarizes the selectable 3D imaging choices available to the clinician.
| Diameter in cm | Height in cm | Collimation: Upper jaw | Collimation: Lower jaw | |||
|---|---|---|---|---|---|---|
| Diameter in cm | Height in cm | Diameter in cm | Height in cm | |||
| Vol1 | 8 | 8 | 8 | 5.5 | 8 | 5.5 |
| Vol 2 | - | - | 5 | 5.5 | 5 | 5.5 |
| Vol 3 | 11 | 10 | 11 | 7.5 | 11 | 8.0 |
| Vol 4 | 17 | 13 | 17 | 7.5 | 17 | 10 |
The main components of the proposed Axeos device are:
- . X-ray source
- . X-ray detector (flat panel and/or PAN sensor)
- Operator panel
- . Laser locator
- Cephalometric arm with detector (Ceph sensor)
- Remote control (only by wire).
- . Test phantoms: Exposure phantom, Constancy test phantom, Contrast element, and Ceph test phantom.
5. Indications for Use
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures.
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6. Substantial Equivalence
The subject Axeos has the same intended use as the predicate device Orthophos SL (K150217). Both the Axeos and the primary predicate device are intended as Computed Tomography X-ray systems under 21 CFR 892.1750.
The proposed Axeos device and predicate Orthophos SL (K150217) incorporate the same functional imaging capabilities (2D panoramic, 2D cephalometric, and 3D volumetric imaging), The principles of operation and patient fixation features of both the proposed and predicate (K150217) devices are identical as is the overall workflow principals.
The primary differences between the proposed Axeos and predicate (K150217) devices is the difference in utilized 3D flat panel sensor. The proposed device utilizes a new version of the flat panel sensor with a larger field of view compared to the flat panel version utilized within the predicate Orthophos SL (K150217). In addition, the proposed Axeos does not include image visualization with lingual-buccal exploration, while the predicate device (K150217) includes this functionality.
Indications for Use
| Predicate Device | Proposed Device |
|---|---|
| Orthophos SL(K150217)The X-ray system creates data for digitalexposures in the maxillofacial area and insubareas for dentistry and pediatric dentistry,for hard-tissue diagnostics within ENTmedicine, and carpus exposures. | AxeosThe X-ray system creates data for digitalexposures in the maxillofacial area and insubareas for dentistry and pediatric dentistry,for hard-tissue diagnostics within ENTmedicine, and carpus exposures. |
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Technological Comparison
| Device | Predicate DeviceOrthophos SL(K150217) | Proposed DeviceAxeos |
|---|---|---|
| Unit data | ||
| Nominal voltage | 200 -240 V | 200 -240 V |
| Permissible deviation | ± 10% | ± 10% |
| Rated current | 12A | 12A |
| Nominal frequency: | 50/ 60 Hz | 50/ 60 Hz |
| Power output of tube assembly | 90 kV/12 mA = 1080 W withany radiation time | 90 kV/12 mA = 1080 W withany radiation time |
| Tube voltage | 60 - 90kV (for 90 kV max. 12mA) | 60 - 90kV (for 90 kV max. 12mA) |
| Tube current | 3 - 16 mA (for 16 mA max. 69kV) | 3 - 16 mA (for 16 mA max. 69kV) |
| Tube setting 3D | LOW: 6-13mASD: 7-13 mAHD: 4-12 mA | LOW: 6-13mASD: 7-13 mAHD: 4-12 mA |
| Maximum setting range | 60 kV / 3 mA to 90 kV / 12 mA | 60 kV / 3 mA to 90 kV / 12 mA |
| Program duration | 11.6-23 sec | 11.6-23 sec |
| Exposure time | 2.2 - 14.9 sec | 2.2 - 16.7 sec |
| Max. FOV(Size of the presentableanatomical area) | Cylinder with a diameter ofapprox. 11 cm and a height ofapprox. 10 cm | Cylinder with a diameter ofapprox. 17 cm and a height ofapprox. 13 cm |
| Slice pitch (voxel size) | 80-220μm | 80-220μm |
| Exposure time for acephalometric image | 4.6 - 14.9 sec | 4.6 - 14.9 sec |
| Number of single exposures | SD: 200 | SD: 200 up to 361 for Vol 4 |
| HD: 800 | HD: up to 1500, depending onVolume Size | |
| Device | Predicate DeviceOrthophos SL(K150217) | Proposed DeviceAxeos |
| Total filtration of X-ray tube assembly | > 2,5 AI / 90 IEC 60522Additional filtration:0,3 mm Cu for volume VOL1/2/3 SD and HD exposures1 mm Cu for volume VOL1/2/3 Low Dose exposures | > 2,5 AI / 90 IEC 60522Additional filtration0,3 mm Cu for volume VOL1/2/3 SD and HD exposures0,5 mm Cu for volume VOL4 SD and HD exposures1 mm Cu for volume VOL1/2/3/4 Low Dose exposures |
| Focal spot size acc. to IEC 60336, measured in the central X-ray beam | Nominal focal spot value (f): 0.5Width (max): 0.75 mmLength (max): 1.10 mm | Nominal focal spot value (f): 0.5Width (max): 0.75 mmLength (max): 1.10 mm |
| Imaging programs | Panorama, transverse, cephalometric, 3D, different collimations | Panorama, transverse, cephalometric, 3D, different collimations |
| X-ray tube | Siemens SR 90/15 FN | Siemens SR 90/15 FN |
| PAN Sensor | CMOS (Direct Conversion Sensor) | CMOS (Direct Conversion Sensor) |
| Active sensor area, Pan type: | 146 mm x 6 mm | 146 mm x 6 mm |
| Detail resolution | 0.1 mm | 0.1 mm |
| Focus-sensor distance | 497 mm | 497 mm |
| Digital flat panel 3D | 3D Hamamatsu 16x16 Flatpanel with amorphous silicon | 3D Hamamatsu 23x16 Flatpanel with amorphous silicon |
| Active sensor area 3D | 160 mm x 160 mm | 230 mm x 160 mm |
| Detail resolution | 0.12 mm | 0.12 mm |
| Focus-sensor distance | 524 mm | 524 mm |
| Device | Predicate DeviceOrthophos SL(K150217) | Proposed DeviceAxeos |
| Ceph sensor | Digital CCD line sensor forCeph exposure technique | Digital CCD line sensor forCeph exposure technique |
| Active sensor area, | 230 mm x 6.48 mm | 230 mm x 6.48 mm |
| Detail resolution | 0.027 mm pixel size | 0.027 mm pixel size |
| Focus-sensor distance | 1714 mm | 1714 mm |
| Dose Area Product (DAP) | ||
| Complete range(Ceph, 3D and 2D)Measuring Method AMeasuring Method B | n.a.1.2 - 3056 mGycm² | 3 - 2199 mGycm²3 - 3139 mGycm² |
| Default 3D maximumMeasuring Method AMeasuring Method B | VOL3/SD/85kV/10mA/4.4sn.a.781 mGycm² | VOL4/SD/85kV/10mA/5.9s580 mGycm²836 mGycm² |
| Visualization/ Imageprocessing | Uses Sidexis 4 image processsoftware. | Uses Sidexis 4 image processsoftware. |
| Image reconstruction | ||
| CBCT algorithm | Filtered back-projection | Filtered back-projection |
| PAN algorithm | Pixel driven back-projection | Pixel drive back-projection |
| CEPH algorithm | Time delay and integration | Time delay and integration |
| 2D Image types | Different panoramic, bite wing,temporomandibular joint, sinusview.. | Different panoramic, bite wing,temporomandibular joint, sinusview |
| Cephalometric main types | A/P, P/A, Lateral view, Carpus | A/P, P/A, Lateral view, Carpus |
| Panoramic images | Full frame pan-technology withAutofocus andlingual-buccalexploration. | Full frame pan-technology withAutofocus for Pan images. |
| 3D | Volumes as chosen by the userbefore the exposure. | Volumes as chosen by the userbefore the exposure. |
| Device | Predicate DeviceOrthophos SL(K150217) | Proposed DeviceAxeos |
| User interface | ||
| Exposure settings | At the operator panel of thedevice: kV, mA, sec, program,height adjustment, laser locatoron/off, rotation of the ring,options. | At the operator panel of thedevice: kV, mA, sec, program,height adjustment, laser locatoron/off, rotation of the ring,options. |
| Patient fixation | Bite block, chin rest, contactsegment for subnasal, supports ifnecessary. | Bite block, chin rest, contactsegment for subnasal, supports ifnecessary. |
| Cephalometer without bite blockand chin rest. | Cephalometer without bite blockand chin rest. | |
| Localization of exposure area | Given through the geometry ofthe device and due the help oflaser. | Given through the geometry ofthe device and due the help oflaser. |
| Additional laser for improvementof mid sagittal head positioning . | Additional laser for improvementof mid sagittal head positioning. | |
| Calibration / Adjustment | Calibration/ adjustment isensured for sensor (includingshading, blemish and gain),geometric, panoramic, volumeand Ceph. | Calibration/ adjustment isensured for sensor (includingshading, blemish and gain),geometric, panoramic, volumeand Ceph. |
| Monthly constancy check | Monthly constancy check |
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Functional testing as well as performance testing of the proposed device Axeos have been performed to verify that the design outputs meet the design input requirements and to validate that the device conforms to the intended user needs and the intended use as defined.
The comparison of the intended use, the indications for use, as well as of technical and technological characteristics of the subject Axeos with the predicate device Orthophos SL (K150217) supports the substantial equivalence of the proposed device to the predicate device.
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7. Non-Clinical Performance Data
Testing to verify the performance requirements of the subject Axeos device was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.
Tests included in this premarket notification verify the conformity of the proposed Axeos with the requirements of:
- . IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- . IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements.
- . IEC 60601-1-3: Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- . IEC 62366: Medical devices - Application of usability engineering to medical devices.
- . ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- IEC 62304: Medical device software – Software lifecycle processes.
- IEC 60601-2-63: Medical electrical equipment Part 2-63: Particular requirements for the . basic safety and essential performance of dental extra-oral X-ray equipment
- IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic . safety and essential performance - Collateral Standard: Usability, (with third edition of 60601-1)
- Verification activities for confirmation of the image quality of the proposed device has . been performed. The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device.
8. Clinical Performance Data
Given the differences from the predicate device, no human clinical data is necessary to support substantial equivalence.
Conclusion Regarding Substantial Equivalence 9.
The information included in this premarket notification supports the substantial equivalence of the subject Axeos. The subject device has the identical intended use as the legally marketed predicate device. The subject device also has the identical indications for use and incorporates the same fundamental technology as the predicate device.
Performance data are included in this premarket notification to demonstrate the performance of the subject Axeos against its design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.
§ 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.