(154 days)
The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
The subject device SensorX device is an intraoral x-ray sensor for dental applications. It detects the x-rays and performs the image acquisition, digitizes the image and makes it available for the PC. The x-ray sensor is connected to the computer via the sensor cable, and if required, the USB extension. The x-ray sensor is equipped with protective cover sheaths (previously 510(k) cleared) and placed in the mouth of the patient. For patient comfort, the ergonomic design is based on human intraoral anatomy. SensorX enables high resolution with a minimum radiation dose. It is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems such as SensorX, is the speed with which images are acquired. SensorX is activated via the imaging software VisionX (K192743) OR DBSWIN (K203287).
The provided document is a 510(k) Premarket Notification from DÜRR DENTAL SE for their device, SensorX. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEXIS Titanium / KaVo IXS HD) rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a traditional sense (e.g., a clinical trial with statistical endpoints).
Therefore, some of the requested information, particularly regarding specific performance metrics against pre-defined acceptance criteria, multi-reader multi-case studies, and detailed ground truth methodologies for a test set, is not explicitly present in this document. The document primarily relies on non-clinical data (i.e., technical specifications and compliance with standards) and a general statement about clinical images.
However, I can extract the available information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
As specific, quantifiable acceptance criteria with corresponding performance results akin to a clinical trial are not presented in this 510(k) summary, I will infer the "acceptance criteria" from the technological characteristics compared to the predicate device, as substantial equivalence is the goal. The reported "device performance" will be the SensorX's specifications.
| Characteristic (Inferred Acceptance Criteria based on Predicate) | SensorX Reported Device Performance | Comments |
|---|---|---|
| Device Name | SensorX | New device name. |
| Type of X-ray Detection Technology | CMOS | Matches predicate. |
| Pixel Size (μm) | 19 | Very close to predicate (19.5 μm). |
| Dynamic Range | 4,096:1 | Matches predicate. |
| X-ray Resolution | 20+ visible lp/mm | Matches predicate ("20+ visible lp/mm"). |
| Scintillator Technology | Cesium Iodide (CsI) Scintillator | Matches predicate. |
| Software Features | USB 2.0 Communication, Noise Filtering, Binning, Basic Image Correction (Gain/offset/pixel Calibration), Monitoring Sensor Health/State, Image Transmission | Matches predicate. |
| PC Interface | USB Type A Plug | Matches predicate. |
| Input Electrical Power | 5.0 V / 0.5 W via USB | Matches predicate. |
| Communication Standard | USB 2.0 | Matches predicate. |
| Motion Sensing Compatibility | Yes | Matches predicate. |
| Safety and EMC Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 14971, EN ISO 10993-5 | Demonstrated compliance with same or similar standards as would be expected for a device of this type and the predicate. |
| Purity of Signal/Image Quality | "excellent resolution and contrast" (from provided dental images) | Qualitative statement, no specific metric or acceptance criteria provided. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly mention a "test set" in the context of an algorithm's performance with a specified sample size. Instead, it refers to "actual dental images were provided which showed excellent resolution and contrast" as part of the non-clinical data. The provenance of these images (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The document states a "clinical evaluation was performed" and "actual dental images were provided," but it does not detail how ground truth was established for these images, nor the number or qualifications of any experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
The document does not mention any MRMC comparative effectiveness study. The SensorX is an intraoral x-ray sensor, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The SensorX device is a hardware component (an intraoral x-ray sensor) that captures images, not a standalone algorithm. Its performance is evaluated based on its technical specifications and image quality, not as an AI algorithm.
7. The Type of Ground Truth Used
The document states that "actual dental images were provided which showed excellent resolution and contrast." This implies an expert assessment of image quality, but the specific type of ground truth (e.g., expert consensus on specific pathologies, pathology reports, or patient outcomes data) is not detailed. Given the device's function as an imaging sensor, the ground truth would likely relate to image quality parameters such and resolution, contrast, and diagnostic interpretability by dentists, evaluated by experts.
8. The Sample Size for the Training Set
The document does not describe the use of a "training set" in the context of an AI algorithm, as the SensorX is a hardware device.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as the document does not describe a training set for an AI algorithm.
{0}------------------------------------------------
March 19, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K203116
Trade/Device Name: SensorX Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: February 4, 2021 Received: February 9, 2021
Dear Mr. Kamm:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
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.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K203116
Device Name SensorX
Indications for Use (Describe)
The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Research Use (Per 21 CFR 601.2 and D) |
|---|
| Commercial Use (21 CFR 601.2) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary, DÜRR DENTAL SE K203116
This Traditional 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92 and the FDA Guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" issued on September 1, 2016.
Date Summary Prepared: February 4, 2021 1.
2. Submitter's Identification:
| Submitter's Identification: | DÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-BissingenGermanyPhone: + 49 (0) 7142 70 5-0Fax: + 49 (0) 7142 705-500E-Mail: info@duerr.dewww.duerrdental.com | Establishment Registration Namein FURLS:Duerr Dental SE |
|---|---|---|
| Establishment RegistrationNumber: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver LangeDirector of Quality ManagementDÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-Bissingen,GermanyPhone: + 49 (0) 7142 70 5-190Email: oliver.lange@duerrdental.com | |
| U.S. Agent & Contact: | Mr. Joseph LatkowskiDirector of Quality and RegulatoryAir Techniques, Inc.1295 Walt Whitman RoadMelville, NY 11747, USAU.S. Phone: 516-214-5574E-Mail: Joseph.Latkowski@airtechniques.com |
{4}------------------------------------------------
Identification of Subject Device: 3.
| Trade /Proprietary Name: | SensorX |
|---|---|
| Device: | System, x-ray, extraoral source, digital |
| Regulation Description: | Extraoral source x-ray system |
| Regulation Medical Specialty: | Dental |
| Review Panel: | Radiology |
| Product Code: | MUH |
| Regulation Number: | 872.1800 |
| Device Class: | II |
4. Predicate Device
| 510(k) Number: | K172918 |
|---|---|
| Manufacturer: | KaVo Dental Technologies, LLC |
| Trade /Proprietary Name: | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) |
| Device: | System, x-ray, extraoral source, digital |
| Regulation Description: | Extraoral source x-ray system |
| Regulation Medical Specialty: | Dental |
| Review Panel: | Radiology |
| Product Code: | MUH |
| Regulation Number: | 872.1800 |
| Device Class: | II |
Device Description 5.
The subject device SensorX device is an intraoral x-ray sensor for dental applications. It detects the x-rays and performs the image acquisition, digitizes the image and makes it available for the x-ray sensor is connected to the computer via the sensor cable, and if required, the USB extension.
The x-ray sensor is equipped with protective cover sheaths (previously 510(k) cleared) and placed in the mouth of the patient. For patient comfort, the ergonomic design is based on human intraoral anatomy:
Image /page/4/Picture/7 description: In the image, a woman is undergoing a medical procedure involving a device inserted into her mouth. The device consists of a circular frame positioned around her face, with a tube extending into her mouth. The woman's face is visible in profile, showing her eye, nose, and mouth. The background is a plain wall.
Image /page/4/Picture/8 description: In the image, a woman is undergoing a dental X-ray procedure. The X-ray machine is positioned near her mouth, capturing images of her teeth and jaw. The woman appears calm and cooperative as the dental professional operates the machine. The image likely aims to showcase the technology and process involved in dental X-rays.
Image /page/4/Picture/9 description: In the image, there are two close-up shots of people's arms. In the left image, a person's arm is positioned under a piece of medical equipment. The right image shows a person's arm with a white wire attached to it.
Figure 1 – SensorX application
{5}------------------------------------------------
SensorX enables high resolution with a minimum radiation dose. It is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems such as SensorX, is the speed with which images are acquired. SensorX is activated via the imaging software VisionX (K192743) OR DBSWIN (K203287).
6. Indications for use.
The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
7. Description of Substantial Equivalence: Technological Characteristics:
The device comparison table below compares the Predicate Device: K172918 KaVo Dental Technologies, LLC to our proposed SensorX devices. Our device has the same intended use and technological characteristics as compared to the predicate device. The small differences do not raise any questions of substantial equivalence. The physical sizes are similar. The technologies are nearly identical. The required computer and computer interfaces are identical. Therefore the DÜRR DENTAL SE SensorX is substantially to the equivalent KaVo device.
8. Summary of the technological characteristics compared to the predicate devices
| Characteristics: | Predicate Device:K172918KaVo Dental Technologies, LLC | Subject Device:DÜRR DENTAL SE | |||
|---|---|---|---|---|---|
| Device Name | DEXIS Titanium | KaVo IXS HDSize 1 | KaVo IXSHD Size 2 | SensorXSize 1 | SensorXSize 2 |
| Indications for Use | The DEXIS / KaVo sensor is a USB-drivendigital sensor which is intended toacquire dental intraoral radiographicimages. The DEXIS / KaVo sensor shall beoperated by healthcare professionals,who are educated and competent toperform the acquisition of dental intra-oral radiographs. The DEXIS / KaVosensor can be used either in combinationwith special positioning devices tofacilitate positioning and alignment withthe x-ray beam or it may be alsopositioned by hand with assistance of thepatient. | The intraoral sensor is intended toconvert x-ray photons into electronicimpulses that may be stored, viewedand manipulated for diagnostic use bydentists.(Same indication as predicate butsimplified wording) |
{6}------------------------------------------------
| Characteristics: | Predicate Device:K172918KaVo Dental Technologies, LLC | Subject Device:DÜRR DENTAL SE |
|---|---|---|
| Device Picture | Image: DEXIS Titanium / KaVo IXS HD Intraoral Sensors | Image: SensorX device |
| Device Description | The DEXIS Titanium / KaVo IXS HDIntraoral Sensors are an indirectconverting x-ray detector, e.g. incident x-rays are converted by a scintillatingmaterial into (visible) light, this light iscoupled optically to a light detectionimager based on CMOS technology. Thedesign of the sensor assembly supportsthe automatic detection of the incidentx-rays to generate digital images fordental intra oral applications. The DEXISTitanium / KaVo IXS HD Intraoral Sensorssupport USB2.0 connectivity to personalcomputers using a dedicated electronicassembly and a sensor software driver. | The subject device SensorX device isan intraoral x-ray sensor for dentalapplications. It detects the x-rays andperforms the image acquisition,digitizes the image and makes itavailable for the PC. The x-ray sensor isconnected to the computer via thesensor cable, and if required, the USBextension. The x-ray sensor isequipped with protective coversheaths (previously 510(k) cleared)and placed in the mouth of thepatient. For patient comfort, theergonomic design is based on humanintraoral anatomy. |
{7}------------------------------------------------
| Characteristics: | Predicate Device:K172918KaVo Dental Technologies, LLC | Subject Device:DÜRR DENTAL SE | |||
|---|---|---|---|---|---|
| SensorX enables high resolution with aminimum radiation dose. It isconnected to a computer to producean image almost instantaneouslyfollowing exposure. The primaryadvantage of direct sensor systemssuch as SensorX, is the speed withwhich images are acquired. SensorX isactivated via the imaging softwareVisionX (K192743) or DBSWIN(K203287). | |||||
| FundamentalTechnology | CMOS | CMOS | |||
| Sensor ExteriorDimension (mm) | 39.9 x29.8 | 37.0 x25.2 | 42.3 x30.4 | 39.0 x 27.4 | 44.7 x 33.1 |
| Sensor Active ImagingArea (mm) | 33.0 x 26.0with fourclippedcorners | 30.1 x 20.2with fourclippedcorners | 36.0 x26.0with fourclippedcorners | 30.0 x 20.0with four clippedcorners | 36.0 x 26.0with four clippedcorners |
| Pixel Size (μm) | 19.5 | 19 | |||
| Dynamic Range | 4,096:1 | 4,096:1 | |||
| Image Resolution | 1692 x 1324pixels | 1539 x1026 pixels | 1842 x1324pixels | 1580 x 1050 pixels | 1896 x 1368pixels |
| USB Cable Exit | 35° angledcable exit | 0° parallelcable exit | 0°parallelcable exit | 0° parallel cable exit | |
| Corner Design | Chamferedcorners | Roundedcorners | Roundedcorners | Chamfered corners | |
| Sensor Cable Length | 3 m | 2.5 m | |||
| X-ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm | |||
| Scintillator Technology | Cesium Iodide (CsI) Scintillator | Cesium Iodide (CsI) Scintillator | |||
| SW Features | USB 2.0 CommunicationNoise Filtering | USB 2.0 CommunicationNoise Filtering |
{8}------------------------------------------------
| Characteristics: | Predicate Device:K172918KaVo Dental Technologies, LLC | Subject Device:DÜRR DENTAL SE |
|---|---|---|
| Binning Basic Image Correction(Gain/offset/pixel Calibration) Monitoring Sensor Health/State Image Transmission | Binning Basic Image Correction(Gain/offset/pixel Calibration) Monitoring Sensor Health/State Image Transmission | |
| Interface to PC | USB Type A Plug | USB Type A Plug |
| Input Electrical Power | 5.0 V / 0.5 W via USB | 5.0 V / 0.5 W via USB |
| Exposure Method | X-Ray Monitor Mode | X-Ray Monitor Mode |
| CommunicationStandard(USB Model) | USB 2.0 | USB 2.0 |
| Motion SensingCompatibility | Yes | Yes |
| Consensus Standards | IEC 60601-1 Basic SafetyIEC 62366-1 UsabilityIEC 60601-2-65 Dental intra-oral X-rayequipmentIEC 60601-1-2 ElectromagneticCompatibilityIEC 62304 (Software testingrequirements) | IEC 60601-1 Basic SafetyIEC 60601-1-6 UsabilityIEC 60601-2-65 Dental intra-oral X-rayequipmentIEC 60601-1-2 ElectromagneticCompatibilityIEC 62304 (Software testingrequirements: Companion softwaresold separately, see chart below) |
Imaging Software:
| Imaging Software to beused with the SubjectDevice (SensorX): | 510(k)Number: | Manufacturer: | Distributor |
|---|---|---|---|
| VisionX | K192743 | DÜRR DENTAL SE In the 510(k) databasereferred to as "Durr Dental SE" | Air TechniquesInc. |
| DBSWIN | K203287 | DÜRR DENTAL SE In the 510(k) databasereferred to as "Durr Dental SE" | Air TechniquesInc. |
Protective covers sheaths must be used before placing the SensorX into the patient's mouth. After usage the device must be cleaned and disinfected using the disinfectants and cleaning agents as listed in the installation and operating instructions.
{9}------------------------------------------------
Accessories to be used with the Subject Device (SensorX):
| Barrier Sleeves / Barrier Envelopes: | 510(k)Number: | Manufacturer: | |
|---|---|---|---|
| TIDIShield® Digital x-ray sensor sheaths | K132953 | TIDI PRODUCTS, LLC | |
| 100S | Digital sensor cover, 1 3/8" X 8", 500/box | K151123 | Pac-Dent International, Inc. |
| 100L | Digital sensor sleeve, 1 5/8" X 8", 500/box | K151123 | Pac-Dent International, Inc. |
| DX-405 | Fits Gendex Size 1, XDR size 1, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-406 | Fits Gendex Size 2, XDR Size 2, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-999 | Fits Dexis, Compares to TIDI # 20999, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-978 | Fits Kodak 6100 Size 1, Compares to TIDI # 20978, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-979 | Fits Kodak 6100 Size 2, Compares to TIDI # 20979, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-890 | Fits Sirona Size 2, Compares to TIDI # 20890, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-904 | Fits Sirona Size 1, Compares to TIDI # 20904, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-824 | Fits Schick Size 1, Compares to TIDI # 20824, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-825 | Fits Schick Size 2, Compares to TIDI # 20825, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| DX-819 | Fits Suni/Lightyear Size 2, Compares to TIDI # 20819, 500pcs/box | K151123 | Pac-Dent International, Inc. |
| PPE-248-2 | #2 Barrier envelopes, 100pcs/box | K151123 | Pac-Dent International, Inc. |
9. Non-Clinical Data and Performance Testing
A clinical evaluation was performed. Furthermore, testing to the following IEC and DIN Standards was completed successfully:
| Standard: | Standard Title: | Compliance Report Provided: |
|---|---|---|
| IEC 14971 | Medical devices – Application of riskmanagement to medical devices | • Risk Analysis |
| IEC 60601-1 | Medical Electrical Equipment, Part I:General requirements for basic safetyand essential performance | • IEC 60601-1 Safety Test Report |
| IEC 60601-1-2 | Medical Electrical Equipment, Part I-2:General requirements for basic safetyand essential performance. CollateralStandard: Electromagnetic Compatibility | • IEC 60601-1-2 EMC Test Report |
| IEC 60601-1-6 | General requirements for basic safetyand essential performance – Collateralstandard: Usability | • IEC 60601-1-6 Test Report |
| IEC 60601-2-65 | Medical electrical equipment - Part 2-65: Particular requirements for the basic | • User Manual |
{10}------------------------------------------------
| Standard: | Standard Title: | Compliance Report Provided: |
|---|---|---|
| safety and essential performance ofdental intra-oral X-ray equipmentApplicable sections for Sensor devices:• 201.7.9.1• 203.6.7.4 | • Computer System Requirements | |
| Software: | ||
| System IntegrationTesting | Subject device integration wasevaluated in accordance with the FDAGuidance for the Content of PremarketSubmissions for Software Contained inMedical Devices. Risk managementactivities were documented. | • Cybersecurity for digital devices• Software System Test Report (ImagingSoftware: VisionX 2.4.10)• Software separately reviewed andcleared by FDA. |
| Reprocessing: | ||
| Cleaning the device | Although the sensor does not normallycome into contact with the patient,incidental contact is possible. | • Validation Report – Manual Reprocessing• User Manual Instructions |
| Biocompatibility: | ||
| EN ISO 10993-5 | Biological Evaluation Report | • Biological Risk Assessment• The device does not come into directcontact with the patient. A separate FDAcleared disposable plastic barrier is used. |
In addition to the tests and reports cited above, actual dental images were provided which showed excellent resolution and contrast.
10. Clinical Data
Clinical data is not required for a finding of substantial equivalence.
11. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, DÜRR DENTAL SE concludes that the SensorX is substantially equivalent to the predicate device as described herein. The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.