(154 days)
No
The description focuses on the hardware (sensor) and basic image acquisition/digitization, with no mention of AI/ML for image analysis or interpretation.
No
The device is described as an intraoral x-ray sensor intended for diagnostic use by dentists, converting x-ray photons into electronic impulses for imaging. It does not provide any therapeutic effect or treatment.
Yes
The device is described as converting x-ray photons into electronic impulses "for diagnostic use by dentists."
No
The device description clearly states it is an intraoral x-ray sensor, which is a physical hardware component that detects x-rays and digitizes images. It is connected to a computer via a cable.
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 SensorX device is an intraoral x-ray sensor. Its function is to capture x-ray images of the inside of the mouth. It does not analyze biological samples.
- Intended Use: The intended use is to convert x-ray photons into electronic impulses for diagnostic use by dentists. This is related to imaging, not in vitro testing.
Therefore, the SensorX device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
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:
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). 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals, specifically dentists.
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)
A clinical evaluation was performed. Non-clinical data and performance testing were conducted to IEC and DIN Standards including: IEC 14971 (Risk Analysis), IEC 60601-1 (Safety Test Report), IEC 60601-1-2 (EMC Test Report), IEC 60601-1-6 (Usability Test Report), IEC 60601-2-65 (Applicable sections for Sensor devices: 201.7.9.1, 203.6.7.4; User Manual, Computer System Requirements), Software System Integration Testing (Cybersecurity for digital devices, Software System Test Report (Imaging Software: VisionX 2.4.10), Software separately reviewed and cleared by FDA), Reprocessing (Validation Report – Manual Reprocessing, User Manual Instructions), and Biocompatibility (Biological Risk Assessment). Actual dental images were provided which showed excellent resolution and contrast. Clinical data is not required for a finding of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K192743, K203287, K132953, K151123
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Phone: + 49 (0) 7142 70 5-0
Fax: + 49 (0) 7142 705-500
E-Mail: info@duerr.de
www.duerrdental.com | Establishment Registration Name
in FURLS:
Duerr Dental SE |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Establishment Registration
Number: | 3015509619 | |
| Submitter's Contact: | Mr. Oliver Lange
Director of Quality Management
DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen,
Germany
Phone: + 49 (0) 7142 70 5-190
Email: oliver.lange@duerrdental.com | |
| U.S. Agent & Contact: | Mr. Joseph Latkowski
Director of Quality and Regulatory
Air Techniques, Inc.
1295 Walt Whitman Road
Melville, NY 11747, USA
U.S. Phone: 516-214-5574
E-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:
K172918
KaVo Dental Technologies, LLC | | | Subject Device:
DÜRR DENTAL SE | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Device Name | DEXIS Titanium | KaVo IXS HD
Size 1 | KaVo IXS
HD Size 2 | SensorX
Size 1 | SensorX
Size 2 |
| Indications for Use | The DEXIS / KaVo sensor is a USB-driven
digital sensor which is intended to
acquire dental intraoral radiographic
images. The DEXIS / KaVo sensor shall be
operated by healthcare professionals,
who are educated and competent to
perform the acquisition of dental intra-
oral radiographs. The DEXIS / KaVo
sensor can be used either in combination
with special positioning devices to
facilitate positioning and alignment with
the x-ray beam or it may be also
positioned by hand with assistance of the
patient. | | | 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.
(Same indication as predicate but
simplified wording) | |
6
| Characteristics: | Predicate Device:
K172918
KaVo 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 HD
Intraoral Sensors are an indirect
converting x-ray detector, e.g. incident x-
rays are converted by a scintillating
material into (visible) light, this light is
coupled optically to a light detection
imager based on CMOS technology. The
design of the sensor assembly supports
the automatic detection of the incident
x-rays to generate digital images for
dental intra oral applications. The DEXIS
Titanium / KaVo IXS HD Intraoral Sensors
support USB2.0 connectivity to personal
computers using a dedicated electronic
assembly and a sensor software driver. | 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. |
7
| Characteristics: | Predicate Device:
K172918
KaVo Dental Technologies, LLC | Subject Device:
DÜRR DENTAL SE | | | |
|------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------|---------------------------------------------|
| | | 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). | | | |
| Fundamental
Technology | CMOS | CMOS | | | |
| Sensor Exterior
Dimension (mm) | 39.9 x
29.8 | 37.0 x
25.2 | 42.3 x
30.4 | 39.0 x 27.4 | 44.7 x 33.1 |
| Sensor Active Imaging
Area (mm) | 33.0 x 26.0
with four
clipped
corners | 30.1 x 20.2
with four
clipped
corners | 36.0 x
26.0
with four
clipped
corners | 30.0 x 20.0
with four clipped
corners | 36.0 x 26.0
with four clipped
corners |
| Pixel Size (μm) | 19.5 | | | 19 | |
| Dynamic Range | 4,096:1 | | | 4,096:1 | |
| Image Resolution | 1692 x 1324
pixels | 1539 x
1026 pixels | 1842 x
1324
pixels | 1580 x 1050 pixels | 1896 x 1368
pixels |
| USB Cable Exit | 35° angled
cable exit | 0° parallel
cable exit | 0°
parallel
cable exit | 0° parallel cable exit | |
| Corner Design | Chamfered
corners | Rounded
corners | Rounded
corners | 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 Communication
Noise Filtering | | | USB 2.0 Communication
Noise Filtering | |
8
| Characteristics: | Predicate Device:
K172918
KaVo 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 |
| Communication
Standard
(USB Model) | USB 2.0 | USB 2.0 |
| Motion Sensing
Compatibility | Yes | Yes |
| Consensus Standards | IEC 60601-1 Basic Safety
IEC 62366-1 Usability
IEC 60601-2-65 Dental intra-oral X-ray
equipment
IEC 60601-1-2 Electromagnetic
Compatibility
IEC 62304 (Software testing
requirements) | IEC 60601-1 Basic Safety
IEC 60601-1-6 Usability
IEC 60601-2-65 Dental intra-oral X-ray
equipment
IEC 60601-1-2 Electromagnetic
Compatibility
IEC 62304 (Software testing
requirements: Companion software
sold separately, see chart below) |
Imaging Software:
| Imaging Software to be
used with the Subject
Device (SensorX): | 510(k)
Number: | Manufacturer: | Distributor |
|----------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------|------------------------|
| VisionX | K192743 | DÜRR DENTAL SE In the 510(k) database
referred to as "Durr Dental SE" | Air Techniques
Inc. |
| DBSWIN | K203287 | DÜRR DENTAL SE In the 510(k) database
referred to as "Durr Dental SE" | Air Techniques
Inc. |
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 risk | |
| management to medical devices | • Risk Analysis | |
| IEC 60601-1 | Medical Electrical Equipment, Part I: | |
| General requirements for basic safety | ||
| and essential performance | • IEC 60601-1 Safety Test Report | |
| IEC 60601-1-2 | Medical Electrical Equipment, Part I-2: | |
| General requirements for basic safety | ||
| and essential performance. Collateral | ||
| Standard: Electromagnetic Compatibility | • IEC 60601-1-2 EMC Test Report | |
| IEC 60601-1-6 | General requirements for basic safety | |
| and essential performance – Collateral | ||
| standard: 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 of | ||
| dental intra-oral X-ray equipment | ||
| Applicable sections for Sensor devices: | ||
| • 201.7.9.1 | ||
| • 203.6.7.4 | • Computer System Requirements | |
| Software: | ||
| System Integration | ||
| Testing | Subject device integration was | |
| evaluated in accordance with the FDA | ||
| Guidance for the Content of Premarket | ||
| Submissions for Software Contained in | ||
| Medical Devices. Risk management | ||
| activities were documented. | • Cybersecurity for digital devices | |
| • Software System Test Report (Imaging | ||
| Software: VisionX 2.4.10) | ||
| • Software separately reviewed and | ||
| cleared by FDA. | ||
| Reprocessing: | ||
| Cleaning the device | Although the sensor does not normally | |
| come 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 direct | ||
| contact with the patient. A separate FDA | ||
| cleared 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.