(44 days)
No
The summary describes a digital X-ray sensor and optional software for image acquisition and basic enhancement/analysis. There is no mention of AI, ML, or any advanced image processing techniques that would typically involve these technologies. The performance studies focus on standard imaging metrics and safety, not AI/ML performance.
No.
The device is a digital X-ray sensor used for acquiring diagnostic images, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is used for "the diagnosis of structural diseases."
No
The device description explicitly states that the OpenSensorX series are "digital intra-oral sensors" and describes hardware components like a "CMOS sensor with directly deposited CsI:Tl scintillator" and a "hi-speed direct USB interface." While there is associated software, the core device is a physical sensor.
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 OpenSensorX Series is a digital intra-oral sensor used in conjunction with dental radiography. Its primary function is to convert X-rays into digital images of the oral cavity.
- Intended Use: The intended use is for dental X-ray examination and the diagnosis of structural diseases based on these images. This involves imaging the internal structures of the mouth using radiation, not analyzing biological samples.
The device is a medical imaging device, specifically a digital X-ray detector for dental applications.
N/A
Intended Use / Indications for Use
The OpenSensorX Series is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.
Product codes
MUH
Device Description
OpenSensorX series are digital intra-oral sensors. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hi-speed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional iRay intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of the OpenSensorX series is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software. The OpenSensorX series has two device models, OpenSensor0001X and OpenSensor0002X.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
trained professionals under the guidance of doctors in hospitals and clinics.
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
Nonclinical study: Electrical Safety and EMC testing according to IEC/ES 60601-1 and IEC60601-2-65 and EMC testing in accordance with IEC 60601-1-2. All test results meet the standard requirements.
Biological Evaluation: Materials of the intra-oral sensor enclosure evaluated with ISO10993-1. Test results assured safety equivalent to predicate device. Sensor position frame evaluated and assured same as predicate device.
Nonclinical Considerations: OpenSensorX series are substantially equivalent to the predicate devices (K092547) based on Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time.
Software: iRayDR software hazard classification, requirements specification, and design specification passed all test cases and complied with intended design specification.
Clinical Consideration: Clinical data is not needed to characterize performance and establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
April 13, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
DentiMax, Inc. % Mr. David Arnett President 4115 E Valley Auto Dr, Suite 101 MESA AZ 85298
Re: K220556
Trade/Device Name: OpenSensorX Series Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: March 18, 2022 Received: March 23, 2022
Dear Mr. Arnett:
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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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) K220556
Device Name OpenSensorX Series
Indications for Use (Describe)
The OpenSensorX Series is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.
| 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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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
February 23, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | DENTIMAX, INC. |
|---|---|
| Company Address: | 4115 E. Valley Auto Drive, Suite 101 Mesa AZ 85206 |
| Contact Person: | David J. Arnett |
| Phone: | (480) 396-1798 |
| Email: | david@dentimax.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | OpenSensorX Series |
|---|---|
| Common Name: | Intraoral X-Ray Imaging System |
| Model Name: | OpenSensorX series |
| Classification Name: | Extraoral Source X-ray System |
| Product Code: | MUH |
| Regulation Number: | 21 CFR 872.1800 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows:
| Manufacturer: | DENTIMAX, INC. |
|---|---|
| Trade Name: | DentiMax Digital X-ray Imaging System |
| Model Name: | SENSORH1 |
| SENSORH2 | |
| Product Code: | MUH |
| Classification Name: | Extraoral Source X-ray System |
| FDA 510 (k) #: | K092547 |
Page 1 of 6
4
5. Description of the Device [21 CFR 807.92(a)(4)]
OpenSensorX series are digital intra-oral sensors. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hi-speed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional iRay intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of the OpenSensorX series is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software. The OpenSensorX series has two device models, OpenSensor0001X and OpenSensor0002X.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Intended Use
The OpenSensorX Series is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.
6.2. Suitable patient
This device is suitable for both adult and pediatric, but not suitable for pregnant women.
6.3. Processing of input and output
The sensor plate of OpenSensorX series are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within CMOS panel, which are composed and processed by connecting to scanning and readout
5
electronics, consequently to form a panel image by transmitting to PC through the user interface.
When OpenSensorX series work continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:
DentiMax Digital X-Ray Imaging
System | Proposed Device:
OpenSensorX Series |
|------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| 510(K) Number | K092547 | To be assigned |
| Classification
Name | Extraoral Source X-ray System | Same |
| Product Code | MUH | Same |
| Regulation Number | 21 CFR 872.1800 | Same |
| Panel | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | CsI | Same |
| Installation Type: | Portable | Same |
| Detector structure: | CCD and thin FOP(fiber optic
plate) | CMOS Photodiode Array |
| Dimensions: | SENSORH1:
41mm×26.4mm×5.8mm
SENSORH2:
42.3mm×30mm×5.8mm | OpenSensor0001X:
38.5mm×25mm×4.5mm
OpenSensor0002X:
40mm×31mm×4.5mm |
| Image Matrix Size: | 1500×1000 pixels for SENSORH1;
1700×1200 pixels for SENSORH2 | 1500×1000 pixels for
OpenSensor0001X;
1800×1300 pixels for
OpenSensor0002X |
| Pixel Pitch: | 20μm | 20μm |
| Effective
Imaging
Area: | 30mm×20mm for SENSORH1;
34mm×24mm for SENSORH2 | 30mm×20mm for
OpenSensor0001X;
35mm×26mm for
OpenSensor0002X |
| Modulation
Transfer
Function (MTF) | 0.1 at 7lp/mm | 0.1 at 12.5lp/mm |
| Item | Predicate Device:
DentiMax Digital X-Ray Imaging
System | Proposed Device:
OpenSensorX Series |
| Power Consumption: | DC +4.5 to 5.5V(480mA Max.) | 5V DC, 400mA |
| Communications: | USB 2.0 | Same |
| Protection against shock | Type BF applied part | Type BF applied part |
| Operation: | Temperature: 0 to 50°C
Humidity: 0 to 70% (Non-
Condensing) | Temperature: 10 to 35°C |
| | | Humidity: 20 to 90% (Non-
Condensing) |
| | | Atmospheric pressure: 70 to 106 kPa |
| | | Altitude: Max. 3000 meters |
| | | Storage and
Transportation:
( detector ) |
| Humidity: 10 to 95%
(Non-Condensing) | | |
| Atmospheric pressure: 70 ~ 106 kPa | | |
| Altitude: Max. 3000 meters | | |
| Software | XRAY Vision Software(XVA3TM) | |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
6
System requirements to operate with other radiographic system components 8.
-
- Recommended Generator Specification:
Energy range: 55~100kV
- Recommended Generator Specification:
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (depending on the generator power)
Note: To our best knowledge, the OpenSensorX series are compatible with the X-ray generators with the specifications described above.
-
- Application Program Interface (API) for system integration manufacturer
Peripheral hardware: OpenSensorX series connected via USB2.0 communication.
- Application Program Interface (API) for system integration manufacturer
| Operating System: | Windows 7 or above 32/64bit |
|---|---|
| CPU: | Intel Core i5 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| USB port: | in accordance with USB2.0 interface |
7
-
- X-ray exposure mode
The AED mode can connect X-ray signal in the OpenSensorX series. Once there the X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the intraoral sensor. Until the exposure is finished, the sensor will receive a signal which represents the end of exposure from the inner trigger module and begin to acquire the image.
- X-ray exposure mode
9. Nonclinical study
-
- Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-65 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results meet the standard requirements.
- Electrical Safety and EMC testing:
-
- Biological Evaluation:
Although there is a single-use protective sheeth prior to each use, the materials of the intra-oral sensor enclosure which may contact patient's oral mucosa have been evaluated with the ISO10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
The sensor position frame is evaluate and assured the same as the predicate device.
-
- Nonclinical Considerations:
According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, The non-clinical studies have been performed and the results have shown that the OpenSensorX series are substantially equivalent to the predicate devices on the Market (K092547):
- Nonclinical Considerations:
Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time.
According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software iRayDR classifies the hazards, defines requirements specification and design specification, all the specification pass all the
8
test cases and complies the intended design specification.
-
- Clinical Consideration:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles.
- Clinical Consideration:
10. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Dentimax Inc. Concludes that OpenSensorX series are substantially equivalent to predicate device with regards to safety and effectiveness.