(79 days)
Not Found
No
The summary describes a standard digital X-ray sensor and associated software for image acquisition, enhancement, analysis, viewing, and sharing. There is no mention of AI or ML algorithms being used for image processing, analysis, or any other function. The performance studies focus on standard imaging metrics and safety, not AI/ML performance.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is an X-ray imaging system used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "used for dental X-ray examination and the diagnosis of structural diseases," indicating its role in the diagnostic process.
No
The device description explicitly states that the system includes a "digital intra-oral sensor" which is a hardware component (CMOS sensor with scintillator). The software is described as "part of the system" and is used to process images from this hardware sensor.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Digital Intra-Oral X-Ray Imaging System" that "convert[s] the X-ray to digital image" for "dental X-ray examination and the diagnosis of structural diseases." It works by capturing X-ray images of the inside of the mouth.
- Lack of Sample Testing: The device does not perform any tests on biological samples taken from the patient. It directly interacts with the patient's body using X-rays to create images.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Digital Intra-Oral X-Ray Imaging System (Pluto0002X) 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 (comma separated list FDA assigned to the subject device)
MUH
Device Description
The PlutoX Digital Intraoral X-Ray Imaging System (Hereinafter contains Pluto0001X and Pluto0002X) is the digital intra-oral sensor. 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 iRay intra-oral software (iRayDR) is part of the system, it is used to acquire, enhance, analyze, view and share images from the sensor. Based on how the operation of the software associated with device function affects the patient or operator, and the effect may be direct or indirect, we hereby certify that the level of concern for our product, use the software 1.0207 version is Moderate. It has not been cleared with other predicate devices but is the initial used in PlutoX.
The major function of the PlutoX 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.
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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 are meet the standard requirements.
- 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. The sensor position frame is evaluate and assured the same as the predicate device.
- Nonclinical Considerations: The non-clinical studies have been performed and the results have shown that the PlutoX series are substantially equivalent to the predicate devices on the Market (K090458): 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 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.
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.
Not Found
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
April 23, 2021
Image /page/0/Picture/1 description: The image contains 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 letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
iRay Technology Taicang Ltd. % Wei Pan Registration and Regulatory Affairs Deputy Director No.33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K210312
Trade/Device Name: PlutoX Digital Intraoral X-rav Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: March 2, 2021 Received: March 3, 2021
Dear Wei Pan:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
Indications for Use
510(k) Number (if known) K210312
Device Name PlutoX Digital Intraoral X-Ray Imaging System
Indications for Use (Describe)
The Digital Intra-Oral X-Ray Imaging System (Pluto0002X) 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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3
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMISSION NUMBER. K210312
4
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
December 20, 2020
2. Submitter;s Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic and |
| Technological Development Zone, Jiangsu, China 215434 | |
| Contact Person: | Wei Pan |
| Phone: | +86 0512-53690872 |
| Fax: | +86 0512-53690872 |
| Email: | Wei.pan@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | PlutoX Digital Intraoral X-Ray Imaging System |
|---|---|
| Common Name: | Extraoral Source X-Ray System |
| Model Name: | Pluto0001X |
| Pluto0002X | |
| Classification Name: | Extraoral Source X-Ray System |
| Product Code: | MUH |
| Regulation Number: | 21 CFR 872.1800 |
| Device Class: | Class II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows:
Manufacturer: Gendex Dental Systems
DEXIS Sensor, VixWin Platinum Trade Name:
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5
iRay Technology Taicang Ltd.
Model Name: GXS-700 Product Code: MUH Classification Name: Extraoral Source X-ray System FDA 510 (k) #: K090458 Class II Device Class:
5. Description of the Device [21 CFR 807.92(a)(4)]
The PlutoX Digital Intraoral X-Ray Imaging System (Hereinafter contains Pluto0001X and Pluto0002X) is the digital intra-oral sensor. 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 iRay intra-oral software (iRayDR) is part of the system, it is used to acquire, enhance, analyze, view and share images from the sensor. Based on how the operation of the software associated with device function affects the patient or operator, and the effect may be direct or indirect, we hereby certify that the level of concern for our product, use the software 1.0207 version is Moderate. It has not been cleared with other predicate devices but is the initial used in PlutoX.
The major function of the PlutoX 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.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1 Intended Use
The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) 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.
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6
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 PlutoX series are direct-deposited with CsI(Cesium Iodide) 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 electronics, consequently to form a panel image by transmitting to PC through the user interface.
When PlutoX series work continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
| Item | Predicate Device:
Gendex Dental Systems | Proposed Device:
Digital Intraoral X-Ray Imaging
System |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Model name | Dexis sensor GSX-700 | PlutoX sensor |
| 510(K) Number | K090458 | K210312 |
| 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: | CMOS Photodiode Array | Same |
| Item | Predicate Device: | Proposed Device: |
| | Gendex Dental Systems | Digital Intraoral X-Ray Imaging System |
| Dimensions: | Size 1: 36.9mm×25.4mm×7.7mm
Size 2: 41.8mm×30.6mm×7.8mm | Pluto0001X:
38.5mm×25mm×4.5mm
Pluto0002X:
40mm×31mm×4.5mm |
| | | |
| Image Matrix Size: | 1539×1026 pixels for Size 1;
1842×1324 pixels for Size 2 | 1500×1000 pixels for Pluto0001X;
1800×1300 pixels for Pluto0002X |
| | | |
| Pixel Pitch: | 19.5µm | 20µm |
| Effective Imaging
Area: | 30.01 mm×20.00 mm for Size 1;
35.92mm×25.82 mm for Size 2; | 30mm×20mm for Pluto0001X;
36mm×26mm for Pluto0002X; |
| Spatial resolution | 20lp/mm | 16lp/mm |
| Modulation
Transfer
Function (MTF) | 0.1 at 13lp/mm | 0.1 at 12.5lp/mm |
| Power Consumption: | 5V DC, 350mA Max | 5V DC, 400mA |
| Communications: | USB 2.0 | Same |
| Cooling: | Air cooling | Same |
| Protection against
matter/Water | IP68 | Same |
| Protection against
shock | Type BF applied part | Same |
| Operation: | Temperature: 5 to 30°C
Humidity: 30 to 95% (Non-
Condensing)
Atmospheric pressure: 70 to 106 kPa | 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 ) | Temperature: -40 to 70°C
Humidity: 10 to 95%
(Non-Condensing)
Atmospheric pressure: 70 to 106 kPa | Temperature: -10 to 55°C
Humidity: 10 to 95%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters |
| | | |
| | | |
| Software | VixWin Platinum | iRayDR |
7
iRay Technology Taicang Ltd.
[510(k)] Application
8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
8
Energy range: 55~100kV
mA range: 101000mA (depending on the generator power) ms range: 106300ms to produce 0.1~1000mAs (depending on the generator power) Note: To our best knowledge, the PlutoX series are compatible with the X-ray generators with the specifications described above.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: PlutoX series connected via USB2.0 communication. Operating System: Windows 7 or above 32/64bit
| Unraining ny surmi. | 11 11 11 11 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 |
|---|---|
| CPU: | Intel Core i5 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| USB port: | in accordance with USB2.0 interface |
-
- X-ray exposure mode
The AED mode can connect X-ray signal in the PlutoX seires. Once there is 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 finished, the sensor will receive a signal which represent 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 are 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:
6 of 7
9
The sensor position frame is evaluate and assured the same as the predicate device.
-
- Nonclinical Considerations:
The non-clinical studies have been performed and the results have shown that the PlutoX series are substantially equivalent to the predicate devices on the Market (K090458):
- 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 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, iRay Technology Taicang Ltd. Concludes that iRay PlutoX series are substantially equivalent to predicate device with regards to safety and effectiveness.