(196 days)
No
The summary describes a digital X-ray sensor and associated software for image acquisition, enhancement, analysis, viewing, and sharing. While image processing is mentioned, there is no explicit mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on the hardware (sensor) and standard image processing functions.
No
The device is an imaging device used for diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states: "The product is used for dental X-ray examination and the diagnosis of structural diseases." This explicitly indicates the device's role in diagnosis.
No
The device description explicitly states that the Pluto0002XW "contains the digital intra-oral sensor" and is a "key component of intra-oral DR system". It also mentions the sensor's physical characteristics (CMOS sensor, scintillator, pixel pitch) and how it converts X-rays to digital images. While software is part of the system, 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 medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pluto0002XW Digital Wireless Intraoral X-Ray Sensor is used to capture X-ray images of the oral cavity. It converts X-rays into digital images.
- Intended Use: The intended use is for dental X-ray examination and the diagnosis of structural diseases based on these images.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It directly interacts with the patient's body (via X-rays) to produce an image.
Therefore, the function and intended use of this device fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) 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 Pluto0002XW Digital Wireless Intraoral X-Ray Sensor (Hereinafter referred to as Pluto0002XW) contains the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. The major function of the Pluto0002XW is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Pluto0002XW 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 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. iRayDR has been cleared with the predicate device (K210312)
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)
- 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.
- Wireless testing: Wireless functionality and wireless coexistence testing in accordance with ANSI IEEE C63.27-2017 was performed. All test results are meet the standard requirements.
- Cybersecurity testing: Cybersecurity threat modeling, risk assessment, and controls and testing were performed to comply with requirements specified in section 524B(b)(2) of the Federal Food, Drug, and Cosmetics Act to provide a reasonable assurance that the subject device with its wireless capabilities are cybersecure.
- Biological Evaluation: Although there is a single-use protective sheath 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.
- Nonclinical Considerations: Main modification from the predicate device is power supply mode, communication, and IP grade. The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Pluto0002X, K210312).
- Clinical Consideration: Intended use, fundamental scientific technology, reguirement, non-clinical performance, labeling, quality-assurance program, keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the wireless functionality if nonclinical information is sufficient to support the 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.
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
October 20, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iRay Imaging Technology (Haining) Limited % Junjie Qian Registration & Regulation Affairs Engineer 3rd floor, Building 1, No. 2, Caohejing Rd. Haining, Jiangsu 314499 CHINA
Re: K230998
Trade/Device Name: Digital Wireless Intraoral X-Ray Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: February 13, 2023 Received: April 7, 2023
Dear Junjie Qian:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230998
Device Name Digital Wireless Intraoral X-Ray Sensor
Indications for Use (Describe)
The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) 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) | |
|---|---|
| X 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
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
February 13, 2023
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Imaging Technology (Haining) Limited | |
|---|---|---|
| Company Address: | 3rd floor, Building 1, No. 2, Caohejing RD., Haining 314499, China | |
| Contact Person: | Junjie Qian | |
| Phone: | 0573-87399739 | |
| Email: | Junjie.qian@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Digital Wireless Intraoral X-Ray Sensor |
|---|---|
| Common Name: | Extraoral Source X-Ray System |
| Model Name: | Pluto0002XW |
| 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: | iRay Technology Co. Ltd. |
|---|---|
| Trade Name: Model | PlutoX Digital Intraoral X-Ray Imaging System |
| Name: Product | Pluto0002X |
| Code: | MUH |
| Regulation Number: | 21 CFR 872.1800 |
| Classification Name: | Extraoral Source X-ray System |
| FDA 510 (k) #: | K210312 |
| Device Class: | Class II |
4
5. Description of the Device [21 CFR 807.92(a)(4)]
The Pluto0002XW Digital Wireless Intraoral X-Ray Sensor (Hereinafter referred to as Pluto0002XW) contains the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution.
The major function of the Pluto0002XW is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Pluto0002XW 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 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. iRayDR has been cleared with the predicate device(K210312)
6. Intended Use [21 CFR 807.92(a)(5)]
6.1 Indications for Use
The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) 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.
5
[510(k)] Application
iRay Imaging Technology (Haining) Limited
6.3. Processing of input and output
The sensor plate of Pluto0002XW is 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 Pluto0002XW works continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:
Digital Dental Intra Oral Sensor | Proposed Device:
Digital Wireless Intraoral X-Ray
Sensor |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K210312 | K230998 |
| 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 |
| Indications for 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 | Same |
| Item | Predicate Device:
Digital Dental Intra Oral Sensor | Proposed Device:
Digital Wireless Intraoral X-Ray
Sensor |
| | 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. | |
| CMOS sensor
dimension: | Pluto0002X:
40mm×31mm×4.5mm | 45mm×31.6mm×4.5mm |
| Image Matrix Size: | Pluto0002X: 1800×1300 pixels | Same |
| Pixel Pitch: | 20μm | Same |
| Effective
Imaging
Area: | Pluto0002X: 36mm×26mm | Same |
| Spatial resolution | 16lp/mm | Same |
| Modulation
Transfer
Function (MTF) | 0.1 at 12.5lp/mm | Same |
| Power Consumption: | 5V DC, 400mA | ≤3.5W |
| Communication | USB 2.0 | Wireless IEEE 802.11 |
| power supply mode | USB 2.0 | Internal battery |
| Cooling: | Air cooling | Same |
| IP grade | COMS Sensor: IP68
USB box: IP20 | CMOS Sensor: IP68
Handle: IP44
Charging Base: IP44 |
| Protection
against
shock | Type BF applied part | Same |
| Operation: | Temperature: 10 to 35°C
Humidity: 20 to 90% (Non-
Condensing)
Atmospheric pressure: 70 to 106
kPa
Altitude: Max. 3000 meters | Temperature: 10 to 35°C
Humidity: 5 to 90% (Non-
Condensing)
Atmospheric pressure: 700 to 1060
hPa
Altitude: Max. 3000 meters |
| Storage and | Temperature: -10 to 55°C | Temperature: -20 to 55°C |
| Transportation: | Humidity: 10 to 95% | Humidity: 5 to 95% |
| Item | Predicate Device:
Digital Dental Intra Oral Sensor | Proposed Device:
Digital Wireless Intraoral X-Ray
Sensor |
| | (Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | (Non-Condensing)
Atmospheric pressure: 700 to 1060 hPa
Altitude: Max. 3000 meters |
| Software | iRayDR | Same |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
6
iRay Imaging Technology (Haining) Limited
[510(k)] Application
7
System requirements to operate with other radiographic system components 8.
- Recommended Generator Specification: 1)
Energy range: 55~100kV
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 Pluto0002XW is compatible with the X-ray
generator with the specifications described above.
-
- Application Program Interface (API) for system integration manufacturer
Peripheral hardware: Pluto0002XW connected via Wireless 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 |
-
- X-ray exposure mode
The AED mode can connect X-ray signal in the Pluto0002XW. 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: 1)
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-65 were performed, and EMC testing was also
8
conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
-
- Wireless testing
Wireless functionality and wireless coexistence testing in accordance with ANSI IEEE C63.27-2017 was performed. All test results are meet the standard requirements.
- Wireless testing
-
Cybersecurity testing 3)
Cybersecurity threat modeling, risk assessment, and controls and testing were performed to comply with requirements specified in section 524B(b)(2) of the Federal Food, Drug, and Cosmetics Act to provide a reasonable assurance that the subject device with its wireless capabilities are cybersecure -
- Biological Evaluation:
Although there is a single-use protective sheath 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:
-
- Nonclinical Considerations:
Main modification from the predicate device is power supply mode, communication, and IP grade
- Nonclinical Considerations:
The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Pluto0002X, K210312).
-
- Clinical Consideration:
Intended use, fundamental scientific technology, reguirement, non-clinical performance, labeling, quality-assurance program, keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the wireless functionality if nonclinical information is sufficient to support the substantial equivalence.
- Clinical Consideration:
9
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 Imaging Technology (Haining) Limited. concludes that Pluto0002XW is substantially equivalent to predicate device with regards to safety and effectiveness.