(79 days)
No
The document describes standard digital X-ray imaging technology and image processing, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The software mentioned ("Ai-Dental") is described in the context of hazard classification and design specifications, not AI/ML capabilities.
No.
Explanation: This device is an imaging system used for diagnosis (dental X-ray examination and diagnosis of structural diseases), not for treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states "The product is used for...the diagnosis of structural diseases of teeth, jaws and mouth." This indicates its use in identifying and determining the nature of medical conditions.
No
The device description explicitly states it is a "digital intra-oral sensor" and describes hardware components like a CMOS sensor, scintillator, and USB interface. While it includes optional software, the core device is a hardware component that converts X-rays to digital images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth." This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details a "Digital intra-oral sensor" that converts X-rays to digital images. This is a component of an X-ray imaging system.
- Input Imaging Modality: The input modality is explicitly stated as "X-ray."
- Anatomical Site: The anatomical site is "teeth, jaws and mouth," which are parts of the human body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis. This device does not perform such analysis on biological specimens.
The device is a medical imaging device that uses X-rays to visualize internal structures for diagnostic purposes, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
Digital intraoral X-ray Imaging System, models i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. 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
The Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are 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 hispeed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of i-Sensor H1 and i-Sensor H2 are 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
teeth, jaws and mouth
Indicated Patient Age Range
both adult and pediatric.
Intended User / Care Setting
hospitals and clinics, operated and used by trained professionals under the guidance of doctors.
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: 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 safety 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 i-Sensor H1 & i-Sensor H2 are substantially equivalent to the predicate devices on the Market (K210312),The below applicable items are evaluated: 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 and the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, the software Ai-Dental classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification. According to the Guidance for the Pediatric Information for X-ray Imaging Device Premarket Notifications, the pediatric capabilities and labeling requirements were considered during the design and development process, the related information is shown in the User's manual.
- 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
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
Image /page/0/Picture/0 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
October 7, 2021
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: K212279
Trade/Device Name: Digital Intraoral X-ray Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: May 31, 2021 Received: July 20, 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
SECTION 4
INDICATIONS FOR USE
The respective Form FDA 3881 is attached within this submission.
SECTION 4 - 1 of 1
3
Indications for Use
510(k) Number (if known) K212279
Device Name Digital Intraoral X-Ray Imaging System
Type of Use (Select one or both, as applicable)
Digital intraoral X-ray Imaging System, models i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. 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.
| ☑ 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"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."
4
Guilin Woodpecker Medical Instrument Co., Ltd.
510(k) Summary of Safety and Effectiveness
5
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
-
- Date Prepared [21 CFR 807.92(a)(1)] May 31, 2021
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: | Guo Wu |
| Phone: | 0512-53698213 |
| Fax: | 0512-53690872 |
| Email: | guo.wu@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Digital Intraoral X-ray Imaging System |
|---|---|
| Common Name: | Extraoral Source X-Ray System |
| Model Name: | i-Sensor H1 |
| i-Sensor H2 | |
| Classification Name: | Extraoral Source X-Ray System |
| Product Code: | MUH |
| Regulation Number: | 21 CFR 872.1800 |
| Device Class: | Class II |
6
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows:
| Manufacturer: | iRay Technology Taicang Ltd. |
|---|---|
| Trade Name: | Digital Intraoral X-ray Imaging System |
| Model Name: | Pluto0001X |
| Model Name: | Pluto0002X |
| Product Code: | MUH |
| Classification Name: | Extraoral Source X-Ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Device Class: | Class II |
| FDA 510 (k) #: | K210312 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are 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 hispeed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of i-Sensor H1 and i-Sensor H2 are 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. Indications for use
7
Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. 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.
6.3. Processing of input and output
The sensor plate is 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 electronics, consequently to form a panel image by transmitting to PC through the user interface. When i-Sensor H1/ i-Sensor H2 work 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 Intraoral X-Ray Imaging
System
Pluto0001X and Pluto0002X | Proposed Device:
Digital Intraoral X-Ray Imaging
System
i-Sensor H1 and i-Sensor H2 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Model name | PlutoX sensor | i-Sensor H1 & i-Sensor H2 |
| 510(K) Number | K210312 | K212279 |
| Classification
Name | Extraoral Source X-ray System | Same |
| Product Code | MUH | Same |
| Item | Predicate Device:
Digital Intraoral X-Ray Imaging
System
Pluto0001X and Pluto0002X | Proposed Device:
Digital Intraoral X-Ray Imaging
System
i-Sensor H1 and i-Sensor H2 |
| 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 |
| Dimensions: | Pluto0001X:
38.5mm×25mm×4.5mm
Pluto0002X:
40mm×31mm×4.5mm | i-Sensor H1:
38.5mm×25mm×4.5mm
i-Sensor H2:
40mm×31mm×4.5mm |
| Image Matrix Size: | 1500×1000 pixels for Pluto0001X
1800×1300 pixels for Pluto0002X | 1500×1000 pixels for i-Sensor H1
1800×1300 pixels for i-Sensor H2 |
| Pixel Pitch: | 20μm | Same |
| Effective Imaging
Area: | 30mm×20mm for Pluto0001X;
36mm×26mm for Pluto0002X; | 30mm×20mm for i-Sensor H1;
36mm×26mm for i-Sensor H2; |
| Spatial resolution | 16lp/mm | Same |
| Modulation
Transfer
Function (MTF) | 0.1 at 12.5lp/mm | Same |
| Power Consumption: | 5V DC, 400mA | 5V DC, 500mA |
| 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: 10 to 35°C
Humidity: 20 to 90% (Non-
Condensing)
Atmospheric pressure: 70 to 106 kPa | Same |
| Item | Predicate Device:
Digital Intraoral X-Ray Imaging
System
Pluto0001X and Pluto0002X | Proposed Device:
Digital Intraoral X-Ray Imaging
System
i-Sensor H1 and i-Sensor H2 |
| Storage and
Transportation:
( detector ) | Temperature: -10 to 55°C
Humidity: 10 to 95%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters | Same |
| Software | iRayDR | Ai-Dental |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
8
Guilin Woodpecker Medical Instrument Co., Ltd.
[510(k)] Application
9
Guilin Woodpecker Medical Instrument Co., Ltd.
[510(k)] Application
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 i-Sensor H1 & i-Sensor H2 are compatible with the X-ray generators with the specifications described above.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: the i-Sensor H1 & i-Sensor H2 connected via USB2.0 communication.
| Operating System: | Windows® 7 or above |
|---|---|
| CPU: | Intel® Core 2 |
| Memory: | 2 GB or above |
| Hard Disk: | 320 GB or above |
| USB port: | 4 high-speed USB 2.0 ports |
-
- X-ray exposure mode
10
The AED mode can connect X-ray signal in the i-Sensor H1 & i-Sensor H2. 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.
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 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.
- Biological Evaluation:
The sensor position frame is evaluate and assured the safety 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 i-Sensor H1 & i-Sensor H2 are substantially equivalent to the predicate devices on the Market (K210312),The below applicable items are evaluated:
- 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 and the Content of Premarket Submissions for
7 of 8
11
Management of Cybersecurity in Medical Devices, the software Ai-Dental classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification. According to the Guidance for the Pediatric Information for X-ray Imaging Device Premarket Notifications, the pediatric capabilities and labeling requirements were considered during the design and development process, the related information is shown in the User's manual.
-
- 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 [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Guilin Woodpecker Medical Instrument Co., Ltd. Concludes that i-Sensor H1 & i-Sensor H2 are substantially equivalent to predicate device with regards to safety and effectiveness.