(63 days)
No
The document describes a flat panel detector for X-ray imaging and mentions standard image processing steps, but there is no mention of AI, ML, or related concepts like deep learning or neural networks.
No.
The device is an imaging component (flat panel detector) used to acquire X-ray images, not to treat a condition.
No
Explanation: The device is described as an imaging component (flat panel detector) that provides radiography images. It collects static image data and outputs it to processing equipment. While imaging is a crucial part of diagnosis, the device itself is a data acquisition component and does not perform the diagnostic interpretation or analysis. The diagnostic function is performed by the overall DR system and the interpreting physician.
No
The device description explicitly states it is a "Digital flat panel detector" which is a hardware component used in X-ray imaging systems. It also mentions physical characteristics like pixel pitch and scintillator material. While it includes software for processing, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is an "imaging component to the system manufacturer" and is used for "radiography imaging for adult via DR system." This describes an in-vivo imaging device, not a device used to examine specimens from the human body in vitro.
- Device Description: The description details a "Digital flat panel detector" that captures X-ray images. This is consistent with an in-vivo imaging device.
- Input Imaging Modality: The input modality is X-Ray, which is used for in-vivo imaging.
- Anatomical Site: The anatomical sites mentioned (long bones, spine) are parts of the human body being imaged directly, not specimens being tested in a lab.
- Performance Studies: The performance studies focus on imaging characteristics (dose to output signal, SNR, MTF, etc.) and electrical/EMC safety, which are relevant to in-vivo imaging devices. There are no studies related to the analysis of biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to capture images of the human body itself using X-rays.
N/A
Intended Use / Indications for Use
The Venul 748V flat panel detector is provided as an imaging component to the system manufacturer. It is mainly used in long bones, spine and other inspection fields. After collecting static imaged data is output to the processing equipment.
This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the final DR system.
It is not intended for mammography, dental applications, neonatal and fluoroscopy.
Product codes
MQB
Device Description
Digital flat panel detector is a cassette-size wired X-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It was developed to provide X -Ray image, which contains an active matrix of 3064×8696 with 139um pixel pitch. Detector's scintillator is CsI(Cesium iodide). The biggest feature of Venu1748V is that it supports imaging of large-scale objects, including long bones and complete spine detection.
Mentions image processing
After collecting static images, the imaged data is output to the processing equipment.
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 TFT 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
long bones, spine
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
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, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-54 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
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 Venu1748V is substantially equivalent to the predicate devices on the Market (K190611):
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 iDtector 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.)
Modulation Transfer Function (MTF): 56% at 1.0 lp/mm
Detective Quantum Efficiency (DQE): 24% at 1.0 lp/mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
April 28, 2022
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
iRay Technology Taicang Ltd. % Jeffrey Wu Regulatory Affairs Engineer No. 33 Xinggang Road, Taicang Port Economic and Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K220536
Trade/Device Name: Digital flat panel detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 21, 2022 Received: February 24, 2022
Dear Jeffrey Wu:
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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
2
Indications for Use
Device Name
Digital flat panel detector
Indications for Use (Describe)
The Venul 748V flat panel detector is provided as an imaging component to the system manufacturer. It is mainly used in long bones, spine and other inspection fields. After collecting static imaged data is output to the processing equipment.
This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the final DR system.
It is not intended for mammography, dental applications, neonatal and fluoroscopy.
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) 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."
EF
PSC Publishing Services (301) 443-6740
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 21, 2022
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 flat panel detector |
|---|---|
| Common Name: | Solid State X-Ray Imager (Flat Panel/Digital |
| Imager) | |
| Model Name: | Venu1748V |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| 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: | Vieworks Co., Ltd. |
|---|---|
| Trade Name: | VIVIX-S 1751S |
| Model Name: | VIVSX-S 1751S |
| Product Code: | MQB |
SECTION 3 - 2 of 7
4
| Classification Name: | Stationary X-Ray System |
|---|---|
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K190611 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Digital flat panel detector is a cassette-size wired X-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It was developed to provide X -Ray image, which contains an active matrix of 3064×8696 with 139um pixel pitch. Detector's scintillator is CsI(Cesium iodide). The biggest feature of Venu1748V is that it supports imaging of large-scale objects, including long bones and complete spine detection.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
The Venu1748V flat panel detector is provided as an imaging component to the system manufacturer. It is mainly used in long bones, spine and other inspection fields. After collecting static images, the imaged data is output to the processing equipment.
This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the final DR system. It is not intended for mammography, dental applications, neonatal and
fluoroscopy.
6.2. Suitable patient
This device is not intended for mammography and applications. This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the DR system. In addition, it is also prohibited for use on pregnant women. Shielding of noneinspection body areas is necessary during X-ray exposure.
SECTION 3 - 3 of 7
5
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 TFT 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.
| Item | Predicate Device:
VIVIX-S 1751S | Proposed Device:
Digital flat panel detector
Venu1748V |
|------------------------------------------|--------------------------------------|--------------------------------------------------------------|
| Model name | VIVIX-S 1751S | Venu1748V |
| 510(K) Number | K190611 | To be assigned |
| Classification
Name | Stationary X-Ray System | Same |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Panel | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | Gd2O2S:Tb
(Gadolinium oxysulfide) | CsI |
| Installation Type: | Portable | Same |
| Detector structure: | Amorphous silicon TFT | Same |
| Dimensions: | 1357.0mm×532.0mm×30.0mm | 1271.4mm×586.6mm×20.8mm |
| Max. Image Matrix
Size: | 3072 × 9216 pixels | 3064 × 8696 pixels |
| Pixel Pitch: | 140μm | 139μm |
| Max. Effective
Imaging Area(H×V): | 430.08mm × 1290.24mm | 425.8mm×1208.7mm |
| Spatial resolution | 3.5 lp/mm | 3.4 lp/mm |
| Greyscales | 16 bit | Same |
| Modulation
Transfer
Function (MTF) | 40% at 1.0 lp/mm | 56% at 1.0 lp/mm |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
SECTION 3 - 4 of 7
6
| Item | Predicate Device:
VIVIX-S 1751S | Proposed Device:
Digital flat panel detector
Venu1748V |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Detective Quantum
Efficiency (DQE) | 20% at 1.0 lp/mm | 24% at 1.0 lp/mm |
| Power Consumption: | Max. 72 W | Max. 50 W |
| Communications: | Wired LAN | Same |
| Cooling: | Air cooling | Same |
| Protection
against
matter/Water | IPX0 | Same |
| Operation: | Temperature: 10 to 35°C
Humidity: 30 to 85% (Non-
Condensing)
Atmospheric pressure: 70 to 106
kPa
Altitude: Max. 3000 meters | Temperature: 5 to 35°C
Humidity: 10 to 90% (Non-
Condensing)
Atmospheric pressure: 70 to 106
kPa
Altitude: Max. 3000 meters |
| Storage and
Transportation:
( detector ) | Temperature: -15 to 55°C
Humidity: 10 to 90%
(Non-Condensing)
Atmospheric pressure: 50 ~ 106
kPa
Altitude: Max. 3000 meters | Temperature: -20 °C ~ 55 °C
Humidity: 5% ~ 95%
(Non-Condensing)
Atmospheric pressure:
70kPa~106kPa
Altitude: Max. 3000 meters |
| Software | VXvue | iDetector |
8. System requirements to operate with other radiographic system components
- 8.1. Recommended Generator Specification:
Energy range: 40~150kV
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 Venu1748V is compatible with the X-ray generators with the specifications described above.
SECTION 3 - 5 of 7
7
8.2. Application Program Interface (API) for system integration manufacturer Peripheral hardware: the Venu1748V connected via wired LAN cable communication.
| Operating System: | Windows 7 64bit |
|---|---|
| CPU: | Intel Core i5 3.6GHz |
| Memory: | 8G DRR3 |
| Hard Disk: | 640 GB |
| Network Board: | Inter Pro EXP9301CT PRO |
8.3. X-ray exposure mode
The inner trigger module is a unit can connect X-ray signal in the Venu1748V. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.
9. Nonclinical study
9.1. Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-54 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
9.2. 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 Venu1748V is substantially equivalent to the predicate devices on the Market (K190611):
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.
SECTION 3 - 6 of 7
8
According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software iDtector classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification.
9.3. 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.
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, iRay Technology Taicang Ltd. Concludes that Venu1748V is substantially equivalent to predicate device with regards to safety and effectiveness.