(25 days)
Venu1748V and DRX-LC, as a major imaging component, are supplied to the manufacturers of medical diagnostic X-ray photography systems, and used in conjunction with the medical diagnostic X-ray photography system to image the object to be checked. They are capable of outputting the acquired static images to a processing device after acquisition.
Venu1748V and DRX-LC digital flat panel detector (Hereinafter referred to as Venu1748V and DRX-LC) are digital large-sized X-ray flat panel detector (FPD) with wireless function based on amorphous silicon (a-Si) thin film transistor (TFT) technology. Two models Venu1748V and DRX-LC are totally same except for the model name, trade mark, artwork of the protection film. They using cesium iodide (CsI) scintillator, and employ a 3064×8696 active pixel matrix with a pixel size of 139 u m, providing high-quality radiographic images. Supporting high-speed wireless communication, the equipment can be powered by internal rechargeable battery packs or/and external power charger, making it more flexible and easy to integrate and operate. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers. iDetector is a tool software based on iRay FPD(Flat Panel Detector) and SDK(Software Development Kit). It can be used for detector configuration, image acquisition, and calibration. So that users can evaluate the performance of iRay detectors at the first time. Also, iDetector can be used as a demonstration program to learn the process controlling and functionality of iRay Detectors and do assessment at user application developing time. This software is moderate level of concern. iDetector does not support image processing after collection.
This document describes the premarket notification (510(k)) for the iRay Imaging Technology (Haining) Limited Digital Flat Panel Detector (models Venu1748V and DRX-LC).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but rather presents a comparison of technological characteristics between the proposed device and a predicate device (K220536). The proposed device meets or improves upon the characteristics of the predicate device.
| Item | Predicate Device (K220536) | Proposed Device (Venu1748V, DRX-LC) |
|---|---|---|
| Model Name | Venu1748V | Venu1748V, DRX-LC |
| Configuration Name | Venu1748V | Venu1748V-WF, DRX-LC |
| 510(k) Number | K220536 | K230059 |
| 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 | CsI | Same |
| Installation Type | Fixed | Transportable |
| Degree of protection against electrical shock | No such Part (Predicate) | Type B (Proposed) |
| Power supply | AC power | AC power and battery |
| Detector structure | Amorphous silicon TFT | Same |
| Dimensions | 1271.4mm×586.6mm×20.8mm | Same |
| Image Matrix Size | 3064 × 8696 pixels | Same |
| Pixel Pitch | 139μm | Same |
| Effective Imaging Area | 425.8mm×1208.7mm | Same |
| ADC Digitization | 16 bit | Same |
| Spatial Resolution | Min. 3.6lp/mm | Same |
| Modulation Transfer Function (MTF) | 56% at 1.0 lp/mm | 58% at 1.0 lp/mm (Improved) |
| Detective Quantum Efficiency (DQE) | 24% at 1.0 lp/mm | 38% at 1.0 lp/mm (Improved) |
| Accessory | Medical adapter, Control Box | Medical adapter, Control Box, Wireless USB adapter, Battery, Detector Cart, Detector weight bearing cap, Battery-Charger |
| Imaging protect Plate | Carbon Fiber Plate | Same |
| Power Consumption | Max. 50W | Same |
| Communications | Wired | Wired and wireless |
| Cooling | Air cooling | Same |
| Protection against matter/Water | IPX0 | Same |
| Operation (Temperature) | 5 to 35°C | Same |
| Operation (Humidity) | 10 to 90% (Non-Condensing) | Same |
| Operation (Atmospheric pressure) | 70 to 106 kPa | Same |
| Operation (Altitude) | Max. 3000 meters | Same |
| Storage & Transportation (Temperature) | -20 °C ~ 55 °C | Same |
| Storage & Transportation (Humidity) | 5% ~ 95% (Non-Condensing) | Same |
| Storage & Transportation (Atmospheric pressure) | 70kPa~106kPa | Same |
| Storage & Transportation (Altitude) | Max. 3000 meters | Same |
| Software | iDetector (edition: 4.1.0.8905) | iDetector (edition: 4.1.3.10016) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document focuses on non-clinical performance testing and comparative analysis against a predicate device. There is no mention of a "test set" in the context of clinical data or human-interpreted image sets for evaluating device diagnostic performance. The studies are non-clinical, evaluating technical specifications of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The reported studies are non-clinical and focus on characterizing device performance parameters (e.g., MTF, DQE, uniformity) rather than diagnostic accuracy based on expert interpretation of images. Therefore, no experts were used to establish ground truth for a diagnostic test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical or human-interpreted test set was used, no adjudication method was employed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a Digital Flat Panel Detector, which is an imaging component. It is not an AI-powered diagnostic device, and therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a Digital Flat Panel Detector, a hardware component for X-ray imaging. Performance is evaluated based on its technical specifications (e.g., MTF, DQE, SNR, uniformity) through non-clinical studies. There is no "algorithm only" performance assessment in the context of diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical studies relies on established scientific and engineering principles for measuring physical parameters of X-ray detectors (e.g., using phantoms, standardized test setups, and calibrated equipment to measure MTF, DQE, SNR, etc.). It does not involve expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This device is a hardware component and does not utilize a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for AI, no ground truth needed to be established for it.
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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 logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".
February 3, 2023
iRay Imaging Technology (Haining) Limited %Mr. Jeffrey Wu Registration & Regulation Affairs Engineer No. 2. Caohejing RD., Haining 314499, Jiaxing Haining. Zheiiang 314499 CHINA
Re: K230059
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: December 29, 2022 Received: January 9, 2023
Dear Mr. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
Lu Jiang 2023.02.03
12:44:36
-05'00'
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
Enclosure
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SECTION 4
Indications for use FDA-3881
SECTION 4- 1 of 1
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230059
Device Name Digital Flat Panel Detector
Indications for Use (Describe)
Venul 748V and DRX-LC, as a major imaging component, are supplied to the manufacturers of medical diagnostic X-ray photography systems, and used in conjunction with the medical diagnostic X-ray photography system to image the object to be checked. They are capable of outputting the acquired static images to a processing device after acquisition.
| 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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SECTION 6
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
SECTION 6 - 1 of 8
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92) K230059
1. Date Prepared [21 CFR 807.92(a)(1)]
December 15, 2022
2. Submitter;s Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Imaging Technology (Haining) Limited | |
|---|---|---|
| Company Address: | No. 2, Caohejing RD., Haining 314499, Jiaxing, ZhejiangP.R.China | |
| Contact Person: | Jeffrey Wu | |
| Phone: | 86-21-50720539 | |
| Fax: | 86-21-50720561 | |
| 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 |
| Model Name: | Venu1748VDRX-LC |
| 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: | iRay Technology Co., Ltd. |
|---|---|
| Trade Name: | Digital Flat Panel Detector |
| Model Name: | Venu1748V |
SECTION 6 - 2 of 8
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| Product Code: | MQB |
|---|---|
| Classification Name: | Stationary x-ray system |
| FDA 510 (k) #: | K220536 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Venu1748V and DRX-LC digital flat panel detector (Hereinafter referred to as Venu1748V and DRX-LC) are digital large-sized X-ray flat panel detector (FPD) with wireless function based on amorphous silicon (a-Si) thin film transistor (TFT) technology.
Two models Venu1748V and DRX-LC are totally same except for the model name, trade mark, artwork of the protection film. They using cesium iodide (CsI) scintillator, and employ a 3064×8696 active pixel matrix with a pixel size of 139 u m, providing high-quality radiographic images.
Supporting high-speed wireless communication, the equipment can be powered by internal rechargeable battery packs or/and external power charger, making it more flexible and easy to integrate and operate.
iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers.
iDetector is a tool software based on iRay FPD(Flat Panel Detector) and SDK(Software Development Kit). It can be used for detector configuration, image acquisition, and calibration. So that users can evaluate the performance of iRay detectors at the first time. Also, iDetector can be used as a demonstration program to learn the process controlling and functionality of iRay Detectors and do assessment at user application developing time. This software is moderate level of concern. iDetector does not support image processing after collection.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Venu1748V and DRX-LC, as a major imaging component, are supplied to the manufacturers of medical diagnostic X-ray photography systems, and used in
SECTION 6 - 3 of 8
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conjunction with the medical diagnostic X-ray photography system to image the object to be checked. They are capable of outputting the acquired static images to a processing device after acquisition.
6.2. Suitable patient
Two models provide digital X-ray imaging technology for the diagnosis of disease, injury, or any health problem, suitable for all common anatomical large objects that require X-ray examination including long bones or the spine. They are not suitable for mammography, dental photography, and dynamic imaging photography. Do not use it in pregnant women.
6.3. Processing of input and output
When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:Digital Flat Panel Detector | Proposed Device:Digital Flat Panel Detector |
|---|---|---|
| Model Name: | Venu1748V | Venu1748V, DRX-LC |
| Configuration Name: | Venu1748V | Venu1748V-WF, DRX-LC |
| 510(K) Number: | K220536 | K230059 |
| ClassificationName: | 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): | CsI | Same |
| Installation Type: | Fixed | Transportable |
| Degree of protectionagainst electricalshock: | No such Part | Type B |
| Item | Predicate Device:Digital Flat Panel Detector | Proposed Device:Digital Flat Panel Detector |
| Power supply: | AC power | AC power and battery |
| Detector structure: | Amorphous silicon TFT | Same |
| Dimensions: | 1271.4mm×586.6mm×20.8mm | Same |
| Image Matrix Size: | 3064 × 8696 pixels | Same |
| Pixel Pitch: | 139μm | Same |
| EffectiveImagingArea: | 425.8mm×1208.7mm | Same |
| ADCDigitization: | 16 bit | Same |
| Spatial Resolution: | Min. 3.6lp/mm | Same |
| ModulationTransferFunction (MTF): | 56% at 1.0 lp/mm | 58% at 1.0 lp/mm |
| DetectiveQuantumEfficiency(DQE): | 24% at 1.0 lp/mm | 38% at 1.0 lp/mm |
| Accessory: | Medical adapter, Control Box | Medical adapter, Control Box,Wireless USB adapter, Battery,Detector Cart, Detector weightbearing cap, Battery-Charger |
| Imaging protectPlate: | Carbon Fiber Plate | Same |
| Power Consumption: | Max. 50W | Same |
| Communications: | Wired | Wired and wireless |
| Cooling: | Air cooling | Same |
| Protectionagainstmatter/Water | IPX0 | Same |
| Operation: | Temperature: 5 to 35°CHumidity: 10 to 90% (Non- | Temperature: 5 to 35°CHumidity: 10 to 90% (Non- |
| Condensing) | Condensing) | |
| Atmospheric pressure: 70 to 106 | Atmospheric pressure: 70 to 106 | |
| kPa | kPa | |
| Altitude: Max. 3000 meters | Altitude: Max. 3000 meters | |
| Storage andTransportation: | Temperature: -20 °C ~ 55 °C | Temperature: -20 °C ~ 55 °C |
| Humidity: 5% ~ 95% | Humidity: 5% ~ 95% | |
| (Non-Condensing) | (Non-Condensing) | |
| Item | Predicate Device:Digital Flat Panel Detector | Proposed Device:Digital Flat Panel Detector |
| ( detector ) | Atmospheric pressure:70kPa~106kPaAltitude: Max. 3000 meters | Atmospheric pressure:70kPa~106kPaAltitude: Max. 3000 meters |
| Software | iDetector(edition: 4.1.0.8905) | iDetector(edition: 4.1.3.10016) |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
SECTION 6 - 4 of 8
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iRay Imaging Technology (Haining) Limited
SECTION 6 - 5 of 8
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iRay Imaging Technology (Haining) Limited
[510(k)] Application
8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150kV
- 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 detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact your distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Venu1748V and DRX-LC connected via wired communication or wireless.
| Operating System: | Windows 7 64bit, or even higher |
|---|---|
| CPU: | Intel Core i5 3.6G, or even higher |
| Memory: | 8G DDR3 or higher |
| Hard Disk: | 640 G or higher |
| Netwoek Card: | Intel Pro EXP9301CT PRO or higher |
-
- X-ray exposure mode
The inner trigger module is a unit can connect X-ray signal in the Venu1748V and DRX-LC. 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
- X-ray exposure mode
SECTION 6 - 6 of 8
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the inner trigger module and begin to acquire the image.
9. Nonclinical study
-
- 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.
- Electrical Safety and EMC testing:
-
- Biological Evaluation:
The top cover surface film of the detector may contact patients' skin, this has been evaluated with the ISO 10993-1.
- Biological Evaluation:
-
- 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 and DRX-LC are substantially equivalent to the predicate devices on the Market (K220536):
- 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 SDK(contains iDetector) 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:
-
- Cybersecurity:
SECTION 6 - 7 of 8
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According to the Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, the Venu1748V and DRX-LC had passed the assessment related to Cybersecurity.
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 iRay Venu1748V and DRX-LC are substantially equivalent to predicate device with regards to safety and effectiveness.
SECTION 6 - 8 of 8
§ 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.