(63 days)
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.
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.
This document is a 510(k) Pre-Market Notification from iRay Technology Taicang Ltd. to the FDA for their Digital Flat Panel Detector, model Venu1748V. It outlines the device's technical characteristics and compares them to a predicate device.
Analysis of Acceptance Criteria and Study Details:
The provided document does not describe a clinical study or a multi-reader, multi-case (MRMC) study to prove the device meets acceptance criteria. Instead, it relies on non-clinical studies (bench testing) to demonstrate substantial equivalence to a predicate device. This is a common approach for imaging components like flat panel detectors where the primary concern is the technical performance of the imaging hardware itself, rather than diagnostic accuracy involving human interpretation when coupled with a full DR system.
Therefore, many of the requested points regarding clinical study design, expert involvement, and human reader performance are not applicable to this submission.
Here's a breakdown based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate table with pass/fail thresholds. Instead, it presents a comparison of key technical specifications between the proposed device (Venu1748V) and the predicate device (VIVIX-S 1751S). The implication is that meeting or exceeding the performance of the predicate device for these parameters constitutes "acceptance."
| Item | Predicate Device: VIVIX-S 1751S | Proposed Device: Digital flat panel detector Venu1748V | Implied Acceptance (Relative to Predicate) | Reported Device Performance (Venu1748V) |
|---|---|---|---|---|
| Model Name | VIVIX-S 1751S | Venu1748V | N/A (Identification) | Venu1748V |
| 510(K) Number | K190611 | To be assigned | N/A (Identification) | To be assigned |
| Classification Name | Stationary X-Ray System | Same | Same | Same |
| Product Code | MQB | Same | Same | Same |
| Regulation Number | 21 CFR 892.1680 | Same | Same | Same |
| Panel | Radiology | Same | Same | Same |
| Classification: | II | Same | Same | II |
| X-Ray Absorber (Scintillator): | Gd2O2S:Tb (Gadolinium oxysulfide) | CsI | Different but acceptable | CsI |
| Installation Type: | Portable | Same | Same | Portable |
| Detector structure: | Amorphous silicon TFT | Same | Same | Amorphous silicon TFT |
| Dimensions: | 1357.0mm × 532.0mm × 30.0mm | 1271.4mm × 586.6mm × 20.8mm | Comparable/Improved Size | 1271.4mm × 586.6mm × 20.8mm |
| Max. Image Matrix Size: | 3072 × 9216 pixels | 3064 × 8696 pixels | Comparable | 3064 × 8696 pixels |
| Pixel Pitch: | 140μm | 139μm | Comparable/Improved Resolution | 139μm |
| Max. Effective Imaging Area (H×V): | 430.08mm × 1290.24mm | 425.8mm × 1208.7mm | Comparable | 425.8mm × 1208.7mm |
| Spatial resolution | 3.5 lp/mm | 3.4 lp/mm | Comparable | 3.4 lp/mm |
| Greyscales | 16 bit | Same | Same | 16 bit |
| Modulation Transfer Function (MTF) | 40% at 1.0 lp/mm | 56% at 1.0 lp/mm | Superior | 56% at 1.0 lp/mm |
| Detective Quantum Efficiency (DQE) | 20% at 1.0 lp/mm | 24% at 1.0 lp/mm | Superior | 24% at 1.0 lp/mm |
| Power Consumption: | Max. 72 W | Max. 50 W | Superior (Lower) | Max. 50 W |
| Communications: | Wired LAN | Same | Same | Wired LAN |
| Cooling: | Air cooling | Same | Same | Air cooling |
| Protection against Matter/Water | IPX0 | Same | Same | IPX0 |
| Operation Temperature: | 10 to 35°C | 5 to 35°C | Comparable/Improved Range | 5 to 35°C |
| Operation Humidity: | 30 to 85% (Non-Condensing) | 10 to 90% (Non-Condensing) | Comparable/Improved Range | 10 to 90% (Non-Condensing) |
| Operation Atmospheric pressure: | 70 to 106 kPa | Same | Same | 70 to 106 kPa |
| Operation Altitude: | Max. 3000 meters | Same | Same | Max. 3000 meters |
| Storage and Transportation Temperature: | -15 to 55°C | -20 °C ~ 55 °C | Comparable/Improved Range | -20 °C ~ 55 °C |
| Storage and Transportation Humidity: | 10 to 90% (Non-Condensing) | 5% ~ 95% (Non-Condensing) | Comparable/Improved Range | 5% ~ 95% (Non-Condensing) |
| Storage and Transportation Atmosphere: | 50 ~ 106 kPa | 70kPa~106kPa | Comparable | 70kPa~106kPa |
| Storage and Transportation Altitude: | Max. 3000 meters | Same | Same | Max. 3000 meters |
| Software | VXvue | iDetector | Different but acceptable | iDetector |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The "test set" here refers to the non-clinical bench testing of the detector's physical performance characteristics. These tests are typically performed on a limited number of manufactured units (e.g., a few samples per batch) to ensure they meet specifications. The document does not specify the exact number of units tested for each parameter.
- Data Provenance: The company is iRay Technology Taicang Ltd., located in Taicang, Jiangsu, CHINA. The testing was performed internally or by a contracted lab. The data is retrospective in the sense that it was collected as part of the device's development and verification, prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For non-clinical tests of a flat panel detector, "ground truth" is established by physical measurement standards and calibrated equipment, not by human expert consensus or clinical diagnosis. For example, MTF is measured using a phantom and analytical methods, not by radiologists.
4. Adjudication Method for the Test Set:
Not applicable. Since no human experts are establishing ground truth for diagnostic decisions, there's no need for adjudication.
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:
No. The document explicitly states: "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." This device is a hardware component (a flat panel detector), not an AI algorithm assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a hardware component. There is no "algorithm only" performance in the sense of an AI diagnostic tool. The detector captures raw image data.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests consists of:
- Physical standards/measurements: For parameters like dimensions, pixel pitch, greyscales, power consumption, temperature/humidity ranges.
- Engineering metrics: For performance characteristics like MTF, DQE, spatial resolution, signal-to-noise ratio, uniformity, defect, minimum triggering dose rate, and low contrast resolution. These are established through standardized testing procedures using phantoms and calibrated instruments.
- Compliance with standards: Electrical safety (IEC/ES 60601-1, IEC60601-2-54) and EMC testing (IEC 60601-1-2) ensure the device meets predefined safety and electromagnetic compatibility benchmarks.
- Software verification: The software "iDetector" hazards, requirements specification, and design specification were tested against the intended design specification.
8. The Sample Size for the Training Set:
Not applicable. This is a hardware device. "Training set" typically refers to data used to train AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for an AI/ML model for this hardware device.
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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
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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
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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
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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/DigitalImager) |
| 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
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| 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
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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 detectorVenu1748V |
|---|---|---|
| Model name | VIVIX-S 1751S | Venu1748V |
| 510(K) Number | K190611 | To be assigned |
| 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): | 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 MatrixSize: | 3072 × 9216 pixels | 3064 × 8696 pixels |
| Pixel Pitch: | 140μm | 139μm |
| Max. EffectiveImaging 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 |
| ModulationTransferFunction (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
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| Item | Predicate Device:VIVIX-S 1751S | Proposed Device:Digital flat panel detectorVenu1748V |
|---|---|---|
| Detective QuantumEfficiency (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 |
| Protectionagainstmatter/Water | IPX0 | Same |
| Operation: | Temperature: 10 to 35°CHumidity: 30 to 85% (Non-Condensing)Atmospheric pressure: 70 to 106kPaAltitude: Max. 3000 meters | Temperature: 5 to 35°CHumidity: 10 to 90% (Non-Condensing)Atmospheric pressure: 70 to 106kPaAltitude: Max. 3000 meters |
| Storage andTransportation:( detector ) | Temperature: -15 to 55°CHumidity: 10 to 90%(Non-Condensing)Atmospheric pressure: 50 ~ 106kPaAltitude: Max. 3000 meters | Temperature: -20 °C ~ 55 °CHumidity: 5% ~ 95%(Non-Condensing)Atmospheric pressure:70kPa~106kPaAltitude: 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
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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
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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.
SECTION 3 - 7 of 7
§ 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.