(30 days)
Mars 1717XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications, pediatric, pregnant women and fluoroscopy.
Mars1717XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT (Thin Film Transistor)/PD (Photo Diode) image sensor flat panel of active area: 42.48cm×42.54cm. The sensor plate of Mars1717XF-GSI Wireless Digital Flat Panel Detector is coated with Gd2O2S (GOS) 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. The major function of the Mars1717XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
The provided document is a 510(k) summary for the iRay Technology Taicang Ltd. Wireless Digital Flat Panel Detector (Mars1717XF-GSI). It compares the proposed device to a predicate device (Mars1417XF-GSI, K182550) to demonstrate substantial equivalence.
Based on the content, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance as would be seen for an AI-powered diagnostic device. Instead, it focuses on demonstrating substantial equivalence by comparing the technical specifications of the proposed device to the predicate device. The implicit "acceptance criteria" here are that the performance metrics of the proposed device are comparable to or better than the predicate device, or within acceptable tolerances for the intended use.
Here's a table focusing on the comparative technical specifications presented, which serve as the "performance" data for establishing equivalence:
| Item | Predicate Device: Mars1417XF-GSI Wireless Digital Flat Panel Detector | Proposed Device: Mars1717XF-GSI Wireless Digital Flat Panel Detector |
|---|---|---|
| Functional/Technical Specs | ||
| X-Ray Absorber (Scintillator): | Gd2O2S (GOS) | Same (Gd2O2S (GOS)) |
| Installation Type: | Wireless, Portable | Same (Wireless, Portable) |
| Readout Mechanism: | Thin Film Transistor | Same (Thin Film Transistor) |
| ADC Digitization | 16 bit | Same (16 bit) |
| Spatial Resolution: | Min. 3.3lp/mm | Same (Min. 3.3lp/mm) |
| Communications: (Wireless functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | Same (Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz)) |
| Imaging protect Plate: | Carbon Fiber Plate | Same (Carbon Fiber Plate) |
| Cooling: | Air cooling | Same (Air cooling) |
| Software | iRay SDK (include iDetector) | Same (iRay SDK (include iDetector)) |
| Performance Metrics | ||
| Image Matrix Size: | 2336 × 2836 pixels | 2832 × 2836 pixels |
| Pixel Pitch: | 150μm | Same (150μm) |
| Effective Imaging Area: | 350.4 mm × 425.4 mm | 424.8 mm × 425.4 mm |
| Modulation Transfer Function (MTF) | 0.45 at 1 lp/mm | 0.44 at 1 lp/mm |
| Detective Quantum Efficiency (DQE) (RQA5, 3.2µGy) | 0.22 at 1 lp/mm | 0.23 at 1 lp/mm |
| Power Consumption: | Max. 19W | Max. 20W |
| Dimensions: | 384 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15 mm |
Note: The primary difference highlighted and addressed in the document is the "panel dimension" which impacts "Image Matrix Size," "Effective Imaging Area," "MTF," "DQE", "Power Consumption", and "Dimensions". The submission argues that non-clinical information is sufficient to support substantial equivalence despite these changes.
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 describes non-clinical testing rather than a clinical study with a "test set" of patient data in the typical sense of AI/diagnostic device trials (i.e., analyzing images of patients to assess diagnostic accuracy). The "study" here refers to:
- Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC/EN 60601-1-2.
- Biological Evaluation: Evaluated with ISO 10993-1 for materials contacting operators' skin.
- Non-clinical Considerations: Performance comparisons, likely quantitative measurements of detector characteristics (MTF, DQE, spatial resolution), and electromagnetic compatibility. This would involve a sample of the manufactured devices, not patient data.
- Clinical Consideration: The submission states that a clinical consideration (study with patient data) was not necessary because the modification from the predicate device to the proposed device is primarily the "panel dimension." It claims "non-clinical information is sufficient to support the substantial equivalence."
Therefore, there is no patient-based "test set" sample size or data provenance (country, retrospective/prospective) relevant to clinical performance assessment mentioned because a clinical study was explicitly deemed unnecessary by the manufacturer, and presumably accepted by the FDA for this direct predicate comparison.
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)
Since no clinical study with a patient imaging test set was conducted (as per point 2), there were no experts used to establish ground truth for a clinical test set. The ground truth in this submission is established through:
- Standardized technical measurements: For parameters like MTF, DQE, spatial resolution, which are objective physical properties of the detector.
- Compliance with international standards: For electrical safety, EMC, and biological compatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no patient-based clinical "test set" requiring adjudication of diagnoses was used.
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 device is a digital flat panel detector (hardware), not an AI-powered diagnostic software. Its purpose is to capture X-ray images, not to interpret them or assist human readers in diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware device (X-ray detector), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for the performance evaluation in this 510(k) submission is based on:
- Objective physical measurements (e.g., MTF, DQE, spatial resolution) using phantoms and calibrated equipment.
- Adherence to international safety and performance standards (e.g., IEC/ES 60601-1, IEC/EN 60601-1-2, ISO 10993-1).
- Demonstration of equivalence to a legally marketed predicate device based on these technical and safety characteristics.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a hardware device.
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Image /page/0/Picture/0 description: The image contains 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. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K183422
Trade/Device Name: Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: November 1, 2018 Received: December 10, 2018
Dear Meng Li:
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 mav, 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 avare 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
January 9, 2019
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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183422
Device Name Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Mars 1717XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications,
We understand the Agency has become aware of situations where solid state detectors inserted into radiographic systems adversely impacted device performance due to improper integration (reference:http://www.fda.gov/downloads/ MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf ).
Below is a summary of the information from the Mars1717XF-GSI user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration.
-
- Mechanical interface requirements.
-
- Computer requirements
-
- Data communication interface requirements
-
Electrical power requirements
-
X-ray trigger interface requirements
Neither the Mars1717XF-GSI detector nor its software act as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.
| 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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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
November 1st, 2018
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 andTechnological Development Zone, Jiangsu, China 215434 |
| Contact Person: | Meng Li |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | meng.li@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| 510(k) Number: | K183422 |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mars1717XF-GSI |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
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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: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1417XF-GSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| FDA 510 (k) #: | K182550 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1717XF-GSI Wireless Digital Flat Panel Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT (Thin Film Transistor)/PD (Photo Diode) image sensor flat panel of active area: 42.48cm×42.54cm.
The sensor plate of Mars1717XF-GSI Wireless Digital Flat Panel Detector is coated with Gd2O2S (GOS) 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.
The major function of the Mars1717XF-GSI Wireless Digital Flat Panel Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Intended Use
Mars1717XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human
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anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. This device is not intended for mammography, dental applications, pediatric, pregnant women and fluoroscopy.
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system conventional photography but not intended for mammography or dental applications. The remaining notes depend on the DR system.
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:Wireless Digital Flat PanelDetector | ProposedDevice:Wireless DigitalFlat PanelDetector |
|---|---|---|
| 510(K)Number | K182550 | To be assigned |
| Intended Use | The Mars1417XF-GSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic system in allgeneral purpose diagnosticprocedures. | Same withMars1417XF-GSI,additionally, it isnot intended formammography,dental |
| Predicate Device: | ProposedDevice: | |
| Item | Wireless Digital Flat PanelDetector | Wireless DigitalFlat PanelDetector |
| IndicationsforUse | Mars1417XF-GSI Wireless DigitalFlat Panel Detector is indicated fordigital imaging solution designedfor providing general radiographicdiagnosis of human anatomy. It isintended to replace radiographicfilm/screen systems in all general-purpose diagnostic procedures. Thisdevice is not intended formammography or dentalapplications.We understand the Agency hasbecome aware of situations wheresolid state detectors inserted intoradiographic systems adverselyimpacted device performance dueto improper integration(reference:http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf). | applications,pediatric,pregnant womenand fluoroscopy.Same withMars1417XF-GSI,additionally, Intheconsideration ofpatient size (i.e.,height, weight,body partthickness) andusable doserange, thedetector couldbe used forgeneral X raydiagnosis ofusual body partfor adult. |
| Item | Predicate Device: | ProposedDevice: |
| Wireless Digital Flat PanelDetector | Wireless DigitalFlat PanelDetector | |
| Below is a summary of theinformation from the Mars1417XF-GSI user manuals covering keyelectromechanicaland computer requirements neededfor X-ray system interface andintegration.1. Mechanical interfacerequirements.2. Computer requirements3. Data communication interfacerequirements4. Electrical power requirements5. X-ray trigger interfacerequirementsNeither the Mars1417XF-GSIdetector nor its software act as anX-ray generator controller, andtherefore, thedevice is not subject to ElectronicProduct Radiation Control (EPRC)performance standards andreporting requirements. | ||
| ClassificationName | Stationary X-ray system | Same |
| Item | Predicate Device:Wireless Digital Flat PanelDetector | Proposed Device:Wireless DigitalFlat PanelDetector |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber(Scintillator): | Gd2O2S (GOS) | Same |
| Installation Type: | Wireless, Portable | Same |
| Readout Mechanism: | Thin Film Transistor | Same |
| Image Matrix Size: | 2336 × 2836 pixels | 2832× 2836 pixels |
| Pixel Pitch: | 150μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective Imaging Area: | 350.4 mm × 425.4 mm | 424.8 mm × 425.4 mm |
| Spatial Resolution: | Min. 3.3lp/mm | Same |
| Modulation Transfer Function (MTF) | 0.45 at 1 lp/mm | 0.44 at 1 lp/mm |
| Detective Quantum Efficiency | 0.22 at 1 lp/mm | 0.23 at 1 lp/mm |
| Item(DQE) | Predicate Device:Wireless Digital Flat PanelDetector | ProposedDevice:Wireless DigitalFlat PanelDetector |
| (RQA5, 3.2µGy) | ||
| PowerConsumption: | Max. 19W | Max. 20W |
| Communications:(Wirelessfunctionality) | Wireless: IEEE 802.11a/b/g/n (2.4GHz / 5 GHz) | Same |
| Communications: | Wireless: IEEE 802.11a/b/g/n (2.4GHz / 5 GHz) | Same |
| ImagingprotectPlate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | 384 mm × 460 mm × 15 mm | 460 mm × 460mm×15 mm |
| Operation:Storage and | Temperature: +5 ~ +30 ℃Humidity: 10 ~ 80%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters | Same |
| Transportation:( detector ) | Temperature: -20 ~ +50 ℃Humidity: 10 ~ 90%(Non-Condensing) | Same |
| Item | Predicate Device: | ProposedDevice: |
| Wireless Digital Flat PanelDetector | Wireless DigitalFlat PanelDetector | |
| Atmospheric pressure: 70 ~ 106 kPa | ||
| Altitude: Max. 3000 meters | ||
| Software | iRay SDK(include iDetector) isintend to supply API interface forDR system manufacturers. DRsystem manufacturer control thedetector by SDK interface. SDK isnot intend to use directly by otherusers beside DR systemmanufacturers. | Same |
| Utilized FDAguidancedocuments | 1. Guidance for the Submission of510(k)'s for Solid State X-rayImaging Devices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions for Managementof Cybersecurity in MedicalDevices;4. Radio Frequency WirelessTechnology in MedicalDevices | Same |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
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8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- 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 still having any questions regarding the compatibility issue for other generators, please contact the distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1717XF-GSI detector connected via wireless communication.
| Operating System: | Windows XP/7 32/64bit |
|---|---|
| CPU: | Intel Core i5 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
3) X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Mars1717XF-GSI. 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. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
- Electrical Safety and EMC testing: 1)
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iRay Technology Taicang Ltd.
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC/EN 60601-1-2. All test results are meet standard requirements.
-
- Biological Evaluation:
The materials of the detector which contact operators' skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
-
- Non-clinical Considerations:
The only modification from the predicate device to Mars1717XF-GSI is the panel dimension, related to Amorphous Silicon (A-Si) panel size and structure size design. The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-GSI, K182550).
- Non-clinical Considerations:
-
- Clinical Consideration:
The only modification from the predicate device to Mars1717XF-GSI is the panel dimension, related to Amorphous Silicon (a-Si) panel size and structure size design. Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence, which is described details in '009 Substantial Equivalence Discussion' in this submission.
- Clinical Consideration:
There was no significant difference between the images of the Mars1717XF-GSI and those of the predicate device.
-
- Conclusion [21 CFR 807.92(b)(3)]
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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 iRay Mars1717XF-GSI Wireless Digital Flat Panel Detectors is substantially equivalent to predicate device with regards to safety and effectiveness.
§ 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.