(28 days)
Mars 1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Mars1417X Wireless Digital Flat Panel Detector is a wireless digital flat panel detector that supports single frame mode. Its key component is a TFT/PD image sensor flat panel with an active area of 35cm×43cm. The sensor plate has a direct-deposited CsI scintillator to convert X-ray to visible photon. These visible photons are transformed to electron signals by a diode capacitor array within the TFT panel, which are composed and processed by connecting to scanning and readout electronics, forming a panel image transmitted to a PC through the user interface. The main function is to convert X-ray to digital image for high resolution X-ray imaging. It is a key component of a DR system, enabling the digitalization of medical X-ray imaging with DR system software. iRay SDK (including iDetector) provides an API interface for DR system manufacturers to control the detector.
The provided text describes a 510(k) premarket notification for the Mars 1417X Wireless Digital Flat Panel Detector. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Mars1417V-TSI) rather than presenting a standalone clinical study with detailed acceptance criteria and performance data.
Therefore, the information required to answer most of your questions (especially those related to a clinical study, reader performance, and ground truth establishment) is not present in the provided text. The document states that "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." This implies that a formal clinical study, as you've outlined, was likely not conducted or required for this 510(k) clearance.
However, I can extract the acceptance criteria and performance related to the device's technical specifications and non-clinical testing as presented in the document, comparing the proposed device (Mars1417X) to its predicate (Mars1417V-TSI).
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence or improvement over the predicate device's technical specifications. The "reported device performance" refers to the specifications of the proposed device, Mars1417X.
| Acceptance Criteria (Predicate: Mars1417V-TSI) | Reported Device Performance (Mars1417X) | Notes on Equivalence / Improvement |
|---|---|---|
| Image Matrix Size: 2304 x 2800 pixels | 3500 x 4300 pixels | Improved: Higher resolution |
| Pixel Size: 150μm | 100μm | Improved: Smaller pixel size, contributing to higher resolution |
| ADC Digitization: 16 bit | Same (16 bit) | Equivalent |
| Effective Imaging Area: 345.6 mm × 420.0 mm | 350.0 mm × 430.0 mm | Improved: Slightly larger imaging area |
| Spatial Resolution: Min. 3.3lp/mm | Min. 4.3lp/mm | Improved: Higher spatial resolution |
| Modulation Transfer Function (MTF) at 1 lp/mm: 0.68 | 0.65 | Slightly lower, but likely within acceptable range for overall equivalence given other improvements. No explicit acceptance range is provided, and the device was deemed substantially equivalent. |
| Detective Quantum Efficiency (DQE) at 1 lp/mm (RQA5, 2.5μGy): 0.36 | 0.54 | Improved: Higher DQE, indicating better signal-to-noise ratio and dose efficiency. |
| Detector IP Grade: IPX1 | IP56 | Improved: Higher ingress protection. |
| Surface Pressure (Uniform load): 150 kg over whole area | 300 kg over whole area | Improved: More robust. |
| Surface Pressure (Local load): 100 kg on 4 cm diameter of center | 150 kg on 4 cm diameter of center | Improved: More robust. |
| Communications (Wireless functionality): IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) | Same | Equivalent |
| X-Ray Absorber (Scintillator): CsI | Same | Equivalent |
| Image Protect Plate: Carbon Fiber Plate | Same | Equivalent |
| Cooling: Air cooling | Same | Equivalent |
| Dimensions: 384 mm × 460 mm × 15 mm | Same | Equivalent |
| Operating Temperature: +5 ~ +35°C | +10 ~ +35 °C | Slightly narrower operating temperature range, but still deemed substantially equivalent. |
| Operating Humidity: 10 ~ 90% (Non-Condensing) | 5 ~ 90% (Non-Condensing) | Slightly wider lower humidity tolerance. |
| Operating Atmospheric Pressure: 70 ~ 106 kPa | 70 ~ 106 kPa | Equivalent |
| Storage/Transportation Temp: -20 ~ +55°C | Same | Equivalent |
| Storage/Transportation Humidity: 5 ~ 95% (Non-Condensing) | Same | Equivalent |
As for the other points, based on the provided text:
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Sample size used for the test set and the data provenance: Not applicable in the context of clinical reads for performance testing. The "test set" here refers to the physical device's specifications being evaluated against the predicate. Data provenance is not described for any clinical study. The device manufacturer is iRay Technology Taicang Ltd. in China. The submission is for a 510(k) Pre-Market Notification, which relies on demonstrating substantial equivalence, often through non-clinical performance data and comparison to an existing device, rather than new clinical trials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical diagnostic performance using expert consensus or pathology is not mentioned, as a clinical performance study of this nature was likely not performed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no mention of adjudication for a clinical test set.
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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, an MRMC study was not done, and this device is a digital flat panel detector, not an AI diagnostic algorithm. Its primary function is to convert X-rays to digital images, not to provide AI assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm but a hardware device. Its performance is measured by its raw imaging capabilities (e.g., spatial resolution, DQE).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the specified improvements (e.g., spatial resolution, DQE), the ground truth is established through physical measurements and standardized imaging tests as per industry standards (e.g., lp/mm, ISO standards for DQE measurement). For safety aspects, compliance with standards like IEC/ES 60601-1 and ISO 10993-1 establishes "ground truth" for electrical safety, EMC, and biological evaluation.
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The sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
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March 3, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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: K210316
Trade/Device Name: Mars 1417X 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: January 13, 2021 Received: February 3, 2021
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 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Mars1417X Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Mars 1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------- |
|X 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)
-
- Date Prepared [21 CFR 807.92(a)(1)]
January 13, 2021
- Date Prepared [21 CFR 807.92(a)(1)]
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: | Junjie.Qian |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | junjie.qian@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Wireless Digital Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mars1417X |
| 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: | Mars1417V-TSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K201004 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Mars1417X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1417X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm.
The sensor plate of Mars1417X 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.
The major function of the Mars1417X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Mars1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, 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.
| Predicate Device: | Proposed Device: | ||
|---|---|---|---|
| Item | Mars1417V-TSI WirelessDigital Flat Panel DetectorMano4336W Wireless DigitalFlat Panel Detector | Mars1417X Wireless DigitalFlat Panel Detector | |
| 510(K) Number | K201004 | K210316 | |
| Intended Use | Mars1417V-TSI WirelessDigital Flat Panel Detector andMano4336W Wireless DigitalFlat Panel Detector areindicated for digital imaging | same | |
| Item | Predicate Device: | Proposed Device: | |
| Mars1417V-TSI WirelessDigital Flat Panel DetectorMano4336W Wireless DigitalFlat Panel Detectorsolution designed for providinggeneral radiographic system inall general-purpose diagnosticprocedures. | Mars1417X Wireless DigitalFlat Panel Detector | ||
| Indications for Use | Mars1417V-TSI wirelessdigital flat panel detector andMano4336W wireless digitalflat panel detector are indicatedfor digital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy including bothadult and pediatric patients.They are intended to replacefilm/screen systems in allgeneral-purpose diagnosticprocedures. These two devicesare not intended formammography, dentalapplications. | Mars1417X wireless digitalflat panel detector is indicatedfor digital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy including bothadult and pediatric patients. Itis intended to replacefilm/screen systems in allgeneral-purpose diagnosticprocedures. The device is notintended for mammography ordental applications. | |
| ClassificationName | Stationary X-ray system | Same | |
| Product Code | MQB | Same | |
| Regulation Number | 21 CFR 892.1680 | Same | |
| Item | Predicate Device:Mars1417V-TSI WirelessDigital Flat Panel DetectorMano4336W Wireless DigitalFlat Panel Detector | Proposed Device:Mars1417X Wireless DigitalFlat Panel Detector | |
| Panel: | Radiology | Same | |
| Classification: | II | Same | |
| X-Ray Absorber(Scintillator): | CsI | Same | |
| Installation Type: | Wireless, Portable | Same | |
| ReadoutMechanism: | Thin Film Transistor | Same | |
| Image Matrix Size: | $2304 \times 2800$ pixels | $3500 \times 4300$ pixels | |
| Pixel Size: | 150μm | 100μm | |
| ADC Digitization | 16 bit | Same | |
| Effective ImagingArea: | $345.6$ mm $\times 420.0$ mm | $350.0$ mm $\times 430.0$ mm | |
| Spatial Resolution: | Min. 3.3lp/mm | Min. 4.3lp/mm | |
| Modulation TransferFunction (MTF) | 0.68 at 1 lp/mm | 0.65 at 1 lp/mm | |
| Detective QuantumEfficiency (DQE) | 0.36 at 1 lp/mm (RQA5,2.5μGy) | 0.54 at 1 lp/mm (RQA5,2.5μGy) | |
| PowerConsumption: | Max. 19W | Same | |
| Item | Predicate Device: | Proposed Device: | |
| Mars1417V-TSI WirelessDigital Flat Panel DetectorMano4336W Wireless DigitalFlat Panel Detector | Mars1417X Wireless DigitalFlat Panel Detector | ||
| Communications:(Wirelessfunctionality) | a) Wired (only forservice) : GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz/ 5 GHz) | Same | |
| Imaging protectPlate: | Carbon Fiber Plate | Same | |
| Cooling: | Air cooling | Same | |
| Dimensions: | $384 mm \times 460 mm \times 15 mm$ | Same | |
| Detector IP grade | IPX1 | IP56 | |
| Surface pressure | Uniform load: 150 kg over thewhole area of the surface;Local load: 100 kg on an area4 cm diameter of center | Uniform load: 300 kg overthe whole area of the surface;Local load: 150 kg on an area4 cm diameter of center | |
| Operation: | Temperature: +5 ~ +35°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters | Temperature: +10 ~ +35 °CHumidity: 5 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters | |
| Storage andTransportation: | Temperature: -20 ~ +55°CHumidity: 5 ~ 95% | Temperature: -20 ~ +55°CHumidity: 5 ~ 95% | |
| Item | Predicate Device: | Proposed Device: | |
| ( detector ) | Mars1417V-TSI WirelessDigital Flat Panel DetectorMano4336W Wireless DigitalFlat Panel Detector | Mars1417X Wireless DigitalFlat Panel Detector | |
| (Non-Condensing)Atmospheric pressure: 70 ~106 kPaAltitude: Max. 3000 meters | (Non-Condensing)Atmospheric pressure: 60 ~106 kPaAltitude: Max. 3000 meters | ||
| Software | iRay SDK(include iDetector) isintend to supply API interfacefor DR system manufacturers.DR system manufacturercontrol the detector by SDKinterface. SDK is not intend touse directly by other usersbeside DR systemmanufacturers. | Same | |
| Utilized FDAguidancedocuments | 1. Guidance for theSubmission of 510(k)'s forSolid State X-ray ImagingDevices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions forManagement of | Additionally:1. The Special 510(k)Program;2. Design Control GuidanceFor Medical DeviceManufacturers;3. Appropriate Use ofVoluntary ConsensusStandards in PremarketSubmissions for MedicalDevices. | |
| Item | Predicate Device: | Proposed Device: | |
| Mars1417V-TSI WirelessDigital Flat Panel DetectorMano4336W Wireless DigitalFlat Panel Detector | Mars1417X Wireless DigitalFlat Panel Detector | ||
| Cybersecurity in MedicalDevices;4. Radio Frequency WirelessTechnology in MedicalDevices;5. Guidance for “PremarketAssessment of PediatricMedical Devices”;6. Guidance for “PediatricInformation for X-rayImaging Device PremarketNotifications”. |
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 you have any questions regarding the compatibility issue for other generators, please contact the distributor or iRay's service office.
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- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417X connected via wireless communication.
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| Operating System: | Windows XP/7/8/10, 32/64bit |
|---|---|
| CPU: | Intel Core i7 3.6G |
| Memory: | 4G 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 Mars1417X. Once there is X-ray generator exposure exist, the AED 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:
Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was 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 materials of the detector which contact operators' or patient's 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:
One main modification from the predicate device is Amorphous Silicon (a-Si) panel size design, related to Amorphous Silicon (A-Si) panel size. Another modification is structure design with higher IP grade and surface pressure performance. 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
- Non-clinical Considerations:
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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 (Mars1417V-TSI, K201004).
-
- Clinical Consideration:
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.
- Clinical Consideration:
10. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. concludes that Mars1417X 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.