Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

K201043 · Iray Technology Taicang , Ltd. · MQB · May 12, 2020 · Radiology

Device Facts

• Record ID: K201043
• Device Name: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
• Applicant: Iray Technology Taicang , Ltd.
• Product Code: MQB · Radiology
• Decision Date: May 12, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Mars1717V-VSI and Mano4343W are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

Device Story

Wireless digital flat panel detectors (Mars1717V-VSI, Mano4343W) capture X-ray images for general-purpose diagnostic procedures. Device uses direct-deposited CsI scintillator to convert X-rays to visible photons, then transforms photons into electron signals via TFT/diode capacitor array. Signals are processed and transmitted to a PC via wireless (IEEE 802.11a/b/g/n/ac) or wired (service only) interface. Operated by technicians/physicians within a DR system; integrated via iRay SDK. AED trigger module detects X-ray exposure to initiate image acquisition. Output is a digital image displayed on a workstation for clinical diagnosis. Benefits include high-resolution digital imaging, replacing traditional film/screen systems, and enabling efficient clinical workflows for adult and pediatric patients.

Clinical Evidence

Bench testing only. Performance evaluated via non-clinical studies including electrical safety (IEC/ES 60601-1), EMC (IEC 60601-1-2), and biological evaluation (ISO 10993-1). Technical parameters (MTF, DQE, spatial resolution) compared against predicate. No clinical data required for these modifications.

Technological Characteristics

Amorphous Silicon (A-Si) TFT panel with direct-deposited CsI scintillator. Active area 427mm x 427mm. Pixel pitch 139μm. 16-bit ADC. Wireless IEEE 802.11a/b/g/n/ac (2.4/5 GHz) and Gigabit Ethernet. Carbon fiber imaging plate. Air cooling. Dimensions 460 x 460 x 15.3 mm. Max power 30W.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in adult and pediatric patients. Not for mammography or dental applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wireless Digital Flat Panel Detector (Mars1717XF-CSI) (K183713)

Submission Summary (Full Text)

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May 12, 2020

iRay Technology Taicang Ltd. % Mr. Junjie Qian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

### Re: K201043

Trade/Device Name: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: April 8, 2020 Received: April 20, 2020

### Dear Mr. Qian:

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 ([e-mail]) or phone [phone] 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) K201043

Device Name

Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W)

Indications for Use (Describe)

Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W) are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatic patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

There are no differences between the 2 models except the model name and label.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

# K201043

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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)]

April 8th, 2020

### 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<br>Technological Development Zone, Jiangsu, China 215434 |
| Contact Person: | Junjie Qian |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | [e-mail] |

### 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: | Mars1717V-VSI |
| | Mano4343W |
| 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: | Mars1717XF-CSI |
| Product Code: | MQB |
| Device Class: | Class II |
| Classification Name: | Stationary x-ray system |
| FDA 510 (k) #: | K183713 |

### 5. Description of the Device [21 CFR 807.92(a)(4)]

Mars1717V-VSI and Mano4343W Wireless Digital Panel Detectors (Hereinafter referred to as Mars1717V-VSI and Mano4343W) are the kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models Mars1717V-VSI and Mano4343W are totally same except for label and model name. The sensor plate of Mars1717V-VSI and Mano4343W 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 Mars1717V-VSI and Mano4343W 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 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. The iRay SDK is unchanged from the predicate device.

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### 6. Intended Use [21 CFR 807.92(a)(5)]

### 6.1. Indications for use

Mars1717V-VSI and Mano4343W are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications. There are no differences between the 2 models except the model name and label.

#### 6.2. Suitable patient

They are 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.

| Item | Predicate Device:<br>Wireless Digital Flat Panel<br>Detector | Proposed Device:<br>Wireless Digital Flat Panel<br>Detector |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | K183713 | K201043 |
| Intended Use | The Mars1717XF-CSI Wireless<br>Digital Flat Panel Detector is<br>indicated for digital imaging | same |
| Item | Predicate Device:<br>Wireless Digital Flat Panel<br>Detector | Proposed Device:<br>Wireless Digital Flat Panel<br>Detector |
| | solution designed for providing<br>general radiographic system in all<br>general-purpose diagnostic<br>procedures. | |
| Indications for<br>Use | Mars1717XF-CSI Wireless<br>Digital Flat Panel Detector is<br>indicated for digital imaging<br>solution designed for providing<br>general radiographic diagnosis of<br>human anatomy.<br><br>It is intended to replace<br>radiographic film/screen systems<br>in all general-purpose diagnostic<br>procedures. This device is not<br>intended for mammography or<br>dental applications.<br><br>We understand the Agency has<br>become aware of situations where<br>solid state detectors inserted into<br>radiographic systems adversely<br>impacted device performance due<br>to improper integration<br>(reference:http://www.fda.gov/do<br>wnloads/MedicalDevices/Resourc | Same with Mars1717XF-CSI,<br>additionally, in the<br>consideration of patient size<br>(i.e., height, weight, body part<br>thickness) and usable dose<br>range, the detector could be<br>used for general X ray<br>diagnosis of usual body part<br>for adults and pediatric<br>patients.<br>. |
| Item | Predicate Device: | Proposed Device: |
| | Wireless Digital Flat Panel<br>Detector | Wireless Digital Flat Panel<br>Detector |
| | esforYou/Industry/UCM385149.pdf). | |
| | Below is a summary of the<br>information from the<br>Mars1717XF-CSI user manuals<br>covering key electromechanical<br>and computer requirements<br>needed for X-ray system interface<br>and integration.<br>1. Mechanical interface<br>requirements.<br>2. Computer requirements<br>3. Data communication interface<br>requirements<br>4. Electrical power requirements<br>5. X-ray trigger interface<br>requirements | |
| | Neither the Mars1717XF-CSI<br>detector nor its software act as an<br>X-ray generator controller, and<br>therefore, the device is not subject<br>to Electronic Product Radiation<br>Control (EPRC) performance<br>standards and reporting<br>requirements. | |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel<br>Detector | Wireless Digital Flat Panel<br>Detector |
| Classification<br>Name | Stationary x-ray system | Same |
| Product Code | MQB | Same |
| Regulation<br>Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber<br>(Scintillator): | CsI | Same |
| Installation<br>Type: | Wireless, Portable | Same |
| Readout<br>Mechanism: | Thin Film Transistor | Same |
| Image Matrix<br>Size: | 2832×2836 pixels | 3072 ×3072 pixels |
| Pixel Pitch: | 150μm | 139μm |
| ADC<br>Digitization | 16 bit | Same |
| Effective<br>Imaging Area: | 424.8 mm × 425.4 mm | 427 mm x 427 mm |
| Spatial<br>Resolution: | 3.3lp/mm | 3.6lp/mm |
| Modulation<br>Transfer<br>Function<br>(MTF) | 0.49 at 1 lp/mm | 0.65 at 1 lp/mm |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel<br>Detector | Wireless Digital Flat Panel<br>Detector |
| Detective<br>Quantum<br>Efficiency<br>(DQE) | $0.40 \text{ at } 1 \text{ lp/mm (RQA5, } 2.5\mu\text{Gy)}$ | Same |
| Power<br>Consumption: | Max. 20W | Max. 30W |
| Communication<br>s:<br>(Wireless<br>functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | a) Wired (only for service) : Gigabit<br>Ethernet (1000BASE-T)<br>b) Wireless: IEEE<br>802.11a/b/g/n/ac (2.4 GHz / 5 GHz) |
| Imaging protect<br>Plate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | 460 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15.3 mm |
| Operation: | Temperature: +5 ~ +30 °C | Temperature: +5 ~ +35 °C |
| | Humidity: 10 ~ 80%<br>(Non-Condensing) | Humidity: 5 ~ 95%<br>(Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 55 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| Storage and<br>Transportation: | Temperature: -20 ~ +50 °C | Temperature: -10 ~ +55 °C |
| | Humidity: 10 ~ 90% | Humidity: 5 ~ 95% |
| Item | Predicate Device:<br>Wireless Digital Flat Panel<br>Detector | Proposed Device:<br>Wireless Digital Flat Panel<br>Detector |
| ( detector ) | (Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa<br>Altitude: Max. 3000 meters | (Non-Condensing)<br>Atmospheric pressure: 55 ~ 106 kPa<br>Altitude: Max. 3000 meters |
| Software | iRay SDK(include iDetector) is<br>intend to supply API interface for<br>DR system manufacturers. DR<br>system manufacturer control the<br>detector by SDK interface. SDK<br>is not intended to use directly by<br>other users beside DR system<br>manufacturers. | Same |
| Utilized FDA<br>guidance<br>documents | 1. Guidance for the Submission<br>of 510(k)'s for Solid State X-<br>ray Imaging Devices;<br>2. The 510(k) Program:<br>Evaluating Substantial<br>Equivalence in Premarket<br>Notifications[510(k)];<br>3. Content of Premarket<br>Submissions for Management<br>of Cybersecurity in Medical<br>Devices;<br>4. Radio Frequency Wireless<br>Technology in Medical<br>Devices. | Same with Mars1717XF-CSI,<br>additionally:<br>1. Guidance for "Premarket<br>Assessment of Pediatric<br>Medical Devices";<br>2. Guidance for "Pediatric<br>Information for X-ray<br>Imaging Device Premarket<br>Notifications". |

### 7. Technological Characteristic [21 CFR 807.92(a)(6)]

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## iRay Technology Taicang Ltd.

## [510(k)] Application

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### iRay Technology Taicang Ltd.

### [510(k)] Application

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### 8. System requirements to operate with other radiographic system components

- 1) Recommended Generator Specification:
Energy range: 40~150keV

mA range: 10~1000mA (depending on the generator power)

ms range: 10~6300ms to produce 0.1~1000mAs (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.

- 2) Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1717V-VSI and Mano4343W are connected via wireless communication.
recommended computer hardware requirement is :

- Windows 7 32/64 bit
- •Intel Core i7 3.6G
- •4G DDR3
- •640 G
- · 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 Mars1717V-VSI and Mano4343W. 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.

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### 9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

- Electrical Safety and EMC testing: 1)
Electrical, mechanical, environmental safety test 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.

- 2) 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.

- 3) Non-clinical Considerations:
One modification from the predicate device to Mars1717V-VSI and Mano4343W is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, proposed device has higher wireless transmission speed.

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 (Mars1717XF-CSI, K183713).

- 4) 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 pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence.

There was no significant difference between the images of the Mars1717V-VSI/Mano4343W and those of the predicate device.

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### 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 Mars1717V-VSI and Mano4343W are substantially equivalent to predicate device with regards to safety and effectiveness.

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