Focus 43C detector, TRIMAX 43C detector

K200622 · Iray Technology Taicang , Ltd. · MQB · Apr 1, 2020 · Radiology

Device Facts

• Record ID: K200622
• Device Name: Focus 43C detector, TRIMAX 43C detector
• Applicant: Iray Technology Taicang , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Apr 1, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Focus 43C and TRIMAX 43C 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. This device is not intended for mammography, dental applications.

Device Story

Wireless digital flat panel detector; converts X-rays to digital images for general radiography. Input: X-ray radiation; Transformation: CsI scintillator converts X-rays to visible photons; TFT/PD sensor array converts photons to electron signals; processed via scanning/readout electronics. Output: Digital image transmitted to PC via iRay SDK/iDetector interface. Used in clinical settings by DR system manufacturers/technicians; integrated into DR systems. Healthcare providers view images on display to aid diagnosis of disease or injury. Benefits: Enables digital X-ray imaging; replaces film/screen systems; supports pediatric and adult imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC/ES 60601-1), EMC (IEC 60601-12), and biological evaluation (ISO 10993-1). Performance metrics (MTF, DQE, spatial resolution) compared to predicate device.

Technological Characteristics

Wireless digital flat panel detector; CsI scintillator; TFT/PD sensor array; 427mm x 427mm active area; 139µm pixel pitch; 16-bit ADC; wireless (IEEE 802.11a/b/g/n/ac) and wired (Gigabit Ethernet) connectivity; carbon fiber plate; air cooling; software-controlled via iRay SDK.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in adult and pediatric patients. Intended to replace film/screen systems in general-purpose diagnostic procedures. 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square 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: K200622

Trade/Device Name: Focus 43C Detector, TRIMAX 43C Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 14, 2020 Received: March 9, 2020

#### 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.

April 1, 2020

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) K200622

Device Name Focus 43C Detector TRIMAX 43C Detector

#### Indications for Use (Describe)

Focus 43C and TRIMAX 43C 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 trade mark.

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## SECTION 6

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

SECTION 6 - 1 of 12

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### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS K200622

(As Required by 21 CFR 807.92)

#### 1. Date Prepared [21 CFR 807.92(a)(1)]

Jan. 8th, 2020

#### 2. Submitter's Information [21 CFR 807.92(a)(1)]

| <b>Company Name:</b> | iRay Technology Taicang Ltd. |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| <b>Company Address:</b> | No.33 Xinggang Road, Taicang Port Economic and<br>Technological Development Zone, Jiangsu, China 215434 |
| <b>Contact Person:</b> | Junjie Qian |
| <b>Phone:</b> | 0512-53690872 |
| <b>Fax:</b> | 0512-53690872 |
| <b>Email:</b> | [e-mail] |

#### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | Focus 43C Detector<br>TRIMAX 43C Detector |
|----------------------|-------------------------------------------|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Focus 43C<br>TRIMAX 43C |
| Classification Name: | Stationary x-ray system |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |

### SECTION 6 - 2 of 12

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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)]

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a 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 TRIMAX 43C and Focus 43C are totally same except for label and trademark.

The sensor plate of Focus 43C and TRIMAX 43C detectors are 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 Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables 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.

### SECTION 6 - 3 of 12

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

#### 6.1. Indications for use

Focus 43C and TRIMAX 43C 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. This device is not intended for mammography, dental applications. There are no differences between the 2 models except the model name and trade mark.

#### 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 | K200622 |
| 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<br>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>. |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel | Wireless Digital Flat Panel |
| | Detector | Detector |
| | esforYou/Industry/UCM385149.p | |
| | df ). | |
| | | |
| | Below is a summary of the | |
| | information from the | |
| | Mars1717XF-CSI user manuals | |
| | covering key electromechanical | |
| | and computer requirements | |
| | needed for X-ray system interface | |
| | and integration. | |
| | 1. Mechanical interface | |
| | requirements. | |
| | 2. Computer requirements | |
| | 3. Data communication interface | |
| | requirements | |
| | 4. Electrical power requirements | |
| | 5. X-ray trigger interface | |
| | requirements | |
| | | |
| | Neither the Mars1717XF-CSI | |
| | 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. | |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel Detector | Wireless Digital Flat Panel Detector |
| Classification Name | Stationary x-ray system | Same |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber (Scintillator): | CsI | Same |
| Installation Type: | Wireless, Portable | Same |
| Readout Mechanism: | Thin Film Transistor | Same |
| Image Matrix Size: | 2832× 2836 pixels | 3072 × 3072 pixels |
| Pixel Pitch: | 150μm | 139µm |
| ADC Digitization | 16 bit | Same |
| Effective Imaging Area: | 424.8 mm × 425.4 mm | 427 mm × 427 mm |
| Spatial Resolution: | 3.3lp/mm | 3.6lp/mm |
| Modulation Transfer Function (MTF) | 0.49 at 1 lp/mm | 0.61 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 at 1 lp/mm (RQA5, 2.5µGy) | 0.46 at 1 lp/mm (RQA5, 2.5µGy) |
| Power<br>Consumption: | Max. 20W | Max. 20W |
| 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 |
| Cooling: | Air cooling | Same |
| Dimensions: | 460 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15.2 mm |
| Operation: | Temperature: +5 ~ +30 °C | Temperature: +5 ~ +35 °C |
| | Humidity: 10 ~ 80%<br>(Non-Condensing) | Humidity: 10 ~ 90%<br>(Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| Storage and<br>Transportation: | Temperature: -20 ~ +50 °C<br>Humidity: 10 ~ 90%…