Focus HD 43 Detector

K213529 · Iray Technology Taicang , Ltd. · MQB · Mar 29, 2022 · Radiology

Device Facts

• Record ID: K213529
• Device Name: Focus HD 43 Detector
• Applicant: Iray Technology Taicang , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Mar 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Focus HD 43 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 generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.

Device Story

Wireless digital flat panel detector; captures X-ray images for general radiographic diagnosis. Input: X-ray radiation; converted to visible photons via CsI scintillator; transformed to electron signals by TFT/diode capacitor array. Output: Digital image transmitted to PC via SDK/API. Used in clinical settings by DR system manufacturers/technicians; integrates into DR systems. Benefits: Enables digitalization of medical X-ray imaging; replaces film/screen systems. Healthcare providers use output for diagnostic decision-making regarding disease or injury.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biological evaluation (ISO 10993-1).

Technological Characteristics

Flat panel detector; CsI scintillator; TFT/diode capacitor array; 42.67cm x 42.67cm active area; 100μm pixel size; 16-bit ADC; wireless (IEEE 802.11a/b/g/n/ac) and wired (Gigabit Ethernet) connectivity; IP56 rating; air cooling; carbon fiber plate.

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

• Mars1717X Wireless Digital Flat Panel Detector (K210314)

Submission Summary (Full Text)

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March 29, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

Re: K213529

Trade/Device Name: Focus HD 43 Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 20, 2021 Received: November 4, 2021

Dear Junjie Oian:

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K213529

Device Name Focus HD 43 Detector

#### Indications for Use (Describe)

Focus HD 43 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 generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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

(As Required by 21 CFR 807.92) K213529

- 1. Date Prepared [21 CFR 807.92(a)(1)]
October 13, 2021

#### 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: | Focus HD 43 Detector |
|----------------------|--------------------------|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Focus HD 43 |
| 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: | Mars1717X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K210314 |

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

Focus HD 43 Detector is a 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: 42.67cm×42.67cm.

The sensor plate of Focus HD 43 Detector 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 Focus HD 43 Detector 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.

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

Focus HD 43 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 generalpurpose 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 Focus HD 43 Detector works continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

| Item | Predicate Device:<br>Mars1717X Wireless Digital<br>Flat Panel Detector | Proposed Device:<br>Focus HD 43 Detector |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K210314 | |
| Intended Use | The Mars1717X Wireless<br>Digital Flat Panel Detector is<br>indicated for digital imaging<br>solution designed for providing<br>general radiographic system in<br>all general-purpose diagnostic<br>procedures. | Same |
| Item | Predicate Device:<br>Mars1717X Wireless Digital<br>Flat Panel Detector | Proposed Device:<br>Focus HD 43 Detector |
| Indications for<br>Use | Mars1717X wireless digital<br>flat panel detector is indicated<br>for digital imaging solutions<br>designed to provide general<br>radiographic diagnosis for<br>human anatomy including both<br>adult and pediatric patients. It<br>is intended to replace<br>film/screen systems in all<br>general-purpose diagnostic<br>procedures. The device is not<br>intended for mammography or<br>dental applications. | Same |
| 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 Type: | Wireless, Portable | Same |
| Readout<br>Mechanism: | Thin Film Transistor | Same |
| Item | Predicate Device:<br>Mars1717X Wireless Digital<br>Flat Panel Detector | Proposed Device:<br>Focus HD 43 Detector |
| Image Matrix<br>Size: | 4267 ×4267 pixels | Same |
| Pixel Size: | 100μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective Imaging<br>Area: | 426.7 mm × 426.7mm | Same |
| Spatial<br>Resolution: | Min. 4.3lp/mm | 5.0 lp/mm |
| Detective<br>Quantum<br>Efficiency<br>(DQE) | 0.54 at 1 lp/mm (RQA5,<br>2.5μGy) | Same |
| Power<br>Consumption: | Max. 19W | Max.42W |
| Communications:<br>(Wireless<br>functionality) | a) Wired (only for<br>service) : Gigabit<br>Ethernet (1000BASE-T)<br>b) Wireless: IEEE<br>802.11a/b/g/n/ac (2.4 GHz<br>/ 5 GHz) | Same |
| Imaging protect<br>Plate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | 460 mm × 460 mm × 15mm | Same |
| Detector IP grade | IP56 | Same |
| Item | Predicate Device:<br>Mars1717X Wireless Digital<br>Flat Panel Detector | Proposed Device:<br>Focus HD 43 Detector |
| Power input port | 4 pin port | 10 pin port |
| Surface pressure | Uniform load: 300 kg over the<br>whole area of the surface;<br>Local load: 150 kg on an area<br>4 cm diameter of center | Uniform load: 300 kg over the<br>whole area of the surface;<br>Local load: 100 kg on an area 4<br>cm diameter of center |
| Operation: | Temperature: +10 ~ +35°C<br>Humidity: 5 ~ 90%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~<br>106 kPa<br>Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C<br>Humidity: 5 ~ 90%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106<br>kPa<br>Altitude: Max. 3000 meters |
| Storage and<br>Transportation:<br>( detector ) | Temperature: -20 ~ +55°C<br>Humidity: 5 ~ 95%<br>(Non-Condensing)<br>Atmospheric pressure: 60 ~<br>106 kPa<br>Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C<br>Humidity: 5 ~ 95%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106<br>kPa<br>Altitude: Max. 3000 meters |
| Software | SDK(include iDetector) is<br>intend to supply API interface<br>for DR system manufacturers.<br>DR system manufacturer<br>control the detector by SDK<br>interface. SDK is not intend to<br>use directly by other users<br>beside DR system<br>manufacturers. | same |
| Item | Predicate Device:<br>Mars1717X Wireless Digital<br>Flat Panel Detector | Proposed Device:<br>Focus HD 43 Detector |
| Utilized FDA<br>guidance<br>documents | 1. Guidance for the<br>Submission of 510(k)'s for<br>Solid State X-ray Imaging<br>Devices;<br><br>2. The 510(k) Program:<br>Evaluating Substantial<br>Equivalence in Premarket<br>Notifications[510(k)];<br><br>3. Content of Premarket<br>Submissions for<br>Management of<br>Cybersecurity in Medical<br>Devices;<br><br>4. Radio Frequency Wireless<br>Technology in Medical<br>Devices.<br><br>5. Guidance for “Premarket<br>Assessment of Pediatric<br>Medical Devices”;<br><br>6. Guidance for “Pediatric<br>Information for X-ray<br>Imaging Device Premarket<br>Notifications”.<br><br>7. Design Control Guidance<br>For Medical Device<br>Manufacturers | same |
| Item | Predicate Device:<br>Mars1717X Wireless Digital<br>Flat Panel Detector | Proposed Device:<br>Focus HD 43 Detector |
| | 8. Appropriate Use of<br>Voluntary Consensus<br>Standards in Premarket<br>Submissions for Medical<br>Devices.<br>9. The Special 510(k)<br>Program | |
| Battery | Model: Battery-KX<br>Rated Voltage:11.55V | same |

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

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

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

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 the distributor or manufacturer's service office.

- 2) Application Program Interface (API) for system integration manufacturer Minimum configuration: Focus HD 43 Detector connected via wireless communication.

| Operating System: | Windows embedded |
|-------------------|-----------------------------------|
| CPU: | Intel Core i3- 8100 3.6GHz 4C 65W |
| Memory: | 16GB (2x8GB) DDR4 2666 DIMM |
| Hard Disk: | 1TB |

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#### 3) X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Focus HD 43 Detector. 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.

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

- 1) 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.

- 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:
Main modification from the predicate device is DC input port change(from 4 pin port to 10 pin port ) . This DC input port is only designed and applicable for DR system manufacturer.

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-clinical consideration of predicate device on the Market (Mars1717X, K210314).

- 4) Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with

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those of predicate device. There is no any change about clinical performance from predicate device

#### 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 Focus HD 43 is substantially equivalent to predicate device with regards to safety and effectiveness.