CareView 1500P X-ray Flat Panel Detectors

K162178 · Careray Digital Medical System Co., Ltd. · MQB · Sep 1, 2016 · Radiology

Device Facts

• Record ID: K162178
• Device Name: CareView 1500P X-ray Flat Panel Detectors
• Applicant: Careray Digital Medical System Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CareView 1500P 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 product is not intended for mammography applications.

Device Story

CareView 1500P is a portable, wireless digital X-ray flat panel detector; 434mm x 355mm imaging area. Device intercepts X-ray photons; scintillator emits visible light; amorphous silicon (a-Si) array converts light to electrical signals; signals digitized for display on monitor. Used in clinical settings; integrated with operating PC and X-ray generator. Supports wired (Gigabit Ethernet) or wireless (IEEE 802.11a/b/g/n) communication. Features include integral handle and protective film on carbon fiber plate. Operates via soft, manual, or auto (FFAED) sync modes with X-ray generators. Provides digital images for physician review to support diagnostic decision-making; replaces traditional film/screen systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety and EMC testing per IEC/ES 60601-1 and IEC/EN 60601-1-2, and comparison of technical performance parameters (MTF, DQE, dynamic range).

Technological Characteristics

CsI scintillator; a-Si TFT readout; 2304 x 2816 pixel matrix; 154μm pixel pitch; 16-bit grayscale. Carbon fiber plate housing. Air cooling. Power: DC +24V (wired or battery). Connectivity: Gigabit Ethernet, IEEE 802.11a/b/g/n. Standards: IEC/ES 60601-1, IEC/EN 60601-1-2.

Indications for Use

Indicated for general radiographic diagnosis of human anatomy in patients requiring general-purpose diagnostic procedures. Not intended for mammography.

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

• CareView 1500Cw (K150929)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2016

CareRay Digital Medical System Co., Ltd. % Xu Wei Manager B3-501, Biobay, 218 Xinghu Street SuZhou Industrial Park SuZhou, Jiangsu 215123 P R CHINA

Re: K162178

Trade/Device Name: CareView 1500P X-ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: July 1, 2016 Received: August 4, 2016

Dear Xu Wei:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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#### Indications for Use

510(k) Number (if known) K162178

Device Name CareView 1500P X-ray Flat Panel Detectors

Indications for Use (Describe)

The CareView 1500P 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 product is not intended for mammography applications.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

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# 510(k) Summary

[As required by 21 CFR 807.92]

## 1. Date Prepared [21 CFR807.92 (a) (1)]

July01, 2016

## 2. Submitter's Information [21 CFR807.92 (a) (1)]

| Company Name: | CareRay Digital Medical System Co., Ltd. |
|------------------|-------------------------------------------------------------------------------------------------|
| Company Address: | A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou<br>Industrial Park, SuZhou 215123, P. R. China |
| Contact Person: | Mr. Xu |
| Phone Number: | (86) 512-86860288 |
| Fax Number: | (86) 512-86860388 |
| E-mail: | [e-mail] |

#### 3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

| Trade Name: | CareView1500P X-ray Flat Panel Detectors |
|----------------------|------------------------------------------|
| Model Name: | CareView 1500P |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB |

#### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicates within this submission are as follows:

| Manufacturer: | CareRay Digital Medical System Co., Ltd |
|----------------------|-----------------------------------------|
| Trade Name: | X-ray Flat Panel Detectors |
| Model Name: | CareView 1500Cw |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |

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| Regulatory Class: | Class II |
|-------------------|----------|
| Product Code: | MQB |
| FDA 510(k) #: | K150929 |

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

CareView 1500P is a kind of portablewireless digital X-ray flat panel detectors which have 434mm×355mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by backup network port) optionally.

The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.

The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

Generally, CareView 1500P is the same as the cleared product, CareView 1500Cw except the mechanical structure:

- 1) The dimension of CareView 1500P is 470.4mm x 18.2mm, while the CareView 1500Cw is 384mm× 460mm× 15mm.
- 2) The CareView 1500P is design with integral handle, while the CareView 1500Cw is design with built-in foldable handle.
- 3) The front cover of CareView 1500P has a protective film on carbon fiber plate, while the front cover ofCareView 1500Cw is carbon fiber plate, not the protective film.
- 4) The external interface of CareView 1500P are power input port and backup network port, while the CareView 1500Cw has a multifunctional (power and network function) I/O port.

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

The CareView 1500P is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographicfilm/screen systems in all general-purpose diagnostic procedures.This product is not intended for mammography applications.

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

| Item | Proposed Device:<br>X-ray Flat Panel Detectors | Predicate Device:<br>X-ray Flat Panel Detectors |
|---------------|------------------------------------------------|-------------------------------------------------|
| 510(K) Number | K162178 | K150929 |

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| Model | CareView 1500P | CareView 1500Cw |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Stationary X-ray system | Stationary X-ray system |
| Product Code | MQB | MQB |
| Regulation Number | 892.1680 | 892.1680 |
| Panel | Radiology | Radiology |
| Class | II | II |
| X-ray Absorber | Csl Scintillator | Csl Scintillator |
| InstallationType | Wireless, Portable | Wireless, Portable |
| ReadoutMechanis<br>m | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 x 2816 pixels | 2304 x 2816 pixels |
| Pixel Pitch | 154μm | 154μm |
| Effective Imaging<br>Area | 355 mm × 434 mm | 355 mm × 434 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | Min. 3.3 line pair/mm | Min. 3.3 line pair/mm |
| Rated<br>Power<br>Supply | DC +24 V, Max. 4 A<br>● Wired Powered by the switching power<br>supply using interface cable<br>● Wireless Powered by the battery pack | DC +24 V, Max.1.5 A<br>Powered by the power box<br>using interface cable<br>Powered by the battery pack |
| Power<br>Consumption | Max. 96 W | Max. 36 W |
| Communications | ● Wired Gigabit Ethernet<br>● Wireless IEEE 802.11a/b/g/n (2.4 / 5 GHz) | Gigabit Ethernet<br>IEEE 802.11a/b/g/n (2.4 / 5 GHz) |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Dimensions | 470.4 mm × 510.4 mm × 18.2 mm | 384 mm x 460 mm x 15 mm |
| Operation | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 75%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 75%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa<br>Altitude: Max.3000 meters |
| Storage and<br>transportation | Temperature: -20 ~ +55°C<br>Humidity: 10 ~ 90%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa | Temperature: -20 ~ +55°C<br>Humidity: 10 ~ 90%<br>(Non-Condensing)<br>Atmospheric pressure: 70 ~ 106 kPa<br>Altitude: Max.3000 meters |
| Intended Use | The CareView 1500P is indicated<br>for digital imaging solution<br>designed for providing general<br>radiographic diagnosis of human<br>anatomy. It is intended to replace<br>radiographicfilm/screen systems in | The CareView1500Cw is<br>indicated for digital imaging<br>solution designed for providing<br>general radiographic diagnosis of<br>human anatomy. It is intended to<br>replace radiographic film/screen |
| | | |
| | all general-purpose diagnostic | systems in all general-purpose |
| | procedures.This product is not | diagnostic procedures.This |
| | intended for mammography | product is not intended for |
| | applications. | mammography applications |
| MTF | ~70%..........(@ 1lp/mm) | ~70%..........(@ 1lp/mm) |
| | ~40%..........(@ 2lp/mm) | ~40%..........(@ 2lp/mm) |
| | ~22%..........(@ 3lp/mm) | ~22%..........(@ 3lp/mm) |
| DQE | (@RQA5, 30µGy) | (@RQA5, 30µGy) |
| | ~65%..........(@ 0lp/mm) | ~65%..........(@ 0lp/mm) |
| | ~20%..........(@ 3lp/mm) | ~20%..........(@ 3lp/mm) |
| Dynamic range | ~80 dB | ~82 dB |

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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

thespecifications described above. If you have questions regarding the compatibility issue for othergenerators, please contact your distributor or CareRay.

- 2) ApplicationProgram Interface (API) for system integration manufacturer
Peripheral hardware: CareView detector connected via wired communication.

CPU: Intel (R) Core (TM) 2 Duo, 2.93GHz or above

RAM: 2 GB or higher

Hard disk: 160 GB or higher

Monitor: 1280 x 1024 or higher

OS: Windows XP or Windows 7

Development environment: MS Visual Studio 2005

- 3) X-ray exposure mode
The synchronous connection mode is the signal transfer modebetween the X-ray generator which sends the X-ray and the detector which receives the X-ray.

CareView 1500P supported typical sync mode contains soft sync, manual sync and auto sync containing FFAED mode.

The detector can't provide feedback to the generator to terminate the x-ray exposure.

The way of connecting to the X-ray generator is shown as below:

- a. Connection in the soft sync mode
The detector communicates with X-ray generator by the DROC workstation and sync box

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by a wired or wireless network connection.

- b. Connection in the manual sync mode
There is no interaction of sync exposure signal between the detector and X-ray generator. Users should control the exposure time manually according to exposure recommendations provided by acquisition software.

- c. Connection in theauto sync mode
There is no interaction of sync exposure signal between the detector and X-ray generator. Users can take to exposure at any time after the hints of permitting to exposure.

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

- > Electrical safety and EMC testing
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 satisfactory.

- A Nonclinical and clinical considerations
The proposed device (CareView 1500P) and predicate device (CareView 1500Cw) share most of primary product specifications including intended use, technology, material, and imaging principle, etc. Difference lies in the mechanical structure. We followed nonclinical consideration section of the Guidance for the Submission of 510(k)'s for Solid State X-ray imaging Devices.

The differences of mechanical structure don't affect the technological parameters and clinical images.

- A Rated Power Supply and Power Consumption
It is mainly due to the different power of readout circuit between the both products. The two types of readout circuits were produced by different companies. Although there is a slight difference in the technology but the principles are the same.

#### 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,the CareView1500P is substantially equivalent to predicate device CareView1500Cw (K150929). Both propose and predicate devices are same in the intended use, the design principle, the applicable standards and specification. Some characteristics, for example,the mechanical structureand power of readout circuitare different. However the test reports in this

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submission documents provide demonstration that these differences do not raise any new questions of safety andeffectiveness. Therefore, CareRay Digital Medical System Co., Ltd. concludes the CareView1500P is substantially equivalent with the predicate deviceCareView1500Cw (K150929).