The FDA letter informs CareRay Digital Medical System Co., Ltd. that their CareView 1500P X-ray Flat Panel Detectors have been found to be substantially equivalent to legally marketed predicate devices. The detectors are intended to replace radiographic film/screen systems for general diagnostic radiography procedures but not for mammography. The FDA determined the devices comply with performance standards and other requirements but advises CareRay of additional labeling, registration, adverse event reporting, and other regulations that apply.
The FDA letter informs CareRay Digital Medical System Co., Ltd. that their CareView 1500P X-ray Flat Panel Detectors have been found to be substantially equivalent to legally marketed predicate devices. The detectors are intended to replace radiographic film/screen systems for general diagnostic radiography procedures but not for mammography. The FDA determined the devices comply with performance standards and other requirements but advises CareRay of additional labeling, registration, adverse event reporting, and other regulations that apply.
The FDA letter informs CareRay Digital Medical System Co., Ltd. that their CareView 1500P X-ray Flat Panel Detectors have been found to be substantially equivalent to legally marketed predicate devices. The detectors are intended to replace radiographic film/screen systems for general diagnostic radiography procedures but not for mammography. The FDA determined the devices comply with performance standards and other requirements but advises CareRay of additional labeling, registration, adverse event reporting, and other regulations that apply.
The FDA letter informs CareRay Digital Medical System Co., Ltd. that their CareView 1500P X-ray Flat Panel Detectors have been found to be substantially equivalent to legally marketed predicate devices. The detectors are intended to replace radiographic film/screen systems for general diagnostic radiography procedures but not for mammography. The FDA determined the devices comply with performance standards and other requirements but advises CareRay of additional labeling, registration, adverse event reporting, and other regulations that apply.
10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002
CareRay Digital Medical System Co., Ltd.
September 1, 2016 Ə;X:HL 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: MQB 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. Page 2—Xu Wei
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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below.
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)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF 510(k) Summary 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.
A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Company Address: Industrial Park, SuZhou 215123, P. R. China Contact Person: Mr. Xu Phone Number: (86) 512-86860288 Fax Number: (86) 512-86860388 E-mail: wei.xu@careray.com
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
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
Page1of5 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 ×510.4mm × 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.
Page2of5 Model CareView 1500P CareView 1500Cw Classification Stationary X-ray system Stationary X-ray system Name Product Code MQB MQB Regulation Number 892.1680 892.1680 Panel Radiology Radiology Class II II X-ray Absorber CsI Scintillator CsI Scintillator InstallationType Wireless, Portable Wireless, Portable ReadoutMechanis Thin Film Transistor Thin Film Transistor m Image Matrix Size 2304 × 2816 pixels 2304 × 2816 pixels Pixel Pitch 154μm 154μm Effective Imaging 355 mm × 434 mm 355 mm × 434 mm Area Grayscale 16 bit, 65536 grayscale 16 bit, 65536 grayscale Spatial Resolution Min. 3.3 line pair/mm Min. 3.3 line pair/mm Rated Power DC +24 V, Max. 4 A DC +24 V, Max.1.5 A Supply Powered by the switching power Powered by the power box Wired supply using interface cable using interface cable Wireless Powered by the battery pack Powered by the battery pack Power Max. 96 W Max. 36 W Consumption Communications Wired Gigabit Ethernet Gigabit Ethernet Wireless IEEE 802.11a/b/g/n (2.4 / 5 GHz) 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 × 460 mm × 15 mm Temperature: +5 ~ +35℃ Temperature: +5 ~ +35℃ Humidity: 30 ~ 75% Humidity: 30 ~ 75% Operation (Non-Condensing) (Non-Condensing) Atmospheric pressure: 70 ~ 106 Atmospheric pressure: 70 ~ 106 kPa kPa Altitude: Max.3000 meters Temperature: -20 ~ +55℃ Temperature: -20 ~ +55℃ Humidity: 10 ~ 90% Humidity: 10 ~ 90% Storage and (Non-Condensing) (Non-Condensing) transportation Atmospheric pressure: 70 ~ 106 Atmospheric pressure: 70 ~ 106 kPa kPa Altitude: Max.3000 meters The CareView 1500P is indicated The CareView1500Cw is for digital imaging solution indicated for digital imaging designed for providing general solution designed for providing Intended Use radiographic diagnosis of human general radiographic diagnosis of anatomy. It is intended to replace human anatomy. It is intended to radiographicfilm/screen systems in replace radiographic film/screen
Page3of5 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 ~70%..........(@ 1lp/mm) ~70%..........(@ 1lp/mm) MTF ~40%..........(@ 2lp/mm) ~40%..........(@ 2lp/mm) ~22%..........(@ 3lp/mm) ~22%..........(@ 3lp/mm) (@RQA5, 30μGy) (@RQA5, 30μGy) DQE ~65%..........(@ 0lp/mm) ~65%..........(@ 0lp/mm) ~20%..........(@ 3lp/mm) ~20%..........(@ 3lp/mm) Dynamic range ~80 dB ~82 dB
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
Page4of5 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. 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. 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
Page5of5 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).
