The CareView 1500C/ CareView 1500L 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.

Device Description

CareView 1500C/ CareView 1500L is a kind of cassette size digital X-ray flat panel detectors which have 434mmx355mm imaging area. The device communicates by wired communication feature (Giga-bit Ethernet communication mode by connecting the power box).

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.

AI/ML Overview

The provided document is a 510(k) summary for the CareView 1500C/CareView 1500L X-ray Flat Panel Detectors. It focuses on demonstrating substantial equivalence to a predicate device (CareView 1500Cw) rather than outlining specific acceptance criteria for algorithm performance and a study proving it meets those criteria.

This document describes a medical device (an X-ray flat panel detector) and its physical and performance specifications, but it does not involve an AI algorithm with specific acceptance criteria that require a test set, ground truth, or expert review. Therefore, I cannot provide the requested information regarding the acceptance criteria for an AI device, the study proving it meets those criteria, sample sizes for test and training sets, expert adjudication, or MRMC studies.

The closest information provided in the document related to "performance" is in the "Technological Characteristics" table on page 6, which compares the proposed device's specifications to those of the predicate device. These are hardware specifications, not AI algorithm performance metrics.

For example, the document states:

Image Matrix Size: 2304 x 2816 pixels for both proposed and predicate devices.
Pixel Pitch: 154µm for both.
Effective Imaging Area: 355 mm x 434 mm for both.
Grayscale: 16 bit, 65536 grayscale for both.
Spatial Resolution: Min. 3.3 line pair/mm for both.

These are engineering specifications of the X-ray detector itself, not acceptance criteria for an AI algorithm's diagnostic performance. The document's conclusion (page 9) explicitly states that differences in connectivity and power supply "do not raise any new questions of safety and effectiveness," implying that the device's imaging performance is considered equivalent to the predicate without needing new clinical performance studies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

November 10, 2015

CareRay Digital Medical Systems Co., Ltd. % Ms. Leilei Li Engineer A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park SuZhou, Jiangsu 215123 P. R. CHINA

Re: K153058

Trade/Device Name: CareView 1500C/CareView 1500L X-ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 14, 2015 Received: October 21, 2015

Dear Ms. 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. 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.

{1}------------------------------------------------

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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Robert Oels

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153058

Device Name

CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors

Indications for Use (Describe)

The CareView 1500C/ CareView 1500L 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 generalpurpose 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."

{3}------------------------------------------------

510(k) Summary

{4}------------------------------------------------

510(k) Summary

[As required by 21 CFR 807.92]

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

Oct. 14, 2015

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, SuZhouIndustrial Park, SuZhou 215123, P. R. China
Contact Person:	Ms. Li
Phone Number:	(86) 512-86860288
Fax Number:	(86) 512-86860388
E-mail:	ll.li@careray.com

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

Trade Name:	X-ray Flat Panel Detectors
Model Name:	CareView 1500C/ CareView 1500L
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

{5}------------------------------------------------

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

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

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 1500C/CareView 1500L is the same as the cleared product, CareView 1500Cw except the following aspects:

1. Based on CareView 1500Cw, the WIFI wireless communication function is cut in CareView 1500C and CareView 1500L. Accordingly, the internal WIFI communication circuit module is removed.
1. Based on CareView 1500Cw, the lithium battery pack is removed. So the power supply mode is simplified. In CareView 1500Cw, both power box and the battery pack can supply power, while in CareView 1500C and CareView 1500L, only the power box can supply power.
1. Based on CareView 1500Cw, CareView 1500C and CareView 1500L removed the power button. Because lithium battery is removed and there is one power switch on power box, so the power button on detector is unnecessary.
Compare with CareView 1500Cw and CareView 1500C, the handle is removed on 4) CareView 1500L. Accordingly, the enclosure of the bottom is changed. The final enclosure is simpler and more compact.

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

{6}------------------------------------------------

Item	Proposed Device:X-ray Flat Panel Detectors	Predicate Device:X-ray Flat Panel Detectors
510(K) Number	To be assigned	K150929
Model	CareView 1500C/ CareView 1500L	CareView 1500Cw
ClassificationName	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
Installation Type	Wired, Cassette	Wireless, Portable
ReadoutMechanism	Thin Film Transistor	Thin Film Transistor
Image Matrix Size	2304 × 2816 pixels	2304 × 2816 pixels
Pixel Pitch	154µm	154µm
Effective ImagingArea	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
RatedPowerSupply● Wired● Wireless	DC +24 V, Max.1 APowered by the power box usinginterface cable/	DC +24 V, Max.1.5 APowered by the power boxusing interface cablePowered by the battery pack
PowerConsumption	Max. 24 W	Max. 36 W
Communications● Wired● Wireless	Gigabit Ethernet/	Gigabit EthernetIEEE 802.11a/b/g/n (2.4 / 5 GHz)
Imaging Plate	Carbon Fiber Plate	Carbon Fiber Plate
Cooling	Air cooling	Air cooling
Dimensions	384 mm × 460 mm × 15 mm	384 mm x 460 mm x 15 mm
Operation	Temperature: +5 ~ +35 ℃Humidity: 30 ~ 75%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPa	Temperature: +5 ~ +35 ℃Humidity: 30 ~ 75%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters
Storage andtransportation	Temperature: -20 ~ +55 ℃Humidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPa	Temperature: -20 ~ +55 ℃Humidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters

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

{7}------------------------------------------------

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 questions regarding the compatibility issue for other generators, please contact your distributor or CareRay.

1. Application Program 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
1. X-ray exposure mode

The synchronous connection mode is the signal transfer mode between the X-ray generator which sends the X-ray and the detector which receives the X-ray.

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

CareView 1500L supported typical sync mode contains external sync, 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.

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

A 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 1500C/ CareView 1500L) and predicate device (CareView 1500Cw) share most of primary product specifications including intended use, technology,

{8}------------------------------------------------

material, and imaging principle, etc. Difference lies in the means of connectivity and power supply. While predicate device supports both wired and wireless connections, the proposed devices provide only a wired connection between the detector and PC. While predicate device supports both internal and external powered, the proposed devices provide only external powered.

The difference of connectivity and power supply don't affect the technological parameters and clinical images.

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 CareView 1500C/ CareView 1500L X-ray flat panel detector is substantially equivalent to predicate device CareView 1500Cw (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 connectivity and power supply are different. However the test reports in this submission documents provide demonstration that these differences do not raise any new questions of safety and effectiveness. Therefore, CareRay Digital Medical System Co., Ltd. concludes the CareView 1500C/ CareView 1500L X-ray flat panel detector is substantially equivalent with the predicate device CareView 1500Cw (K150929).

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
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.(b)
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.