The Care View 1800Le 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

The CareView 1800Le detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode via connecting the power box). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device. The software that supports the functions of the digital detector CareView 1800Le is unchanged from the predicate. Generally, CareView 1800Le is the same as the cleared product, CareView 1800L except the pixel size. The pixel size of CareView 1800Le is 140 μm, while the CareView 1800L is 154 μm.

AI/ML Overview

The provided text describes a 510(k) summary for the CareView 1800Le X-ray Flat Panel Detectors. This document explicitly states that the device is "substantially equivalent" to a predicate device (CareView 1800L). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require a full safety and effectiveness evaluation as would be needed for a PMA.

Therefore, the study performed to "prove the device meets the acceptance criteria" is a non-clinical study to demonstrate substantial equivalence to a predicate device. There are no acceptance criteria in the sense of specific clinical performance metrics (e.g., sensitivity, specificity for disease detection) because this is a 510(k) for an X-ray detector, not a diagnostic AI algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance

The acceptance criteria are implicitly that the proposed device (CareView 1800Le) performs comparably to the predicate device (CareView 1800L) across key technical specifications, and that any differences do not raise new questions of safety or effectiveness. The reported device performance is a direct comparison of technical specifications.

Item	Acceptance Criteria (Implicitly, comparable to Predicate)	Reported Device Performance (CareView 1800Le)	Predicate Device Performance (CareView 1800L)
Intended Use	Same as predicate	Digital imaging solution for general radiographic diagnosis of human anatomy; replace film/screen systems; not for mammography.	Digital imaging solution for general radiographic diagnosis of human anatomy; replace film/screen systems; not for mammography.
Classification Name	Same as predicate	Stationary X-ray system	Stationary X-ray system
Product Code	Same as predicate	MQB	MQB
Regulation Number	Same as predicate	892.1680	892.1680
X-ray Absorber	Same as predicate	CsI Scintillator	CsI Scintillator
Installation Type	Same as predicate	Wired, Cassette	Wired, Cassette
Readout Mechanism	Same as predicate	Thin Film Transistor	Thin Film Transistor
Image Matrix Size	Comparable to predicate	3072 × 3072 pixels	2816 × 2816 pixels
Pixel Pitch	Different from predicate, but must not raise new safety/effectiveness questions	140μm	154μm
Effective Imaging Area	Comparable to predicate	430 mm × 430 mm	434 mm × 434 mm
Grayscale	Same as predicate	16 bit, 65536 grayscale	16 bit, 65536 grayscale
Spatial Resolution	Equal or better than predicate	3.57 line pair/mm	3.3 line pair/mm
MTF (@ 1lp/mm)	Comparable to predicate	≥63%	~70%
MTF (@ 2lp/mm)	Comparable to predicate	≥35%	~40%
MTF (@ 3lp/mm)	Comparable to predicate	≥17%	~22%
MTF (@ 3.5lp/mm)	New for proposed device, but demonstrates performance	≥10%	N/A (predicate only up to 3lp/mm reported)
DQE (@RQA5, 30μGy, 0lp/mm)	Comparable to predicate	≥62%	~65%
DQE (@RQA5, 30μGy, 1lp/mm)	New for proposed device, but demonstrates performance	≥45%	N/A (predicate only up to 3lp/mm reported)
DQE (@RQA5, 30μGy, 3lp/mm)	Comparable to predicate	≥17%	~20%
DQE (@RQA5, 30μGy, 3.5lp/mm)	New for proposed device, but demonstrates performance	≥10%	N/A (predicate only up to 3lp/mm reported)
Rated Power Supply	Same as predicate	DC +24 V, Max.1 A; Powered by power box using interface cable	DC +24 V, Max.1 A; Powered by power box using interface cable
Communications	Same as predicate	Gigabit Ethernet	Gigabit Ethernet
Imaging Plate	Same as predicate	Carbon Fiber Plate	Carbon Fiber Plate
Cooling	Same as predicate	Air cooling	Air cooling
Dimensions	Same as predicate	460 mm × 460 mm × 15 mm	460 mm × 460 mm × 15 mm
Operation/Storage Conditions	Same as predicate	Specified temperature, humidity, atmospheric pressure ranges	Specified temperature, humidity, atmospheric pressure ranges
Electrical Safety & EMC	Must meet standards	Testing according to IEC/ES 60601-1 and IEC/EN 60601-1-2 performed with satisfactory results.	Implied similar for predicate device as per regulatory requirements.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical testing rather than a study with a test set of patient cases. The testing focused on technical specifications (e.g., spatial resolution, MTF, DQE). The sample size for these technical measurements is not specified in the summary, but it would typically involve multiple measurements of the device itself under controlled conditions according to relevant standards. There is no information on data provenance relating to patient data as it's not a clinical study in that sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI diagnostic device that requires expert-established ground truth on medical images. The measurements of performance metrics like MTF and DQE are objective physical measurements of the detector's imaging capabilities, established through standard metrology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a clinical study involving human readers or interpretation of results that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI device that assists human readers. It is an X-ray flat panel detector.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense. The "standalone" performance here refers to the physical and technical performance of the X-ray detector itself. The summary outlines the technical specifications (e.g., pixel pitch, spatial resolution, MTF, DQE) that characterize the device's standalone imaging capabilities. This is the primary subject of the "Nonclinical and clinical considerations" section, which compares these specifications to the predicate device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of clinical ground truth for disease. The "ground truth" here is the actual physical performance of the device as measured against established engineering and physics standards for X-ray detectors (e.g., line pair patterns for spatial resolution, standardized test objects for MTF/DQE).

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

December 13, 2019

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

Re: K193173

Trade/Device Name: X-ray Flat Panel Detectors (CareView 1800Le) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: November 19, 2019 Received: November 22, 2019

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. 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 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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K193173

Device Name

X-ray Flat Panel Detectors (CareView 1800Le)

Indications for Use (Describe)

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)

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006_510(k) Summary

K193173

Page 1 of 6

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510(k) Summary

K193173

[As required by 21 CFR 807.92]

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

Nov. 04, 2019

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

Company Name:	CareRay Digital Medical Technology 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 1800Le
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 Technology Co., Ltd.
Trade Name:	X-ray Flat Panel Detectors
Model Name:	CareView 1800L
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) #:	K153492

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

The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.

The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device.

The software that supports the functions of the digital detector CareView 1800Le is unchanged from the predicate.

Generally, CareView 1800Le is the same as the cleared product, CareView 1800L except the

pixel size. The pixel size of CareView 1800Le is 140 μm, while the CareView 1800L is 154 μm.

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

The CareView 1800Le 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.

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

Item	Proposed Device:X-ray Flat Panel Detectors	Predicate Device:X-ray Flat Panel Detectors
510(K) Number	To be assigned	K153492
Model	CareView 1800Le	CareView 1800L
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	CsI Scintillator	CsI Scintillator
Installation Type	Wired, Cassette	Wired, Cassette

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ReadoutMechanism	Thin Film Transistor	Thin Film Transistor
Image Matrix Size	3072 × 3072 pixels	2816 × 2816 pixels
Pixel Pitch	140μm	154μm
Effective ImagingArea	430 mm × 430 mm	434 mm × 434 mm
Grayscale	16 bit, 65536 grayscale	16 bit, 65536 grayscale
Spatial Resolution	3.57 line pair/mm	3.3 line pair/mm
MTF	≥63%..........(@ 1lp/mm)≥35%..........(@ 2lp/mm)≥17%..........(@ 3lp/mm)≥10%..........(@ 3.5lp/mm)	~70%..........(@ 1lp/mm)~40%..........(@ 2lp/mm)~22%..........(@ 3lp/mm)
DQE	(@RQA5, 30μGy)≥62%..........(@ 0lp/mm)≥45%..........(@ 1lp/mm)≥17%..........(@ 3lp/mm)≥10%..........(@ 3.5lp/mm)	(@RQA5, 30μGy)~65%..........(@ 0lp/mm)~20%..........(@ 3lp/mm)
RatedPowerSupply	DC +24 V, Max.1 APowered by the power box usinginterface cable	DC +24 V, Max.1 APowered by the power boxusing interface cable
Communications	Gigabit Ethernet	Gigabit Ethernet
Imaging Plate	Carbon Fiber Plate	Carbon Fiber Plate
Cooling	Air cooling	Air cooling
Dimensions	460 mm × 460 mm × 15 mm	460 mm × 460 mm × 15 mm
Operation	Temperature: +5 ~ +35°C	Temperature: +5 ~ +35°C
	Humidity: 30 ~ 75%	Humidity: 30 ~ 75%
	(Non-Condensing)	(Non-Condensing)
	Atmospheric pressure: 700 ~ 1060	Atmospheric pressure: 700 ~
	hPa	1060 hPa
Storage andtransportation	Temperature: -20 ~ +55°C	Temperature: -20 ~ +55°C
	Humidity: 10 ~ 90%	Humidity: 10 ~ 90%
	(Non-Condensing)	(Non-Condensing)
	Atmospheric pressure: 700 ~ 1060	Atmospheric pressure: 700 ~
	hPa	1060 hPa

8. System requirements to operate with other radiographic system components

The submitted medical device is the CareView 1800Le digital detector. The other x-ray system components referred below are for information purpose only.

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)

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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: 6 GB or higher

Hard disk: 80 GB or higher

Monitor: 1280 x 1024 or higher

OS: Windows XP or Windows 7 or Windows 10

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 1800Le 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 1800Le) and predicate device (CareView 1800L) share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc. The only difference is the pixel size. While the predicate device pixel size is 154 um, the proposed device pixel size is 140 um. The difference of pixel size doesn'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 1800Le X-ray flat panel detector is substantially equivalent to predicate device CareView 1800L(K153492).

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Both propose and predicate devices are same in the intended use, the design principle, the applicable standards and specification. Some characteristics, for example, pixel size is different. However the test reports in this submission documents provide demonstration that this difference doesn't raise any new questions of safety and effectiveness. Therefore, CareRay Digital Medical Technology Co., Ltd. concludes the CareView 1800Le X-ray flat panel detector is substantially equivalent with the predicate device CareView 1800L (K153492).

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.