(141 days)
The CareView 3600RF 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-purposic procedures. This product is not intended for mammography applications.
The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode).
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 information provided indicates that the CareRay Digital Medical Technology Co., Ltd. CareView 3600RF X-ray Flat Panel Detector is seeking market clearance through a 510(k) submission, asserting substantial equivalence to the iRay Technology (Shanghai) Ltd. Mars1417V-PSI Wireless Digital Flat Panel Detector (K161730). Since this is a 510(k) submission for a traditional medical device (X-ray Flat Panel Detector) and not a software-as-a-medical-device (SaMD) or AI/ML-driven device with clinical performance endpoints based on diagnostic accuracy, the acceptance criteria and study detailed primarily focus on technical performance metrics rather than clinical efficacy involving human readers or AI algorithms.
Here's a breakdown of the available information regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
For an X-ray Flat Panel Detector, the "acceptance criteria" and "reported device performance" are typically defined by various technical specifications and physical performance metrics, often compared against a predicate device and industry standards. The submission highlights several of these:
| Performance Metric | Acceptance Criteria (Predicate Device K161730) | Reported Device Performance (CareView 3600RF) |
|---|---|---|
| X-ray Absorber | GOS Scintillator | GOS Scintillator |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 x 2800 pixels | 5632 x 2816 pixels |
| Pixel Pitch | 150 µm | 154 µm |
| Effective Imaging Area | 355 mm x 434 mm | 867.5 mm x 433.1 mm |
| Grayscale | 14 bit | 16 bit |
| Spatial Resolution | 3.4 lp/mm | 3.4 lp/mm |
| MTF (@ 0.5 lp/mm) | 0.75 (75%) | 75% |
| MTF (@ 1 lp/mm) | (Not specified explicitly, but generally expected to be comparable based on spatial resolution) | 50% |
| DQE (@ RQA5, 3.2 µGy, 0.5 lp/mm) | 0.27 (27%) | 28% |
| DQE (@ RQA5, 3.2 µGy, 1 lp/mm) | (Not specified explicitly) | 20% |
| Communications | Wired: Gigabit Ethernet, Wireless: IEEE 802.11a/b/g/n (2.4 GHz/ 5 Glz) | Gigabit Ethernet (Wired only) |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Operation Temperature | +5 ~ +35°C | +10 ~ +40°C |
| Operation Humidity | 30 ~ 75% RH (Non-Condensing) | 30 ~ 75% RH (Non-Condensing) |
| Operation Atmospheric Pressure | 700 ~ 1060 hPa | 700 ~ 1060 hPa |
| Operation Altitude | Max. 3000 meters | Max. 3000 meters |
| Storage/Transport Temperature | -20 ~ +55°C | -20 ~ +55°C |
| Storage/Transport Humidity | 10 ~ 90% RH (Non-Condensing) | 10 ~ 90% RH (Non-Condensing) |
| Storage/Transport Atmospheric Pressure | 700 ~ 1060 hPa | 700 ~ 1060 hPa |
| Storage/Transport Altitude | (Not specified explicitly for predicate) | Max. 3000 meters |
| Electrical Safety & EMC | Compliance with IEC/ES 60601-1, IEC/EN 60601-1-2 | All test results satisfactory |
The acceptance criteria here are implicitly drawn from the predicate device's characteristics and the relevant performance standards for X-ray detectors. The "reported device performance" are the measurements taken from the CareView 3600RF. The statement "All test results are satisfactory" for electrical safety and EMC indicates compliance with relevant standards as the acceptance criteria.
2. Sample size used for the test set and the data provenance
The document describes non-clinical studies that evaluated the device's technical performance. These studies typically use physical phantoms or test objects rather than patient data. Therefore, the concept of "sample size" in terms of patient images or clinical cases, and "data provenance" (country of origin, retrospective/prospective) as it applies to clinical studies, is not directly applicable here. The "test set" would consist of various physical measurements performed on the detector itself, following standardized protocols (e.g., those for DQE, MTF, NPS).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is based on technical, physical performance characteristics of the X-ray detector (e.g., DQE, MTF), not on diagnostic interpretation of medical images by human experts. The "ground truth" for these technical metrics is established by physical measurement methods and calibrated equipment, compared against defined industry standards.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert disagreement on ground truth needs resolution.
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
There is no indication that an MRMC comparative effectiveness study was performed. This submission is for an X-ray Flat Panel Detector, which is a hardware component for image acquisition, not an AI-driven image analysis or diagnostic assistance software. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no indication of a standalone algorithm performance study. The device is a hardware detector, and the software mentioned (CareRay software, APIs) is for controlling the detector and transferring images, not for independent diagnostic interpretation or AI-driven analysis.
7. The type of ground truth used
For the non-clinical studies mentioned (Detective quantum efficiency (DQE), Modulation transfer function (MTF), Noise power spectrum (NPS), Spatial resolution, etc.), the "ground truth" is based on objective physical measurements and standardized phantom evaluations. These measurements assess the intrinsic performance characteristics of the detector itself, following recognized international and national standards for medical imaging devices.
8. The sample size for the training set
This information is not applicable. The CareView 3600RF is an X-ray Flat Panel Detector, a hardware device. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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.
CareRay Digital Medical Tehnology Co., Ltd. % Leilei Li RA Manager A2-201/B3-501, Biobay, 218 Xinghu Street SuZhou Industrial Park Suzhou, Jiangsu 215123 CHINA
February 19, 2021
Re: K202995
Trade/Device Name: X-ray Flat Panel Detectors/CareView 3600RF Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 15, 2021 Received: January 22, 2021
Dear Leilei 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
{1}------------------------------------------------
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 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K202995
Device Name X-ray Flat Panel Detectors/CareView 3600RF
Indications for Use (Describe)
The CareView 3600RF 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-purposic 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}------------------------------------------------
006_510(k) Summary
{4}------------------------------------------------
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Sep. 28, 2020
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 3600RF |
| 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: | iRay Technology (Shanghai) Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1417V-PSI |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
{5}------------------------------------------------
| Regulatory Class: | Class II |
|---|---|
| Product Code: | MQB |
| FDA 510(k) #: | K161730 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode).
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.
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 3600RF 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.
| Item | Proposed Device:X-ray Flat Panel Detectors | Predicate Device:Wireless Digital Flat PanelDetector | ||
|---|---|---|---|---|
| 510(K) Number | To be assigned | K161730 | ||
| Model | CareView 3600RF | Mars1417V-PSI | ||
| Intended Use | The CareView 3600RF detectoris indicated for digital imagingsolution designed for providinggeneral radiographic diagnosis ofhuman anatomy. It is intended toreplace radiographic film/screensystems in all general-purposediagnostic procedures. Thisproduct is not intended formammography applications. | Mars1417V-PSI Wireless DigitalFlat Panel Detector is indicated fordigital imaging solution designed forproviding general radiographicdiagnosis of human anatomy. It isintended to replace radiographicfilm/screen systems in allgeneral-purpose diagnosticprocedures. This product is notintended for mammography ordental applications. | ||
| ClassificationName | Stationary X-ray system | Stationary X-ray system | ||
| Product Code | MQB | MQB | ||
| Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | ||
| Panel | Radiology | Radiology | ||
| Class | II | II | ||
| X-ray Absorber | GOS Scintillator | GOS Scintillator | ||
| Installation Type | Wired | Wireless, Portable | ||
| ReadoutMechanism | Thin Film Transistor | Thin Film Transistor | ||
| Image Matrix Size | 5632 x 2816 pixels | 2304 x 2800 pixels | ||
| Pixel Pitch | 154μm | 150μm | ||
| Effective ImagingArea | 867.5 mm x 433.1 mm | 355 mm x 434 mm | ||
| Grayscale | 16 bit | 14 bit | ||
| Spatial Resolution | 3.4 lp/mm | 3.4 lp/mm | ||
| MTF | 75%..........(@ 0.5lp/mm)50%..........(@ 1lp/mm) | 0.75..........(@ 0.5lp/mm) | ||
| DQE | (@RQA5, 3.2µGy)28%..........(@ 0.5lp/mm)20%..........(@ 1lp/mm) | (@RQA5, 3.2µGy)0.27..........(@ 0.5lp/mm) | ||
| PowerConsumption | ~50W | Max. 13W | ||
| Communications | Gigabit Ethernet | Wired: Gigabit EthernetWireless: IEEE 802.11a/b/g/n(2.4 GHz/ 5 GHz) | ||
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate | ||
| Cooling | Air cooling | Air cooling | ||
| Dimensions | 916.9mm x 486.4mm x 42.8mm | 384mm x 460mm x 15mm | ||
| Operation | Temperature: +10 ~ +40°CHumidity: 30 ~ 75% RH(Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPaAltitude: Max. 3000 meters | Temperature: +5 ~ +35°CHumidity: 30 ~ 75% RH(Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPaAltitude: Max. 3000 meters | ||
| Storage andtransportation | Temperature: -20 ~ +55°CHumidity: 10 ~ 90% RH(Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPaAltitude: Max. 3000 meters | Temperature: -20 ~ +55°CHumidity: 10 ~ 90% RH(Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPa | ||
| Software | CareRay software provides a setof predefined APIs (ApplicationProgramming Interfaces), anadapter layer between aCareView 3600RF detector andan upstream program on theclient side, commonly known asDROC (Digital RadiographyOperator Console).DROC communicates with theCareRay detectors via APIs. In | iRay DRThe iRay DR used for getting DigitalX-ray radiography images from theflat panel detectors. iRay DR isused to handle the DICOM protocol(DICOM 3.0),iRay DR is responsible for the DRequipment management,acquisition and processingfunctions to provides patient | ||
| general, APIs are provided in theform of DLL (Dynamic-LinkLibraries) files. The upstreamprogram imports these DLL filesand calls relevant APIcommands to manipulate aCareView 3600RFdetector—query status, selectapplication mode, calibratedetector, acquire images, andpreprocess images—withoutcaring about the implementationdetails of the algorithm orworkflow under the hood. | ||||
| Utilized FDAguidancedocuments | 1. Guidance for the Submissionof 510(k)s for Solid StateX-ray Imaging Devices2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)]3. Pediatric Information forX-ray Imaging DevicePremarket Notifications4. Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices5. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices | 1. Guidance for the Submission of510(k)s for Solid State X-rayImaging Devices2. The 510(k) Program: EvaluatingSubstantial Equivalence inPremarket Notifications[510(k)]3. Pediatric Information for X-rayImaging Device PremarketNotifications4. Radio Frequency WirelessTechnology in Medical devices5. Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices6. Content of PremarketSubmissions for Managementof Cybersecurity in MedicalDevices |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
{6}------------------------------------------------
{7}------------------------------------------------
8. System requirements to operate with other radiographic system components
The submitted medical device is the CareView 3600RF digital detector. The other x-ray system components referred below are for information purpose only.
- Recommended Generator Specification:
Energy range: 40~150kVp
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (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
{8}------------------------------------------------
other generators, please contact your distributor or CareRay.
-
- 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 7 or Windows 10 Development environment: MS Visual Studio 2005 3) 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.
- 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 7 or Windows 10 Development environment: MS Visual Studio 2005 3) X-ray exposure mode
CareView 3600RF supported typical sync mode contains external sync 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. -
Nonclinical and clinical considerations A
The non-clinical studies have been performed and the results have shown that the CareView 3600RF X-ray flat panel detectors is substantially equivalent to the predicate device on the market (Mars1417V-PSI Wireless Digital Flat Panel Detector, K161730):
Detective quantum efficiency (DQE). Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag(Erasure thoroughness), Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, & Black level
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 3600RF X-ray flat panel detector is substantially equivalent to predicate device Mars1417V-PSI Wireless
{9}------------------------------------------------
Digital Flat Panel Detector (K161730). Both propose and predicate devices are same in the intended use, the design principle and the applicable standards. Therefore, CareRay Digital Medical Technology Co., Ltd. concludes the CareView 3600RF X-ray flat panel detector is substantially equivalent with the predicate device with regard to safety and effectiveness..
§ 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.