(25 days)
The CareView 1800Cwe/ CareView 1500Cwe 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.
The CareView 1800Cwe/ CareView 1500Cwe detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm×356mm. The detector communicates with wireless and an optional wired communication feature (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 1800Cwe/ CareView 1500Cwe is unchanged from the predicate. And the API for the digital detector CareView 1800Cwe/ CareView 1500Cwe is the same as that for the predicate device. Besides, there are only minor differences between the firmware for the CareView 1800Cwe/ CareView 1500Cwe and predicate device except to support battery supply and wireless communication.
Generally, CareView 1800Cwe is the same as the cleared product, CareView 1800Le except the wireless function. And CareView 1500Cwe is the same as the cleared product, CareView 1800Le except the wireless function and dimension.
The provided text is a 510(k) summary for an X-ray Flat Panel Detector (CareView 1800Cwe / CareView 1500Cwe). It describes the device and its intended use, and argues for substantial equivalence to a predicate device (CareView 1800Le).
However, the document does not contain specific acceptance criteria or a detailed study of the device's clinical performance against such criteria for AI/algorithm performance. It primarily focuses on demonstrating substantial equivalence to a predicate device regarding safety and effectiveness from a regulatory perspective.
The document discusses "technological characteristics" which include physical specifications, image quality metrics (MTF, DQE, spatial resolution), and operational parameters. These are compared between the proposed device and the predicate device. For example:
- Spatial Resolution: Both proposed and predicate devices measure 3.57 line pair/mm.
- MTF: For 1lp/mm, the proposed device has "~63%" while the predicate device has "≥63%". Similar values are given for 2lp/mm and 3lp/mm.
- DQE: For 0lp/mm, the proposed device has "~62%" while the predicate device has "≥62%". Similar values are given for 1lp/mm and 3lp/mm.
These are technical specifications and performance indicators for the hardware component (the X-ray flat panel detector itself) and are used to show that the new device performs comparably to the predicate device.
The document does not describe a study involving human readers, AI assistance, or an algorithm-only standalone performance evaluation for diagnostic accuracy. It is not a clinical study on diagnostic performance with AI. The context is regulatory clearance for an X-ray detector, which is a hardware component for imaging, not an AI-powered diagnostic tool.
Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, experts, adjudication, MRMC studies, standalone algorithm performance, and ground truth for AI models cannot be extracted from this document, as it is not relevant to the content provided.
The document explicitly states: "The software that supports the functions of the digital detector CareView 1800Cwe/ CareView 1500Cwe is unchanged from the predicate. And the API for the digital detector CareView 1800Cwe/ CareView 1500Cwe is the same as that for the predicate device. Besides, there are only minor differences between the firmware for the CareView 1800Cwe/ CareView 1500Cwe and predicate device except to support battery supply and wireless communication." This indicates that the core image processing algorithm, if any, is largely the same as the predicate device.
To answer your prompt based only on the provided text:
Acceptance Criteria and Device Performance Study for CareRay Digital Medical Technology Co., Ltd. X-ray Flat Panel Detectors (CareView 1800Cwe / CareView 1500Cwe)
The provided document describes the substantial equivalence determination for an X-ray Flat Panel Detector, a hardware component for medical imaging. It does not detail specific acceptance criteria or a dedicated study for Artificial Intelligence (AI) or software-based diagnostic performance. The performance metrics discussed relate to the physical characteristics and image quality of the X-ray detector hardware.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in the context of a clinical performance study with AI. Instead, it presents technological characteristics of the proposed device (CareView 1800Cwe / CareView 1500Cwe) and compares them to a predicate device (CareView 1800Le) to demonstrate substantial equivalence. The "performance" here refers to physical and imaging specifications of the detector.
| Item | Proposed Device (CareView 1800Cwe / CareView 1500Cwe) | Predicate Device (CareView 1800Le) |
|---|---|---|
| Image Matrix Size | 3072 x 3072 pixels (1800Cwe) / 3072 x 2560 pixels (1500Cwe) | 3072 x 3072 pixels |
| Pixel Pitch | 140µm | 140µm |
| Effective Imaging Area | 430 mm x 430 mm (1800Cwe) / 430 mm x 356 mm (1500Cwe) | 430 mm x 430 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | 3.57 line pair/mm | 3.57 line pair/mm |
| MTF (@ 1lp/mm) | ~63% (@ RQA5, 27µGy) | ≥63% (@ RQA5, 30μGy) |
| MTF (@ 2lp/mm) | ~35% (@ RQA5, 27µGy) | ≥35% (@ RQA5, 30μGy) |
| MTF (@ 3lp/mm) | ~17% (@ RQA5, 27µGy) | ≥17% (@ RQA5, 30μGy) |
| DQE (@ 0lp/mm) | ~62% (@ RQA5, 27µGy) | ≥62% (@ RQA5, 30μGy) |
| DQE (@ 1lp/mm) | ~45% (@ RQA5, 27µGy) | ≥45% (@ RQA5, 30μGy) |
| DQE (@ 3lp/mm) | ~17% (@ RQA5, 27µGy) | ≥17% (@ RQA5, 30μGy) |
The document states, "The difference of wireless function and dimension don't affect the technological parameters and clinical images." This implies that the performance metrics of the proposed device are considered equivalent to or meeting the predicate device's performance, which serves as the "acceptance" standard for these technical parameters.
2. Sample size used for the test set and the data provenance
The document discusses "Nonclinical and clinical considerations" stating that "The proposed device (CareView 1800Cwe/ CareView 1500Cwe) and predicate device (CareView 1800Le) share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc." It concludes that the differences "don't affect the technological parameters and clinical images."
This implies that the "test set" for assessing substantial equivalence primarily involved technical evaluation and comparison to the predicate device's established performance, rather than a separate clinical dataset for diagnostic accuracy evaluation with a new algorithm. No specific sample size for a clinical image test set or data provenance (country, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical study requiring expert-established ground truth for diagnostic accuracy. The evaluation is focused on the hardware's technical specifications.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication is described.
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
Not applicable. This document does not describe any MRMC study or AI assistance. The device is an X-ray flat panel detector, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The document focuses on the X-ray detector hardware. It states the software and API are "unchanged from the predicate" and firmware has "minor differences" to support wireless communication and battery supply. There is no mention of a standalone algorithm for diagnostic interpretation.
7. The type of ground truth used
Not applicable. The evaluation is based on technical specifications and established performance of the predicate device, not on diagnostic ground truth (e.g., pathology, outcomes data).
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML algorithm that required a training set. The device is an X-ray detector.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI/ML algorithm that required a training set with established ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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 Technology Co., Ltd. % Leilei Li RA Manager, Regulation Department A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park, SuZhou, Jiangsu 215123 CHINA
August 7, 2020
Re: K201932
Trade/Device Name: X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: July 1, 2020 Received: July 13, 2020
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
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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
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510(k) number: K201932
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)]
July 01, 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 1800Cwe/ CareView 1500Cwe |
| 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 1800Le |
| 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) #: | K193173 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The CareView 1800Cwe/ CareView 1500Cwe detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm×356mm. The detector communicates with wireless and an optional wired communication feature (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 1800Cwe/ CareView 1500Cwe is unchanged from the predicate. And the API for the digital detector CareView 1800Cwe/ CareView 1500Cwe is the same as that for the predicate device. Besides, there are only minor differences between the firmware for the CareView 1800Cwe/ CareView 1500Cwe and predicate device except to support battery supply and wireless communication.
Generally, CareView 1800Cwe is the same as the cleared product, CareView 1800Le except the wireless function. And CareView 1500Cwe is the same as the cleared product, CareView 1800Le except the wireless function and dimension.
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 1800Cwe/ CareView 1500Cwe 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 PanelDetectors | |
|---|---|---|---|
| 510(K) Number | K201932 | K193173 | |
| Model | CareView 1800Cwe | CareView 1500Cwe | CareView 1800Le |
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| Classification 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 | |
| Installation Type | Wireless, Cassette | Wired, Cassette | |
| ReadoutMechanism | Thin Film Transistor | Thin Film Transistor | |
| Image Matrix Size | 3072 x 3072 pixels | 3072 x 2560 pixels | 3072 x 3072 pixels |
| Pixel Pitch | 140µm | 140µm | |
| Effective ImagingArea | 430 mm x 430 mm | 430 mm x 356 mm | 430 mm x 430 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale | |
| Spatial Resolution | 3.57 line pair/mm | 3.57 line pair/mm | |
| ~63%.........(@ 1lp/mm) | ≥63%.........(@ 1lp/mm) | ||
| MTF | ~35%.........(@ 2lp/mm) | ≥35%.........(@ 2lp/mm) | |
| ~17%.........(@ 3lp/mm) | ≥17%.........(@ 3lp/mm) | ||
| (@RQA5, 27µGy) | (@RQA5, 30μGy) | ||
| DQE | ~62%.........(@ 0lp/mm)~45%.........(@ 1lp/mm) | ≥62%.........(@ 0lp/mm)≥45%.........(@ 1lp/mm) | |
| ~17%.........(@ 3lp/mm) | ≥17%.........(@ 3lp/mm) | ||
| RatedPowerSupply | DC +24 V, Max.2 A | DC +24 V, Max.1.5 A | DC +24 V, Max.1 A |
| ●Wireless | • Powered by the battery | ● Poweredbythe | |
| ●Wired | • Powered by the power box using interfacecable | powerboxusinginterface cable | |
| Wirelesscommunications | IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | / | |
| Network interface | Gigabit Ethernet | Gigabit Ethernet | |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate | |
| Cooling | Air cooling | Air cooling | |
| Dimensions | 460 mm x 460 mm x15 mm | 460 mm x 384 x 15mm | 460 mm x 460 mm x 15mm |
| Temperature: +5 ~+35°C | |||
| Operation | Temperature: +5 ~ +35°C | Humidity: 30 ~ 75%(Non-Condensing) | |
| Humidity: 30 ~ 75% (Non-Condensing) | |||
| Atmospheric pressure: 700 ~ 1060 hPa | Atmospheric pressure:700 ~ 1060 hPa | ||
| Temperature: -20 ~+55°C | |||
| Temperature: -20 ~ +55 ℃ | Humidity: 10 ~ 90%(Non-Condensing) | ||
| Storage andtransportation | Humidity: 10 ~ 90% (Non-Condensing) | ||
| Atmospheric pressure: 700 ~ 1060 hPa | Atmospheric pressure:700 ~ 1060 hPa | ||
| API | V4.8.0 | V4.8.0 | |
| Firmware | V0.96e | V0.96j | |
| UtilizedFDA | 1. | Guidance for the Submission of 510(k)s for | Guidance for the1. |
| guidance documents | |||
| Solid State X-ray Imaging Devices2. The 510(k) Program: Evaluating SubstantialEquivalence in PremarketNotifications[510(k)]3. Pediatric Information for X-ray ImagingDevice Premarket Notifications4. Radio Frequency Wireless Technology inMedical devices5. Guidance for the Content of PremarketSubmissions for Software Contained inMedical Devices6. Content of Premarket Submissions forManagement of Cybersecurity in MedicalDevices | Submission of510(k)s for SolidState X-ray ImagingDevices2. The 510(k) Program:EvaluatingSubstantialEquivalence inPremarketNotifications[510(k)]3. Pediatric Informationfor X-ray ImagingDevice PremarketNotifications4. Guidance for theContent ofPremarketSubmissions forSoftware Containedin Medical Devices5. Content ofPremarketSubmissions forManagement ofCybersecurity inMedical Devices |
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8. System requirements to operate with other radiographic system components
The submitted medical device is the CareView 1800Cwe/ CareView 1500Cwe digital detector. The other x-ray system components referred below are for information purpose only.
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- Recommended Generator Specification:
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 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
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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
-
- 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.
- X-ray exposure mode
CareView 1800Cwe/ CareView 1500Cwe supported typical sync mode contains soft sync, manual sync and F²AED modes.
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
The proposed device (CareView 1800Cwe/ CareView 1500Cwe) and predicate device (CareView 1800Le) share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc. The only difference is the wireless function and dimension.
The difference of wireless function and dimension 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 1800Cwe/ CareView 1500Cwe X-ray flat panel detector is substantially equivalent to predicate device CareView 1800Le(K193173). Both propose and predicate devices are same in the intended use, the design principle, the applicable standards and specification. Some characteristics, for example, wireless function and dimension are 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.,
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Ltd. concludes the CareView 1800Cwe/ CareView 1500Cwe X-ray flat panel detector is substantially equivalent with the predicate device CareView 1800Le(K193173).
§ 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.