(28 days)
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.
CareView 1500P is a kind of portable wireless 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.
The provided text describes a 510(k) premarket notification for the CareView 1500P X-ray Flat Panel Detectors. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove meeting acceptance criteria in the context of an AI/algorithm-based device.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this document, as it pertains to an X-ray detector itself, not an AI algorithm.
However, I can extract information related to the device's technical specifications and the comparison made for substantial equivalence.
Here's a summary based on the provided text, indicating when information is not applicable (N/A) or not provided (NP):
1. Table of Acceptance Criteria and Reported Device Performance
The document directly compares the proposed device (CareView 1500P) with its predicate device (CareView 1500Cw) to demonstrate substantial equivalence, rather than listing specific "acceptance criteria" in the sense of performance thresholds for an AI/algorithm. The performance specifications are presented as direct comparisons.
| Item | Acceptance Criteria (Predicate: CareView 1500Cw) | Reported Device Performance (Proposed: CareView 1500P) |
|---|---|---|
| X-ray Absorber | Csl Scintillator | Csl Scintillator |
| Installation Type | Wireless, Portable | Wireless, Portable |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 x 2816 pixels | 2304 x 2816 pixels |
| Pixel Pitch | 154μm | 154μm |
| Effective Imaging Area | 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 |
| Rated Power Supply | DC +24 V, Max.1.5 A; Powered by power box or battery pack | DC +24 V, Max. 4 A; Wired Powered by switching power supply, Wireless Powered by battery pack |
| Power Consumption | Max. 36 W | Max. 96 W |
| Communications | Gigabit Ethernet; IEEE 802.11a/b/g/n (2.4 / 5 GHz) | Wired Gigabit Ethernet; Wireless IEEE 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 x 460 mm x 15 mm | 470.4 mm × 510.4 mm × 18.2 mm |
| Operation Temperature | +5 ~ +35°C | +5 ~ +35°C |
| Operation Humidity | 30 ~ 75% (Non-Condensing) | 30 ~ 75% (Non-Condensing) |
| Operation Atmospheric Pressure | 70 ~ 106 kPa | 70 ~ 106 kPa |
| Storage/Transport Temperature | -20 ~ +55°C | -20 ~ +55°C |
| Storage/Transport Humidity | 10 ~ 90% (Non-Condensing) | 10 ~ 90% (Non-Condensing) |
| Storage/Transport Atmospheric Pressure | 70 ~ 106 kPa | 70 ~ 106 kPa |
| MTF (@ 1lp/mm) | ~70% | ~70% |
| MTF (@ 2lp/mm) | ~40% | ~40% |
| MTF (@ 3lp/mm) | ~22% | ~22% |
| DQE (@RQA5, 30µGy, 0lp/mm) | ~65% | ~65% |
| DQE (@RQA5, 30µGy, 3lp/mm) | ~20% | ~20% |
| Dynamic range | ~82 dB | ~80 dB |
| Mechanical Structure | 384mm x 460mm x 15mm; built-in foldable handle; carbon fiber plate front cover; multifunctional I/O port | 470.4mm x 18.2mm; integral handle; protective film on carbon fiber plate front cover; power input port and backup network port |
Study Proving Device Meets Acceptance Criteria:
The document states that Electrical safety and EMC testing according to IEC/ES 60601-1 and IEC/EN 60601-1-2 was performed, and "All test results are satisfactory."
For performance, the document relies on a comparison to the predicate device, CareView 1500Cw (K150929). It argues that the proposed device, CareView 1500P, maintains similar technological characteristics and performance (e.g., MTF, DQE, imaging specifications) to the cleared predicate, and that the differences in mechanical structure and power consumption do not raise new questions of safety and effectiveness.
2. Sample size used for the test set and the data provenance: Not applicable (N/A) – this is a hardware device clearance, not an AI algorithm. No clinical test set data is described in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - no test set involving expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A - no test set 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: N/A - this is a hardware device, not an AI product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A - this is a hardware device, not an AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A - no ground truth in the context of an AI algorithm is mentioned. The ground truth for the device's technical specifications would be engineering measurements and adherence to standards.
8. The sample size for the training set: N/A - no AI training set is described.
9. How the ground truth for the training set was established: N/A - no AI training set is described.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
CareRay Digital Medical System Co., Ltd. % Xu Wei 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: MOB 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.
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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.
Michael D.'Hara
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
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Indications for Use
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) |
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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)]
July01, 2016
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: | 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)]
| Trade Name: | CareView1500P X-ray Flat Panel Detectors |
|---|---|
| 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 |
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| 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:
-
- The dimension of CareView 1500P is 470.4mm x 18.2mm, while the CareView 1500Cw is 384mm× 460mm× 15mm.
-
- The CareView 1500P is design with integral handle, while the CareView 1500Cw is design with built-in foldable handle.
-
- 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.
-
- 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.
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 | K162178 | K150929 |
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| Model | CareView 1500P | 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 |
| InstallationType | Wireless, Portable | Wireless, Portable |
| ReadoutMechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 x 2816 pixels | 2304 x 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 | DC +24 V, Max. 4 A● Wired Powered by the switching powersupply using interface cable● Wireless Powered by the battery pack | DC +24 V, Max.1.5 APowered by the power boxusing interface cablePowered by the battery pack |
| PowerConsumption | Max. 96 W | Max. 36 W |
| Communications | ● Wired Gigabit Ethernet● Wireless IEEE 802.11a/b/g/n (2.4 / 5 GHz) | 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 | 470.4 mm × 510.4 mm × 18.2 mm | 384 mm x 460 mm x 15 mm |
| Operation | Temperature: +5 ~ +35°CHumidity: 30 ~ 75%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPa | Temperature: +5 ~ +35°CHumidity: 30 ~ 75%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max.3000 meters |
| Storage andtransportation | Temperature: -20 ~ +55°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPa | Temperature: -20 ~ +55°CHumidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max.3000 meters |
| Intended Use | The CareView 1500P is indicatedfor digital imaging solutiondesigned for providing generalradiographic diagnosis of humananatomy. It is intended to replaceradiographicfilm/screen systems in | The CareView1500Cw isindicated for digital imagingsolution designed for providinggeneral radiographic diagnosis ofhuman anatomy. It is intended toreplace radiographic film/screen |
| 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 | |
| MTF | ~70%..........(@ 1lp/mm) | ~70%..........(@ 1lp/mm) |
| ~40%..........(@ 2lp/mm) | ~40%..........(@ 2lp/mm) | |
| ~22%..........(@ 3lp/mm) | ~22%..........(@ 3lp/mm) | |
| DQE | (@RQA5, 30µGy) | (@RQA5, 30µGy) |
| ~65%..........(@ 0lp/mm) | ~65%..........(@ 0lp/mm) | |
| ~20%..........(@ 3lp/mm) | ~20%..........(@ 3lp/mm) | |
| Dynamic range | ~80 dB | ~82 dB |
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8. System requirements to operate with other radiographic system components
-
- 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
thespecifications described above. If you have questions regarding the compatibility issue for othergenerators, please contact your distributor or CareRay.
-
- ApplicationProgram Interface (API) for system integration manufacturer
Peripheral hardware: CareView detector connected via wired communication.
- ApplicationProgram Interface (API) for system integration manufacturer
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
-
- 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.
- X-ray exposure mode
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
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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. -
A 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.
- A 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
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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).
§ 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.