(25 days)
Not Found
No
The summary describes a digital X-ray detector that converts X-ray photons into electrical signals to create an image. There is no mention of AI or ML in the intended use, device description, or performance studies. The changes from the predicate device are limited to pixel size.
No.
The device is indicated for digital imaging and diagnosis, which means it aids in identifying medical conditions rather than treating them.
Yes
The "Intended Use / Indications for Use" section states that the detector is "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This explicitly indicates its use for diagnosis.
No
The device description explicitly details a physical flat panel detector that intercepts X-ray photons and converts them into electrical signals, which are then digitized and displayed. This involves significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This describes a device used for in vivo imaging (imaging within the living body), not in vitro testing (testing of samples outside the body).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images of the human anatomy. This process is consistent with medical imaging, not laboratory diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Care View 1800Le detector is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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) K193173
Device Name
X-ray Flat Panel Detectors (CareView 1800Le)
Indications for Use (Describe)
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.
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
Page 1 of 6
4
510(k) Summary
[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, Suzhou |
| Industrial 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 |
5
| Regulatory Class: | Class II |
|---|---|
| Product Code: | MQB |
| FDA 510(k) #: | K153492 |
5. Description of the Device [21 CFR 807.92(a)(4)]
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.
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 |
| 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 | CsI Scintillator | CsI Scintillator |
| Installation Type | Wired, Cassette | Wired, Cassette |
6
| Readout
| Mechanism | Thin Film Transistor | Thin Film Transistor |
|---|---|---|
| Image Matrix Size | 3072 × 3072 pixels | 2816 × 2816 pixels |
| Pixel Pitch | 140μm | 154μm |
| Effective Imaging | ||
| Area | 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) | ||
| Rated | ||
| Power | ||
| Supply | DC +24 V, Max.1 A | |
| Powered by the power box using | ||
| interface cable | DC +24 V, Max.1 A | |
| Powered by the power box | ||
| using 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 and | ||
| transportation | 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.
-
- 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)
7
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.
- Application Program Interface (API) for system integration manufacturer
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
-
- 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).
8
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).