(34 days)
Not Found
No
The description focuses on the hardware components and basic image processing (conversion of X-ray to digital image) without mentioning any AI/ML algorithms for image analysis, interpretation, or enhancement. The performance studies are related to safety, EMC, and substantial equivalence based on non-clinical and clinical considerations, not AI/ML performance metrics.
No
Explanation: The device is described as a digital imaging solution for general radiographic diagnosis, converting X-rays to digital images for diagnostic purposes. It is not intended for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to provide general radiographic diagnosis for human anatomy."
No
The device description explicitly states that the device is a "wireless digital flat panel detector" and describes its hardware components (TFT/PD image sensor, CsI scintillator, diode capacitor array, scanning and readout electronics). It converts X-ray to digital images, which is a hardware function. While it uses software (iRay SDK) to interface with DR systems, the core device is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This describes an in-vivo imaging device, not a device used to examine specimens from the human body outside of the body (in vitro).
- Device Description: The description details how the device converts X-rays to digital images of the human anatomy. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
The device is a digital X-ray detector used for medical imaging of the human body.
N/A
Intended Use / Indications for Use
Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.
Product codes (comma separated list FDA assigned to the subject device)
MOB, MQB
Device Description
Focus 35C Detector and TRIMAX 35C Detector (Hereinafter referred to as Focus 35C and TRIMAX 35C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Two models TRIMAX 35C and Focus 35C are totally same except for label and trademark.
The sensor plate of Focus 35C and TRIMAX 35C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics. consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 35C and TRIMAX 35C detectors are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Adult and pediatric patients
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)
Electrical Safety and EMC testing: 1) 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 60601-1-2. All test results are meet the standard requirements.
Biological Evaluation: The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
Non-clinical Considerations: One modification from the predicate device to Focus 35C and TRIMAX 35C is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, predicate device has higher wireless transmission speed.
The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551).
Clinical Consideration: Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in · Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence. There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device.
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
iRay Technology Taicang Ltd. Meng Li Registration & Regulatory Affairs Engineer No.33 Xinggang Rd., Taicang Port Economic & Technological Development Zone TAICANG, Jiangsu 215434 CHINA
Re: K192512
Trade/Device Name: Focus 35C Detector, Trimax 35C Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: September 1, 2019 Received: September 12, 2019
Dear Meng 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.
October 16, 2019
1
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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192512
Device Name Focus 35C Detector TRIMAX 35C Detector
Indications for Use (Describe)
Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.
| 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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3
SECTION 6
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
4
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS K192512
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
October 10th, 2019
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic and |
| Technological Development Zone, Jiangsu, China 215434 | |
| Contact Person: | Meng Li |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | meng.li@iraychina.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Focus 35C Detector |
|---|---|
| TRIMAX 35C Detector | |
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Focus 35C |
| TRIMAX 35C | |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
-
- Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]
2 of 11
5
| Manufacturer: | iRay Technology Taicang Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1417XF-CSI |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| FDA 510 (k) #: | K182551 |
The identification predicates within this submission are as follows:
5. Description of the Device [21 CFR 807.92(a)(4)]
Focus 35C Detector and TRIMAX 35C Detector (Hereinafter referred to as Focus 35C and TRIMAX 35C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Two models TRIMAX 35C and Focus 35C are totally same except for label and trademark.
The sensor plate of Focus 35C and TRIMAX 35C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics. consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 35C and TRIMAX 35C detectors are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
6
Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.
6.2. Suitable patient
They are suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system.
6.3. Processing of input and output
When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | K182551 | To be assigned |
| Intended Use | The Mars1417XF-CSI Wireless
Digital Flat Panel Detector is
indicated for digital imaging
solution designed for providing
general radiographic system in
all general purpose diagnostic
procedures. | Same with Mars1417XF-CSI,
additionally, in the consideration
of patient size (i.e., height,
weight, body part thickness) and
usable dose range, the detector
could be used for general X ray
diagnosis of usual body part for |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| | We understand the Agency has
become aware of situations
where solid state detectors
inserted into radiographic
systems adversely impacted
device performance due to
improper integration
(reference:http://www.fda.gov/d
ownloads/MedicalDevices/Reso
urcesforYou/Industry/UCM3851
49.pdf ).
Below is a summary of the
information from the
Mars1417XF-CSI user manuals
covering key electromechanical
and computer requirements
needed for X-ray system
interface and integration.
- Mechanical interface
requirements. - Computer requirements
- Data communication interface
requirements - Electrical power requirements
- X-ray trigger interface
requirements | both adults and pediatric
patients. |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| | Neither the Mars1417XF-CSI
detector nor its software act as
an X-ray generator controller,
and therefore, the device is not
subject to Electronic Product
Radiation Control (EPRC)
performance standards and
reporting requirements. | |
| Classification
Name | Stationary X-ray system | Same |
| Product Code | MQB | Same |
| Regulation
Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | CsI | Same |
| Installation
Type: | Wireless, Portable | Same |
| Readout
Mechanism: | Thin Film Transistor | Same |
| Image Matrix
Size: | 2336× 2836 pixels | 2304 × 2800 pixels |
| Pixel Pitch: | $150\mu m$ | Same |
| ADC
Digitization | 16 bit | Same |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| Effective
Imaging Area: | $350.4 mm \times 425.4 mm$ | $345.6 mm \times 420.0 mm$ |
| Spatial
Resolution: | Min. 3.3lp/mm | Same |
| Modulation
Transfer
Function
(MTF) | 0.5 at 1 lp/mm | 0.61 at 1 lp/mm |
| Detective
Quantum
Efficiency
(DQE) | 0.37 at 1 lp/mm (RQA5,
2.5μGy) | 0.42 at 1 lp/mm (RQA5,
2.5μGy) |
| Power
Consumption: | Max. 19W | Max. 18W |
| Communication
s:
(Wireless
functionality) | Wireless: IEEE 802.11a/b/g/n
(2.4 GHz / 5 GHz) | a) Wired (only for service) :
Gigabit Ethernet
(1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac (2.4 GHz /
5 GHz) |
| Imaging protect
Plate: | Carbon Fiber Plate | Same |
| Cooling: | Air cooling | Same |
| Dimensions: | $384 mm \times 460 mm \times 15 mm$ | Same |
| Operation: | Temperature: +5 ~ +30 °C
Humidity: 10 ~ 80%
(Non-Condensing) | Temperature: +5 ~ +35 °C
Humidity: 10 ~ 90%
(Non-Condensing) |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| | Temperature: -20 ~ +50°C | Temperature: -20 ~ +55°C |
| Storage and
Transportation:
( detector ) | Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters |
| Software | iRay SDK(include iDetector) is
intend to supply API interface
for DR system manufacturers.
DR system manufacturer control
the detector by SDK interface.
SDK is not intend to use directly
by other users beside DR system
manufacturers. | Same |
| Utilized FDA
guidance
documents | 1. Guidance for the Submission
of 510(k)'s for Solid State
X-ray Imaging Devices; - The 510(k) Program:
Evaluating Substantial
Equivalence in Premarket
Notifications[510(k)]; - Content of Premarket
Submissions for
Management of | Same with Mars1417XF,
additionally: - Guidance for “Premarket
Assessment of Pediatric
Medical Devices”; - Guidance for “Pediatric
Information for X-ray
Imaging Device Premarket
Notifications”. |
| Item | Predicate Device: | Proposed Device: |
| | Wireless Digital Flat Panel | Wireless Digital Flat Panel |
| | Detector | Detector |
| | Cybersecurity in Medical
Devices; | |
| | 4. Radio Frequency Wireless
Technology in Medical
Devices. | |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
7
8
9
10
11
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 the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact your distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Focus 35C and TRIMAX 35C detectors connected via wireless communication.
| Operating System: | Windows XP/7 32/64bit |
|---|---|
| CPU: | Intel Core i5 3.6G |
| Memory: | 8G DDR3 |
| Hard Disk: | 640 G |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
-
- X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Focus 35C and TRIMAX 35C. Once there is X-ray generator exposure exist, the inner trigger
- X-ray exposure mode
9 of 11
12
module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
-
Electrical Safety and EMC testing: 1)
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 60601-1-2. All test results are meet the standard requirements. -
- Biological Evaluation:
The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
-
- Non-clinical Considerations:
One modification from the predicate device to Focus 35C and TRIMAX 35C is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, predicate device has higher wireless transmission speed.
- Non-clinical Considerations:
The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551).
-
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in · Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the dimensions of the image
- Clinical Consideration:
10 of 11
13
receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.
There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device.
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, iRay Technology Taicang Ltd. Concludes that Focus 35C and TRIMAX 35C are substantially equivalent to predicate device with regards to safety and effectiveness.