Predicate Devices

Reference Devices

Mars1417V-TSI, K201004

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components and basic image processing for converting X-ray to a digital image, with no mention of AI or ML algorithms for image analysis or interpretation.

Therapeutic

No
The device is described as a component of a digital radiography (DR) system for diagnostic imaging, which is used to obtain information about human anatomy, not to treat or alleviate a medical condition.

Diagnostic

Yes
The intended use explicitly states "general radiographic diagnosis for human anatomy," indicating it is used for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "wireless digital flat panel detector" with a physical image sensor (TFT/PD) and associated electronics, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This describes a device used for in vivo imaging (imaging within the living body), not in vitro testing (testing outside the body, typically on biological samples).
Device Description: The description details how the device converts X-rays into digital images for medical X-ray imaging. This is consistent with an in vivo imaging device.
Input Imaging Modality: The input modality is X-ray, which is used for imaging the internal structures of the body.
Anatomical Site: The anatomical site is "human anatomy", further indicating in vivo use.

IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This device's function is to capture images of the body itself using X-rays.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Mars 1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

Product codes

MQB

Device Description

Mars1417X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1417X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm.

The sensor plate of Mars1417X is 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 Mars1417X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.

iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

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

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)

Non-clinical studies were performed, and the results showed that the sections of 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 (Mars1417V-TSI, K201004).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201004

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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March 3, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

iRay Technology Taicang Ltd. % Meng Li Registration & Regulation Affairs Engineer No.33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K210316

Trade/Device Name: Mars 1417X Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 13, 2021 Received: February 3, 2021

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210316

Device Name Mars1417X Wireless Digital Flat Panel Detector

Indications for Use (Describe)

Mars 1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental 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)
------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

K210316

1. Date Prepared [21 CFR 807.92(a)(1)]
  January 13, 2021

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:	Junjie.Qian
Phone:	0512-53690872
Fax:	0512-53690872
Email:	junjie.qian@iraygroup.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	Wireless Digital Flat Panel Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Mars1417X
Classification Name:	Stationary X-Ray System
Product Code:	MQB
Regulation Number:	21 CFR 892.1680
Device Class:	Class II

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4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification predicates within this submission are as follows:

Manufacturer:	iRay Technology Taicang Ltd.
Trade Name:	Wireless Digital Flat Panel Detector
Model Name:	Mars1417V-TSI
Product Code:	MQB
Classification Name:	Stationary X-Ray System
Regulation Number:	21 CFR 892.1680
Device Class:	Class II
FDA 510 (k) #:	K201004

5. Description of the Device [21 CFR 807.92(a)(4)]

Mars1417X Wireless Digital Flat Panel Detector (Hereinafter referred to as Mars1417X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm.

The sensor plate of Mars1417X is 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 Mars1417X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.

iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

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5

6. Intended Use [21 CFR 807.92(a)(5)]

6.1. Indications for use

Mars1417X wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

6.2. Suitable patient

It is 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.

	Predicate Device:	Proposed Device:
Item	Mars1417V-TSI Wireless
Digital Flat Panel Detector
Mano4336W Wireless Digital
Flat Panel Detector	Mars1417X Wireless Digital
Flat Panel Detector
510(K) Number	K201004	K210316
Intended Use	Mars1417V-TSI Wireless
Digital Flat Panel Detector and
Mano4336W Wireless Digital
Flat Panel Detector are
indicated for digital imaging	same
Item	Predicate Device:	Proposed Device:
	Mars1417V-TSI Wireless
Digital Flat Panel Detector
Mano4336W Wireless Digital
Flat Panel Detector
solution designed for providing
general radiographic system in
all general-purpose diagnostic
procedures.	Mars1417X Wireless Digital
Flat Panel Detector
Indications for Use	Mars1417V-TSI wireless
digital flat panel detector and
Mano4336W wireless digital
flat panel detector 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. These two devices
are not intended for
mammography, dental
applications.	Mars1417X wireless digital
flat panel detector is indicated
for digital imaging solutions
designed to provide general
radiographic diagnosis for
human anatomy including both
adult and pediatric patients. It
is intended to replace
film/screen systems in all
general-purpose diagnostic
procedures. The device is not
intended for mammography or
dental applications.
Classification
Name	Stationary X-ray system	Same
Product Code	MQB	Same
Regulation Number	21 CFR 892.1680	Same
Item	Predicate Device:
Mars1417V-TSI Wireless
Digital Flat Panel Detector
Mano4336W Wireless Digital
Flat Panel Detector	Proposed Device:
Mars1417X Wireless Digital
Flat Panel Detector
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:	$2304 \times 2800$ pixels	$3500 \times 4300$ pixels
Pixel Size:	150μm	100μm
ADC Digitization	16 bit	Same
Effective Imaging
Area:	$345.6$ mm $\times 420.0$ mm	$350.0$ mm $\times 430.0$ mm
Spatial Resolution:	Min. 3.3lp/mm	Min. 4.3lp/mm
Modulation Transfer
Function (MTF)	0.68 at 1 lp/mm	0.65 at 1 lp/mm
Detective Quantum
Efficiency (DQE)	0.36 at 1 lp/mm (RQA5,
2.5μGy)	0.54 at 1 lp/mm (RQA5,
2.5μGy)
Power
Consumption:	Max. 19W	Same
Item	Predicate Device:	Proposed Device:
	Mars1417V-TSI Wireless
Digital Flat Panel Detector
Mano4336W Wireless Digital
Flat Panel Detector	Mars1417X Wireless Digital
Flat Panel Detector
Communications:
(Wireless
functionality)	a) Wired (only for
service) : Gigabit
Ethernet (1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac (2.4 GHz
/ 5 GHz)	Same
Imaging protect
Plate:	Carbon Fiber Plate	Same
Cooling:	Air cooling	Same
Dimensions:	$384 mm \times 460 mm \times 15 mm$	Same
Detector IP grade	IPX1	IP56
Surface pressure	Uniform load: 150 kg over the
whole area of the surface;
Local load: 100 kg on an area
4 cm diameter of center	Uniform load: 300 kg over
the whole area of the surface;
Local load: 150 kg on an area
4 cm diameter of center
	Operation:	Temperature: +5 ~ +35°C
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters	Temperature: +10 ~ +35 °C
Humidity: 5 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters
Storage and
Transportation:		Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%	Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%
Item		Predicate Device:	Proposed Device:
( detector )		Mars1417V-TSI Wireless
Digital Flat Panel Detector
Mano4336W Wireless Digital
Flat Panel Detector	Mars1417X Wireless Digital
Flat Panel Detector
		(Non-Condensing)
Atmospheric pressure: 70 ~
106 kPa
Altitude: Max. 3000 meters	(Non-Condensing)
Atmospheric pressure: 60 ~
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 | Additionally:
The Special 510(k)
Program;
Design Control Guidance
For Medical Device
Manufacturers;
Appropriate Use of
Voluntary Consensus
Standards in Premarket
Submissions for Medical
Devices. | |
| Item | Predicate Device: | Proposed Device: | |
| | Mars1417V-TSI Wireless
Digital Flat Panel Detector
Mano4336W Wireless Digital
Flat Panel Detector | Mars1417X Wireless Digital
Flat Panel Detector | |
| | Cybersecurity in Medical
Devices;
Radio Frequency Wireless
Technology in Medical
Devices;
Guidance for “Premarket
Assessment of Pediatric
Medical Devices”;
Guidance for “Pediatric
Information for X-ray
Imaging Device Premarket
Notifications”. | | |

7. Technological Characteristic [21 CFR 807.92(a)(6)]

6

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9

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8. System requirements to operate with other radiographic system components

1. Recommended Generator Specification:
  Energy range: 40~150kVp

mA range: 10~1000mA (depending on the generator power)

ms range: 10~~6300ms to produce 0.1~~1000mAs (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 the distributor or iRay's service office.

1. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417X connected via wireless communication.

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Operating System:	Windows XP/7/8/10, 32/64bit
CPU:	Intel Core i7 3.6G
Memory:	4G DDR3
Hard Disk:	640 G
LAN Card:	Intel Pro EXP9301CT PRO
	Gigabit Network Adapter with PCIe interface

3) X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Mars1417X. Once there is X-ray generator exposure exist, the AED trigger 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)]

1. Electrical Safety and EMC testing:
  Electrical, mechanical, environmental safety 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.
1. 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.
1. Non-clinical Considerations:
  One main modification from the predicate device is Amorphous Silicon (a-Si) panel size design, related to Amorphous Silicon (A-Si) panel size. Another modification is structure design with higher IP grade and surface pressure performance. 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

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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 (Mars1417V-TSI, K201004).

1. 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.

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 Mars1417X is substantially equivalent to predicate device with regards to safety and effectiveness.