The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This devices are intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This devices are not intended for mammography applications.

Device Description

The EXPD 4343D, EXPD 3643D are flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 4343D, EXPD 3643D differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.

The EXPD 4343D, EXPD 3643D Detector are indirect conversion devices in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the incoming X-ray quanta.

The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

AI/ML Overview

The provided FDA 510(k) summary for the DRTECH EXPD 4343D and EXPD 3643D digital X-ray detectors focuses on demonstrating substantial equivalence to a predicate device (K192400), rather than a clinical study establishing new acceptance criteria for diagnostic performance.

Therefore, many of the requested items related to clinical studies, expert-established ground truth, and human reader performance are not applicable in this context.

Here's the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on equivalence to the predicate device's measured physical performance parameters (DQE and MTF) and compliance with recognized standards. The "study" proving this is a bench test report.

Parameter	Acceptance Criteria (Predicate Device Performance)	Reported Subject Device Performance
DQE at 1.0 lp/mm	EVS 4343A: 52.9%EVS 3643A: 50.5%	Typ. 55.0%
MTF at 2.0 lp/mm	EVS 4343A: 44.1%EVS 3643A: 44.5%	Typ. 40.0%
Resolution	3.5 lp/mm	3.5 lp/mm
Compliance with various standards (e.g., ISO 14971, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, NEMA PS 3.1 - 3.20, IEC 62220-1-1)	Met (implicitly by submission)	Met (implicitly by submission)

The document states: "According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device."
This indicates that the acceptance criteria for DQE was for the subject device to be at least equal to or better than the predicate, and for MTF, it was to be at least equal to or better than the predicate.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This was a bench test on the physical performance of the X-ray detectors, not a study involving patient data or a test set of images.
Data Provenance: Not applicable, as it's a bench test. The manufacturer (DRTECH Corporation) is located in South Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" here is objective physical measurements (DQE, MTF, Resolution) taken from the devices themselves, not expert interpretation of diagnostic images.

4. Adjudication method for the test set

Not applicable. No diagnostic images or expert reviews were involved in establishing the performance parameters for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission does not describe a comparative effectiveness study involving human readers or AI. It's for a digital X-ray detector (hardware).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device (digital X-ray detector), not an algorithm or AI software for image analysis.

7. The type of ground truth used

Physical measurements/Instrumental data: DQE, MTF, and Resolution measurements are determined through standardized test procedures defined by documents like IEC 62220-1-1.

8. The sample size for the training set

Not applicable. This submission does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This submission does not involve a training set.

Summary

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November 16, 2023

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DRTECH Corporation % Kim Minjeong Manager Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero 541 Beon-Gil Jungwon-Gu Seongnam-Si, Gyeonggi-Do 13216 SOUTH KOREA

Re: K232753

Trade/Device Name: EXPD 4343D, EXPD 3643D Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 8, 2023 Received: October 23, 2023

Dear Kim Minjeong:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232753

Device Name EXPD 4343D, EXPD 3643D

Indications for Use (Describe)

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 - K232753

[As required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

09/08/2023

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor: DRTECH Corporation Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, ●
Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
Contact Name: Minjeong Kim
- 82-31-779-7783 Telephone No.: ●
Fax No.: + 82-31-779-7790
Email Address : drtechra@drtech.com ●
Registration Number: 3005172103 .
Name of Manufacturer: Same as Sponsor ●

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

• Trade Name:	EXPD 4343D, EXPD 3643D
---------------	------------------------

Common Name: Digital Flat Panel X-ray Detector
Classification Name: Stationary X-ray System
Classification Panel: Radiology ●
Classification Regulation: 21 CFR 892.1680
Product Code: ● MOB
Device Class: II

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

510(k) Number:	K192400
- - - - - - - - - - - - - - - - - - - - - - - -	ADTECH C - -------------------------------------------------------------------------------------------------------------------------------------------------------------------

DRTECH Corporation ● Applicant: Trade Name:
EVS 4343A, EVS 3643A Classification Name: ● Stationary X-ray System
Classification Panel: Radiology ●
Classification Regulation: 21 CFR 892.1680
Product Code: MQB
Device Class: II ●

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

Addition of EXPD 4343D, EXPD 3643D : The differences between the subject devices and the predicate devices are TFT Panel and performance (MTF & DQE). Predicate devices used Amorphous silicon TFT, however, subject devices use IGZO TFT.

		Subject Device	Predicate Device
Model Name		EXPD 4343D, EXPD 3643D	EVS 4343A, EVS 3643A
TFT panel		IGZO	Amorphous Silicon
Performance	DQE	Typ. 55.0 % at 1.0 lp/mm	EVS 4343A: 52.9% at 1.0 lp/mmEVS 3643A: 50.5 % at 1.0 lp/mm
	MTF	Typ. 40.0 % at 2.0 lp/mm	EVS 4343A: 44.1% at 2.0 lp/mmEVS 3643A: 44.5 % at 2.0 lp/mm

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

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

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DRTECH

1. Firmware
- Level of Concern : Moderate

: DRTECH Firmware includes System Module, Control Module, Image Acquisition Module, Network Module. System Module performs various tasks and initialization for stable system operation and manages the overall system. The control module controls electronic equipment necessary for the detector system drive to S / W and operates according to the purpose. The Image Acquisition Module obtains the image according to the scenario required from PC. The obtained image is assigned to the memory. The network module transmits and receive the information which is necessary for the system drive and image acquisition to the TCP / IP Socket communication.

Image /page/5/Figure/5 description: The image shows a diagram of the DRTECH Firmware System. The system consists of four components: Network, Image Acquisition, Control, and System. The DRTECH Firmware System is connected to a PC API through a network.

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8. Substantial Equivalence [21 CFR 807.92(b)]

Parameter		Subject Device	Predicate Device
510(K) Number		Unknown	K192400
Manufacturer		DRTECH Corporation	DRTECH Corporation
Model Name		EXPD 4343D, EXPD 3643D	EVS 4343A, EVS 3643A
Classification Name		Stationary X-ray System	Stationary X-ray System
Classification Panel		Radiology	Radiology
	ClassificationRegulation	21 CFR 892.1680	21 CFR 892.1680
	Product Code	MQB	MQB
	Device Class	Class II	Class II
	Intended Use	The EXPD 4343D, EXPD 3643D DigitalX-ray detector are indicated for digitalimaging solution designed for providinggeneral radiographic diagnosis of humananatomy. This devices are intended toreplace film or screen based radiographicsystems in all general purpose diagnosticprocedures. This devices are not intendedfor mammography applications.	The EVS 4343A / EVS 3643A DigitalX-ray detector is indicated for digitalimaging solution designed for providinggeneral radiographic diagnosis of humananatomy. This device is intended toreplace film or screen based radiographicsystems in all general purpose diagnosticprocedures. This device is not intendedfor mammography applications.
	PanelShape	EXPD 4343D : Square PanelEXPD 3643D : Rectangular Panel	EVS 4343A: Square PanelEVS 3643A: Rectangular Panel
	DetectorSize	EXPD 4343D : 17" x 17"EXPD 3643D : 13" x 17"	EVS 4343A: 17" x 17"EVS 3643A: 13" x 17"
Design	Dimensions	EXPD 4343D: 460(W) x 483(L) x 15.5(H)EXPD 3643D: 460(W) × 409 (L) × 15.5 (H)	EVS 4343A: 460(W) x 483(L) x 15.5(H)EVS 3643A: 460(W) × 409(L) × 15.5(H)
	Pixel Pitch	140μm	140μm
	Image Size	EXPD 4343D: 3,072 x 3,072EXPD 3643D: 2,560 x 3,072	EVS 4343A: 3,072 x 3,072EVS 3643A: 2,560 x 3,072
	Panel & ScintillatorMaterials	Panel Material : TFT - IGZOScintillator Material : CsI	Panel Material : TFT - amorphousSiliconScintillator Material : CsI

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DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, Dunchon-Daero 541beon-gil, Jung Gyeonggi-do, 13216, Republic of

Typ. 55.0 %

Parameter

Perfor-

DQE

Subject Device	Predicate Device
	EVS 4343A: 52.9% at 1.0 lp/mm
at 1.0 lp/mm	EVS 3643A: 50.5 % at 1.0 lp/mm
	EVS 4343A: 44.1% at 2.0 lp/mm
at 2.0 lp/mm	EVS 3643A: 44.5 % at 2.0 lp/mm

mance	MTF	Typ. 40.0 % at 2.0 lp/mm	EVS 4343A: 44.1% at 2.0 lp/mm
	EVS 3643A: 44.5 % at 2.0 lp/mm
	Resolution	3.5 lp/mm	3.5 lp/mm
	Anatomical Sites	General Radiography	General Radiography
Power Supply		100-240V~, 50-60 Hz	100~~240V~~, 50/60 Hz
Components		POE Adaptor & AC Power CordLAN Cable ALAN Cable BSYNC Cable	PoE AdaptorLan cables(2 ea)AC Power CableEthernet Connector Bracket
	CommunicationInterface	Wired: Ethernet	Wired: Ethernet
Software	(ImageProcessing Program)	EConsole1(K152172)	EConsole1(K152172)

When compared to the predicate devices (K192400), the EXPD 4343D, EXPD 3643D presented in this submission have similar:

. Intended Use
Technological characteristics .
Operating principle .
. Performance (Resolution)
Communication Method .
Components .
Size Intended Use .
Software (Image Processing Program) .

A few differences are as follows

. Panel Material
. Performance (DQE and MTF)

There are no significant differences between the EXPD 4343D, EXPD 3643D and the predicate device(s) that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device.

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DRTECH

10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]

The non-clinical performance testing constrains the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or worth the predicate device as the following table:

Parameter	Subject Device	Predicate Device
DQE	Typ. 55.0 % at 1.0 lp/mm	EVS 4343A: 52.9% at 1.0 lp/mm
		EVS 3643A: 50.5 % at 1.0 lp/mm
MTF	Typ. 40.0 % at 2.0 lp/mm	EVS 4343A: 44.1% at 2.0 lp/mm
		EVS 3643A: 44.5 % at 2.0 lp/mm

The EXPD 4343D, EXPD 3643D detector comply with the following international and FDA-recognized consensus standards:

RecognitionNo.	Standard No.	Title of Standard	Date ofRecognition
5-125	ISO 14971 Third Edition2019-12	Medical devices - Application of riskmanagement to medical devices	12/23/2019
19-46	ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance (IEC 60601-1:2005, MOD) [Including Amendment 2(2021)]	05/30/2022
19-36	IEC 60601-1-2 Edition 4.12020-09 CONSOLIDATEDVERSION	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - CollateralStandard: Electromagnetic disturbances -Requirements and tests	12/21/2020
5-132	IEC 60601-1-6 Edition 3.22020-07 CONSOLIDATEDVERSION	Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateralstandard: Usability	12/21/2020

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DRTECH

RecognitionNo.	Standard No.	Title of Standard	Date ofRecognition
5-129	IEC 62366-1 Edition 1.12020-06 CONSOLIDATEDVERSION	Medical devices - Part 1: Application ofusability engineering to medical devices	07/06/2020
13-79	IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION	Medical device software - Software lifecycle processes	01/14/2019
12-349	NEMA PS 3.1 - 3.20 2022d	Digital Imaging and Communications inMedicine (DICOM) Set	12/19/2022
12-289	IEC 62220-1-1 Edition 1.02015-03	Medical electrical equipment-Characteristics of digital X-ray imagingdevices Part 1-1: Determination of thedetective quantum efficiency Detectorsused in radiographic imaging	08/14/2015

11. Related FDA Guidance documents

We reviewed the below FDA guidance documents and it was reflected in the development of the modified EXPD 4343D, EXPD 3643D detector.

Title of Guidance	Remark
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Pediatric Information for X-ray Imaging Device Premarket Notifications

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DRTECH

12. Conclusion [21 CFR 807.92(b)(3)]

The modified EXPD 4343D and EXPD 3643D detectors(K232753) are substantially equivalent to the currently marketed and predicate device (K192400) in terms of fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus

standards, ANSI AAMI ES60601-1:2005/AMD2:2021, IEC 60601-1-2:2020, IEC 60601-1-6 Edition 3.2, IEC 62304:2015 and IEC 6220-1-1 which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.

The results of these tests demonstrate that The EXPD 4343D and EXPD 3643D meet the acceptance criteria and are adequate for this intended use. The comparison of technological characteristics, nonclinical performance data, and safety testing demonstrates that the device is as effective, and performs as well or better than the predicate devices.

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.