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

Device Description

The EVS 3643 is a wired/wireless 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. EVS 3643 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.

EVS 3643 consists of main components such as SSU. USB Switch Box, Battery Pack, Battery charger and other accessories (Tether Interface Cable, Hand Switch, Generator Interface Cable, LAN Cable, Interface cable, AC Power Code).

EVS 3643 should be integrated with an operating PC and an X-Ray generator.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EVS 3643 device, based on the provided document:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate EVS 4343 Performance)	Reported Device Performance (EVS 3643)
DQE (at 1.0 Lp/mm)	52%	50%
MTF (at 2.0 Lp/mm)	36.6%	35%
Resolution	3.6 LP/mm	3.5 LP/mm

Note: The document states that the EVS 3643 is functionally identical and shares similar performance to the predicate device (EVS 4343) with minor differences in these specified metrics, which are presented as the acceptance criteria against which the new device was compared. The conclusion is that the EVS 3643 "meets the acceptance criteria and is adequate for this intended use."

Study Information

Sample size used for the test set and the data provenance:
- The document mentions "Clinical images were provided," but does not explicitly state the specific sample size of images used in the clinical study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study was conducted as a "single-blinded concurrence study," which implies it was likely a prospective collection for this specific study, but the source of the images themselves is not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states a "single-blinded concurrence study" was conducted. It does not specify the number of experts or their qualifications (e.g., years of experience, specific board certifications) used to establish ground truth or evaluate diagnostic capability.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document describes a "single-blinded concurrence study." This typically implies that reader evaluations are compared to a predetermined ground truth, or to evaluations by other readers, but it doesn't specify an adjudication method like "2+1" or "3+1." The phrase "concurrence study" suggests agreement among observers or with a known reference, but the precise adjudication process is not detailed.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described.
- The study was a "single-blinded concurrence study" to confirm "equivalent diagnostic capability to the predicate devices," not to measure human performance improvement with AI assistance. The device itself is an X-ray detector, not an AI interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, performance metrics such as DQE, MTF, and Resolution were evaluated for the device itself (EVS 3643) and compared to the predicate device (EVS 4343) in a "comparison test." This represents standalone performance. The clinical study also implicitly assesses the standalone image quality produced by the detector.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical "concurrence study," the ground truth was based on the premise of "equivalent diagnostic capability to the predicate devices." This implies that the images produced by EVS 3643 were deemed to provide equivalent information that would lead to the same diagnosis as those from the predicate device or a recognized standard, likely established by expert review ("concurrence"). The specific method of establishing this diagnostic ground truth (e.g., expert consensus on specific findings, long-term outcomes) is not further detailed.
The sample size for the training set:
- The document does not describe the use of a training set for an AI/algorithm system. The device is a digital X-ray detector, and the description focuses on its hardware and imaging characteristics, not on machine learning model development. Therefore, a training set for an AI model is not applicable here.
How the ground truth for the training set was established:
- As there's no mention of a training set for an AI/algorithm, there's no information on how its ground truth was established.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2015

DRTech Corporation % Mr. Choul-Woo Shin Vice President Suite No.2, 3td Floor 29 Dunchon-daero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do 462-807 REPUBLIC OF KOREA

Re: K151942

Trade/Device Name: EVS 3643 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 2, 2015 Received: September 9, 2015

Dear Mr. Shin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ools

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number (if known)	K151942
Device Name	EVS 3643

Indications for Use (Describe)

The EVS 3643 Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic

The EVS 3643 Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographis diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) Summary

[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)]

06/01/2014

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

Name of Sponsor:	DRTECH Corporation.
Address:	Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gilJungwon-gu, Seongnam-si, Gyeonggi-do 462-807Republic of Korea
Contact Name:	Choul-Woo Shin
	Telephone #: +82-31-784-8856
	Fax #: +82-31-784-8899
	Email: cwshin@drtech.co.kr
Registration Number:	3005172103
Name of Manufacturer:	Same as Sponsor

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

Model Name:	EVS 3643
Common Name:	Digital Flat Panel X-ray Detector
Regulation Name:	Stationary x-ray system
Regulation Number:	21 CFR 892.1680
Product Code:	MQB
Device Class:	2
Review Panel:	Radiology

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

510(k) Number: K142475
Applicant: DRTECH Corporation.
Model Name: EVS 4343
Common Name: Digital Flat Panel X-ray Detector
Regulation Name: Stationary x-ray system
Regulation Number: 21 CFR 892.1680
Product Code: MQB
Device Class: 2

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

EVS 3643 should be integrated with an operating PC and an X-Ray generator.

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

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

The EVS 3643 Detector is an indirect conversion device 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 spatial distribution 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.

Comparisons with the predicate, devices show the technological characteristics of the EVS 3643 to be same to the predicate devices. The EVS 3643 is functionally identical to the predicate devices.

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

EVS 3643 is a series of the predicate device EVS 4343. The size of the detector, power supply to the detector and the wireless connection are improved.

When compared to the predicate devices (K142475), the EVS 3643 presented in this submission has the same of the followings:

Intended Use
· Technological characteristics
· Design features
Communication Method
Scintillator Materials

The two devices share the similar performance as the following:

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Performance (MTF)
· Performance (DQE)
Resolution
· Software version

However, the size of the predicate device's detector is 17" X 17" whereas that of EVS 3643 is 14" X 17". Also, the predicate device connects the detector to the SSU through a wire for power supply and data communication whereas the EVS 3643 is also capable of using the battery inside the detector and wireless communication of top of the method the predicate device uses.

Also, there is a change in the version of the software due to the different size of the detector, but there is no change in the function of the software.

In summary, after comparing EVS 3643 and the predicate device, no significant difference was observed. Also, the main comparison items including the intended use and technological characteristics were highly similar or the same. Therefore, EVS 3643 is substantially equivalent to the predicate device.

Parameter	Subject Device	Predicate Device
510(k) Number	Unknown	K142475
Model Name	EVS 3643	EVS 4343
Manufacturer	DRTECH Corporation
Common Name	Digital Flat Panel X-ray Detector
Regulation Name	Stationary x-ray system
Classification Panel	Radiology
Classification Regulation	21 CFR 892.1680
Product Code	MQB
Device Class	Class II
Intended Use	The EVS 3643 Digital X-raydetector is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomy.This device is intended to replacefilm or screen based radiographicsystems in all general purposediagnostic procedures. Thisdevice is not intended formammography applications	The EVS 4343 Digital X-raydetector is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomy.This device is intended toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. This device is notintended for mammographyapplications
Panel Shape	Rectangular Panel	Square Panel
Detector Size	13" X 17"	17" X 17"
Pixel Pitch	140μm	140μm

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Scintillator	TFT -amorphous SiliconCsI (Indirect)	TFT -amorphous SiliconCsI (Indirect)
CommunicationMethod	Wire	Wire
	Wireless• IEEE 802.11a//g/n(2.4 GHz / 5 GHz)• Security:WEP/WPA/WPA2	Wireless• IEEE 802.11a//g/n(2.4 GHz / 5 GHz)• Security:WEP/WPA/WPA2
DQE	50% (at 1.0 Lp/mm)	52% (at 1.0 Lp/mm)
MTF	35% (at 2.0 Lp/mm)	36.6% (at 2.0 Lp/mm)
Resolution	3.5 LP/mm	3.6 LP/mm
Anatomical Sites	General Radiography	General Radiography
Exposure Mode	USB SW ModeSync Trigger ModeAuto Trigger Mode	USB SW ModeSync Trigger ModeAuto Trigger Mode
Power Supply	100~240V, 50/60 Hz	100~240V, 50/60 Hz

9. Summary of Non-Clinical Data

A comparison test was conducted between the EVS3643 and the predicate device (K142475) on the items such as DQE, MTF and spatial resolution.

These detectors comply with the following international and FDA-recognized consensus standards:

IEC 60601-1:	Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And Essential Performance
IEC 60601-1-2:	Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
IEC 62220-1:	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detectivequantum efficiency
IEC 62133:	Secondary Cells And Batteries Containing Alkaline OrOther Non-Acid Electrolytes•Safety Requirements ForPortable Sealed Secondary Cells, And For Batteries MadeFrom Them, For Use In Portable Applications [Including:Corrigendum 1 (2013)
EN 300 328 1.8.1:	Electromagnetic compatibility and Radio spectrum Matters(ERM); Wideband transmission systems; Data transmissionequipment operating in the 2,4 GHz ISM band and usingwide band modulation techniques; Harmonized EN

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covering the essential requirements of article 3.2 of theR&TTE Directive
EN 301 893 1.7.1: Broadband Radio Access Networks (BRAN); 5 GHz highperformance RLAN; Harmonized EN covering the essentialrequirements of article 3.2 of the R&TTE Directive

10. Summary of Clinical Data

A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors EVS 3643 provide images of equivalent diagnostic capability to the predicate devices (K142475) and its results demonstrate substantial equivalence.

Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray detector technology that is identical to the predicate device) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.

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

The EVS 3643 is substantially equivalent to the currently marketed and predicate devices (K142475) in terms of design features, 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, IEC60601-1, IEC 60601-1-2, IEC62220-1 and IEC 62133 and the clinical test, 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 EVS 3643 meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well 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.