(99 days)
The EVS 4343 and EVS 4343G 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 radio graphic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The EVS 4343(G) is a wired 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 4343(G) 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 EVS 4343(G) 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.
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the acceptance criteria are based on equivalence to predicate devices (K142475 and K150766). The study aimed to demonstrate that the new detectors provide "images of equivalent diagnostic capability." While specific numeric acceptance thresholds are not explicitly stated, the performance metrics (DQE and MTF) are compared against the predicate devices.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (EVS 4343) | Reported Device Performance (EVS 4343G) | Remark |
|---|---|---|---|---|
| DQE | K142475: 28% at 1 lp/mm, 13% at 3 lp/mm | 43.9% at 1 lp/mm, 16.5% at 3 lp/mm | 23.6% at 1 lp/mm, 5% at 3 lp/mm | Similarity |
| (Detective | K150766: 29.7% at 1 lp/mm, 5.0% at 3 lp/mm | |||
| Quantum | ||||
| Efficiency) | ||||
| MTF | K142475: 35% at 2.0 lp/mm | 35% at 2.0 lp/mm | 34% at 2.0 lp/mm | Same |
| (Modulation | K150766: 17.4% at 2.0 lp/mm | |||
| Transfer | ||||
| Function) | ||||
| Resolution | 3.5 lp/mm (for both predicates and new devices) | 3.5 lp/mm | 3.5 lp/mm | Same |
Note regarding DQE: While the "Remark" column states "similarity," for EVS 4343, the DQE values are higher than both predicates, suggesting better performance. For EVS 4343G, the DQE at 1 lp/mm is lower than both predicates, and at 3 lp/mm, it is the same as K150766 but lower than K142475. The document concludes "similarity," indicating that these differences were deemed acceptable for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
The document states that a "single-blinded concurrence study" was conducted to confirm "equivalent diagnostic capability" to the predicate devices. However, the sample size for the test set is not explicitly provided.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts used or their qualifications for the single-blinded concurrence study. It only mentions that the study was conducted according to "CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."
4. Adjudication Method for the Test Set:
The document mentions a "single-blinded concurrence study." This implies that readers were blinded to the source of the image (test device vs. predicate) and their readings were compared for agreement or concordance. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document refers to a "single-blinded concurrence study" to assess "equivalent diagnostic capability," which suggests a type of reader study. However, it does not explicitly state that it was an MRMC comparative effectiveness study in the formal sense, nor does it provide an effect size of how much human readers improve with AI vs. without AI assistance. The device described is an X-ray detector, not an AI-powered diagnostic tool, so the concept of "AI assistance" is not applicable in this context.
6. Standalone Performance Study:
Yes, a standalone study of the algorithm's performance (in this case, the detector's physical performance) was done. The document explicitly includes "Summary of Non-Clinical Data" which reports the DQE (Detective Quantum Efficiency) and MTF (Modulation Transfer Function) values for the EVS 4343 and EVS 4343G devices. These are intrinsic performance characteristics of the detector itself, independent of human interpretation.
7. Type of Ground Truth Used:
For the non-clinical performance data (DQE, MTF), the ground truth is established through physical measurements and international standards (IEC 62220-1 for DQE).
For the "single-blinded concurrence study" assessing "equivalent diagnostic capability," the ground truth implicitly seems to be expert consensus on diagnostic capability comparing images from the new device against images from the predicate devices. However, the specific method for establishing this "ground truth" (e.g., if a definitive diagnosis was available for the cases used) is not detailed.
8. Sample Size for the Training Set:
The document does not provide information on a training set sample size. The EVS 4343(G) is an X-ray detector, a hardware device, not an AI algorithm that typically requires a large training dataset.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" for the device itself (being a hardware detector), this question is not applicable based on the provided document. The performance metrics (DQE, MTF) are physical properties measured according to established standards rather than "trained" by data.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
DRTECH Corporation % Choul-Woo Shin Suite No. 2, 310 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13230 REPUBLIC OF KOREA
Re: K162555
Trade/Device Name: EVS 4343. EVS 4343G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 2, 2016 Received: December 6, 2016
Dear Choul-Woo 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 Ochs
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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Indications for Use
510(k) Number (if known) K162555
Device Name EVS 4343, EVS 4343G
Indications for Use (Describe)
The EVS 4343 and EVS 4343G 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 radio graphic 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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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)]
09/08/2016
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-gil, |
| Jungwon-gu, Seongnam-si, Gyeonggi-do, 13230 | ||
| Republic of Korea | ||
| • | Contact Name: | Choul-Woo Shin |
| • | Telephone No.: | + 82-31-779-7783 |
| • | Fax No .: | + 82-31-779-7790 |
| • | Email Address : | 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)]
| • | Trade Name: | EVS 4343, EVS 4343G |
|---|---|---|
| • | 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: | MQB |
| • | Device Class: | II |
| • | 501(k) Number: | K162555 |
| • |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| Parameter | Predicate Device |
|---|---|
| • 510(k) Number: | K142475 K150766 |
| • Applicant: | DRTECH Corporation Carestream Health, Inc. |
| • Trade Name: | Carestream DRX-1 System w/ DRX Plus Detectors EVS 4343 |
| • 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)]
- The EVS 4343 was removed the function of wireless communication to transfer data.
- . Addition of EVS 4343G: This is to notify that EVS 4343 / EVS 4343G are same Hardware, Software and components. But scintillator layer are different. Scintillator is a phosphor that produces scintillations.
| Model Name | Scintillator layer |
|---|---|
| EVS 4343 | CsI (Cesium Iodide) |
| EVS 4343G | GoS (Gadolinium Oxysulfide) |
The EVS 4343(G) is a wired 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 4343(G) 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.
6. Intended Use [21 CFR 807.92(a)(5)]
The intended use has not changed as a result of the modification and is as follows:
The EVS 4343 and EVS 4343G 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The EVS 4343(G) 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 4343(G) to be same to the predicate devices. The EVS 4343(G) is functionally identical to the predicate devices.
The subject device integrates with X-ray system through three modes such as Auto Trigger mode (AT), Sync. Trigger mode and USB SW mode. The Auto Trigger Mode (AT) is available for acquiring images without any connection to X-ray generator interface cable is not required. The Sync. Trigger mode is the most common and recommended exposure mode at B2B scopes. User can achieve the high quality images with Sync. Tigger Mode. The USB SW Mode is the most common and recommended exposure mode at a retrofit scope. User can achieve high quality images with USB SW Mode.
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8. Hardware and Software Requirements
- X-ray System Requirement
| Contents | Requirements | |
|---|---|---|
| Generator | Power frequency | 30kHz ~ 240kHz |
| KV | 40kVp ~ 150kVp | |
| mA Range | 10mA ~ 1000mA | |
| Exposure Time | 0.001~10sec | |
| mAs Range | 0.1~1000mAs | |
| Accuracy | $\pm$ 5% | |
| Bucky | Operating Type | movingStepping MotorSpringCAM Motor type |
| Static(Fixed) | ||
| Trey size (mm) | 460 x 460 x 15 or higher | |
| Grid | Ratio | 5:1, 6:1, 8:1, 10:1, 12:1, 15:1 |
| Line | 85 ~ 215 Line | |
| SID | 100 ~ 180 cm |
- The EVS 4343(G) detector is not compatible with trays that are less than 460 mm x 15 mm.
- Software Requirement
The EVS 4343(G) detector is compatible with Econsole1 (K152172).
9. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| 510(K) Number | Unknown | K142475 | K150766 | - | |
| Manufacturer | DRTECHCorporation | DRTECHCorporation | CarestreamHealth, Inc. | - | |
| Model Name | EVS 4343, EVS4343G | EVS 4343 | Carestream DRX-1System w/ DRXPlus Detectors | - | |
| ClassificationName | Stationary X-ray System | same | |||
| Classification Panel | Radiology | same | |||
| ClassificationRegulation | 21 CFR 892.1680 | same | |||
| Product Code | MQB | same | |||
| Device Class | Class II | same | |||
| Intended Use | The EVS 4343 andEVS 4343G DigitalX-ray detector isindicatedfor digital imagingsolution designed forproviding general | The EVS 4343Digital X-raydetector isindicatedfor digital imagingsolution designedfor providing | The device isintended tocapture fordisplayradiographicimages of human | same | |
| radiographicdiagnosis of humananatomy. This deviceis intended to replacefilm or screen basedradiographic systemsin all general purposediagnosticprocedures. Thisdevice is notintended formammographyapplications | generalradiographicdiagnosis ofhuman anatomy.This device isintended toreplace film orscreen basedradiographicsystems in allgeneral purposediagnosticprocedures. Thisdevice is notintended formammographyapplications | anatomyincluding bothpediatric andadult patients.The device isintended for usein generalprojectionradiographicapplicationswhereverconventionalscreen-filmsystems or CRsystems may beused. Excludedfrom theindications foruse aremammography,fluoroscopy, andangiographyapplications. | |||
| Design | PanelShape | Square Panel | Square Panel | Rectangular Panel | same |
| DetectorSize | 17" X 17" | 17" X 17" | 13" X 17" | same | |
| Dimensions | 460(W) x 460(L) x15(H) | 460(W) x 460(L)x 15(H) | - | same | |
| PixelPitch | 140μm | 140μm | 139µm | same | |
| ImageSize | 3,072 x 3,072 | 3,072 x 3,072 | - | same | |
| MaterialsScintillator | TFT -amorphousSilicon | TFT -amorphousSilicon | TFT -amorphousSilicon | same | |
| EVS 4343: CsIEVS 4343G: GOS | EVS 4343: CsI | GOS | same | ||
| Performance | DQE | EVS 4343:43.9 % at 1 lp/mm16.5 % at 3 lp/mmEVS 4343G:23.6 % at 1 lp/mm5 % at 3 lp/mm | 28 % at 1 lp/mm13 % at 3 lp/mm | 29.7 % at 1 lp/mm5.0 % at 3 lp/mm | similarity |
| MTF | EVS 4343: 35 % at2.0 lp/mm | 35 % at 2.0 lp/mm | 17.4% at 2 lp/mm | same | |
| EVS 4343G: 34 % at2.0 lp/mm | same | ||||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | 3.5 lp/mm | same | |
| Anatomical Sites | General Radiography | General Radiography | General Radiography | same | |
| Power Supply | 100 | 100 | 100 | same | |
| CommunicationInterface | Wired: Ethernet | Wireless:2.4g/802.11g/n5g/802.11a/nWired: Ethernet | - | different |
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IDRTECH
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Image /page/7/Picture/0 description: The image shows the logo for DR TECH. The logo is in blue and features a square above the letters 'DR'. The letters 'TECH' are in a slightly lighter shade of blue than the 'DR'. A mouse cursor is visible near the left side of the logo.
When compared to the predicate device (K142475 and K150766), the EVS 4343(G) presented in this submission has the same:
- Intended Use
- Technological characteristics
- Operating principle
- · Design features
- · Performance (DQE, MTF, Resolution)
- Materials Scintillator
A few differences are as follows
- Communication Method
There are no significant differences between the EVS 4343(G) 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.
10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The non-clinical performance testing constrains that the main physical values for comparison of Xray devices like DQE and MTF are basically equal or worth than the predicate device as following table:
| Parameter | Modified Device | Predicate Device | Remark | |
|---|---|---|---|---|
| K142475 | K150766 | |||
| DQE | EVS 4343:43.9 % at 1lp/mm16.5% at 3 lp/mm | 28 % at 1 lp/mm13 % at 3 lp/mm | 29.7 % at 1 lp/mm5.0 % at 3 lp/mm | samesimilarity |
| EVS 4343G:23.6 % at 1lp/mm5 % at 3 lp/mm | ||||
| MTF | EVS 4343: 35 % at 2.0 lp/mm | 35 % at 2.0 lp/mm | 17.4% at 2.0 lp/mm | same |
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| EVS 4343G:34 % at 2.0lp/mm | same |
|---|---|
| ------------------------------------ | ------ |
The EVS 4343(G) complies with the following international and FDA-recognized consensus standards:
| AAMI ANSI ES60601-1: | Medical Electrical Equipment -- Part 1: General Requirements for BasicSafety And Essential Performance (IEC 60601-1:2005, Mod) |
|---|---|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For BasicSafety And Essential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices.(General I (QS/RM)) |
| IEC 62220-1: | Medical electrical equipment - Characteristics of digital X-ray imagingdevices - Part 1: Determination of the detective quantum efficiency |
| NEMA PS 3.1 - 3.20: | Digital Imaging and Communications in Medicine (DICOM) Set |
11. Summary of Clinical Data [21 CFR 807.92(b)(2)]
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 4343G provide images of equivalent diagnostic capability to the predicate devices (K142475 and K150766) 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.
12. Conclusion [21 CFR 807.92(b)(3)]
The modified EVS 4343(G) is substantially equivalent to the currently marketed and predicate device (EVS 4343, 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-recogmized consensus standards, IEC60601-1, IEC 60601-1-2, IEC6220-1 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 4343(G) 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 or better than the predicate devices.
§ 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.