EVS 2430W, EVS 2430GW

K171137 · DRTECH Corporation · MQB · May 15, 2017 · Radiology

Device Facts

• Record ID: K171137
• Device Name: EVS 2430W, EVS 2430GW
• Applicant: DRTECH Corporation
• Product Code: MQB · Radiology
• Decision Date: May 15, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The EVS 2430W and EVS 2430GW 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 Story

EVS 2430W/GW are wired/wireless flat-panel digital X-ray detectors; replace film/screen systems. Input: X-ray quanta. Operation: Indirect conversion; scintillator (CsI or GoS) converts X-rays to visible light; optical sensor/TFT array generates electrical charge; analog-to-digital conversion. Output: Digital radiographic images. Used in clinical settings; operated by radiology staff. Integrates with X-ray generators via Auto Trigger, Sync Trigger, or USB SW modes. Output viewed by clinicians for diagnostic decision-making; enables faster image acquisition than film-based systems.

Clinical Evidence

Single-blinded clinical concurrence study conducted per CDRH guidance. Clinical images compared against predicate (K162552) to demonstrate equivalent diagnostic capability. No clinical performance metrics (sensitivity/specificity) reported; study served as supplemental evidence to bench testing.

Technological Characteristics

Indirect conversion flat-panel detector. Scintillator: CsI (EVS 2430W) or GoS (EVS 2430GW). Sensor: Amorphous Silicon TFT. Connectivity: Wired/Wireless (IEEE 802.11a/g/n, 2.4/5 GHz). Standards: AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 62220-1, NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for general radiographic diagnosis of human anatomy in patients requiring diagnostic imaging. Not intended for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EVS 3643, EVS 3643G (K162552)

Reference Devices

• Econsole1 (K152172)

Submission Summary (Full Text)

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

May 15, 2017

DRTECH Corporation % Choul-Woo Shin Vice President Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-Do 13230 REPUBLIC OF KOREA

Re: K171137

Trade/Device Name: EVS 2430W. EVS 2430GW Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 14, 2017 Received: April 17, 2017

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael D.'Hara

For

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) K171137

Device Name EVS 2430W, EVS 2430GW

#### Indications for Use (Describe)

The EVS 2430W and EVS 2430GW 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;width:20px;text-align:center;"><b>X</b></div> |
|----------------------------------------------|--------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;width:20px;text-align:center;"></div> |

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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)]

04/14/2017

#### 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 : | [e-mail] |
| • Registration Number: | 3005172103 |
| • Name of Manufacturer: | Same as Sponsor |

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

| ● Trade Name: | EVS 2430W, EVS 2430GW |
|------------------------------|-----------------------------------|
| ● 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 |

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

| ● 510(k) Number: | K162552 |
|------------------|--------------------|
| ● Applicant: | DRTECH Corporation |

- Trade Name: EVS 3643, EVS 3643G ●
- 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)]

<Modification>

- Addition of EVS 2430(G)W: The differences between the subject device and the predicate device are the detector size, pixel pitch and performance (Resolution, DQE) of their detectors. These EVS 2430W and EVS 2430GW differ in terms of the layers of their scintillators as shown in the following table:

| Model Name | Scintillator layer |
|------------|-----------------------------|
| EVS 2430W | CsI (Cesium Iodide) |
| EVS 2430GW | GoS (Gadolinium Oxysulfide) |

The EVS 2430(G)W 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 2430(G)W 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 2430W and EVS 2430GW 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 2430(G)W 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 2430(G)W to be same to the predicate devices. The EVS 2430(G)W 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 | moving Stepping Motor<br>Spring<br>CAM Motor type |
| | | Static(Fixed) |
| | Trey size (mm) | 267.5 mm x 327.5 mm x 15.6 mm 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 2430(G)W detector is not compatible with trays that are less than 267.5 mm x 15.6 mm.

- Software Requirement

The EVS 2430(G)W detector is compatible with Econsole1 (K152172).

# 9. Substantial Equivalence [21 CFR 807.92(b)]

| Parameter | Subject Device | Predicate Device |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | Not Known | K162552 |
| Manufacturer | DRTECH Corporation | DRTECH Corporation |
| Model Name | EVS 2430G, EVS2430GW | EVS 3643, EVS 3643G |
| Classification Name | Stationary X-ray System | |
| Classification Panel | Radiology | |
| Classification<br>Regulation | 21 CFR 892.1680 | |
| Product Code | MQB | |
| Device Class | Class II | |
| Intended Use | The EVS 2430W, EVS 2430GW 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 | The EVS 3643, EVS 3643G 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 |

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| Design | Panel Shape | Rectangular Panel | Rectangular Panel |
|------------------------|---------------|----------------------------------------------------|---------------------------------------------------|
| | Detector Size | 240 x 300 mm | 360 x 430 mm |
| | Pixel Pitch | 76 um | 140µm |
| Materials Scintillator | | TFT -amorphous Silicon | TFT -amorphous Silicon |
| | | EVS 2430W: CsI | EVS 3643: CsI |
| | | EVS 2430GW: GoS | EVS 3643G: GoS |
| Performance | DQE | EVS 2430W:<br>45% at 1.0 lp/mm<br>30% at 3.0 lp/mm | EVS 3643:<br>28% at 1.0 lp/mm<br>13% at 3.0 lp/mm |
| | | EVS 2430GW:<br>25% at 1.0 lp/mm<br>5% at 3.0 lp/mm | EVS 3643G:<br>22% at 1.0 lp/mm<br>5% at 3.0 lp/mm |
| | | MTF | EVS 2430W: 35% at 2.0 lp/mm |
| | | | EVS 2430GW: 35% at 2.0 lp/mm |
| | | Resolution | 3072 x 3840 |
| | | Wireless Charging | available |
| Anatomical Sites | | General Radiography | General Radiography |
| Power Supply | | 100~240V~, 50/60 Hz | 100~240V~, 50/60 Hz |
| Communication Method | | Wire | Wire |
| | | Wireless | Wireless |
| | | • IEEE 802.11a//g/n | • IEEE 802.11a//g/n |
| | | (2.4 GHz / 5 GHz) | (2.4 GHz / 5 GHz) |
| | | • Security: | • Security: |
| | | WEP/WPA/WPA2 | WEP/WPA/WPA2 |

When compared to the predicate device (K162552), the EVS 2430(G)W presented in this submission has the same:

- Intended Use
- Technological characteristics
- · Operating principle
- Materials Scintillator
- · Design features
- · Performance (MTF)

A few differences are as follows

- · Image Size
- · Performance (Resolution, DQE)

There are no significant differences between the EVS 2430(G)W and the predicate devices 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. The difference in the sizes of the detectors only result in the difference in the X-ray images can be taken. Therefore, the difference in the sizes of the detectors does not affect the safety and effectiveness. Also, even though the resolution and DQE of the predicate device and the subject device are different, the results of the clinical image evaluation proved the clinical effectiveness of the subject device.

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#### 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 higher the predicate device as following table:

| Parameter | Modified Device | Predicate Device<br>(K162552) | Remark |
|-----------|----------------------------------------------------|---------------------------------------------------|--------------------------------|
| DQE | EVS 2430W:<br>45% at 1.0 lp/mm<br>30% at 3.0 lp/mm | EVS 3643:<br>28% at 1.0 lp/mm<br>13% at 3.0 lp/mm | Different |
| | EVS 2430GW:<br>25% at 1.0 lp/mm<br>5% at 3.0 lp/mm | EVS 3643G:<br>22% at 1.0 lp/mm<br>5% at 3.0 lp/mm | Similar |
| | MTF | EVS 2430W:<br>35% at 2.0 lp/mm | EVS 3643:<br>35% at 2.0 lp/mm |
| | | EVS 2430GW:<br>35% at 2.0 lp/mm | EVS 3643G:<br>30% at 2.0 lp/mm |

The EVS 2430(G)W complies with the following international and FDA-recognized consensus standards:

| AAMI ANSI ES60601-1: | Medical Electrical Equipment -- Part 1: General Requirements for Basic<br>Safety And Essential Performance (IEC 60601-1:2005, Mod) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General Requirements For Basic<br>Safety And Essential Performance – Collateral Standard: Electromagnetic<br>Compatibility - Requirements And Tests (Edition 3) |
| ISO 14971: | Medical Devices - Application of Risk Management to Medical Devices<br>(General I (QS/RM)) |
| IEC 62220-1: | Medical electrical equipment - Characteristics of digital X-ray imaging<br>devices - Part 1: Determination of the detective quantum efficiency |
| NEMA PS 3.1 - 3.20: | Digital Imaging and Communications in Medicine (DICOM) Set |

The EVS 2430(G)W software complies with the following FDA Guidance documents:

"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

#### 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 x-ray detectors EVS 2430(G)W provide images of equivalent diagnostic capability to the predicate devices (K162552) 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.

008-5/6 510(k) Summary

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

The EVS 2430(G)W is substantially equivalent to the currently marketed and predicate device (EVS 3643(G)(K162552) 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, 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 2430(G)W 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 demonstrate that the device is as safe and effectiveness.