EVS 4343

K142475 · DRTECH Corporation · MQB · Jan 15, 2015 · Radiology

Device Facts

• Record ID: K142475
• Device Name: EVS 4343
• Applicant: DRTECH Corporation
• Product Code: MQB · Radiology
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The EVS 4343 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 4343 is a wired/wireless flat-panel digital X-ray detector; replaces film/screen-based systems. Captures projection radiographic images in electronic format. Components include SSU, USB switch box, tether interface cable, access point, hand switch, and generator interface cables. Used in clinical settings for general radiography; operated by radiology staff. Detector uses amorphous silicon TFT with CsI scintillator to convert X-rays to digital signals. Output is a digital image for diagnostic review by a physician. Benefits include rapid image acquisition and elimination of chemical film processing.

Clinical Evidence

Single-blinded clinical concurrence study conducted per CDRH guidance. Compared EVS 4343 images to predicate Xmaru1717. Study confirmed equivalent diagnostic capability.

Technological Characteristics

Flat-panel detector; 17" x 17" size; 140μm pixel pitch. Indirect conversion using CsI scintillator and amorphous silicon (a-Si) TFT. Power: 100-240V, 50/60 Hz. Connectivity: Wired/wireless. 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 digital radiographic diagnosis of human anatomy in general purpose diagnostic procedures. Not 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

• Xmaru1717 (K091090)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains 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

January 15, 2015

DRTech Corporation % Mr. Choul-Woo Shin Vice President Suite No. 2, 3td Floor, Dunchon-daero541beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do 462-807 REPUBLIC OF KOREA

Re: K142475

Trade/Device Name: EVS 4343 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 3, 2014 Received: December 5, 2014

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.

{1}------------------------------------------------

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,

Robert A Ochs

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K142475

Device Name EVS 4343

#### Indications for Use (Describe)

The EVS 4343 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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)]

#### 08/27/2014

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

| • Name of Sponsor: | DRTECH Corporation |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| • Address: | Suite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil<br>Jungwon-gu, Seongnam-si, Gyeonggi-do 462-807<br>Republic of Korea |
| • Contact Name: | Choul-Woo Shin<br>Telephone No.: [phone]<br>Fax No.: [phone]<br>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 4343 |
|------------------------------|-----------------------------------|
| • 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: | K091090 |
|------------------------------|-----------------------------------|
| • Applicant: | E-WOO TECHNOLIGY |
| • Trade Name: | Xmaru1717 |
| • 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}------------------------------------------------

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

The EVS 4343 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 4343 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 4343 consists of main components such as SSU, USB Switch Box and other accessories (Tether Interface Cable, Access Point, Hand Switch, Generator Interface Cable, LAN Cable, Interface cable, AC Power Code).

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

The Intended Use of the DRTECH EVS 4343 Digital X-ray detector is identical to that of the currently marketed and predicate device, E-Woo Technology Xmaru1717 (cleared in K091090, August 9, 2010) and is as follows:

The EVS 4343 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)]

Based on a technical feature comparison, the subject device was found to be similar to predicate devices with regard to detector technology (Indirect, CsI) which has the same pane size.

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

| Parameter | Subject Device | Predicate Device | Remark | |
|---------------------------|------------------------------------------------------|------------------|--------|------|
| 510(k) Number | Unknown | K091090 | - | |
| Manufacturer | DRTECH Corporation | E-WOO TECHNOLOGY | - | |
| Model Name | EVS 4343 | Xmaru 1717 | - | |
| Common Name | Digital Flat Panel X-ray Detector | | | Same |
| Classification Name | Solid State X-ray Imager (Flat Panel/Digital Imager) | | | Same |
| Classification Panel | Radiology | | | Same |
| Classification Regulation | 21 CFR 892.1680 | | | Same |
| Product Code | MQB | | | Same |
| Device Class | Class II | | | Same |

<Device Comparison table>

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the text "DRTECH" in a bold, sans-serif font. The text is a bright blue color. The image appears to be a logo or brand name.

Suite No. 2, 3 Floor, 29, Du Jungwon-gu, Seongna

| | | | | | 462-807 Republic of Korea |
|---------------------------|-------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use | | | The EVS 4343 Digital X-<br>ray detector is indicated<br>for digital imaging<br>solution designed for<br>providing general<br>radiographic diagnosis of<br>human anatomy. This<br>device is intended to<br>replace film or screen<br>based radiographic<br>systems in all general<br>purpose diagnostic<br>procedures. This device is<br>not intended for<br>mammography<br>applications | Xmaru1717 Digital Flat<br>Panel X-ray Detector is<br>indicated for digital<br>imaging solution designed<br>for providing general<br>radiographic diagnosis of<br>human anatomy. It is<br>intended to replace film or<br>screen based radiographic<br>systems in all general<br>purpose diagnostic<br>procedures. Not to be<br>used for mammography. | Same |
| Design | | Panel Shape | Square Panel | Square Panel | Same |
| | | Detector Size | 17" X 17" | 17" X 17" | Same |
| | | Dimensions<br>(W x L x H) | 460(W)x460(L)x15(H) | 497(W)×500(L)×45(H) | Similarity |
| | | Pixel Pitch | 140μm | 143μm | Similarity |
| | | Image Size | 3,072 x 3,072 | 3,072 x 3,072 | Same |
| Materials<br>Scintillator | | | TFT -amorphous Silicon<br>CsI (Indirect) | TFT -amorphous Silicon<br>CsI (Indirect) | Same |
| | Performance | | DQE | 34.7% (at 1.0lp/mm) | 36.2% (at 1.0lp/mm) |
| | | MTF | 64.3% (at 1.0lp/mm) | 49.1% (at 1.0lp/mm) | Difference |
| | | Resolution | 3.6LP/mm | 3.6LP/mm | Same |
| Anatomical Sites | | | General Radiography | General Radiography | Same |
| Power Supply | | | 100~240V~ 50/60 Hz | 100~240V~ 50/60 Hz | Same |

When compared to the predicate device (K091090), the EVS 4343 presented in this submission has the same:

- Intended Use
- Technological characteristics
- · Operating principle
- · Design features
- Performance
- · Communication Method

There are no significant difference between the EVS 4343 and the predicate device 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.

{6}------------------------------------------------

#### 9. Summary of Non-Clinical Data

The non-clinical performance testing constrains that the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or better than the predicate device ranging 64.3% (predicate 18.8%) for MTF at 1.01p/mm and 34.7% (predicate 36.2%) for DQE at 1.0lp/mm.

The DRTECH EVS 4343 Digital X-ray detector complies with the following international and FDA-recognized consensus standards:

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

#### 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 4343 provide images of equivalent diagnostic capability to the predicate device, the E-WOO TECHNOLOGY Xmaru1717, and its results demonstrate substantial equivalence.

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

The DRTECH EVS 4343 Digital X-ray detector is substantially equivalent to the currently marketed and predicate device (E-WOO TECHNOLOGY Xmaru1717 K091090) 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 FDArecognized consensus standards, AAMI ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 6220-1 and NEMA PS 3.1 - 3.20 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 DRTECH EVS 4343 Digital X-ray detector 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 effective, and performs as well or better than the predicate devices.