Who is the manufacturer of EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

DRTECH Corporation filed the 510(k) submission for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP (K193017).

What is the FDA product code for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

Q: What are the predicate devices for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

EVS 3643 / EVS 3643G (K162552).

K193017 · DRTECH Corporation · MQB · Nov 22, 2019 · Radiology

Device Facts

Record ID	K193017
Device Name	EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
Applicant	DRTECH Corporation
Product Code	MQB · Radiology
Decision Date	Nov 22, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP 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

Digital flat panel X-ray detector; captures X-ray quanta and converts to visible light via scintillator (CsI or GOS); optical sensor generates electrical charge; thin film transistors (TFT) convert charges to modulated electrical signals; signals amplified and digitized for viewing/storage. Compatible with Econsole1 software. Used in clinical settings for general radiography; operated by healthcare professionals. Subject devices offer varied sizes and TFT materials (amorphous Silicon or amorphous IGZO). IGZO TFTs provide lower resistance and leakage current compared to a-Si. Output is a digital image for diagnostic interpretation. Benefits include replacement of film/screen systems with digital imaging, potentially improving workflow and image quality.

Clinical Evidence

Single-blind clinical image evaluation conducted per FDA guidance. Compared EVS 4343WP/3643WP (IGZO TFT) against predicate EVS 3643 (a-Si TFT). Evaluated 8 body part positions (Chest PA, C-spine AP/LAT, L-spine LAT, Shoulder AP/LAT, Extremities). Results showed no significant difference in image performance; score differences were within one standard deviation, confirming equivalent diagnostic capability.

Technological Characteristics

Indirect conversion digital X-ray detector. Scintillators: CsI or GOS. Photodiode: a-Si PIN diode. TFT: amorphous Silicon or amorphous IGZO. Pixel pitch: 140μm. Connectivity: Wired (USB Type C to Ethernet/LAN) or Wireless (IEEE 802.11a/g/n). Power: 100-240V, 50/60 Hz. Standards: ANSI AAMI ES60601-1, IEC 62220-1, ISO 14971, IEC 60601-1-6, IEC 60601-1-2, ANSI AAMI IEC 62304. DICOM compliant.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in general purpose diagnostic procedures. Not for mammography. Applicable to all patient populations requiring general radiography.

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)

Related Devices

K232753 — EXPD 4343D; EXPD 3643D · DRTECH Corporation · Nov 16, 2023
K231959 — EXPD 4357; EXPD 4357P · DRTECH Corporation · Aug 1, 2023
K163703 — VIVIX-S 1417N · Vieworks Co., Ltd. · Feb 8, 2017
K201932 — X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) · Careray Digital Medical System Co., Ltd. · Aug 7, 2020
K200787 — BSD3543W · Bontech Co., Ltd. · Apr 23, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ January 26, 2023 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. DRTECH Corporation Shin Dongwook Regulatory Affairs Responsible Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 Dunchon-daero541 beon-gil, Jungwon-gu, Seongam-si, 13216 REPUBLIC OF KOREA Re: K193017 Trade/Device Name: EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643W / EVS 3643WG / EVS 3643WP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dear Shin Dongwook: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 22, 2019. Specifically, FDA is updating this SE Letter as an administrative correction to update the 510(k) Summary document, where the dimensions of several detector models were previously misstated as "13" instead of "14". Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Lu Jiang, OHT8: Office of Radiological Health, 240-402-5779, lu.jiang@fda.hhs.gov. Sincerely, Z. H. Ke Laurel Burk, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 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. November 22, 2019 DRTECH Corporation % Shin Dongwook Regulatory Affairs Responsible Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 Dunchon-daero541 beon-gil, Jungwon-gu, Seongam-si, 13216 REPUBLIC OF KOREA Re: K193017 Trade/Device Name: EVS 4343W / EVS 4343WG / EVS 3643WP / EVS 3643W / EVS 3643WG / EVS 3643WP Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 28, 2019 Received: October 29, 2019 Dear Shin Dongwook: 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. 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 located 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. {2}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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, Hole 2. Nils Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193017 Device Name EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP Indications for Use (Describe) The EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG / EVS 3643WP 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) | | |-------------------------------------------------------------------------------------------|----------------------------------------------| | 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: > Department of Health and Human Services Food and Druq 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." {4}------------------------------------------------ ## 510(k) Summary [As required by 21 CFR 807.92] ## K193017 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)] 11/22/2019 #### 2. Submitter's Information [21 CFR 807.92(a) (1)] - Name of Sponsor: DRTECH Corporation ● Address: Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, ● Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea ● Contact Name: DONGWOOK, SHIN - Telephone No.: + 82-31-779-7783 - Fax No.: + 82-31-779-7790 ● - Email Address : dwshin@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 4343W / EVS 4343WG / EVS 4343W EVS 3643W / EVS 3643WG / EVS 3643W | |-------------------------|--------------------------------------------------------------------------| | • Common Name: | Digital Flat Panel X-ray Detector | | • Classification Name: | Stationary X-ray System | | • Classification Panel: | Radiology | - 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 ● 006 1/8 510(k) Summary {5}------------------------------------------------ #### 5. Description of the Modified Device [21 CFR 807.92(a) (4)] <Modification> Addition of EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643 WP: The differences between the subject devices and the predicate devices are the size and the performance (MTF, DQE) of their detectors. In case of EVS 3643WP and EVS 4343WP, the TFT type was changed from amorphous Silicon to amorphous IGZO. These detectors differ in terms of the layers of their scintillators and TFT Type as shown in the following table: | Model Name | Scintillator layer | Photodiode | TFT | |------------|-----------------------------|-----------------|-------------------| | EVS 4343W | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous Silicon | | EVS 4343WG | GOS (Gadolinium Oxysulfide) | a-Si(PIN diode) | amorphous Silicon | | EVS 3643W | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous Silicon | | EVS 3643WG | GOS (Gadolinium Oxysulfide) | a-Si(PIN diode) | amorphous Silicon | | EVS 4343WP | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous IGZO | | EVS 3643WP | CsI (Cesium Iodide) | a-Si(PIN diode) | amorphous IGZO | IGZO is compound of indium(In)-gallium(Ga)-zinc(Zn)oxygen(O) and this compound is utilized as semiconductor material of TFT. Semiconductor material is only different material between conventional amorphous silicon TFT, that utilizing silicon as semiconductor material, and amorphous IGZO TFT. As IGZO has less resistance and leakage current on TFT switch off status than conventional amorphous silicon TFT, resistance capacity delay time for signal output could be reduced compare to conventional amorphous silicon TFT and also, line noise could be reduced compare to conventional amorphous silicon TFT. Difference between amorphous IGZO and conventional amorphous silicon TFT is shown in below table and right figure. Image /page/5/Figure/7 description: The image shows a graph of transfer characteristics, with the x-axis representing gate voltage in volts and the y-axis representing log drain current in amperes. Two curves are plotted on the graph, one for IGZO and one for a-Si. The IGZO curve is solid and the a-Si curve is dashed. The graph also includes annotations indicating 'Low Ron' and 'Low leakage current'. | Category | IGZO TFT | a-Si TFT | |---------------------------------------------|-----------------------------------------------|---------------| | Active Layer (Semiconductor Material) | indium(In)-gallium(Ga)-zinc(Zn)- oxygen(O) | Silicon(Si):H | | Crystal structure | Amorphous | Amorphous | | On Resistance(Ron) | 0.1~0.9MΩ | 1~10MΩ | | Leakage current (TFT switch off status) | <10-15A | <10-14A | In wired mode, Predicate devices used SSU or functional cable, however, subject devices use USB Type C to Ethernet and Lan cable. Optional components were removed such as generator interface cable. USB switch box and hand switch, USB cable and X-ray cable compared to predicated devices components. {6}------------------------------------------------ ORTECH The x-ray generator, a necessary component for a complete diagnostic system, is not part of the device. The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP detectors are compatible with the Econsolel software(Cleared under K152172). The subject software is the same as the predicate. #### 6. Indication For Use [21 CFR 807.92(a)(5)] The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP 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 svstems 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 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP 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 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP to be same to the predicate devices. The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP is functionally identical to the predicate devices. {7}------------------------------------------------ # DRTECH ### 8. Substantial Equivalence [21 CFR 807.92(b)] | Parameter | Subject Device | Predicate Device | | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | 510(K) Number | K193017 | K162552 | | | Manufacturer | DRTECH Corporation | DRTECH Corporation | | | Model Name | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | EVS 3643 / EVS 3643G | | | Classification Name | Stationary X-ray System | | | | Classification Panel | Radiology | | | | Classification Regulation | 21 CFR 892.1680 | | | | Product Code | MQB | | | | Device Class | Class II | | | | Intended Use | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP 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. | 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 | | | Design | Panel Shape | EVS 4343W: Square Panel EVS 4343WG: Square Panel EVS 4343WP: Square Panel EVS 3643W: Rectangular Panel EVS 3643WG: Rectangular Panel EVS 3643WP: Rectangular Panel | Rectangular Panel | | | Detector Size | EVS 4343W: 17" X 17" EVS 4343WG: 17" X 17" EVS 4343WP: 17" X 17" EVS 3643W: 14" X 17" EVS 3643WG: 14" X 17" EVS 3643WP: 14" X 17" | 14" X 17" | | | Dimensions | EVS 4343W: 460(W) x 460(L) x 15(H) EVS 4343WG: 460(W) x 460(L) x 15(H) EVS 4343WP: 460(W) x 460(L) x 15(H) EVS 3643W: 460(W) x 386(L) x 15(H) EVS 3643WG: 460(W) x 386(L) x 15(H) EVS 3643WP: 460(W) x 386(L) x 15(H) | 460(W) x 380(L) x 14.7(H) | | Parameter | Subject Device | Predicate Device | | | Pixel Pitch | 140μm | 140μm | | | Image Size | EVS 4343W: 3,072 x 3,072 EVS 4343WG: 3,072 x 3,072 EVS 4343WP: 3,072 x 3,072 EVS 3643W: 2,560 x 3,072 EVS 3643WG: 2,560 x 3,072 EVS 3643WP: 2,560 x 3,072 | 2,560 x 3,072 | | | Materials Scintillator | EVS 4343W: CsI EVS 3643W: CsI EVS 4343WP: CsI EVS 3643WP: CsI | EVS 3643: CsI | | | | EVS 4343WG: GOS EVS 3643WG: GOS | EVS 3643G: GOS | | | TFT | EVS 4343W: amorphous Silicon EVS 3643W: amorphous Silicon EVS 4343WP: amorphous IGZO EVS 3643WP: amorphous IGZO EVS 4343WG: amorphous Silicon EVS 3643WG: amorphous Silicon | EVS 3643: amorphous Silicon EVS 3643G: amorphous Silicon | | | DQE | EVS 4343W: 52.8% at 1.0 lp/mm EVS 3643W: 53.3% at 1.0 lp/mm EVS 4343WP: 50.0% at 1.0 lp/mm EVS 4343WP: 53.1% at 1.0 lp/mm | EVS 3643: 55.3 % at 1.0 lp/mm | | | | EVS 4343WG: 25.1% at 1.0 lp/mm EVS 3643WG: 25.9% at 1.0 lp/mm | EVS 3643G: 23.6 % at 1.0 lp/mm | | | Performance | MTF | EVS 4343W: 50.0% at 2.0 lp/mm EVS 3643W: 42.5% at 2.0 lp/mm EVS 4343WP: 48.4% at 2.0 lp/mm EVS 4343WP: 42.9% at 2.0 lp/mm | EVS 3643: 37.8% at 2.0 lp/mm | | | EVS 4343WG: 50.1% at 2.0 lp/mm EVS 3643WG: 47.8% at 2.0 lp/mm | EVS 3643G: 34 % 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 | | | Communication Method | Wire Wireless IEEE 802.11a//g/n (2.4 GHz / 5 GHz) Security: WEP/WPA/WPA2 | Wire Wireless IEEE 802.11a//g/n (2.4 GHz / 5 GHz) Security: WEP/WPA/WPA2 | | {8}------------------------------------------------ {9}------------------------------------------------ When compared to the predicate devices (K162552), the EVS 4343WG / EVS 4343WB / EVS 3643W / EVS 3643WG / EVS 3643WP presented in this submission have the same: - Intended Use . - . Technological characteristics - . Operating principle - . Performance (Resolution) - Communication Method • A few differences are as follows - Size - . TFT Type - Performance (DQE and MTF) - . Components There are no significant differences between the EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP 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. #### 9. 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 X-ray devices like DQE and MTF are basically equal or worth than the predicate device as following table: | Parameter | Modified Device | Predicate Device | |-----------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | DQE | EVS 4343W: 52.8% at 1.0 lp/mm EVS 3643W: 53.3% at 1.0 lp/mm EVS 4343WP: 50.0% at 1.0 lp/mm EVS 3643WP: 53.1% at 1.0 lp/mm | EVS 3643: 55.3% at 1.0 lp/mm | | | EVS 4343WG: 25.1% at 1.0 lp/mm EVS 3643WG: 25.9% at 1.0 lp/mm | EVS 3643G: 23.6% at 1.0 lp/mm | | MTF | EVS 4343W: 50.0% at 2.0 lp/mm EVS 3643W: 42.5% at 2.0 lp/mm EVS 4343WP: 48.4% at 2.0 lp/mm EVS 3643WP: 42.9% at 2.0 lp/mm | EVS 3643: 37.8% at 2.0 lp/mm | | | EVS 4343WG: 50.1% at 2.0 lp/mm EVS 3643WG: 47.8% at 2.0 lp/mm | EVS 3643G: 34% at 2.0 lp/mm | {10}------------------------------------------------ # RTECH The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643WG / EVS 3643WG / EVS 3643WP detector complies with the following international and FDA-recognized consensus standards: | Recognition No. | Standard No. | Title of Standard | Remark | |-----------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | 19-4 | ANSI AAMI ES60601- 1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | | | 12-289 | IEC 62220-1 Edition 1.0 2015-03 | Medical electrical equipment- Characteristics of digital X- ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging | | | 5-40 | ISO 14971 Second edition 2007-03-01 | Medical devices - Application of risk management to medical devices | | | 5-89 | IEC 60601-1-6 Edition 3.1 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | | 12-300 | PS 3.1 - 3.20 (2016) | Digital Imaging and Communications in Medicine (DICOM) Set | | | 19-8 | IEC 60601-1-2 Edition 4.0 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | | 13-32 | ANSI AAMI IEC 62304:2006 | Medical device software - Software life cycle processes | | The software of EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP comply 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" A single blind clinical image evaluation according to CDRH's "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was conducted as EVS 4343WP, EVS 3643WP utilized IGZO TFT that is different from predicate device. In this evaluation, 8 positions of body parts (Chest PA, Cspine AP, C-spine LAT, L-spine LAT, Shoulder AP, Shoulder LAT, Extremities) were {11}------------------------------------------------ selected to compare image performance between EVS 4343WP, EVS 3643WP and EVS 3643(K162552). Through this clinical image evaluation, it is indicated that there is no significant difference of image performance between EVS 4343WP, EVS 3643WP and EVS 3643 as difference in the score is within one standard deviation. Thus, this clinical image evaluation confirmed that the subject x-ray detectors(EVS 4343WP, EVS 3643WP) provide images of equivalent diagnostic capability to the predicate device (EVS 3643 -K162552). #### 10. Conclusion [21 CFR 807.92(b)(3)] The modified EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP detector is substantially equivalent to the currently marketed and predicate device (EVS 3643 / EVS 3643G, K162552) in terms of fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, Substantial equivalence was demonstrated through the non-clinical and clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, ANSI AAMI IEC 62304:2006, IEC 6220-1-1 and clinical image evaluation 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 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data and safety testing demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.