(24 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the DRTECH EVS detectors, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new devices (EVS 4343WP, EVS 3643WP) were primarily to demonstrate equivalent diagnostic capability to the predicate device (EVS 3643). This was assessed through clinical image evaluation, comparing image performance scores. For other device models and parameters (DQE, MTF), the acceptance typically involved being "basically equal or [better] than the predicate device."
Here's a table summarizing the comparison for key performance metrics:
| Parameter | Acceptance Criteria (relative to Predicate EVS 3643/EVS 3643G) | Reported Device Performance (Subject Devices) | Predicate Device Performance (EVS 3643/EVS 3643G) |
|---|---|---|---|
| DQE (CsI models) | Equal or better at 1.0 lp/mm | EVS 4343W: 52.8%EVS 3643W: 53.3%EVS 4343WP: 50.0%EVS 3643WP: 53.1% | EVS 3643: 55.3% |
| DQE (GOS models) | Equal or better at 1.0 lp/mm | EVS 4343WG: 25.1%EVS 3643WG: 25.9% | EVS 3643G: 23.6% |
| MTF (CsI models) | Equal or better at 2.0 lp/mm | EVS 4343W: 50.0%EVS 3643W: 42.5%EVS 4343WP: 48.4%EVS 3643WP: 42.9% | EVS 3643: 37.8% |
| MTF (GOS models) | Equal or better at 2.0 lp/mm | EVS 4343WG: 50.1%EVS 3643WG: 47.8% | EVS 3643G: 34% |
| Resolution | 3.5 lp/mm (matching predicate) | 3.5 lp/mm | 3.5 lp/mm |
| Clinical Image Performance (for IGZO TFT models) | No significant difference in image performance compared to predicate. | Difference in score within one standard deviation. | (EVS 3643 as predicate for comparison) |
Note: For DQE and MTF, the acceptance criterion implicitly means that the values should be close to or exceed the predicate's performance, indicating comparable or improved image quality metrics. The document states "basically equal or [better] than the predicate device." In some cases (e.g., EVS 4343W/EVS 3643W DQE vs. EVS 3643), the subject device values are slightly lower than the predicate, but this is presented within the context of "basically equal or [better] than" and ultimately deemed acceptable for substantial equivalence. For the GOS models, the subject devices showed improvement in DQE and MTF.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "8 positions of body parts (Chest PA, Cspine AP, C-spine LAT, L-spine LAT, Shoulder AP, Shoulder LAT, Extremities)" were selected for the clinical image evaluation. It does not explicitly state the number of images per body part or the total number of images in the test set. It also doesn't specify if these were real patient cases or phantoms.
- Data Provenance: Not explicitly stated. The manufacturer is based in the Republic of Korea, so the data could originate from there, but this is not confirmed. The study is described as a "clinical image evaluation." It's not specified if it's retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Described as a "single blind clinical image evaluation." This implies that the readers were blind to which device produced the image (subject vs. predicate). However, the specific method of consensus or individual scoring (e.g., 2+1, 3+1, none) among multiple readers is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: The document describes a "single blind clinical image evaluation" to compare image performance. This sounds like a MRMC study, as it compares the image performance of multiple devices (subject vs. predicate) using human readers.
- Effect Size of Human Reader Improvement: The document states that "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." This implies equivalence rather than an improvement with AI vs. without AI assistance, as this is a comparison of X-ray detectors themselves, not an AI software. The study's focus was on the diagnostic capability of the new hardware, not an AI's impact on human performance. Thus, no effect size of human improvement with AI is provided.
6. Standalone Performance (Algorithm Only)
- This section does not involve an algorithm with standalone performance, as the device is a digital X-ray detector (hardware). The software (Econsolel) is mentioned and being the same as the predicate's, but the evaluation focuses on the hardware's image acquisition performance.
7. Type of Ground Truth Used
- Ground Truth: For the clinical image evaluation, the "ground truth" was established by comparing the "image performance" scores between the subject device's images and the predicate device's images. This is an expert consensus or subjective evaluation of image quality and diagnostic capability, rather than an objective pathology or outcomes data.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes the evaluation of an X-ray detector, which is hardware, not an AI algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of an AI algorithm training set.
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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
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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.
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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
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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) |
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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 4343WEVS 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
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5. Description of the Modified Device [21 CFR 807.92(a) (4)]
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(SemiconductorMaterial) | 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.
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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.
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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 / EVS4343WP / EVS 3643W / EVS3643WG / EVS 3643WP Digital X-ray detector is indicatedfor digital imaging solutiondesigned for providing generalradiographic diagnosis of humananatomy. This device is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Thisdevice is not intended formammography applications. | EVS 3643, EVS 3643G Digital X-raydetector is indicatedfor digital imaging solution designedfor providing general radiographicdiagnosis of human anatomy. Thisdevice is intended to replace film orscreen based radiographic systems inall general purpose diagnosticprocedures. This device is not intendedfor mammography applications | |
| Design | Panel Shape | EVS 4343W: Square PanelEVS 4343WG: Square PanelEVS 4343WP: Square PanelEVS 3643W: Rectangular PanelEVS 3643WG: Rectangular PanelEVS 3643WP: Rectangular Panel | Rectangular Panel |
| DetectorSize | 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 3,072EVS 4343WG: 3,072 x 3,072EVS 4343WP: 3,072 x 3,072EVS 3643W: 2,560 x 3,072EVS 3643WG: 2,560 x 3,072EVS 3643WP: 2,560 x 3,072 | 2,560 x 3,072 | |
| Materials Scintillator | EVS 4343W: CsIEVS 3643W: CsIEVS 4343WP: CsIEVS 3643WP: CsI | EVS 3643: CsI | |
| EVS 4343WG: GOSEVS 3643WG: GOS | EVS 3643G: GOS | ||
| TFT | EVS 4343W: amorphous SiliconEVS 3643W: amorphous SiliconEVS 4343WP: amorphous IGZOEVS 3643WP: amorphous IGZOEVS 4343WG: amorphous SiliconEVS 3643WG: amorphous Silicon | EVS 3643: amorphous SiliconEVS 3643G: amorphous Silicon | |
| DQE | EVS 4343W: 52.8% at 1.0 lp/mmEVS 3643W: 53.3% at 1.0 lp/mmEVS 4343WP: 50.0% at 1.0 lp/mmEVS 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/mmEVS 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/mmEVS 3643W: 42.5% at 2.0 lp/mmEVS 4343WP: 48.4% at 2.0 lp/mmEVS 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/mmEVS 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 | 100 | |
| Communication Method | WireWirelessIEEE 802.11a//g/n(2.4 GHz / 5 GHz)Security:WEP/WPA/WPA2 | WireWirelessIEEE 802.11a//g/n(2.4 GHz / 5 GHz)Security:WEP/WPA/WPA2 |
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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/mmEVS 3643W: 53.3% at 1.0 lp/mmEVS 4343WP: 50.0% at 1.0 lp/mmEVS 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/mmEVS 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/mmEVS 3643W: 42.5% at 2.0 lp/mmEVS 4343WP: 48.4% at 2.0 lp/mmEVS 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/mmEVS 3643WG: 47.8% at 2.0 lp/mm | EVS 3643G: 34% at 2.0 lp/mm |
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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 andA1:2012 | Medical electrical equipment- Part 1: Generalrequirements for basic safetyand essential performance(IEC 60601-1:2005, MOD) | |
| 12-289 | IEC 62220-1 Edition 1.02015-03 | Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1:Determination of thedetective quantum efficiencyDetectors used inradiographic imaging | |
| 5-40 | ISO 14971 Second edition2007-03-01 | Medical devices - Applicationof risk management tomedical devices | |
| 5-89 | IEC 60601-1-6 Edition 3.1 | Medical electrical equipment- Part 1-6: Generalrequirements for basic safetyand essential performance -Collateral standard: Usability | |
| 12-300 | PS 3.1 - 3.20 (2016) | Digital Imaging andCommunications in Medicine(DICOM) Set | |
| 19-8 | IEC 60601-1-2 Edition 4.0 | Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances- Requirements and tests | |
| 13-32 | ANSI AAMI IEC62304:2006 | 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
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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.
§ 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.