(29 days)
The EXPD 4357, EXPD 4357P 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 EXPD 4357, EXPD 4357P are 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. EXPD 4357P differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The EXPD 4357, EXPD 4357P Detector are indirect conversion devices 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 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.
The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than outlining specific clinical acceptance criteria and related studies for the EXPD 4357 and EXPD 4357P. The document primarily discusses non-clinical performance (DQE, MTF, Resolution) and compliance with regulatory standards.
Therefore, many of the requested details about acceptance criteria, study design, and clinical performance cannot be extracted from this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document provides performance data for non-clinical parameters and compares them to the predicate device. It does not state explicit clinical acceptance criteria in the sense of accuracy, sensitivity, or specificity for diagnosis. Instead, it compares the technical performance to show equivalence or superiority.
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device (EXPD 4357 / 4357P) Performance |
|---|---|---|
| DQE (Detective Quantum Efficiency) | EXPD 129P, EXPD 86P: 50.0 % at 0.5 lp/mm; EXPD 129PG, EXPD 86PG: 25.0 % at 0.5 lp/mm | Typ. 55.0 % at 0.5 lp/mm |
| MTF (Modulation Transfer Function) | EXPD 129P, EXPD 86P: 45.0 % at 2.0 lp/mm; EXPD 129PG, EXPD 86PG: 45.0 % at 2.0 lp/mm | Typ. 45.0 % at 2.0 lp/mm |
| Resolution | 3.5 lp/mm | 3.5 lp/mm |
Note: The document states that "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." This phrasing suggests the "acceptance criteria" are simply to perform comparably or better than the predicate for these technical specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical bench testing. There is no mention of a test set comprising patient data or clinical images. The performance data (DQE, MTF, resolution) are derived from technical measurements, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This was a non-clinical/technical performance evaluation, not a clinical study involving expert interpretation of images or establishment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The EXPD 4357/4357P is a digital X-ray detector, which is a hardware device for capturing images. It is not an AI-assisted diagnostic tool for which an MRMC study would be conducted to evaluate reader performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device. Its "performance" is in image capture quality, not diagnostic interpretation by an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance characteristics (DQE, MTF, Resolution), the "ground truth" is established through standardized physical measurement methods as outlined in IEC 62220-1-1. This is not a clinical ground truth.
8. The sample size for the training set
The document describes a hardware device, not an AI or software algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this hardware device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
August 1, 2023
DRTECH Corporation % Lee Youna Assistant Manager Suite No.1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-Daero 541 Beon-Gil. Jungwon-Gu Seongnam-si, Gyeonggi-do 13216 SOUTH KOREA
Re: K231959
Trade/Device Name: EXPD 4357, EXPD 4357P Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: June 30, 2023 Received: July 3, 2023
Dear Lee Youna:
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.
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
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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 (OS) 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team 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
Enclosure
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Indications for Use
510(k) Number (if known) K231959
Device Name EXPD 4357, EXPD 4357P
Indications for Use (Describe)
The EXPD 4357, EXPD 4357P 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) Number: K231959
DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
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)]
06/30/2023
2. Submitter's Information [21 CFR 807.92(a) (1)]
- Name of Sponsor: ● DRTECH Corporation ● Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea ● Contact Name: Minjeong Kim
-
- 82-31-779-7710 Telephone No.: ●
- Fax No .: + 82-31-779-7790
- Email Address : drtechra@drtech.com ●
- Registration Number: 3005172103 ●
- Name of Manufacturer: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| • Trade Name: | EXPD 4357, EXPD 4357P |
|---|---|
| --------------- | ----------------------- |
- 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: MOB
- . Device Class: II
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| • 510(k) Number: | K223124 |
|---|---|
| • Applicant: | DRTECH Corporation |
| • Trade Name: | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PC |
| • 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)]
Addition of EXPD 4357, EXPD 4357P : The differences between the subject devices and the predicate devices are Dimension , TFT panel material, and Components(optional). The Dimension of Subject devices is shorter than predicate devices.
6. Indication for Use [21 CFR 807.92(a)(5)]
The EXPD 4357. EXPD 4357P 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 EXPD 4357, EXPD 4357P are 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. EXPD 4357P differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The EXPD 4357, EXPD 4357P Detector are indirect conversion devices 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 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.
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DRTECH
8. Integrated Configuration for X-Ray system
The EXPD 4357, EXPD 4357P are connected with General diagnostic X-ray system.
Image /page/5/Figure/4 description: This image shows a diagram of an X-ray system. The diagram includes components such as an X-ray system generator, an EXPD 4357/EXPD 4357P, a console PC, and a hospital network. The components are connected by cables, including a SYNC cable, a POE cable, a LAN cable, and an Ethernet cable. The diagram also shows an adaptor connected to AC 220V.
| No. | Component | Description |
|---|---|---|
| ① | POE Cable | 1) DC 24V voltage2) It is supplied from Adaptor to Detector. |
| ② | LAN Cable | 1) Gigabit Ethernet Communications2) It is transmitted from the detector to the CONSOLE PC. |
| ③ | SYNC Cable | 1) two-way TTL communication2) It is communicated between the detector and the X-ray System Generator. |
| ④ | Ethernet Cable | 1) DICOM communication2) It is transmitted from the CONSOLE PC to the hospital network. |
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For successful integration of detector with X-ray system, we designed the hardware of EXPD 4357, EXPD 4357P as below function. The Energy of generator is controlled by Radiography imaging software(Econsole1, K152172), not firmware of Detector.
| Mode | Description |
|---|---|
| AED/AWC Mode | The detector detects actual amount of X-rays without any connection to the X-raygenerator.No signal used (No need of connector interface cable) |
| Sync. Trigger Mode | The detector receives EXP_REQ signal that X-ray generator is prepared togenerate X-rays.The detector prepares image acquiring and then responds EXP_OK signal to theX-ray generator.The X-ray generator confirms EXP_OK signal and generates X-ray, then thedetector performs image acquiring, according to image acquisition time andtransmits the image data.EXP_REQ (Generator→ Detector), EXP_OK (Detector →Generator) |
9. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device | |
|---|---|---|---|
| 510(K) Number | Unknown | K223124 | |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | |
| Model Name | EXPD 4357, EXPD 4357P | EXPD 86P, EXPD 86PG,EXPD 129P, EXPD 129PG | |
| Classification Name | Stationary X-ray System | Stationary X-ray System | |
| Classification Panel | Radiology | Radiology | |
| ClassificationRegulation | 21 CFR 892.1680 | 21 CFR 892.1680 | |
| Product Code | MQB | MQB | |
| Device Class | Class II | Class II | |
| Intended Use | The EXPD 4357, EXPD 4357P DigitalX-ray detector is indicated for digitalimaging solution designed for providinggeneral radiographic diagnosis ofhuman anatomy. This device is intendedto replace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Thisdevice is not intended formammography applications. | The EXPD 86P/ EXPD 86PG/ EXPD129P/ EXPD 129PG Digital X-raydetector is indicated for digital imagingsolution designed 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. | |
| Parameter | Subject Device | Predicate Device | |
| mammography applications | |||
| Design | Panel Shape | Rectangular Panel | EXPD 129P, EXPD 129PG, EXPD 86P, EXPD 86PG : Rectangular Panel |
| Detector Size | 17" × 22" | EXPD 129P, EXPD 129PG: 17" × 51"EXPD 86P, EXPD 86PG: 17" × 34" | |
| Dimensions | 604mm (W) × 460mm (L) × 15.5mm (H) [±0.5mm] | EXPD 129P, EXPD 129PG: 460mm (W) × 1324mm (L) × 20mm (H) [±0.5mm]EXPD 86P, EXPD 86PG: 460mm (W) × 894.14mm (L) × 15.5mm (H) [±0.5mm] | |
| Pixel Pitch | 140μm | 140μm | |
| Image Size | 3,072 × 7,096 | EXPD 129P, EXPD 129PG: 3,072 × 9,216EXPD 86P, EXPD 86PG: 3,072 × 6,144 | |
| Panel & ScintillatorMaterials | Panel Material- EXPD 4357 : TFT - amorphous Silicon- EXPD 4357P : TFT - IGZO | TFT - amorphous Silicon | |
| Scintillator Material : CsI | Scintillator Material- EXPD 129P, EXPD 86P: CsI- EXPD 129PG, EXPD 86PG: Gadox | ||
| Perfor-mance | DQE | Typ. 55.0 % at 0.5 lp/mm | EXPD 129P, EXPD 86P: 50.0 % at 0.5 lp/mmEXPD 129PG, EXPD 86PG: 25.0 % at 0.5 lp/mm |
| MTF | Typ. 45.0 % at 2.0 lp/mm | EXPD 129P, EXPD 86P: 45.0 % at 2.0 lp/mmEXPD 129PG, EXPD 86PG: 45.0 % at 2.0 lp/mm | |
| Resolution | 3.5 lp/mm | 3.5 lp/mm | |
| Parameter | Subject Device | Predicate Device | |
| Anatomical Sites | General Radiography | General Radiography | |
| Power Supply | 100-240V~, 50-60 Hz | 100 | |
| Components | Adaptor & AC Power CordPOE CableSYNC CableLAN Cable | Adaptor & AC Power CordLLD POE CableLLD Sync Cable | |
| CommunicationInterface | Wired: Ethernet | Wired: Ethernet |
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Image /page/7/Picture/1 description: The image shows the word "DRTECH" in blue font. The letters are all capitalized and evenly spaced. There is a small square above the letter "D".
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When compared to the predicate devices (K223124), the EXPD 4357P presented in this submission have similar:
- Intended Use •
- . Technological characteristics
- . Operating principle
- . Performance (Resolution)
- Communication Method .
- Software(Firmware) •
A few differences are as follows
- Size .
- Performance (DQE and MTF) •
- . Panel Material
- . Components
There are no significant differences between the EXPD 4357P 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..
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DRTI
10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The non-clinical performance testing constrains the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or worth the predicate device as the following table:
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| DQE | Typ. 55.0 % at 0.5 lp/mm | EXPD 129P, EXPD 86P: 50.0 % at 0.5 lp/mmEXPD 129PG, EXPD 86PG: 25.0 % at 0.5 lp/mm |
| MTF | Typ. 45.0 % at 2.0 lp/mm | EXPD 129P, EXPD 86P: 45.0 % at 2.0 lp/mmEXPD 129PG, EXPD 86PG: 45.0 % at 2.0 lp/mm |
The EXPD 4357, EXPD 4357P detector comply with the following international and FDA-recognized consensus standards:
| RecognitionNo. | Standard No. | Title of Standard | Date ofRecognition | Remark |
|---|---|---|---|---|
| 5-125 | ISO 14971 Third Edition2019-12 | Medical devices - Application of riskmanagement to medical devices | 12/23/2019 | |
| 19-46 | ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021] | Medical electrical equipment - Part 1:General requirements for basic safety andessential performance (IEC 60601-1:2005, MOD) [Including Amendment 2(2021)] | 05/30/2022 | |
| 19-36 | IEC 60601-1-2 Edition 4.12020-09 CONSOLIDATEDVERSION | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - CollateralStandard: Electromagnetic disturbances -Requirements and tests | 12/21/2020 | |
| 5-132 | IEC 60601-1-6 Edition 3.22020-07 CONSOLIDATEDVERSION | Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateralstandard: Usability | 12/21/2020 |
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DRTECH
| RecognitionNo. | Standard No. | Title of Standard | Date ofRecognition | Remark |
|---|---|---|---|---|
| 5-129 | IEC 62366-1 Edition 1.12020-06 CONSOLIDATEDVERSION | Medical devices - Part 1: Application ofusability engineering to medical devices | 07/06/2020 | |
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION | Medical device software - Software lifecycle processes | 01/14/2019 | |
| 12-349 | NEMA PS 3.1 - 3.20 2022d | Digital Imaging and Communications inMedicine (DICOM) Set | 12/19/2022 | |
| 12-289 | IEC 62220-1-1 Edition 1.02015-03 | Medical electrical equipment-Characteristics of digital X-ray imagingdevices Part 1-1: Determination of thedetective quantum efficiency Detectorsused in radiographic imaging | 08/14/2015 |
11. Related FDA Guidance documents
We reviewed the below FDA guidance documents and it was reflected in the development of the modified EXPD 4357, EXPD 4357P detector.
| Title of Guidance | Remark |
|---|---|
| Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | |
| Pediatric Information for X-ray Imaging Device Premarket Notifications | |
| Guidance for the Content of Premarket Submissions for Software Contained in MedicalDevices |
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DRTECH
12. Conclusion [21 CFR 807.92(b)(3)]
The modified EXPD 4357 and EXPD 4357P detectors are substantially equivalent to the currently marketed and predicate device (K223124) in terms of 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, ANSI AAMI ES60601-1:2005/AMD2:2021, IEC 60601-1-2:2020, IEC 60601-1-6 Edition 3.2, IEC 62304:2015 and IEC 6220-1-1 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 EXPD 4357P meet the acceptance criteria and are adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, and safety testing demonstrates that the device is 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.