(107 days)
No
The document describes a standard portable X-ray system and its components. There is no mention of AI, ML, image processing, or any related technologies in the intended use, device description, or performance studies. The focus is on the hardware and basic software control of the X-ray generation.
No.
The device is described as a portable X-ray system intended for acquiring X-ray images for diagnostic purposes, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The device may be used for handheld diagnostic imaging of body extremities" and "The device may be used for diagnostic imaging of the head, abdomen, cervical spine, or extremities."
No
The device description explicitly states it is a "portable X-ray system" composed of hardware components like an X-ray tube, device controller, power controller, user interface, and beam limiting part. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EzRay M18 is an X-ray system. It uses radiation to create images of the internal structures of the body. It does not analyze biological samples.
- Intended Use: The intended use clearly states that the device is used to "acquire X-ray images of the desired parts of a patient's anatomy." This is a diagnostic imaging function, not an in vitro diagnostic function.
Therefore, the EzRay M18 is a medical imaging device, specifically an X-ray system, and not an IVD.
N/A
Intended Use / Indications for Use
EzRay M18 (Model: VMX-P400) is a portable X-ray system, intended for use by a qualified/trained physician or technician to acquire X-ray images of the desired parts of a patient's anatomy on adult and pediatric patients (including head, chest, abdomen, cervical spine, and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
-
The device may be used for diagnostic imaging of the head, abdomen, cervical spine, or extremities.
-
The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
Product codes
IZL
Device Description
EzRay M18 (Model: VMX-P400), a medical portable X-ray system, operates on 57.6 Vdc supplied by a rechargeable Li-ion battery pack. The system is composed of an X-ray generating part including an X-ray tube, a device controller, a power controller, a user interface, a beam limiting part, and two optional components: remote controller and stand. The device software supports the EzRay M18 system, and the software is of Moderate level of concern. The device is designed for the human body using image receptors. The image detectors, a necessary component for a fully-functional x-ray system, are not part of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, chest, abdomen, cervical spine, and extremities
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained physician or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Image performance testing was performed on the EzRay M18 in comparison with a reference device XR5 (K150663) using a FDA-cleared flat-panel detector, 1417WCC (K171418). The results of MTF, spatial frequency, DQE and NPS were compared under the same exposure conditions. The results demonstrated that the general image performance of the subject device is equivalent to the reference device. The difference between the two devices is that EzRay M18 is a portable X-ray system whereas the reference device is a stationary diagnostic X-ray system. It is concluded that EzRay M18 demonstrated adequate image quality performance through comparative study with the reference device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
February 11, 2022
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 FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Vatech Co., Ltd. % Mr. Dave Kim Contact Title Medical Device Regulatory Affairs Mtech Group 7707 Fannin St., Ste. 200-V111 HOUSTON TX 77054
Re: K213462
Trade/Device Name: EzRay M18 (Model: VMX-P400) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: January 7, 2022 Received: January 13, 2022
Dear Mr. Kim:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213462
Device Name EzRay M18 (Model: VMX-P400)
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
EzRay M18 (Model: VMX-P400) is a portable X-ray system, intended for use by a qualified/trained physician or technician to acquire X-ray images of the desired parts of a patient's anatomy on adult and pediatric patients (including head, chest, abdomen, cervical spine, and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
-
The device may be used for diagnostic imaging of the head, abdomen, cervical spine, or extremities.
-
The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 – 510(k) Summary K213462
1. Traditional 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
2. Date 510K Summary prepared: January 7, 2022
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group
Address: 7705 Fannin St., Ste. 610, Houston, TX 77054
Tel: +713-467-2607
Contact person: Mr. Dave Kim (davekim@mtech-inc.net) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VATECH Co., Ltd.
Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea
Tel: +82-31-379-9492
Fax: +82-31-379-9400
Contact person: Daniel Kim / Manager (daniel.kim@vatech.com) |
4. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | EzRay M18 (Model: VMX-P400) |
| Common or Usual Name: | Medical Portable X-ray System |
| Regulation Classification: | Mobile X-ray system (21 CFR 892.1720) |
| Product Code: | IZL |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | MinXray, Inc. |
|---|---|
| Trade or Proprietary Name: | TR90BH |
| Common or Usual Name: | Mobile Diagnostic X-Ray System |
| Regulation Classification: | Mobile X-ray system (21 CFR 892.1720) |
| Product Code: | IZL |
| Class of Device: | Class II |
| Panel: | Radiology |
| 510(k) Number: | K 182207 |
4
6. Reference Device Information
| Manufacturer: | OSKO, Inc. |
|---|---|
| Trade or Proprietary Name: | XR5 |
| Common or Usual Name: | Stationary x-ray system |
| Regulation Classification: | Stationary x-ray system (21 CFR 892.1680) |
| Product Code: | KPR |
| Class of Device: | Class II |
| Panel: | Radiology |
| 510(k) Number: | K150663 |
7. Device Description
EzRay M18 (Model: VMX-P400), a medical portable X-ray system, operates on 57.6 Vdc supplied by a rechargeable Li-ion battery pack. The system is composed of an X-ray generating part including an X-ray tube, a device controller, a power controller, a user interface, a beam limiting part, and two optional components: remote controller and stand. The device software supports the EzRay M18 system, and the software is of Moderate level of concern. The device is designed for the human body using image receptors. The image detectors, a necessary component for a fully-functional x-ray system, are not part of this submission.
8. Indications for use
EzRay M18 (Model: VMX-P400) is a portable X-ray system, intended for use by a qualified/trained physician or technician to acquire X-ray images of the desired parts of a patient's anatomy on adult and pediatric patients (including head, chest, abdomen, cervical spine, and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
-
The device may be used for diagnostic imaging of the head, abdomen, cervical spine, or extremities.
-
The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
5
9. Substantial Equivalence Chart
| Subject Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Device Name | EzRay M18 (Model: VMX-P400) | TR90BH | XR5 | |
| Applicant Name | VATECH Co., Ltd. | MinXray, Inc. | OSKO, INC. | |
| 510(k) Number | K213462 | K182207 | K150663 | |
| Device Classification Name | Mobile X-ray system | Mobile X-ray system | Stationary X-ray system | |
| Classification Product Code | IZL | IZL | KPR | |
| Regulation Number | 21 CFR 892.1720 | 21 CFR 892.1720 | 21 CFR 892.1680 | |
| Regulation Class | II | II | II | |
| Indications for Use | EzRay M18 (Model: VMX-P400) is | |||
| a portable X-ray system, intended | ||||
| for use by a qualified/trained | ||||
| physician or technician to acquire | ||||
| X-ray images of the desired parts | ||||
| of a patient's anatomy on adult | ||||
| and pediatric patients (including | ||||
| head, chest, abdomen, cervical | ||||
| spine, and extremities). | ||||
| The device may be used for | ||||
| handheld diagnostic imaging of | ||||
| body extremities. | ||||
| The system is subject to the | ||||
| following limitations of use when | ||||
| stand-mounted: |
- The device may be used for
diagnostic imaging of the head,
abdomen, cervical spine, or
extremities. - The device may be used for
imaging of the chest when used
without a grid.
This device is not intended for
mammography. | The TR90BH is a portable X-ray system with
following limitations of use:
The device may be used for handheld
diagnostic imaging of body extremities
The device may be used for stand mounted
diagnostic imaging of head, abdomen, or
extremities.
The device may be used for stand mounted
imaging of the chest when used without a
grid. - Not to be used on bariatric patients,
unless imaging body extremities - Not for mammography use
- The TR90BH is not intended to replace a
stationary radiographic system, which may
be required for full optimization of image
quality and radiation exposure for different
exam types. | The XR5 diagnostic X-ray system
is intended for use on adult and
pediatric patients for taking
diagnostics radiographic
exposure of all body parts and
operated by a qualified/trained
doctor or technician. The XR5
diagnostic X-ray system is
designed to be used with
conventional film/screen, CR
cassettes or digital detectors.
NOT intended for
Mammography use. | |
| | | | | |
| | Size: Body | 214 x 305 x 309 mm
(excluding Skin Distance Bar) | 219 x 442 x 190 mm | 1,940 mm (Tube stand height),
1,480 mm (Vertical movement),
2,540 mm (Longitudinal
movement) |
| Technol
ogical | Weight | 5.88 kg | 7.5 kg | - |
| | Collimator | Four manually and steplessly
adjustable shutters with LED
Light
x-ray field indicator | Mikasa BLD34L | Manual (K062788) |
| | User Interface | Soft touch push buttons | Soft touch push buttons | push buttons |
| | Energy source | Rechargeable 57.6 V DC
Li-ion battery pack | Lithium-ion Rechargeable Battery
(57.6DC), 300 exposures per charge. | 110-220 VAC |
| | Exposure times | 0.02 sec - 2.0 sec: R'20 sec Step
(Exposure conditions follow R'20
in combination of mAs) | 0.01 sec - 1.0 sec : 0.01 sec Step
High Power Mode
0.01 sec - 0.3 sec : 0.01 sec Step | 6.3 sec Max. |
| | mA | 20 mA @ 40 - 90 kV (1 kV steps)
15 mA @ 61 – 90 kV (1 kV steps)
10 mA @ 81 – 90 kV (1 kV steps) | 20 mA @ 40 kVDC – 60 kVDC (2 kVP steps)
15 mA @ 62 kVDC – 80 kVDC (2 kVP steps)
10 mA @ 82 kVDC – 90 kVDC (2 kVP steps)
High Power Mode
15 mA @ 82 kVDC – 90 kVDC (2 kVP steps) | 10 - 500 mA |
| | Memory
settings | 10 memories via pushbutton | 5 memories via pushbutton | No |
| | HF Generator | High Frequency | High Frequency | High Frequency |
| | kW | 1.8 kW | 1.35 kW | 40 kW |
| | kVp | 40 – 90kVp | 40 – 90kVp | 40-125 kVp |
| | X-ray Tube | D-0814 | D-0814 | E7239x |
| | FDA Performance Standard | Complies | Complies | Complies |
6
VATECH Co., Ltd. Premarket Notification 510(k)=
7
9. The differences between the subject device and the predicate device
The subject device described in this traditional 510(k) is similar to the predicate device (K182207) in its indications for use and technological application. Both the subject and predicate devices are taking diagnostic Xrays using a variable tube voltage (kVp) and current time product (mAs) or exposure time. The collimator of the EzRay M18 device is a continuously adjustable light beam type similar to the predicate TR90BH. The user can irradiate X-ray by adjusting the X-ray filed size of the desire body part. Exposure parameters are similar for both EzRay M18 and TR90BH using the same Canon X-ray tube model D-However, EzRay 18 has a larger capacity of the X-ray mono tank within the X-ray tube spec, resulting in 0814. higher exposure output. The high power mode of the predicate device, TR90BH, is 15 mA, the output (KW) is 1.35 kW for the maximum tube voltage 90kV. EzRay M18 emits a maximum of 20 mA and the output of 1.8 kW when the maximum tube voltage is 90kV. Because EzRay M18 is capable of setting a higher mA under the same maximum tube voltage of 90kV, it is possible to capture radiographic images of the same body parts intended for the predicate device. For the energy source, battery pack, the subject device receives power from the built-in rechargeable Li-ion battery pack which as same as the predicate device (K182207) uses. Rechargeable Li-ion battery pack has been tested and is in conformity with the standard IEC 62133. Other differences include device design such as exposure time, size and user interface.
10. Non clinical Testing
Testing was performed successfully according to the following standards:
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 ●
- . IEC 60601-1-2:2014
- . IEC 60601-1-3:2008 (Second Edition) + A1:2013
- IEC 60601-2-28:2017
- IEC 60601-2-54:2009, AMD1:2015, AMD2:2018
- IEC 62133-2:2017
Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:
"The Content of Premarket Submissions for Software Contained in Medical Devices" "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use"
The device also conforms to the following:
21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products
21 CFR 1020.30: Diagnostic x-ray system and their major components
21 CFR 1020.31: Radiographic Equipment
Image performance testing was performed on the EzRay M18 in comparison with a reference device XR5 (K150663) using a FDA-cleared flat-panel detector, 1417WCC (K171418). The results of MTF, spatial frequency, DQE and NPS were compared under the same exposure conditions. The results demonstrated that the general image performance of the subject device is equivalent to the reference device. The difference between the two devices is that EzRay M18 is a portable X-ray system whereas the reference device is a stationary diagnostic X-ray system. It is concluded that EzRay M18 demonstrated adequate image quality performance through comparative study with the reference device.
8
11. Conclusions
In reference to the comparison information provide in Substantial Equivalence Chart, the subject device and the predicate device have little difference with its technological features. As demonstrated in the performance bench testing, X-ray performance and X-ray Safety of the subject device was tested in accordance with Federal standard 21CFR Part 1020.30 and 31 as well as international standards such as IEC 60601-1, 60601-2-54. Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. VATECH Co., Ltd. concludes that EzRay M18 (Model: VMX-P400) is substantially equivalent to the predicate device and its image quality performed equivalently in comparison with XR5 (K150663) using 1417WCC, a FDA-cleared digital detector (K171418) under the same exposure condition.