(139 days)
Not Found
No
The summary describes a standard portable dental X-ray system and its components. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for image analysis, exposure control, or any other function. The performance studies focus on the physical characteristics and radiation output of the device, not on any analytical capabilities.
No
The device is described as an "extraoral diagnostic dental X-ray source" used to "produce X-ray images" and "diagnose tooth and jaw". It is used for diagnosis, not treatment, which means it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states: "VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors." The "Device Description" also mentions it is "designed to diagnose tooth and jaw through X-ray exposure".
No
The device description explicitly states it is a "portable dental X-ray system" composed of hardware components like an "x-ray generating part with an x-ray tube," "device controller," "power controller," "user interface," "beam limiting part," and "back scattering shield." This indicates it is a hardware device, not software-only.
Based on the provided information, the VEX-P300 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The VEX-P300 is an X-ray source used to produce images of the teeth and jaw within the patient's body. It does not analyze biological samples.
- The intended use and device description clearly state it's an extraoral diagnostic dental X-ray source. This is a type of medical imaging device, not an IVD.
- The performance studies focus on the technical aspects of the X-ray system (focal spot distance, loading factors, Air KERMA, HVL, leakage radiation) and compare it to another dental X-ray system. This is typical for imaging devices, not IVDs.
Therefore, the VEX-P300 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.
Product codes
EHD
Device Description
VEX-P300, a portable dental X-ray system, operates on 22.2V DC supplied by a rechargeable Li-ion polymer battery pack. The portable x-ray system is an x-ray generating device which is mainly designed for dental examination (teeth and jaw). The portable X-ray system is composed of an x-ray generating part with an x-ray tube including a device controller, a power controller, a user interface, a beam limiting part, a back scattering shield, and an optional remote exposure switch. VEX-P300 is designed to diagnose tooth and jaw through X-ray exposure using intraoral image receptors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth and jaw
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
dental 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
The performance test for the subject device, VEX-P300 and the predicate device, NOMAD Pro X-ray System (K081664) confirmed that the focal spot to skin distance for both devices were longer than the minimum length of 20 cm. Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex. kVp ≤ ±10 %). Both devices demonstrated similar performance outcomes in terms of HVL, limitation of the x-ray field and leakage radiation test which rendered satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements.
Key Metrics
Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex. kVp ≤ ±10 %).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the profiles, creating a visual representation of health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K161063
Trade/Device Name: EzRay Air (Model VEX-P300) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 19, 2016 Received: July 26, 2016
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161063
Device Name EzRay Air VEX-P300
Indications for Use (Describe)
VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 – 510(k) Summary
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: July 15, 2016
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group
Address: 12946 Kimberley Ln, Houston, TX 77079
Tel: +713-467-2607
Fax: +713-464-8880
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.co.kr) |
4. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | EzRay Air (Model: VEX-P300) |
| Common or Usual Name: | Portable X-ray System |
| Regulation Classification: | Extraoral source x-ray system (21 CFR 872.1800) |
| Product Code: | EHD |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | Aribex, Inc. |
|---|---|
| Trade or Proprietary Name: | NOMAD Pro X-ray System |
| Common or Usual Name: | Portable X-ray System |
| Regulation Classification: | Extraoral source x-ray system (21 CFR 872.1800) |
| Product Code: | EHD |
| Class of Device: | Class II |
| Panel: | Radiology |
| 510(k) Number: | K081664 |
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6. Device Description
VEX-P300, a portable dental X-ray system, operates on 22.2V DC supplied by a rechargeable Li-ion polymer battery pack. The portable x-ray system is an x-ray generating device which is mainly designed for dental examination (teeth and jaw). The portable X-ray system is composed of an x-ray generating part with an x-ray tube including a device controller, a power controller, a user interface, a beam limiting part, a back scattering shield, and an optional remote exposure switch. VEX-P300 is designed to diagnose tooth and jaw through X-ray exposure using intraoral image receptors.
7. Indication for use
VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.
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8. Substantial Equivalence Chart
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Device Name | EzRay Air(Model: VEX-P300) | NOMAD Pro X-ray System | |
| Applicant Name | VATECH Co., Ltd. | Aribex, Inc. | |
| 510(k) Number | N/A | K081664 | |
| Device Classification Name | Extraoral source x-ray system | Extraoral source x-ray system | |
| Classification Product Code | EHD | EHD | |
| Regulation Number | 21 CFR 872.1800 | 21 CFR 872.1800 | |
| Indications for Use | VEX-P300 is an extraoral diagnostic | ||
| dental X-ray source to produce X-ray | |||
| images using intraoral image | |||
| receptors. It is indicated for use by a | |||
| dentist or a dental technician for | |||
| both adult and pediatric patients. | The NOMAD Pro X-ray System is | ||
| indicated for use only by a trained | |||
| and qualified dentist or dental | |||
| technician for both adult and | |||
| pediatric subjects as an extraoral | |||
| diagnostic dental X-ray source to | |||
| produce X-ray images using intraoral | |||
| image receptors. | |||
| Size (L x W x H) | 280 x 165 x 296 mm | 266.7 x 133.35 x 304.8 mm | |
| Mech | |||
| anical | Source to skin | ||
| distance | 200 mm | 210 mm | |
| X-ray field Size | 60 mm round | 60 mm round | |
| User Interface | Jog dial for operating mode selection. | ||
| Additionally, several user-selectable | |||
| preset times with patient size and | |||
| tooth selection icons on a display | |||
| module. | Up-down buttons for exposure time | ||
| selection, with timer display. | |||
| Additionally, several user-selectable | |||
| preset times with patient size, image- | |||
| receptor type, and tooth selection | |||
| icons on an LCD display. | |||
| Backscatter | |||
| radiation | |||
| protection | 165 mm dia., Pb-filled acrylic plastic, | ||
| Back Scattering shield | 171.45 mm dia. Pb-filled acrylic | ||
| plastic scatter shield | |||
| Exposure Switch | Exposure button on the handset | Trigger on Handset | |
| Tube head | |||
| mounting | Handheld | Handheld | |
| Electr | |||
| ical | Energy source | Rechargeable 22.2 V DC Li-ion | |
| polymer battery pack | Rechargeable 22.2 V DC Lithium | ||
| Polymer battery pack | |||
| Exposure time | 0.05 - 0.5 seconds in 0.01 increments | 0.02 - 1.00 seconds in 0.01 | |
| increments | |||
| mA | 2.5 mA fixed | 2.5 mA fixed | |
| kVp | 60 or 65 kVp fixed | 60 kVp fixed | |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | |
| Applied Standard | IEC 60601-1, IEC 60601-1-3, IEC | ||
| 60601-2-65, IEC 60601-1-2, 21 CFR | |||
| 1020.30, 1020.31 | IEC 60601-1, EN 60601-1, EN 60601- | ||
| 1-2, IEC 60601-1-3, IEC 60601-2-7, 21 | |||
| CFR 1020.30, 1020.31 |
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9. Performance Data
- Summary of Performance Testing
The performance test for the subject device, VEX-P300 and the predicate device, NOMAD Pro X-ray System (K081664) confirmed that the focal spot to skin distance for both devices were longer than the minimum length of 20 cm. Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex. kVp ≤ ±10 %). Both devices demonstrated similar performance outcomes in terms of HVL, limitation of the x-ray field and leakage radiation test which rendered satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements.
- Safety, EMC and Performance Data
The subject device complies with the safety and performance standards listed in the chart above, 'Substantial Equivalence Chart'. Test reports were provided to demonstrate conformance. All test results were complied with the requirements.
10. The differences between the subject device and the predicate device
The VEX-P300 Portable X-ray system described in this traditional 510(k) is similar to the predicate device in its indications for use, design, technology, functions, and principle of operation. The differences between the subject device and the predicate device are as follows:
① Device Size Subject device-280 x 165 x 296 mm Predicate device-266.7 x 133.35 x 304.8 mm હી ટેટા
Subject device-200 mm Predicate device-210 mm
3 Backscatter radiation protection size (diameter):
Subject device-165 mm dia. Predicate device-171.45 mm dia.
(4) Exposure time Subject device-0.05 - 0.5 seconds in 0.01 increments Predicate device-0.02 - 1.00 seconds in 0.01 increments
ട്ര Tube voltage (kVp), Tube current(mA)
Subject device-2.5 mA fixed, 60 or 65 kVp fixed Predicate device-2.5 mA fixed, 60 kVp fixed
The Performance Bench Testing demonstrated that these differences do not raise new questions of safety and effectiveness in comparison with the predicate device.
11. Conclusions
The subject device and the predicate device have similar indications for use and demonstrated similar design, technology, functions, and principle of operation. As demonstrated in the performance bench testing, X-ray performance and X-ray Safety and Image evaluation of the new and predicate devices were tested in accordance with Federal standard 21CFR Part 1020.30 and 31 as well as international standards such as IEC 60601-1, 60601-2-65, and 61223-3-4. Both the subject and predicate devices met the essential performance parameters
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including accuracy of loading factors, Reproducibility of Air KERMA, Focal Spot to Skin Distance, Leakage radiation, and Low Contrast & Line Pair performance requirements.
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 VEX-P300 is substantially equivalent to predicate device as described herein.