EzRay Air (Model VEX-P300)

K161063 · VATECH Co., Ltd. · EHD · Sep 1, 2016 · Dental

Device Facts

• Record ID: K161063
• Device Name: EzRay Air (Model VEX-P300)
• Applicant: VATECH Co., Ltd.
• Product Code: EHD · Dental
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

EzRay Air (VEX-P300) is a portable dental X-ray system designed for imaging teeth and jaws. It consists of an X-ray generating tube, device controller, power controller, user interface, beam limiting component, backscattering shield, and optional remote exposure switch. Powered by a 22.2V DC Li-ion polymer battery, the device is handheld by dental technicians in clinical settings. The operator selects exposure parameters (kVp, time) via a jog dial and display module based on patient size and tooth type. The device generates X-rays to expose intraoral image receptors. The resulting images assist clinicians in dental diagnosis and treatment planning, providing a portable alternative to stationary X-ray units.

Clinical Evidence

Bench testing only. Performance testing compared the VEX-P300 to the predicate NOMAD Pro system. Evaluations included focal spot to skin distance, accuracy of loading factors (kVp), reproducibility of Air KERMA, half-value layer (HVL), X-ray field limitation, and leakage radiation. Results confirmed compliance with 21 CFR 1020.30/31 and IEC 60601-1, 60601-1-3, and 60601-2-65 standards. Both devices met essential performance parameters.

Technological Characteristics

Portable X-ray system; 22.2V DC Li-ion polymer battery power; 60/65 kVp fixed; 2.5 mA fixed; 0.05-0.5s exposure time. Includes Pb-filled acrylic backscatter shield. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31. User interface features jog dial and display for mode/preset selection.

Indications for Use

Indicated for adult and pediatric patients requiring extraoral diagnostic dental X-ray imaging using intraoral receptors; for use by dental technicians.

Regulatory Classification

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.

Predicate Devices

• NOMAD Pro X-ray System (K081664)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>Address: 12946 Kimberley Ln, Houston, TX 77079<br>Tel: [phone]<br>Fax: [phone]<br>Contact person: Mr. Dave Kim ([e-mail]) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VATECH Co., Ltd.<br>Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea<br>Tel: [phone]<br>Fax: [phone]<br>Contact person: Daniel Kim / Manager ([e-mail]) |

# 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<br>dental X-ray source to produce X-ray<br>images using intraoral image<br>receptors. It is indicated for use by a<br>dentist or a dental technician for<br>both adult and pediatric patients. | The NOMAD Pro X-ray System is<br>indicated for use only by a trained<br>and qualified dentist or dental<br>technician for both adult and<br>pediatric subjects as an extraoral<br>diagnostic dental X-ray source to<br>produce X-ray images using intraoral<br>image receptors. |
| | Size (L x W x H) | 280 x 165 x 296 mm | 266.7 x 133.35 x 304.8 mm |
| Mech<br>anical | Source to skin<br>distance | 200 mm | 210 mm |
| | X-ray field Size | 60 mm round | 60 mm round |
| | User Interface | Jog dial for operating mode selection.<br>Additionally, several user-selectable<br>preset times with patient size and<br>tooth selection icons on a display<br>module. | Up-down buttons for exposure time<br>selection, with timer display.<br>Additionally, several user-selectable<br>preset times with patient size, image-<br>receptor type, and tooth selection<br>icons on an LCD display. |
| | Backscatter<br>radiation<br>protection | 165 mm dia., Pb-filled acrylic plastic,<br>Back Scattering shield | 171.45 mm dia. Pb-filled acrylic<br>plastic scatter shield |
| | Exposure Switch | Exposure button on the handset | Trigger on Handset |
| | Tube head<br>mounting | Handheld | Handheld |
| Electr<br>ical | Energy source | Rechargeable 22.2 V DC Li-ion<br>polymer battery pack | Rechargeable 22.2 V DC Lithium<br>Polymer battery pack |
| | Exposure time | 0.05 - 0.5 seconds in 0.01 increments | 0.02 - 1.00 seconds in 0.01<br>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<br>60601-2-65, IEC 60601-1-2, 21 CFR<br>1020.30, 1020.31 | IEC 60601-1, EN 60601-1, EN 60601-<br>1-2, IEC 60601-1-3, IEC 60601-2-7, 21<br>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.