EzRay Air Portable (Model: 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 Description

EzRay Air Portable (Model: VEX-P300), a portable dental X-ray system, operates on 21.6V DC supplied by a rechargeable Li-ion polymer battery pack. The portable 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 user interface, a beam limiting part, a back scattering shield, and an optional remote exposure switch. EzRay Air Portable (Model: VEX-P300) is designed to diagnose tooth and jaw through X-ray exposure using intraoral image receptors.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental X-ray device, the EzRay Air Portable (Model: VEX-P300). This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.

Therefore, much of the requested information regarding acceptance criteria and a study to prove device performance as a new device is not directly applicable or available in the provided text. The document primarily details bench testing to confirm that changes to an existing device do not raise new questions of safety or effectiveness.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Specified Standard/Requirement)	Reported Device Performance (Subject Device - EzRay Air Portable (Model: VEX-P300))
Focal Spot to Skin Distance	Minimum length of 20 cm (implicit from comparison to predicate)	Longer than 20 cm
Accuracy of Loading Factors (kVp)	≤ ±10% (essential performance requirement)	Met essential performance requirements
Reproducibility of Air KERMA	Met essential performance requirements	Met essential performance requirements
HVL (Half-Value Layer)	Satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements	Demonstrated similar performance outcomes to predicate, complied with requirements
Limitation of the X-ray Field	Satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements	Demonstrated similar performance outcomes to predicate, complied with requirements
Leakage Radiation Test	Satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements	Demonstrated similar performance outcomes to predicate, complied with requirements
Low Contrast & Line Pair Performance	Met requirements (implicit from "essential performance parameters" and standards compliance)	Met requirements
Battery Safety (for new battery)	Conformity with IEC 62133 (Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells)	In conformity with IEC 62133
General Safety and Performance Standards	Compliance with IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31	Complies with listed standards; all test results complied with requirements

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing and does not refer to a "test set" in the context of patient data or images. The "test set" would be the physical device itself and its components tested in a lab setting. The provenance of this test data (i.e., whether the bench tests were conducted in a particular country) is not specified. The testing is not based on a retrospective or prospective study with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth for image interpretation or disease diagnosis is not relevant in this type of bench testing. The "ground truth" for the performance tests comes from the established physical standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601 series). The experts involved would be engineers and physicists performing the standard compliance tests, not medical professionals establishing diagnostic ground truth from images.

4. Adjudication Method (for the test set)

Not applicable. There is no "adjudication method" in the context of diagnostic interpretation mentioned. The compliance of the device with technical standards is determined by direct measurement and comparison to defined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is designed to assess the performance of human readers, often with and without AI assistance, on diagnostic tasks involving patient cases. This document focuses on the technical safety and performance of an X-ray source, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The EzRay Air Portable (Model: VEX-P300) is an X-ray generating device, not an algorithm or AI product. Its performance is measured by its ability to produce X-rays according to specified technical parameters, not by an algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used

The ground truth used for the device's technical performance is based on established regulatory and international standards for medical X-ray equipment. This includes:

Physical measurements (e.g., focal spot to skin distance, leakage radiation).
Electrical and X-ray beam parameters (e.g., kVp accuracy, Air KERMA reproducibility, HVL, X-ray field limitation).
Safety standards (e.g., battery safety per IEC 62133).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is hardware, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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February 11, 2020

Image /page/0/Picture/1 description: The image contains 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.

Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs MtechGroup 7707 Fannin St., Ste. 200-V111 HOUSTON TX 77054

Re: K200182

Trade/Device Name: EzRay Air Portable (Model: VEX-P300) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: January 21, 2020 Received: January 24, 2020

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

For

Thalia T. Mills, Ph.D. Director 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

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Indications for Use

510(k) Number (if known) K200182

Device Name EzRay Air Portable (Model: VEX-P300)

Indications for Use (Describe)

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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Section 5 – 510(k) Summary K200182

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 21, 2020

3. Administrative Information

Official Correspondent:	Dave Kim / Mtech GroupAddress: 7707 Fannin St., Ste. 200-V111, Houston, TX 77054Tel: +713-467-2607Fax: +713-464-8880Contact 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, KoreaTel: +82-31-379-9492Fax: +82-31-379-9400Contact person: Daniel Kim / Manager (daniel.kim@vatech.co.kr)

4. Device Information

Type of 510(k) Submission:	Special
Trade or Proprietary Name:	EzRay Air Portable (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:	VATECH Co., Ltd.
Trade or Proprietary Name:	EzRay Air Portable (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
510(k) Number:	K161063

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6. Device Description

The device software is the same as the predicate device.

7. Indication for use

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8. Substantial Equivalence Chart

		Subject Device	Predicate Device
Device Name		EzRay Air Portable (Model: VEX-P300)	EzRay Air Portable (Model: VEX-P300)
Applicant Name		VATECH Co., Ltd.	VATECH Co., Ltd.
510(k) Number		N/A	K161063
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		EzRay Air Portable (Model: 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.	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.
	Size (L x W x H)	280 x 165 x 296 mm	280 x 165 x 296 mm
	Source to skin distance	200 mm	200 mm
	X-ray field Size	60 mm round	60 mm round
Mechanical	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.	Jog dial for operating mode selection. Additionally, several user-selectable preset times with patient size and tooth selection icons on a display module.
	Backscatter radiation protection	165 mm dia., Pb-filled acrylic plastic, Back Scattering shield	165 mm dia., Pb-filled acrylic plastic, Back Scattering shield
	Exposure Switch	Exposure button on the handset	Exposure button on the handset
	Tube head mounting	Handheld	Handheld
Electrical	Energy source1	Rechargeable 21.6 V DC Li-ion polymer battery pack (Nominal Capacity: 2,500 mAh)	Rechargeable 22.2 V DC Li-ion polymer battery pack (Nominal Capacity: 1,000 mAh or 900 mAh)
	Exposure time2	0.05 - 1.0 seconds in 0.01 increments	0.05 - 0.5 seconds in 0.01 increments
	mA	2.5 mA fixed	2.5 mA fixed
	kVp	60 or 65 kVp fixed	60 or 65 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, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31

Note: The differences between the subject device and the predicate device, No. 1 and 2, are discussion in the Section 10 below.

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9. Performance Data

- Summary of Performance Testing

The performance test for the subject device, EzRay Air Portable (Model: VEX-P300)and the predicate device, VEX-P300 (K161063) 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

EzRay Air Portable (Model: VEX-P300) described in this special 510(k) is same as the predicate device in its indications for use, design, technology, functions, and principle of operation. The differences are as follows:

(1) Energy source

Subject device-Rechargeable 21.6 V DC Li-ion polymer battery pack (Nominal Capacity: 2,500 mAh) Predicate device-Rechargeable 22.2 V DC Li-ion polymer battery pack (Nominal Capacity: 1,000 mAh or 900 mAh)

EzRay Air Portable (Model: VEX-P300)receives power from the built-in rechargeable Li-ion polymer battery pack. The batter pack has been updated to 21.6 V DC compared to the 22.2 V DC of the predicate device (K161063). The battery's nominal capacity has also been increased from 1,000 mAh to take more radiographic images per charge. Rechargeable 21.6 V DC Li-ion polymer battery pack with increased capacity has been tested and is in conformity with the standard IEC 62133(Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications )

(2) Exposure time

Subject device-0.05 - 1.0 seconds in 0.01 increments Predicate device-0.05 - 0.5 seconds in 0.01 increments

The irradiation time of EzRay Air Portable (Model: VEX-P300), the subject device, ranges 0.05~1.0 seconds compared to 0.05-0.5 seconds for the predicate device (EzRay Air Portable (Model: VEX-P300) – K161063). The increase of the maximum exposure time by 0.5 seconds would enable the users to choose a phosphor plate as well as a digital sensor as an intra oral X-ray receptor for convenience. The increased irradiation time has been tested and validated through the following tests: Accuracy of loading factors, HVL and Total filtration, limitation of the x-ray field, reproducibility of Air KERMA, Linearity of AIR KERMA and leakage radiation test. All test results are in compliance with Federal Standard (21CFR 1020.30 and 31) requirements.

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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 same 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 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 EzRay Air Portable (Model: VEX-P300) is substantially equivalent to predicate device as described herein.

Regulation Number and Section

§ 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.