Ai Ray Dental X-Ray Device 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

Ai Ray Dental X-Ray Device is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable supercapacitor to allow for the use of the Portable Dental X-ray Device where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.

AI/ML Overview

This document describes the Ai Ray Dental X-Ray Device, an extraoral diagnostic dental X-ray source. The information provided focuses on the device's substantial equivalence to a predicate device, the EzRay Air Portable (Model: VEX-P300).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ai Ray Dental X-Ray Device are based on its compliance with various international and FDA standards for medical electrical equipment, radiation protection, and software lifecycle processes. The reported device performance is demonstrated by its adherence to these standards and its substantial equivalence to the predicate device.

Characteristic	Acceptance Criteria (Compliance with Standards/Predicate Equivalence)	Reported Device Performance (as stated in the document)
Safety and EMC	Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, and other relevant safety and electromagnetic compatibility standards.	The device demonstrates compliance with ANSI AAMI ES60601-1, IEC 60601-1-2. The documentation states "The performance test demonstrated that the difference doesn't raise safety and effectiveness issues." for differences in electrical characteristics like exposure time, tube current, and tube voltage.
Radiation Protection	Compliance with IEC 60601-1-3, IEC 60601-2-65, FDA Guidance for Radiation Safety, and 21 CFR 1020.30 regarding radiation protection in diagnostic X-ray equipment and for handheld use.	The device demonstrates compliance with IEC 60601-1-3, IEC 60601-2-65. The backscattering shield meets FDA requirements. "The performance test demonstrated that the difference doesn't raise safety and effectiveness issues." for tube current and tube voltage.
Imaging Performance	Compliance with IEC 61223-3-4 for imaging performance of dental X-ray. The device should produce diagnostic quality X-ray images.	The device is designed to "produce diagnostic quality X-rays images." The performance testing demonstrated compliance with the noted standards, including imaging performance.
Software Life Cycle Processes	Compliance with IEC 62304:2006/A1:2015 and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.	The device demonstrates compliance with IEC 62304:2006/A1:2015 and relevant FDA Guidance.
Usability Engineering	Compliance with IEC 62366-1 Edition 1.0 2015-02 for application of usability engineering to medical devices.	The device demonstrates compliance with IEC 62366-1.
Cybersecurity	Compliance with FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.	The device demonstrates compliance with relevant FDA Guidance.
Substantial Equivalence	The device should be substantially equivalent to the Vatech Co., Ltd, Inc. EzRay Air Portable (Model: VEX-P300) in terms of indications for use, target populations, treatment method, and technological characteristics. Differences should not raise new or different questions of safety or effectiveness.	The document concludes that "The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Ai Ray Dental X-Ray Device is substantially equivalent to the Vatech Co., Ltd, Inc. EzRay Air Portable (Model: VEX-P300) cleared under K200182 with respect to the indications for use, target populations, treatment method, and technological characteristics."

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

The document does not provide details on a specific "test set" for performance evaluation in the context of clinical data. Instead, it refers to Non-Clinical Performance Testing to verify substantial equivalence, focusing on compliance with established standards.

Sample Size for Test Set: Not applicable in the context of clinical data for this submission. Performance was validated through compliance with standards.
Data Provenance: Not applicable for clinical data. The device itself is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd. in China.

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

As no clinical data or test set requiring expert ground truth for comparison was used for this 510(k) submission, this information is not applicable. The device's performance was evaluated against technical and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication of ground truth was described.

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

No. The document explicitly states: "No clinical data was required to demonstrate substantial equivalence." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, this device is a physical X-ray device, not an AI algorithm. Its performance is related to its ability to generate X-ray images, not to interpret them or to function as a standalone AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptance is its compliance with technical and safety standards (e.g., IEC 60601 series, FDA regulations 21 CFR 1020.30, 21 CFR 1020.31) and its substantial equivalence to a legally marketed predicate device. This is primarily assessed through non-clinical performance testing to verify the device's technical specifications and safety parameters.

8. The Sample Size for the Training Set

Not applicable. As this device is a physical X-ray generator, it does not involve a "training set" in the context of machine learning or AI algorithms.

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

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

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.

November 23, 2022

Guilin Woodpecker Medical Instrument Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive CHANDLER, AZ 85249

Re: K222569

Trade/Device Name: Ai Ray Dental X-Ray Device Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: August 24, 2022 Received: August 24, 2022

Dear Charles Mack:

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

{1}------------------------------------------------

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 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 medical devices and radiation-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,

2022.11.23
Lu Jiang 09:33:38 -05'00'

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K222569

Device Name Ai Ray Dental X-Ray Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Remediation Use (Part 21 CFR 221 Subpart B)
Source Term Control Use (21 CFR 1271 Subpart D)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K22269	510(k) SUMMARY
Preparation Date:	November 21, 2022
Manufacturer's Name and Address:	Guilin Woodpecker Medical InstrumentCo LtdInformation Industrial Park, GuilinNational High-Tech Zone, Guilin City,Guangxi Province, China 541004
Corresponding Official:	Charles Mack
Telephone Number:	931-625-4938
Email Address:	charliemack@irc-us.com
Trade Name:	Ai Ray Dental X-Ray Device
Common Name(s):	unit, x-ray, extraoral with timer,
Regulation Name(s):	Extraoral source x-ray system
Regulation Number(s):	21CFR872.1800
Product Code:	EHD
Device Class:	Class II
Predicate Device:	Vatech Co., Ltd K200182
Trade Name:	EzRay Air Portable (Model: VEX-P300)
Common Name(s):	unit, x-ray, extraoral with timer,
Regulation Name(s):	Extraoral source x-ray system
Regulation Number(s):	21CFR872.1800
Product Code:	EHD
Device Class:	Class II

{4}------------------------------------------------

Device Description:

The proposed Ai Ray Dental X-Ray Device is similar in design to the predicate EzRay Air Portable, VEX-P300 (K200182). The proposed Ai Ray Device and the predicates is a portable dental X-ray system intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

The differences between the proposed Ai Ray Dental X-Ray Device and the predicate EzRay Air Portable, VEX-P300 (K200182) are as follows:

The opening key is positioned differently, EzRay Air Portable at the bottom and Ai Ray at the top.
The structural shapes of the two devices are different.

Principles of Operation

The equipment acquires images by emitting X-rays continuously on a human tooth. X-rays are emitted when high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit the anode to produce X-rays.

{5}------------------------------------------------

Characteristics	Subject Device	Predicate Device	Discussion
Device	Ai Ray Dental X-Ray Device	EzRay Air Portable (Model: VEX-P300)	-
510K Applicant	Guilin Woodpecker Medical Instrument Co., Ltd.	Vatech Co., Ltd	-
510(K) Number Regulation Number	PendingCFR872.1800	K200182CFR872.1800	Identical
Product Code	EHD	EHD	Identical
Classification Name	Extraoral source x-ray system	Extraoral source x-ray system	Identical
OTC or Prescription	Prescription Use	Prescription Use	Identical
Medical Specialty	Dental	Dental	Identical
Indication for Use	Ai Ray Dental X-Ray Device 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.	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.	Identical
Principle of Use	X-ray tube	X-ray tube	Identical
Mechanical
Size (L x W x H)	$114mm×363.8mm×2$45.6mm	280 x 165 x 296 mm	Different. Note 1
Source to Skin Distance	200~230mm	200 mm	Different. Note 2
X-ray Field Size	Ф5.6cm±0.1cm	6cm round	Different. Note 3
Mechanical
Characteristics	Subject Device	Predicate Device	Discussion
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.	Identical
Backscatter Radiation Protection	162 mm dia., Pb-filled acrylic plastic, Back Scattering shield	165 mm dia., Pb-filled acrylic plastic, Back Scattering shield	Different. Note 4
Exposure Switch	Exposure button on the handset	Exposure button on the handset	Identical
Tube Head Mounting	Handheld	Handheld	Identical
Electrical
Energy Source	Rechargeable 10.8V DC Li-ion polymer battery pack (Nominal Capacity: 2450~2500mAh )	Rechargeable 21.6 V DC Li-ion polymer battery pack (Nominal Capacity: 2,500 mAh)	Different. Note 5
Exposure Time	0.04-1.0 seconds in 0.01 increments	0.05 - 1.0 seconds in 0.01 increments	Different. Note 6
Tube Current (mA)	3 mA fixed, error±20%	2.5 mA fixed	Different. Note 7
Tube Voltage (kVp)	70 kV fixed, error±10%	60 or 65 kV fixed	Different. Note 8
Waveform	Constant Potential (DC)	Constant Potential (DC)	Identical
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 CFR1020.30, 1020.31	Identical

Comparison of Technological Characteristics with the Predicate Device

{6}------------------------------------------------

{7}------------------------------------------------

Differences Discussion:

Note1 The physical shape/size difference has no impact on safety and performance. Both devices conform to the same safety and performance standards.

Note 2 The distance difference has no impact on safety and performance. Both devices conform to the same safety and performance standards.

Note 3 The difference has no impact on safety and performance. Both devices conform to the same safety and performance standards.

Note 4 The size of the backscattering shield is different due to different device shapes. The radiation leakage value of the device with a backscattering shield after testing meets the requirements of the FDA. Security and performance are not affected.

Note 5 Although the battery specifications are different, they conform to the same requirement of IEC 62133 for the rechargeable battery. The differences do not raise issues of safety and effectiveness.

Note 6 Both devices conform to the same requirement of federal standard requirements. The performance test demonstrated that the difference doesn't raise safety and effectiveness issues.

Note 7 Although the X-ray tube's specifications are not identical and conform to the same performance standards IEC 60601-2-65, The performance test demonstrated the difference doesn't raise safety and effectiveness issues.

Note 8 Although the X-ray tube's specifications are not identical, and they conform to the same performance standards IEC 60601-2-65. The performance test demonstrated that the difference doesn't raise safety and effectiveness issues.

{8}------------------------------------------------

Performance Testing

Performance testing was provided to support the substantial equivalence determination and to validate and verify that the Ai Ray Dental X-Ray Device met all requirements of related applicable standards. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.

Non-Clinical Performance Testing

Non-clinical performance testing was performed to verify substantial equivalence to predicate devices.

Safety and EMC:

ANSI AAMI ES60601-1:2005 Medical electrical equipment Part 1: General । requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

Performance:

IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment Part 1-3: । General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment Part 1-6: -General requirements for basic safety and essential performance - Collateral standard
IEC 60601-2-65 Edition 1.1 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
IEC 62304:2006/A1:2015 "Medical device software Software life cycle processes."

{9}------------------------------------------------

IEC 62366-1 Edition 1.0 2015-02 Medical devices Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
FDA Guidance for the Content of Premarket Submissions for Software -Contained in Medical Devices
FDA Guidance for Radiation Safety Considerations for X-Ray Equipment -Designed for Handheld Use
FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket -Notifications," dated November 28, 2017
21 CFR 1020.30 Diagnostic x-ray system and their major components -
Content of Premarket Submissions for Management of Cybersecurity in -Medical Devices

Clinical Performance Data

No clinical data was required to demonstrate substantial equivalence.

Conclusions:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Ai Ray Dental X-Ray Device is substantially equivalent to the Vatech Co., Ltd, Inc. EzRay Air Portable (Model: VEX-P300) cleared under K200182 with respect to the indications for use, target populations, treatment method, and technological characteristics.

-END-

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.