The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.

Device Description

The device is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located outside the mouth. All three conventional types of intraoral receptors can be used with this device: analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The Bi Image-X Evolution is a wall mounted device or can also be a floor model on a stand.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the BI IMAGE-X EVOLUTION, an extraoral X-ray system. The submission aims to demonstrate substantial equivalence to a predicate device, the Dental X-Ray Z70 (K122582).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the typical sense of quantitative performance thresholds for a diagnostic AI device (e.g., specific sensitivity, specificity, or AUC targets). Instead, it establishes substantial equivalence by comparing technological characteristics and adherence to safety standards.

Below is a table summarizing the technological comparison, which serves as the primary basis for demonstrating equivalence rather than meeting specific performance metrics for image analysis.

Characteristic	Acceptance Criteria (Predicate Device K122582)	Reported Device Performance (Subject Device BI IMAGE-X EVOLUTION)
Intended Use	Extraoral X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.	Extraoral X-ray generator that provides radiation for radiographic image formation for diagnosis.
Indications for Use	X-ray generator providing radiation for radiographic image formation for diagnosis.	Extraoral X-ray generator system for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
Electric Power Voltage	120 VAC ± 10% or 230 VAC ± 10%	108-132 VAC Monophase rectified
Rated Current	9 A (120V) - 4A (230V)	10A max (120V)
Type of Power Supply	50/60 Hz	50/60 Hz
kVp (kilovolt peak)	70 kVp ± 10%	70 kVp +/- 15% with 108-132 V
Exposure Time	0.06 — 2.50 sec	0.01-2.2 sec
Current to Tube	7 mA ± 1.40	10 mA +/- 20%
Maximum Radiation Field	Ø 60 mm	Ø 60 mm
Focal Point	0.8 mm x 0.8 mm (IEC 336)	0.8mm (IEC366)
X-Ray Generator	AC - Alternate Current	AC - Alternate Current
Operator Exposure Control	Deadman Switch	Deadman Switch
Exposure Interval (Duty Cycle)	1:60	1:32
Minimum Distance SSD	20 cm	20 cm
Fuses	10A 230V	10A 250V
Operating Temperature Range	-20°C - + 55°C	-20°C - + 70°C
Fixed Arm	27.56 inches (70 cm)	27.56 inches (70 cm)
Standards of Conformity	EN 60601-1, EN 60601-2-28, EN 60601-2-54, EN 60601-1-3, EN 60601-1-2	IEC 60601-1, IEC 60601-6, IEC 60601-3, IEC 60601-2-28, EN 60601-1-2

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

This document describes an X-ray generator, not an AI/ML-driven diagnostic device that relies on a "test set" in the context of image analysis. Therefore, there is no mention of a test set sample size or data provenance related to image data. The "testing data reports" mentioned are for electrical, mechanical, and safety performance of the hardware.

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

Not applicable. As this is not an AI/ML diagnostic device analyzing medical images, there's no "ground truth" established by experts in this context. The evaluation is based on technical specifications and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. There is no test set for image analysis requiring adjudication.

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

No. This document does not describe an MRMC study. The device is an X-ray generator aiming for substantial equivalence based on hardware and safety parameters, not on human reader performance with or without AI assistance.

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

No. This is not an algorithm-only (AI) device. It is an X-ray generator.

7. The Type of Ground Truth Used

The "ground truth" in this context is adherence to recognized electrical and safety standards (IEC 60601 series, EN 60601 series, and 21CFR 1020.030, 1020.31). The testing involved physical measurements and evaluations against these objective standards by an independent laboratory.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. No training set is involved.

Summary of the Study and Evidence Presented:

The study presented to prove the device meets acceptance criteria is primarily a technical comparison and compliance testing to demonstrate substantial equivalence to the predicate device (Dental X-Ray Z70, K122582) and adherence to relevant safety and performance standards.

Evidence Type:
- Technological Comparison: A detailed table (Table 5) comparing the subject device's specifications (e.g., kVp, mA, exposure time, focal point, power requirements) against those of the predicate device. The conclusion drawn is that the devices have "substantially similar technology characteristics."
- Performance Data: The submission includes "testing data reports" from an independent laboratory (Met Laboratories, Inc.) for:
  - EMC and Electrical Safety: Conformance to IEC 60601-1 3rd Edition (including IEC 60601-1-6, 60601-1-3, 60601-2-28) and EN 650601-1-2.
  - Radiation Performance Standards: Conformance to 21CFR 1020.030 and 1020.31 (presumably related to radiation output and limits for diagnostic X-ray systems).
- Software Verification and Validation: Performed by Radiotech, the manufacturer, and included in the submission. This indicates testing of the device's control software to ensure it functions as intended and safely.
- Risk Analysis: A risk assessment was performed, including recommendations for radiation exposure mitigation for users.
Conclusion of the Study: "The subject and the predicate device have the same intended use and the same technological features. The BI IMAGE – X and the Dental X-Ray Z70 share the same principles of operation and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate."

In essence, the "acceptance criteria" are implicitly met by demonstrating that the device is technically comparable to a legally marketed predicate and complies with established international and national safety and performance standards for X-ray equipment. No clinical studies or AI performance metrics are
mentioned because the device itself is an X-ray generator, not an imaging analysis tool.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2016

Radiotecnologia Industrial S.A. De C.V. % Claude Berthoin, President Denterprise International, Inc./ 510k FDA Consulting 100 East Granada Blvd Suite 219 Ormond Beach, FL 32176

Re: K160458

Trade/Device Name: BI IMAGE-X EVOLUTION Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: May 6, 2016 Received: May 10, 2016

Dear Claude Berthoin:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ResourcesforYou/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,

Robert Oaks

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) K160458

Device Name

BI IMAGE-X EVOLUTION

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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510k FDA Consulting

Medical Device Clearance

100 East Granada Blvd., Suite 219

Ormond Beach, FL 32176

386-506-8711

510(k) Summary

Submitter/Applicant

Radiotecnologia Industrial S.A. de C.V. Calle Puebla Sur, Manzana 4 Lote 5 Colonia Jardin Industria Ixtapaluca, Estado de Mexico, Mexico 56535

Contact: Marcelo Mojica, Engineering Manager Telephone: (01) 800-681-05-38 Date Prepared: February 15, 2016

Preparer/Consultant

Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176

Phone: 386-506-8711 Fax: 855-235-7902

Primary Contact:	Joyce St. Germain, Regulatory Executive
	Joyce@510kFDA.com
Secondary Contract:	Claude Berthoin, President
	Claude@510kFDA.com

Device Classification

Trade Name:
Common Name:
Classification Name:
Regulation Number:
Product Code:
Regulatory Class:
510k Review Panel:

BI IMAGE-X EVOLUTION Extraoral Source X-ray System Unit, X-Ray, Extraoral with Timer 21 CFR 872.1800 EHD 2 Dental

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Predicate Device

The subject device claims equivalence to the following legally marketed predicate:

510(k) Number:	K122582
Date Cleared	December 7, 2012
Trade Name:	Dental X-Ray Z70
Common Name:	Extraoral Source X-ray System
Classification Name:	Unit, X-Ray, Extraoral with Timer
Regulation Number:	21 CFR 872.1800
Product Code:	EHD
Regulatory Class:	2
510k Review Panel:	Dental

Indication for Use

The BI IMAGE-X EVOLUTION is an extraoral x-ray generator system is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.

Intended Use

The BI IMAGE -X EVOLUTION device is an extroral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

Device Description

Different models neither affect the device's indications for use nor raise differing issues of safety or effectiveness.

Comparison of Technological data on next page

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Characteristics with Predicate

The following table compares technological and other characteristics of the subject and predicate device.

Table 5 -- Technological Comparison

	Subject Device	Predicate DeviceK122582
Device	BI IMAGE-X	Dental X-Ray Z70
510(k) Owner	RadiotecnologiaIndustrial S.A. de C.V.(Mexico)	XZeal Technologies, Inc.(Kissimmee, FL)
Classification & ProductCode	872.72.1800; EHD	872.1800; EHD
Device Description	Extroral x-ray systemused for dentalradiographicexaminations anddiagnosising.	Extroral x-ray systemused for dentalradiographicexaminations anddiagnosising.
Common Name	Extraoral Source X-raySystem	Extraoral Source X-raySystem
Models	Wall Mount, Mobileand Column Units	Wall Mount, Mobileand Column Units
Indication for Use	The BI IMAGE-XEVOLUTION is anextraoral x-raygenerator system isdesigned to be used bydental professionals forradiographicexaminations to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structurein combination with anintraoral imagereceptor.	TheDental X-ray Z70device is an X-Raygenerator thatprovides the radiationnecessary for theformation of aradiographic imagefrom which aradiographic diagnosismay be made.
Intended Use	The BI IMAGE -XEVOLUTION device is anextraoral x-raygenerator that providesthe radiation necessaryfor the formation of aradiographic imagefrom which a	Extraoral source X-raysystem for dentalradiographicexamination anddiagnosis of diseasesof the teeth.
	radiographic diagnosismay be made.
Electric Power Voltage	108-132 VAC Monophaserectified	120 VAC ± 10% or230 VAC ± 10%
Rated Current	10A max (120V)	9 A (120V) - 4A (230V)
Type of Power Supply	50/60 Hz	50/60 Hz
kVp (kilovolt peak)	70 kVp +/- 15% with 108-132 V	70 kVp ± 10%
Exposure Time	0.01-2.2 sec	0.06 — 2.50 sec
Current to Tube	10 mA +/- 20%	7 mA ± 1.40
Maximum Radiation Field	Ø 60 mm	Ø 60 mm
Focal Point	0.8mm (IEC366)	0.8 mm x 0.8 mm(IEC 336)
X-Ray Generator	AC - Alternate Current	AC - Alternate Current
Operator Exposure Control	Deadman Switch	Deadman Switch
Exposure Interval(Duty Cycle)	1:32	1:60
Minimum Distancebetween the source andthe skin - SSD	20 cm	20 cm
Fuses	10A 250V	10A 230V
Operatiang TemperatureRange	-20°C - + 70°C	-20°C - + 55°C
Fixed Arm	27.56 inches (70 cm)	27.56 inches (70 cm)
Standards of Conformity	IEC 60601-1IEC 60601-6IEC 60601-3IEC 60601-2-28EN 60601-1-2	EN 60601-1EN 60601-2-28EN 60601-2-54EN 60601-1-3EN 60601-1-2

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The above comparison shows the subject and predicate devices have substantially similar technology characteristics.

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Performance Data

The following performance data were provided in support of the substantial equivalence determination.

EMC and Electrical Safety – IEC 60601-1 3rd Edition (which include IEC test specifications: 60601-1-6, 60601-1-3, 60601-2-28) and EN 650601-1-2. The testing data reports for the subject device are provided in this petition. Tests were conducted by independent laboratory (Met Laboratories, Inc. 33439 Western Avenue, Union city, CA 94587.

This device conforms to all applicable performance standards in 21CFR 1020.030 and 1020.31.

Software - Software verification and validation testing and risk analysis assessment were performed by Radiotech and is a part of this submission.

Risk Analysis Information

Risk analysis includes particular recommendations to address radiation exposure to the user under mobile operating conditions. Operators should always read the user manuals for medical devices and take the necessary precautions before using the device. Methods to reduce exposure is recommended safety precautions such as wearing personnel monitoring and protective equipment.

Conclusion

The subject and the predicate device have the same intended use and the same technological features. The BI IMAGE – X and the Dental X-Ray Z70 share the same principles of operation and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate.

The BI IMAGE - X warrants a finding of substantial equivalence to the legally marketed Dental X-Ray Z70 and thus clearance for premarket activities in the United States.

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.