RiX70 DC X-ray Unit is designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.

Device Description

The subject device is RiX70 DC X-rav Unit and it is an extraoral source dental x-ray system intended for intraoral imaging. The subject device is a device comprised of a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively:

A control unit equipped with wall plate, extension arm and wired control . device.
A tube head with x-ray tube.
X-ravs are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology. X-rav emission at 70 kV and 7 mA (maximum power), and the xray unit automatically calculates the best exposure time (from 0.01 s to 2.00 s) based on the selected tooth and patient size, as well as an adjustable arm that allows for easy positioning. This device may also be adjusted manually to the user's specific radiographic technique.
The system can be used either with conventional film or a digital imaging system.
The RiX70 DC is available in two configurations: a wall-mount configuration and a floor-standing configuration, and provides for three selections of kVp: 60kVp, 65kVp, and 70kVp.

AI/ML Overview

This submission is for an X-ray unit, which is hardware, not an AI/ML device. Therefore, the questions related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

Here's an analysis of the provided document focusing on the acceptance criteria and study for the RiX70 DC X-ray Unit:

Acceptance Criteria and Study for RiX70 DC X-ray Unit

The provided document describes the substantial equivalence determination for the RiX70 DC X-ray Unit to a predicate device (RX DC). The acceptance criteria primarily revolve around meeting recognized performance standards and demonstrating similar technological characteristics and safety profiles to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an X-ray unit and not an AI/ML device, the acceptance criteria are based on compliance with electrical, safety, and performance standards. The "reported device performance" reflects the device's conformity to these standards and its characteristics compared to the predicate.

Acceptance Criteria Category	Specific Criteria (Applied to RiX70 DC)	Reported Device Performance
Indications for Use / Intended Use	Must be substantially equivalent to predicate device.	Same as Predicate:- Designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes.- Can be used with traditional x-rays (chemicals) or digital x-ray sensors.- Designed for acquisition of intraoral images of teeth, jaw, and mouth structure for diagnostic purposes.
Device Description	Similar core function as the predicate device (extraoral source dental x-ray system for intraoral imaging).	Similar to Predicate:- Double mobile and articulate support arm.- Control unit with wall plate, extension arm, wired control device.- Tube head with x-ray tube.- High frequency and constant potential generators with built-in round collimator.- High frequency (HF) technology.- Automatically calculates exposure time based on selected tooth and patient size, or adjustable manually.- Can be used with conventional film or digital imaging.- Available in wall-mount and floor-standing configurations.- 60kVp, 65kVp, and 70kVp selections.
Technological Characteristics	Similar operating principles, key components (X-ray tube, HV generator, anode material), and safety features. Any differences must be well-justified and proven equivalent.	Mostly Same/Similar to Predicate:- Principle of use: X-ray tube (Same)- HV generator: High frequency, Constant potential (Same)- Anode material: Tungsten (Same)- Focal spot size: 0.4mm (IEC 60336/1993) (Same)- Leakage radiation: < 0.25 mGy/h (@ 1 m) (Same)- Exposure times control: Microprocessor controlled (Same)- Exposure modes: Preset loading factors or manual mode (Same)- Selectable parameter: Patient type, anatomical position, film type (Similar - predicate listed patient type/anatomical position, implicit film type for both)- Patient type: Adult-Child (Same)- Tooth type: Molar, Premolars, Incisors/canines, Bite wing (Same)- Film type: Photo-stimulated plate or sensor (Same)- Installation configuration: Wall-mounted standard version (Same), Subject has additional Stand mobile version (Similar - additional option)- X-ray emission control: Wired control (Different - predicate had remote control)- Tube voltage (kV): 60, 65, 70 kV (Different - predicate had 60 kV only)- Tube current (mA): 7 mA fixed (Similar - predicate had 7 mA, 3.5 mA)- Exposure time: 0.02 sec-2 sec (R' so steps) (Different - predicate had 0.01 sec - 1 sec (in R 20 steps))- X-ray tube & Anode angle: 16° (Similar - predicate had 12.5°)- Focus film distance: Standard round (fix): 200 mm (8"), Standard rectangular (removable): 45x35mm (Different size - predicate had Short round (fix): 200 mm (8"), Long rectangular (removable): 300mm (12"))- Diameter of x-ray beam cone: Short round (fix): Ø 60 mm (Different size - predicate had Short round (fix): Ø 60 mm, Long rectangular (removable): Ø 45x35mm, Round (removable): Ø 55 mm)
Performance Standards	Must comply with relevant national and international electrical, safety, and medical device standards.	Compliant:- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (Medical electrical equipment - General requirements for basic safety and essential performance)- IEC 60601-1-6:2010 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability)- IEC 62366: 2007 (Medical devices - Application of usability engineering to medical devices)- IEC 60601-1-3:2008 (Second Edition) (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment)- IEC 60601-2-65:2012 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment)- IEC 60601-1-2:2007 (EMC) (Medical electrical equipment - Electromagnetic compatibility - Requirements and tests)- IEC 62304 (Medical device software: Software Life Cycle Processes)- ISO 14971 (Medical devices - Application of risk management to medical devices)Outcome: All requirements met. CB certificate obtained.
Software/Firmware	Must be developed and tested according to appropriate risk levels (e.g., Moderate Level of Concern) and relevant software standards.	Compliant:- Software/Firmware quality activities conducted for a Moderate Level of Concern.- Activities for conformance with IEC 62304.
Risk Analysis	Must identify and mitigate risks associated with the device's use, particularly radiation exposure.	Compliant:- Risk management performed according to ISO 14971.- Addressed radiation exposure to the user under mobile operating conditions.- Recommendations for safety precautions (e.g., personnel monitoring, protective equipment) in the user manual.

Study Proving Device Meets Acceptance Criteria:

The study to prove the device meets acceptance criteria is primarily a non-clinical performance study focusing on bench testing and compliance with recognized standards.

Type of Study: Non-clinical (bench testing, standards compliance, comparison to predicate).
Methodology:
- Direct Comparison with Predicate Device: A detailed comparison of technological characteristics (Table 5.1) was performed to demonstrate substantial equivalence in terms of intended use, indications for use, and technological features. Differences were noted and implicitly deemed not to raise new questions of safety or effectiveness.
- Compliance Testing to Recognized Standards: The device underwent rigorous testing to ensure conformity with various IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility (EMC), radiation protection, usability, and software lifecycle processes.
- Risk Analysis: A risk management process was conducted in accordance with ISO 14971.

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

Sample Size: Not applicable in the traditional sense for an AI/ML model's test set. For an X-ray unit, the "sample" would be the device itself subjected to various tests outlined by the standards. These tests are typically performed on a limited number of units (e.g., one or a few production units) to demonstrate design and manufacturing compliance. The document does not specify the exact number of units tested but implies that tests were performed on the "subject device."
Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML model. The "data" here refers to test results from a lab environment. The CB certificate from IMQ Italy indicates the testing body and country of origin for the compliance testing.

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

Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation. The "ground truth" for an X-ray unit is its ability to meet engineering specifications and safety standards as measured by calibrated equipment and assessed by qualified test engineers and regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable. There is no subjective interpretation or consensus-building on image findings. Compliance is determined by objective measurements against predefined thresholds in standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This device is an X-ray unit, which produces images, it does not interpret them with or without AI assistance.

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

Not applicable. This is an X-ray unit, not an AI/ML algorithm. Its "standalone performance" is its ability to generate X-rays within specified parameters and meet safety standards.

7. The Type of Ground Truth Used:

Engineering Specifications and Recognized International Standards: The "ground truth" for this device is compliance with the objective electrical, mechanical, radiation, and software safety requirements defined in the listed IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 62366, ISO 14971). The device's performance metrics (like leakage radiation, focal spot size, tube voltage, current, exposure time) are compared against the requirements and specifications, some of which are standardized.

8. The Sample Size for the Training Set:

Not applicable. This is an X-ray unit, not an AI/ML device that requires training data.

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

Not applicable.

Summary

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September 13, 2018

Trident s.r.l % Joyce St. Germain Regulatory Consultant The 510k Consulting LLC 1449 Springleaf Dr. Ormond Beach, Florida 32174

Re: K182206

Trade/Device Name: RiX70 DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: August 8. 2018 Received: August 15, 2018

Dear Joyce St. Germain:

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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Nils

Robert A. 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) K182206

Device Name RiX70 DC

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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510(k) Summary

Submitter/Applicant

Trident s.r.l. Via Artigiani 4, Castenedolo, 25014 (BS), Italy

Phone: +39 0302732485 Fax: +39 0302731647 Contact: Giorgio Rizzo, President Giorgio.rizzo33@trident-dental.com

Date Prepared: August 08, 2018

Preparer/Consultant

The 510k Consulting, LLC Phone: 904-477-3203 Primary Contact: Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com

Device Classification

Trade Name:	RiX70 DC
Common Name:	Unit, X-Ray, Extraoral with Timer
Regulation Name:	Extraoral Source X-ray System
Regulation Number:	21 CFR 872.1800
Product Code:	EHD
Regulatory Class:	II
510k Review Panel:	Dental

Predicate Device

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

510(k) Number:	K163519
Date Cleared	January 13, 2017
Trade Name:	RX DC
Common Name:	Unit, X-Ray, Extraoral with Time
Regulation Name:	Extraoral Source X-ray System
Regulation Number:	21 CFR 872.1800
Product Code:	EHD
Regulatory Class:	II
510k Review Panel:	Dental

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Indications for Use

Intended Use

The RiX70 DC is designed for the acquisition of intraoral images of the teeth, jaw and the mouth structure for diagnostic purposes.

Device Description

A control unit equipped with wall plate, extension arm and wired control . device.
A tube head with x-ray tube.

X-ravs are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology. X-rav emission at 70 kV and 7 mA (maximum power), and the xray unit automatically calculates the best exposure time (from 0.01 s to 2.00 s) based on the selected tooth and patient size, as well as an adjustable arm that allows for easy positioning. This device may also be adjusted manually to the user's specific radiographic technique.

The system can be used either with conventional film or a digital imaging system.

The RiX70 DC is available in two configurations: a wall-mount configuration and a floor-standing configuration, and provides for three selections of kVp: 60kVp, 65kVp, and 70kVp.

Comparison of Technological Characteristics with Predicate on next page.

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

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Table 5.1 -- Technological Comparison

	Subject Device	Predicate Device	Comparison
Device	RiX70 DC	RX DC	NA
Manufacturer	Trident s.r.l., Italy	Isemed Srl, Italy	NA
510(k) Number	NA	K163519	NA
Classification &Product Code	872.1800; EHD	872.1800; EHD	Same
Device Description	Dental X-raySystem	Dental X-raySystem	Same
Common Name	Extraoral SourceX-ray System	Extraoral SourceX-ray System	Same
Indications for use	RiX70 DC X-rayUnit is designedfor use in dentalsurgery to makeendo-oral x-raysfor diagnosticpurposes. Thisequipment can beused to producetraditional x-raysdeveloped usingchemicals or,alternatively, itcan be used withdigital x-raysensors.	RX DC x-ray unitis designed foruse in dentalsurgery to makeendo-oral x-raysfor diagnosticpurposes. Thisequipment can beused to producetraditional x-raysdeveloped usingchemicals or,alternatively, itcan be used withdigital x-raysensors.	Same
Intended use	The RiX70 DC isdesigned for theacquisition ofintraoral images ofthe teeth, jaw andthe mouthstructure fordiagnosticpurposes.	Same asIndications forUse Statement	Same
Principle of use	X-ray tube	X-ray tube	Same
Installationconfiguration	Wall-mountedstandard versionand Stand mobileversion	Wall-mountedstandard version	Similar /Subject devicehas anadditionaloption
X-ray emissioncontrol	Wired control	Remote control	Different
HV generator	High frequencyConstant potential	High frequencyConstantpotential	Same
Anode material	Tungsten	Tungsten	Same
Tube voltage(kV)	60, 65, 70 kV	60 kV	Different
Tube current(mA)	7 mA fixed	7 mA3.5 mA	Similar
Exposure time	0.02 sec-2 sec (R'so steps)	0.01 sec - 1 sec(in R 20 steps)	Different
X-ray tube &Anode angle	16°	12.5°	Similar
Focal spot size	0.4mmIEC 60336/1993	0.4mm	Same
Leakageradiation	< 0.25 mGy/h (@1 m)	< 0.25 mGy/h (@1 m)	Same
Focus filmdistance	Standard round(fix): 200 mm (8")Standardrectangular(removable):45x35mm	Short round (fix):200 mm (8")Longrectangular(removable):300mm (12")	Different size
Diameter of x-ray beam cone	Short round (fix):Ø 60 mm	Short round(fix): Ø 60 mmLongrectangular(removable): Ø45x35mmRound(removable):Ø 55 mm	Different size
Exposure timescontrol	Microprocessorcontrolledexposure times	Microprocessorcontrolledexposure times	Same
Exposuremodes	Preset loadingfactors or manualmode	Preset loadingfactors or manualmode	Same
Selectableparameter	Patient type,anatomicalposition, film type	Patient type,anatomicalposition	Same
Patient type	Adult--Child	Adult--Child	Same
Tooth type	Molar (upper andlower)Premolars (upperand lower)Incisors/canines(upper and lower)Bite wing	Molar (upper andlower)Premolars (upperand lower)Incisors/canines(upper and lower)Bite wing	Same
Film type	Photo-stimulatedplate or sensor	Photo-stimulatedplace or sensor	Same
Standards	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-65IEC 62304IEC 62366ISO 14971	IEC 60601-1IEC 60601-1-2IEC 62304	Subject deviceperformedmore IECstandards onthe device.Both passedall standardsperformed.

Table of Comparison

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

Non-Clinical Performance Data

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

Non clinical tests performed on the subject device:

Safety and EMC tests conducted in compliance with the declared standards:

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) .
IEC 60601-1-6:2010
IEC 62366: 2007
IEC 60601-1-3:2008 (Second Edition)
. IEC 60601-2-65:2012
. IEC 60601-1-2:2007 (EMC)

For all consensus standards here above all requirements have been met. Trident has obtained a CB certificate (CBTC IT-16415 2016-01-29) from IMQ ltalv.

Software/Firmware quality activities were conducted as appropriate for a Moderate Level of Concern, and included activities for conformance with IEC 62304, Medical device software: Software Life Cycle Processes.

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. Additional information for safety is found in the user manual for this device. Risk management was performed according to ISO 14971. This device is known as a moderate level of concern.

Conclusion

The subject and the predicate device have the same indications for use and the same intended use and the similar technological features. The RiX70 DC and the predicate, RX DC 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.

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Page 7 of 7

The RiX70 DC warrants a finding of substantial equivalence to the legally marketed RX DC 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.