(29 days)
Not Found
No
The description mentions the device automatically calculates exposure time based on selected tooth and patient size, but this is likely a rule-based algorithm or lookup table, not AI/ML. There are no mentions of AI, ML, or related terms, nor any descriptions of training or test data sets which are typical for AI/ML devices.
No
The device is described as an X-ray unit for diagnostic purposes (e.g., making endo-oral x-rays for diagnostic purposes), not for therapy.
Yes
The intended use explicitly states that the device is "designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes." This indicates its role in obtaining information for diagnosis.
No
The device description clearly outlines physical hardware components including a control unit, support arm, tube head with x-ray tube, and generators, indicating it is a hardware device with integrated software.
Based on the provided information, the RiX70 DC X-ray Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the RiX70 DC X-ray Unit is used to make endo-oral x-rays directly on the patient for diagnostic purposes. It produces images of the teeth, jaw, and mouth structure.
- The device description focuses on the generation and capture of X-rays. There is no mention of analyzing biological samples or using reagents, which are hallmarks of IVD devices.
The RiX70 DC X-ray Unit is a medical imaging device used for diagnostic purposes, but it operates by generating and capturing radiation within the patient's body, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
EHD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw and the mouth structure
Indicated Patient Age Range
Adult--Child
Intended User / Care Setting
dental surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests performed on the subject device include 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). All requirements have been met, and Trident has obtained a CB certificate (CBTC IT-16415 2016-01-29) from IMQ ltalv. Software/Firmware quality activities were conducted for conformance with IEC 62304. Risk management was performed according to ISO 14971, and the device is considered a moderate level of concern. The conclusion is that the subject device is as safe and effective as the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features an abstract design of a human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
Indications for Use
510(k) Number (if known) K182206
Device Name RiX70 DC
Indications for Use (Describe)
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.
| 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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3
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 |
4
Indications for Use
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.
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
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.
Comparison of Technological Characteristics with Predicate on next page.
The following table compares technological and other characteristics of the subiect and predicate device.
5
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-ray | ||
| System | Dental X-ray | ||
| System | Same | ||
| Common Name | Extraoral Source | ||
| X-ray System | Extraoral Source | ||
| X-ray System | Same | ||
| Indications for use | 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. | RX 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. | Same | ||
| Intended use | The RiX70 DC is | ||
| designed for the | |||
| acquisition of | |||
| intraoral images of | |||
| the teeth, jaw and | |||
| the mouth | |||
| structure for | |||
| diagnostic | |||
| purposes. | Same as | ||
| Indications for | |||
| Use Statement | Same | ||
| Principle of use | X-ray tube | X-ray tube | Same |
| Installation | |||
| configuration | Wall-mounted | ||
| standard version | |||
| and Stand mobile | |||
| version | Wall-mounted | ||
| standard version | Similar / | ||
| Subject device | |||
| has an | |||
| additional | |||
| option | |||
| X-ray emission | |||
| control | Wired control | Remote control | Different |
| HV generator | High frequency | ||
| Constant potential | High frequency | ||
| Constant | |||
| potential | Same | ||
| Anode material | Tungsten | Tungsten | Same |
| Tube voltage | |||
| (kV) | 60, 65, 70 kV | 60 kV | Different |
| Tube current | |||
| (mA) | 7 mA fixed | 7 mA | |
| 3.5 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 | 0.4mm | ||
| IEC 60336/1993 | 0.4mm | Same | |
| Leakage | |||
| radiation |