I-View Gold and Imagen Gold Dental Sensors

K200625 · Trident S.R.L · MUH · Apr 15, 2020 · Dental

Device Facts

• Record ID: K200625
• Device Name: I-View Gold and Imagen Gold Dental Sensors
• Applicant: Trident S.R.L
• Product Code: MUH · Dental
• Decision Date: Apr 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

I-View Gold sensors are digital dental intraoral sensors intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. Radiographic examination to assist with diagnosis of the teeth, jaw, and oral structure.

Device Story

Intraoral digital x-ray system consisting of a CMOS-based sensor and image management software (Deep-View/Archimed Suite). Sensor connects to PC via USB 2.0. Operates by collecting dental x-ray photons, converting to light via scintillator, filtering through fiber optics, and converting to digital signals via CMOS sensor. Used by dentists, radiologists, and qualified professionals in clinical settings. Device acts as a receiver; does not control x-ray generators. Provides near-instantaneous image acquisition for storage, viewing, and manipulation. Benefits include improved diagnostic workflow speed, ergonomic design for patient comfort, and lower dose exposure compared to film. Technical support provided by manufacturer.

Clinical Evidence

Bench testing only. Performance data includes electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2. Technical specifications (DQE, MTF, pixel pitch) compared to predicate to demonstrate equivalence. No clinical data provided.

Technological Characteristics

CMOS-based intraoral digital x-ray sensor. Sizes: 36.8x25.4mm (Size 1) and 42.9x31.3mm (Size 2). Thickness: 4.8mm. Connectivity: USB 2.0. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62336, EN 62304, IEC 60529, ISO 15223-1, ISO 14971. Power supplied via PC USB port.

Indications for Use

Indicated for dental radiographic examination to assist in the diagnosis of diseases of the teeth, jaw, and oral structure in patients requiring dental x-ray imaging.

Regulatory Classification

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.

Predicate Devices

• EzSensor Classic; HDI-U10DB and HDI-U20DB (K153060)

Reference Devices

• Archimed Suite / Deep-View software (K160386)
• Archimed Suite / Deep-View software (K162619)
• K150823
• K151926

Submission Summary (Full Text)

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April 15, 2020

Trident s.r.l % Joyce St. Germain Regulatory Consultant The 510K Consulting, LLC 1449 Springleaf Drive ORMOND BEACH FL 32174

Re: K200625

Trade/Device Name: I-View Gold and Imagen Gold Dental Sensors Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: March 5, 2020 Received: March 10, 2020

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 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 ([e-mail]) or phone [phone] 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) K200625

Device Name

I-View Gold and Imagen Gold Dental Sensors

Indications for Use (Describe)

I-View Gold sensors are digital dental intraoral sensors intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg fill="none" height="16" style="vertical-align: middle;" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.375L5.75 10.875L2.75 7.875" stroke="#000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
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| <div> <span> <svg fill="none" height="16" style="vertical-align: middle;" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="13" rx="1.5" stroke="#000" stroke-width="1" width="13" x="1.5" y="1.5"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows a stylized key design. The key is composed of two intertwined lines, one in gold and one in black. The top of the key forms a diamond shape, and the bottom forms the key's teeth. The design is simple and modern.

# The 510k Consulting, LLC

1449 Springleaf Dr., Ormond Beach, FL 32174 Key to success in obtaining your medical device clearance [e-mail]

# 510(k) Summary

### Submitter/Applicant

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

| Phone: | [phone] |
|----------|----------------------------------------------|
| Fax: | [phone] |
| Contact: | Giorgio Rizzo, CEO [e-mail] |

### Consultant/Contact

The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174

Phone: [phone] Joyce St. Germain, Regulatory Consultant, [e-mail] Contact:

### Device Classification

| Trade/Model Names: | I-View Gold and Imagen Gold Dental Sensors |
|----------------------|--------------------------------------------|
| Common Name: | Intraoral Digital X-ray Dental Sensors |
| Classification Name: | System, X-ray, Extraoral Source, Digital |
| Regulation Name: | Extraoral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Regulatory Class: | II |
| 510k Review Panel: | Radiology |

### Predicate Device

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

| 510(k) Number: | K153060 |
|----------------|-------------------------------------------|
| Date Cleared: | November 10, 2015 |
| Trade Name: | EzSensor Classic; HDI-U10DB and HDI-U20DB |

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| Common Name: | Intraoral Digital X-ray Dental Sensors |
|----------------------|------------------------------------------|
| Classification Name: | System, X-ray, Extraoral Source, Digital |
| Regulation Name: | Extraoral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Regulatory Class: | II |
| 510k Review Panel: | Radiology |

The predicate device, K153060, is the identical sensor as the subject and manufactured by Rayence. The devices for this submission have different trade names and different software brand names. The difference in the subject and predicate devices are the software packages; however, their functionality is the same.

#### Indications for Use

I-View Gold sensors are digital dental intra oral sensors intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

#### Intended Use

Radiographic examination to assist with diagnosis of the teeth, jaw, and oral structure.

### Device Description

The subject I-View Gold and Imagen Gold sensors are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port: and (2) an Image Management Software package.

The subject comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm² and two brand names.

Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure.

The primary advantage of direct sensor systems is the speed with which images are acquired.

For patient comfort, the ergonomic design is based on human intraoral anatomy.

- · Excellent image quality based on advanced CMOS technology
- · More comfortable sensor ergonomic shape for the human oral structure
- · Lower dose exposure (Compared to film sensor)
- Enhanced durability
- Easy-to-use USB interface

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The I-View Gold and Imagen Gold sensors have reference numbers as follows:

I-View Gold - size 1 Ref # ISO14-S I-View Gold – size 2 Ref # ISO15-S Imagen - size 1 Ref # ISO 18-S Imagen - size 2 Ref # ISO19-S

NOTE: Two different trade names are for marketing purposes.

Before Trident sells these devices, their technicians discuss the hardware and software that the dentist has, to make sure that their systems are compatible with the these sensors. Trident offers technical support for these devices to ensure proper operation and to answer any questions regarding the function of the devices. A means to contact Trident is provided to all end users in their user manual.

The type of x-ray systems that integrate with the I-View Gold and Imagen sensors are wall-mounted generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time.

This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver.

Archimed Suite is a software produced by Digital Imaging and Deep-View is a brand name for Trident. Archimed Suite / Deep-View software was cleared with K160386 and K162619.

I-View Gold sensors use DEEP-VIEW software that is connected by a 'USB A' cable to a compatible Windows XP or Windows Vista or Windows 7 PC. I-VIEW GOLD is provided the power from PC. Support for the I-VIEW GOLD is provided by compatible software programs such as Deep-View.

DEEP-VIEW and ARCHIMED SUITE complies with the European Directive 93/42 EEC (and its revised version) and CE Certification issued by IMO 0051. Italy.

The subject device is intended to be used by dentists, radiologists and other legally qualified professionals.

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## Comparison of Technological Characteristics with Predicate

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

## Table 5 -- Technological Comparison

| | Subject Device<br>I-View Gold,<br>Imagen Gold | Predicate<br>Device<br>EzSensors<br>(Detailed list<br>on page 1 of<br>this<br>document) | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 510(k) | Not assigned yet | K153060<br>(Cleared November 10,<br>2015) | NA |
| Applicant | Trident s.r.l.,<br>Italy | Rayence, Korea | NA |
| Manufacturer—<br>Imaging Software<br>Component | Deep-View brand name<br>of Archimed Suite<br>produced by Digital<br>Imaging | Easy Dent/EzDent-I<br>Rayence | by Difference |
| Classification;<br>Product Code | 872.1800; MUH | 872.1800; MUH | None |
| Common name | Intraoral Digital X-<br>Ray Sensor | Intraoral Digital X-Ray<br>Sensor | None |
| Indications for Use | I-View Gold (and<br>Imagen Gold)<br>sensors are digital<br>dental intra oral<br>sensors intended to<br>collect dental x-ray<br>photons and convert<br>them into electronic<br>impulses that may<br>be stored, viewed,<br>and manipulated for | Digital Dental Intra<br>Oral Sensor is intended<br>to collect dental x-ray<br>photons and convert<br>them into electronic<br>impulses that may be<br>stored, viewed and<br>manipulated for<br>diagnostic use by<br>dentists. | None |
| | diagnostic use by<br>dentists. | | |
| Intended use | Radiographic<br>examination to assist<br>with diagnosis of<br>diseases of the teeth,<br>jaw and oral structure. | Radiographic<br>examination to assist<br>with diagnosis of<br>diseases of the teeth, jaw<br>and oral structure. | None |
| Principles of operation | X-ray (radiation) =><br>scintillator (convert to<br>light) => fiber optic<br>(filtering) => CMOS<br>(convert to digital) =><br>electronics => PC<br>(capture & display<br>image) | X-ray (radiation) =><br>scintillator (convert to<br>light) => fiber optic<br>(filtering) => CMOS<br>(convert to digital) =><br>electronics => PC<br>(capture & display<br>image) | None |
| Sensor Dimensions (mm) | Size 1.0: 36.8 x 25.4<br>Size 2.0: 42.9 x 31.3 | Size 1.0: 36.8 x 25.4<br>Size 1.5: 39.5 x 29.2<br>Size 2.0: 42.9 x 31.3 | Difference<br>(Predicate has a<br>additional size<br>sensor) |
| Sensor Thickness (mm) | 4.8 | 4.8 | None |
| Active Area (mm) | Size 1.0: 30.01 x 20.01<br>Size 2.0: 35.99 x 25.99 | Size 1.0: 30.01 x 20.01<br>Size 1.5: 33.00 x 23.98<br>Size 2.0: 35.99 x 25.99 | Difference<br>(Predicate has a<br>additional size<br>sensor) |
| USB Module | Integrated USB 2.0<br>module | Integrated USB 2.0<br>module | None |
| Pixel Pitch<br>Full resolution /<br>Binning mode | 14.8 / 29.6 | 14.8 / 29.6 | None |
| DQE (6lp/mm)<br>Full resolution /<br>Binning mode | 0.38 / 0.34 | 0.38 / 0.34 | None |
| MTF (3lp/mm)<br>Full resolution /<br>Binning mode | 0.642 / 0.630 | 0.642 / 0.630 | None |
| Typical dose range | Incisor & Canine:<br>300 ~ 500 / Molar:<br>400~ 600 | Incisor & Canine:<br>300 ~ 500 / Molar:<br>400~ 600 | None |
| Standards of<br>Conformity | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-65<br>IEC 62336<br>EN 62304<br>IEC 60529<br>ISO 15223-1<br>ISO 14971 | IEC 60601-1<br>IEC 60601-1-2 | Both devices<br>passed standards<br>performed |

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#### Guidance Documents

This petition was prepared in conformance with the following FDA guidance instructions and documents:

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014

Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.

Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016

Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Document issued on: May 11, 2005 Medical Devices, Document issued on: May 11, 2005

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### Non-Clinical Performance Data

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

Biocompatibility... Biocompatible testing for the subject is not warranted because there are no direct or indirect patient-contacting components in the subject device. It is covered with a single-use protective barrier prior to each use just like the Ravence predicate device.

Electrical Safety and EMC... The device does require EMC and Electrical Safetv evaluation. EMC and electrical safety testing data reports for the subject device are provided in this petition.

· The I View and Imagen Sensors conforms to electrical and safety standard IEC 60601-1 (Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance).

· The I View and Imagen Sensor conforms to electrical and safety standard IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential 3271 performance - collateral standard: Electromagnetic compatibility).

Software ... The device does contain software/firmware. I-View Gold and Imagen Sensor electronics contains firmware along with a driver and both use image management software provided by Digital Imaging, Italy; therefore, only firmware and driver documentation for the subject device are included in this petition.

Performance Testing ... Bench tests were performed and the SSIX Report is shown in this submission. Additional certificates for the device are also within this submission.

### Conclusion

The subject and the predicate device have the same intended use and the same technological features. I View Gold and Imagen Gold Sensors and share the same principles of operation, sensor technology, use the same USB connection to PC and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate. As previously stated, these devices are identical in structure and use. The sensors will only have different brand names for marketing purposes.

Again, K150823 and K151926 are identical to the subject sensors I View Gold and Imagen Gold Sensor. The software packages of the subject device and the predicate are different. The subject device software, Deep-View has been FDA cleared with other similar devices. Additional information regarding Deep-View is stated throughout the submission.

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The I-View Gold and Imagen Gold Sensors warrants a finding of substantial equivalence to both the legally marketed EzSensor Classic Series and thus clearance for premarket activities in the United States.