(36 days)
No
The summary describes a standard digital dental x-ray sensor and image management software without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used to collect and convert dental x-ray photons into electronic impulses for diagnostic use by dentists, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the sensors convert x-ray photons into electronic impulses that "may be stored, viewed, and manipulated for diagnostic use by dentists." This directly indicates a diagnostic purpose.
No
The device description explicitly states it is comprised of two components: an intraoral detector (hardware) and an Image Management Software package. This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The I-View Gold sensors are used to capture dental x-ray images directly from the patient's mouth. They convert x-ray photons into electronic signals for viewing and diagnosis.
- Lack of Sample Analysis: The device does not analyze biological samples taken from the body. It interacts directly with the patient's anatomy using an external energy source (x-rays).
Therefore, the I-View Gold sensors fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists, radiologists and other legally qualified professionals.
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 Performance Data:
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 Rayence predicate device.
Electrical Safety and EMC: The device does require EMC and Electrical Safety 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K160386, K162619, K150823, K151926
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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The 510k Consulting, LLC
1449 Springleaf Dr., Ormond Beach, FL 32174 Key to success in obtaining your medical device clearance Joyce510kfda@gmail.com
510(k) Summary
Submitter/Applicant
Trident s.r.l. Via Artigiani 4 Castenedolo, (BS) Italy 25014
| Phone: | +39-0302732485 |
|---|---|
| Fax: | +39-0302731647 |
| Contact: | Giorgio Rizzo, CEO Giorgio.Rizzo33@gmail.com |
Consultant/Contact
The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174
Phone: 904-477-3203 Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com 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 |
4
| 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
5
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.
6
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
I-View Gold,
Imagen Gold | Predicate
Device
EzSensors
(Detailed list
on page 1 of
this
document) | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 510(k) | Not assigned yet | K153060
(Cleared November 10,
2015) | NA |
| Applicant | Trident s.r.l.,
Italy | Rayence, Korea | NA |
| Manufacturer—
Imaging Software
Component | Deep-View brand name
of Archimed Suite
produced by Digital
Imaging | Easy Dent/EzDent-I
Rayence | by Difference |
| Classification;
Product Code | 872.1800; MUH | 872.1800; MUH | None |
| Common name | Intraoral Digital X-
Ray Sensor | Intraoral Digital X-Ray
Sensor | None |
| Indications for Use | I-View Gold (and
Imagen 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 | Digital Dental Intra
Oral Sensor is 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. | None |
| | diagnostic use by
dentists. | | |
| Intended use | Radiographic
examination to assist
with diagnosis of
diseases of the teeth,
jaw and oral structure. | Radiographic
examination to assist
with diagnosis of
diseases of the teeth, jaw
and oral structure. | None |
| Principles of operation | X-ray (radiation) =>
scintillator (convert to
light) => fiber optic
(filtering) => CMOS
(convert to digital) =>
electronics => PC
(capture & display
image) | X-ray (radiation) =>
scintillator (convert to
light) => fiber optic
(filtering) => CMOS
(convert to digital) =>
electronics => PC
(capture & display
image) | None |
| Sensor Dimensions (mm) | Size 1.0: 36.8 x 25.4
Size 2.0: 42.9 x 31.3 | Size 1.0: 36.8 x 25.4
Size 1.5: 39.5 x 29.2
Size 2.0: 42.9 x 31.3 | Difference
(Predicate has a
additional size
sensor) |
| Sensor Thickness (mm) | 4.8 | 4.8 | None |
| Active Area (mm) | Size 1.0: 30.01 x 20.01
Size 2.0: 35.99 x 25.99 | Size 1.0: 30.01 x 20.01
Size 1.5: 33.00 x 23.98
Size 2.0: 35.99 x 25.99 | Difference
(Predicate has a
additional size
sensor) |
| USB Module | Integrated USB 2.0
module | Integrated USB 2.0
module | None |
| Pixel Pitch
Full resolution /
Binning mode | 14.8 / 29.6 | 14.8 / 29.6 | None |
| DQE (6lp/mm)
Full resolution /
Binning mode | 0.38 / 0.34 | 0.38 / 0.34 | None |
| MTF (3lp/mm)
Full resolution /
Binning mode | 0.642 / 0.630 | 0.642 / 0.630 | None |
| Typical dose range | Incisor & Canine:
300 ~ 500 / Molar:
400~ 600 | Incisor & Canine:
300 ~ 500 / Molar:
400~ 600 | None |
| Standards of
Conformity | 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 | IEC 60601-1
IEC 60601-1-2 | Both devices
passed standards
performed |
7
8
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.