(45 days)
I-View dental sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
The subject device I View is an 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 Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
The Size 1 sensor is also known as factory code S11684-12; Size 2 sensor is known as factory code S116845-12. I View and Imagen Sensor will both have Size 1 and Size 2. Two different trade names are for marketing purposes.
The provided text is a 510(k) summary for the "I View and Imagen Sensor" dental x-ray system, which is a Class II medical device. The document states that the subject device is substantially equivalent to a predicate device, the "QuickRay HD." The primary method used to demonstrate this equivalence is by asserting that the subject device is identical in hardware and firmware to the predicate device, with only the software package being different (though its functionality is claimed to be the same).
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
Because the device is claimed to be identical to a predicate that was already cleared, the acceptance criteria are largely linked to demonstrating this identity and conformity to relevant standards rather than establishing new performance metrics.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Characteristics Comparison to Predicate | Must be identical or substantially similar to predicate (QuickRay HD). | The subject device (I View/Imagen Sensor) is claimed to be identical in hardware and firmware to the QuickRay HD and EDLENi predicate devices. | The document explicitly states: "K151926 and K150823 are identical to the subject device. The devices are exactly the same except for the trade names being different for marketing purposes." and "The subject device is identical to the predicate and reference predicate in firmware/hardware from Hamamatsu." |
| Software Functionality Comparison | Software package for subject device must provide the same functionality as the predicate device's software. | The subject device uses "DEEP-VIEW" software, which is stated to have the "same functionality as the software of the predicate device." DEEP-VIEW was previously cleared by the FDA (K160386). | This is a key point of difference but functionality is asserted to be equivalent, and prior clearance of the software is cited. |
| Clinical Performance (Diagnostic Equivalence) | Images produced must be diagnostically relevant and reliable. | Clinical images previously examined for the predicate device by Dr. Parham (a qualified practitioner) were found to be diagnostically relevant and reliable. | No new clinical study was conducted for the subject device because it's deemed identical to the predicate. |
| Biocompatibility | Device components in contact with patients must be biocompatible. | Biocompatibility testing was deemed "not warranted" because the device does not have direct or indirect patient-contacting components. It uses a single-use protective barrier. | This relies on the use of standard protective barriers. |
| Electrical Safety and EMC | Device must conform to relevant electrical safety and electromagnetic compatibility (EMC) standards. | The device conforms to IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-65 (specific for dental). | Test reports were provided in the petition. |
| Software Verification and Validation (V&V) | Firmware and driver must be verified and validated. | Firmware and driver documentation (from Hamamatsu) were included. The image management software (Deep-View) itself was previously cleared (K160386). | The V&V for the image management software relies on its previous clearance. |
| Bench Testing | Device performance must meet standards for digital x-ray imaging characteristics and IP codes. | Bench tests were performed in conformance with IEC 62220-1 (Detective Quantum Efficiency) and IEC 60529 (IP Codes). | This refers to specific technical performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new, specific "test set" in terms of patient images or cases for the subject device. Instead, it relies on:
- Clinical images from the predicate device: The text states, "Clinical images were examined by Dr. Parham... and found to be diagnostically relevant and reliable. These tests were provided for the predicate device submission..."
- The provenance of these predicate clinical images is vague, only mentioning "Dr. Parham, a qualified practitioner in Ormond Beach, FL." It does not specify the country of origin of the data nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document mentions one expert: "Dr. Parham, a qualified practitioner in Ormond Beach, FL."
- Qualifications: Described as a "qualified practitioner." No further details on specific certifications (e.g., dentist, radiologist), years of experience, or specialty are provided.
4. Adjudication Method for the Test Set
- None specified for the subject device. The reliance is on a single "qualified practitioner" for the predicate device's clinical images. There's no mention of a consensus or multi-reader adjudication process described for either the predicate's original evaluation or for the current submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission establishes substantial equivalence primarily through technical and functional identity to a predicate device, not through a comparative clinical study. Therefore, no effect size of human readers improving with or without AI assistance is reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No, a standalone study was not done as the device itself is a digital x-ray sensor for capturing images, not an AI algorithm for interpreting them without human involvement. The "Deep-View" software is an "image management software package" that assists dental professionals in diagnosing, implying human-in-the-loop performance. While the software has its own prior clearance (K160386), this document doesn't detail a standalone performance study for the interpretation aspect within this submission.
7. The Type of Ground Truth Used
- For the clinical performance validation (from the predicate device), the ground truth appears to be based on expert assessment/consensus (from Dr. Parham). The statement "found to be diagnostically relevant and reliable" implies an expert opinion as the ground truth. There is no mention of pathology, long-term outcomes data, or other objective measures for ground truth.
8. The Sample Size for the Training Set
- The document does not describe a training set in the context of machine learning or AI algorithms for image interpretation for this device. The software "Deep-View" is an image management software. If the term "training set" refers to data used to develop the core firmware/hardware for image acquisition, that information is not provided or deemed unnecessary given the equivalence claim to the predicate.
9. How the Ground Truth for the Training Set Was Established
- As no training set (in the ML/AI sense) is described, this information is not applicable and not provided in the document. The device is an image acquisition hardware, not an image interpretation AI, making the concept of a "training set" for ground truth determination irrelevant to this 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Trident s.r.l. % Mr. Claude Berthoin President Denterprise International, Inc. 100 East Granada Blvd., Suite 219 ORMOND BEACH FL 32174
Re: K162619
Trade/Device Name: I View and Imagen Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: September 15, 2016 Received: September 20, 2016
Dear Mr. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
November 4, 2016
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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/Resourcesfor You/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) K162619
Device Name I View and Imagen Sensor
Indications for Use (Describe)
I-View dental sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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100 E. Granada Blvd. Suite 219 Ph: 386-672-0450 800-323-2690 Ormond Beach, FL 32176
Traditional 510 (k) Summary
Submitter
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-506-8711 386-672-4402 Fax: Primary Contact: Joyce St. Germain, Regulatory Assistant (joyce@510kfda.com) Secondary Contact: Claude Berthoin, President (claude@denterpriseintl.com) Date Prepared: September 15, 2016
Device Classification
| Trade Name: | I View and Imagen Sensor |
|---|---|
| Common Name: | Intraoral Digital X-Ray Sensor |
| Regulation Number: | 21 CFR 872.1800 |
| Classification Name: | Extraoral Source X-Ray System |
| Product Code: | MUH |
| Submission Type: | 510(k) |
| Regulatory Class: | 2 |
| Medical Specialty: | Dental |
Predicate Device
The following predicate is a legally marketed, post-amendment device:
| 510(k) Number: | K151926 |
|---|---|
| Clearance Date: | December 14, 2015 |
| Actual Trade Name: | QuickRay HD |
| Regulation & PC: | 872.1800; MUH |
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Reference Device:
510(k) Number: K150823 Clearance Date: Actual Trade Name: EDLENi Intra-oral Sensor Regulation & PC:
K151926 and K150823 are identical to the subject device. The devices are exactly the same except for the trade names being different for marketing purposes. All devices are made by Hamamatsu, Japan. The only difference in the subject and predicate are the software packages; however their functionality is the same. The subject device uses Deep-View and this software package has already been cleared with FDA in another device for Trident, K160386.
Device Description
The subject device I View is an 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 Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
The Size 1 sensor is also known as factory code S11684-12; Size 2 sensor is known as factory code S116845-12. I View and Imagen Sensor will both have Size 1 and Size 2. 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 I View sensor. Trident offers technical support for these devices to ensure proper operation and to answer any questions regarding the function of the device. 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 sensor are wall-mounted x-ray 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.
The DEEP-VIEW software, is supported on Windows XP, Vista, 7,8,8.1. Absolute minimum requirements for PC hardware for the sensor and combination would be a Pentium 4 or better processor. At least 1 GB of RAM (2 GB optimal), 200MB of hard
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drive space for the software, plus additional space for the user database (recommended 80GB minimum), a USB 2.0 or 3.0 and a 100MB wired Ethernet connection is needed if networked.
Images are captured by the sensor and transmitted in digital form via USB connection for display, storage and printing on the computer using ARCHIMED SUITE image capturing and management software. This software is brand labeled for Trident, known as DEEP VIEW and has the same functionality as the software of the predicate device. ARCHIMED SUITE complies with the European Directive 93 / 42 EEC and CE Certification 1575/MMD issued by IMQ 0051 Italy.
The subject device is identical to the predicate and reference predicate in firmware/hardware from Hamamatsu. The predicate device QuickRay HD is cleared with K151926 and reference predicate, EDLENi cleared with K150823. Hamamatsu is the main subcontractor for all of these sensors. The devices are identical in firmware from Hamamatsu and having the same model number. The software is different; however, provides the same technology and intended use. The subject and predicate devices and the software difference does not change the safety and effectiveness of the subject device.
The latest publication of CR Clinicians the November newsletter reports that 70% of all the practices use dental sensors and only 16% use film. This newsletter may be reviewed in section 21_Other. This show the increase of dental sensors and that FDA has cleared these devices which shows the safety and effectiveness.
Indications for Use
I-View dental sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Intended Use
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The I-View is a dental sensor intended to replace film and to capture an intraoral x-rav image, when exposed to X-rays, for dental diagnostic purposes.
Comparison of Technological Characteristics with Predicate
The subject device I View and predicate QuickRay HD are the exact same dental devices.
Both are comprised of the following two components...
- . Intraoral Detector System... The subject device and predicate device includes an intraoral detector. flexible cord, and direct USB 2.0 plug, as described in subject I View and predicate QuickRay HD and marketing literature is in this petition.
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- Imaging Software... The subject device is using "DEEP-VIEW" that is a brand name ● for Trident of the software "Archimed Suite", a software produced by Digital Imaging. Archimed complies with the European Directive 93/42/EEC and subsequent amendments and additions (CE certification 1575/MMD issued by IMQ 0051, Italy). The predicate uses third party software called Xray Vision which is manufactured by Apteryx in Akron, Ohio (K983111) cleared November 16, 1998.
| I-View Dental Sensor(Subject) | QuickRay HD DentalSensor(Predicate) | Differences | |
|---|---|---|---|
| 510(k) | Not assigned yet | K151926 (ClearedDecember 14, 2015) | NA |
| Applicant/Assembler/Repackager/Relabeler | Denterprise International(Ormond Beach, FL) | NA | |
| Manufacturer-Imaging SWComponent | DEEP-VIEW (DigitalImaging, Italy) | Xray Vision (ApteryxAkron, OH) | Similar |
| Classification & Product Code | 872.1800; MUH | 872.1800; MUH | None |
| Common name | Intraoral Digital X-RaySensor | Intraoral Digital X-RaySensor | None |
| Indications for Use | I-View dental sensor isused for a radiographicexamination by a dentalprofessional to assist inthe diagnosing ofdiseases of the teeth, jawand oral structures. | QuickRay HD dentalsensor is used for aradiographic examinationby a dental professionalto assist in the diagnosingof diseases of the teeth,jaw and oral structures. | None |
| Intended use | Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structure. | Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structure. | None |
| Principles of operation | X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital) =>electronics => PC(capture & display image) | X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital) =>electronics => PC(capture & display image) | None |
| Software-Firmware | Firmware combined onsensor electronic board | Firmware combined onsensor electronic board | None |
| Software—Image Management | DEEP-VIEW (packagefrom Digital Imaging,Italy) | Xray Vision (packagefrom Apteryx, USA) | None |
| Sensor technology | I View: CMOS chip +optical fiber plate + CSiscintillator | QuickRay HD: CMOS chip+ optical fiber plate + CSiscintillator | None |
| Matrix dimensions (mm2) | Active area: 600mm²(Size 1) 884mm² (Size 2) | Active area: 600mm²(Size 1); 900mm² (Size 2) | None |
| Matrix dimensions (pixels) | 1000 lines X 1500columns (Size 1); 1300 X1700 (Size 2). | 1000 lines X 1500columns (Size 1); 1300 X1700 (Size 2). | None |
| Lifespan CMOS | Min. 100,000 cycles | Min. 100,000 cycles | None |
| Resolution | Real ≥ 20pl/mm | Real ≥ 20pl/mm | None |
| Pixel size | 20 X 20μm | 20 X 20μm | None |
| Grey levels | 14 bits | 14 bits | None |
| Sensor board | All control electronicsdirectly integrated onCMOS sensor chip | All control electronicsdirectly integrated onCMOS sensor chip | None |
| Sensor shell | Specific shape design;material is ABS and theflammability is HB if YK-94 (UL File No. 49895) | Specific shape design;material is ABS and theflammability is HB if YK-94 (UL File No. 49895) | None |
| Cable material and design | Cable consists of PVC,ETFE, copper, plugconnector and sensorconnector, diameter ф3.7±0.3 and cable length 2meters. | Cable consists of PVC,ETFE, copper, plugconnector and sensorconnector, diameter ф3.7±0.3 and cable length 2meters. | None |
| Connection to imaging practicePC | USB 2.0 High-Speed | USB 2.0 High-Speed | None |
| Operating temperature | 0°C to 35°C | 0°C to 35°C | None |
| Sensor input voltage and current | 5V (via USB connection);0.15A Max | 5V (via USB connection);0.15A Max | None |
| Standards of conformity | IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)62220-1 (Performance)60529 (IP Code)60601-2-65 | IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)62220-1 (Performance)60529 (IP Code) | One additionaltest for subjectdevice |
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Performance Data
Clinical images were examined by Dr. Parham, a qualified practitioner in Ormond Beach, FL and found to be diagnostically relevant and reliable. These tests were provided for the predicate device submission because the subject device is identical to the predicate dental sensor, test reports for the I-View / Imagen sensor are not necessary to demonstrate device effectiveness.
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 QuickRay HD predicate.
Electrical Safety and EMC
EMC and electrical safety testing data reports for the subject device are provided in this petition.
- . The I View and Imagen Sensor 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 3271performance - collateral standard: Electromagnetic compatibility).
Software Verification and Validation Testing
I view and Imagaen Sensor electronics contains firmware along with a driver both provided by Hamamatsu. Additionally, I View and Imagen Sensor uses image management software provided by Digital Imaging, Italy; therefore, only firmware and driver documentation for the subject device are included in this petition.
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Bench Testing
Bench tests were performed in conformance with IEC 62220-1 (Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices-Part 1: Determination of the Detective Quantum Efficiency and IEC 60529 (Degrees of Protection Provided by Enclosures-IP Codes).
Conclusions
The subject and the predicate device have the same intended use and the same technological features. I View and Imagen Sensor and QuickRay HD 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 and Imagen 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.
The I-View and Imagen Sensor warrants a finding of substantial equivalence to both the legally marketed original QuickRay HD and the EDLENi sensor and thus clearance for premarket activities in the United States.
§ 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.