(29 days)
No
The summary describes a digital x-ray system and image management software. While it mentions image processing, there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is used for radiographic examination to assist in diagnosing diseases, which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use explicitly states that the device is "to assist in the diagnosing of diseases of the teeth, jaw and oral structures."
No
The device description explicitly states it is comprised of two previously cleared components: an intraoral detector component (hardware) and an image management software package. It also mentions the detector comes in two sizes and uses a Hamamatsu CMOS area image sensor, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures." This involves capturing and processing medical images, which is a function of a medical imaging device, not an IVD.
- Device Description: The description details an extraoral digital x-ray system comprised of an intraoral detector and image management software. It receives x-rays and processes the resulting image data. This aligns with the function of a medical imaging system.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device is a medical imaging system used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Televere Digital Dental Imaging System is intended for radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. Not for mammography. Not for fluorosopy.
Product codes
MUH
Device Description
The Televere Digital Dental Imaging System is an extraoral digital x-ray system comprised of two previously cleared individual components: (1) an intraoral detector component (K162619) which connects to a PC via a USB port and (2) and image management software package (i.e., Tigerview Professional, K061035). The device detector comes in two sizes: 600mm² (Hamamatsu CMOS area image sensor, S11684-12) and 884mm² (Hamamatsu CMOS area image sensor, S116845-12). X-ray generators that can integrate with the Televere Digital Dental Imaging System are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15mA inclusive, and with a tube voltage between 50 and 100kV inclusive, with built in controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. The device and software cannot act as an x-ray generator controller. All control of xray generation is done by controls built into the generator itself. There is no connection between the device and the x-ray generator. The device is an x-ray receiver and does not control the generator.
The previously cleared Tigerview™ Professional software (K061035) provides basic image adjustment features. An image adjustment system allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Tigerview™ Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. NOTE: The Tigerview ™ Professional software incorporated into the Televere Digital Dental Imaging system is unchanged from the Predicate software (i.e., K061035)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Teeth, jaw and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional
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)
The results of clinical image inspection, bench, and laboratory test results demonstrate that the new device is as safe and effective as the predicate device. Clinical images highlight equal or better image quality as compared to the predicate.
Bench Testing: IEC Standards have been employed for: Electrical Safety and Electromagnetic Compatibility. The panel power supply is UL Listed. The CMOS area image sensor manufacturer conducted performance testing according to the FDA guidance document for solid state digital x-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Since no software modifications were required, confirmation testing was performed. Labeling was developed to comply with the FDA solid state panel guidance document.
Clinical Testing: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2018
Televere Systems, LLC % Robert Bakin Regulatory Consultant Technology and Business Law Advisors, LLC 1244 Capuchino Ave. BURLINGAME CA 94010
Re: K181358
Trade/Device Name: Televere Digital Dental Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: May 20, 2018 Received: May 22, 2018
Dear Robert Bakin:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K181358
Device Name
Televere Digital Dental Imaging System
Indications for Use (Doscribo)
The Televere Digital Dental Imaging System is intended for radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. Not for mammography. Not for fluorosopy.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, with a stylized font. Below that, in smaller, gray letters, is the word "SYSTEMS". The logo is simple and modern.
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510(k) Summary:
Televere Systems, LLC 1160 Cavalier Road Arnold, MD 21012 Email: rquaal@tigerview.com Establishment Registration Number: 2954358
CONTACT: Robert E. Bakin Email: rbakin@tblawadvisors.com Technology & Business Law Advisors, LLC 1244 Capuchino Avenue, Burlingame, CA 94010 Phone: 571-215-3507 Prepared May 20, 2018
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Identification of the Device: Proprietary-Trade Name: Televere Digital Dental Imaging System Classification Name: Extraoral Source X-ray System Product Code: MUH Common/Usual Name: Intraoral Digital X-Ray Sensor Device Class/Regulation Number: Class II per regulation 21 C.F.R. §872.1800
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Equivalent legally marketed device: I View and Imagen Sensor (K162619). Classification Name: Extraoral Source X-ray System Product Code: MUH Common/Usual Name: Intraoral Digital X-Ray Sensor Device Class/Regulation Number: Class II per regulation 21 C.F.R. §872.1800
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Associated legally marketed devices: TigerView Professional (PACS Software) K061035. This is the software used with this device.
Classification Name: System, Image Processing, Radiological, Code LLZ Common/Usual Name: Picture Archiving and Communications System Device Class/Regulation Number: Class II per regulation 21 C.F.R. §892.2050
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Indications for Use: The Televere Digital Dental Imaging System is used for a radiographic examination by a dental professional to assist in the diagnosing of disease of the teeth, jaw and oral structures. Not for mammography. Not for fluoroscopy.
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Device Description: The Televere Digital Dental Imaging System is an extraoral digital x-ray system comprised of two previously cleared individual components: (1) an intraoral detector component (K162619) which connects to a PC via a USB port and (2) and image management software package (i.e., Tigerview Professional, K061035). The device detector comes in two sizes: 600mm² (Hamamatsu CMOS area image sensor, S11684-12) and 884mm² (Hamamatsu CMOS area image sensor, S116845-12). X-ray generators that can integrate with the Televere Digital Dental Imaging System are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15mA inclusive, and with a tube voltage between 50 and 100kV inclusive, with built in controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. The device and software cannot act as an x-ray generator controller. All control of xray generation is done by controls built into the generator itself. There is no connection between the device and the x-ray generator. The device is an x-ray receiver and does not control the generator.
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Image /page/4/Picture/0 description: The image contains the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, and the word "SYSTEMS" is in gray and is located below the word "TELEVERE". The font is sans-serif.
SQUARE STORE SQUARE
The previously cleared Tigerview™ Professional software (K061035) provides basic image adjustment features. An image adjustment system allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Tigerview™ Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. NOTE: The Tigerview ™ Professional software incorporated into the Televere Digital Dental Imaging system is unchanged from the Predicate software (i.e., K061035)
- Safety and Effectiveness, Comparison to predicate device. The results of clinical image inspection, bench, and laboratory test results demonstrate that the new device is as safe and effective as the predicate device. Clinical images highlight equal or better image quality as compared to the predicate.
| Predicate Device | Proposed Device | |
|---|---|---|
| Device Name | I-View and Imagen Sensor K162619 | Televere Digital Dental Imaging System |
| CMOS Sensor | Hamamatsu, S11684/5-12 | SAME |
| Intended Use | The Televere Digital Dental Imaging | |
| System is used for a radiographic | ||
| examination by a dental professional | ||
| to assist in the diagnosing of disease of | ||
| the teeth, jaw and oral structures. Not | ||
| for mammography. Not for | ||
| fluoroscopy. | SAME | |
| Configuration | CMOS sensor and imaging software | |
| only. No generator or stand provided. | SAME | |
| Digital Panel Pixels | 1000 x 1056 (S11684-12) | |
| 1300 x 1700 (S11685-12) | SAME | |
| Software | Deep-View™ | TIgerview Professional™, K061035 |
| Scintillator | Cesium Iodide (CsI) | SAME |
| Interface | USB 2.0 | SAME |
| Power Source | External Power Supply 100-240 VAC | SAME |
| Standards | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 62220-1-1:2015 | ||
| ANSI 60529-2004 | ||
| IEC 60601-2-65:2012 | SAME |
7. Substantial Equivalence Chart
Substantial Equivalence Conclusion: The comparison table reveals there are no new technical issues of safety or effectiveness raised by substitution of the imaging software component. Professional evaluation of imaging samples were of excellent quality, high resolution, clinically acceptable and substantially equivalent to the predicate device.
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Summary of Bench Testing Conducted: IEC Standards have been employed for: Electrical Safety and Electromagnetic Compatibility. The panel power supply is UL Listed. The CMOS area image sensor manufacturerconductedperformancetestingaccordingtotheFDAguidancedocumentforsolidstate digital x-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDAguidancedocuments. Sincenosoftwaremodificationswererequired,confirmationtestingwas performed. Labeling was developed to comply with the FDA solid state panel guidance document.
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Summary of Clinical Testing: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.
Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable 10. standards, it is the conclusion of Televere that the Televere Digital Dental Imaging System is as safe and effective as the predicate device K162619, has few technological differences, and has no new indication(s) for use, thus rendering it substantially equivalent to the predicate device.