(57 days)
No
The description mentions "electronic circuits to analyze the digital image" but does not specify any AI/ML techniques. There is no mention of AI, DNN, or ML in the provided text, nor is there information about training or test sets typically associated with ML development.
No
The device is used for capturing x-ray images for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "for dental diagnostic purposes."
No
The device description explicitly mentions hardware components like a CCD area image sensor, scintillator, and electronic circuits, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device captures an image of the inside of the mouth using X-rays. It does not analyze biological specimens.
- Intended Use: The intended use is to capture an intraoral X-ray image for dental diagnostic purposes, which is a form of medical imaging, not in vitro testing.
The description clearly indicates it's an imaging device used directly on the patient's body (intraoral) to produce an image for diagnosis, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
Product codes
MUH, MQB, EAP
Device Description
The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file. The porposed and predicated devices are substantially equivalent, similar devices that have been used by dentists int he US since 1989 and well accepted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside 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/1 description: The image shows the logo for Video Digital RF America. The logo is in black and white and features a stylized "Video" with radio waves emanating from the "V". The word "Digital" is stacked vertically to the right of "Video", and "RF America" is below "Digital". The text is pixelated.
ා ව ධිරිස් ලියානයය සිහුස්ල දා 11, පිළිබඳ 200 Ormond Peach, [7] 17 - 1 (1 80-11-2... 120 73 - 14 - 2414 力:"快乐"的一个人 www.videodental.com
PREMARKET SUMMARY (As Required By 21 CFR 807393)
MAY 1 3 2008
Contact person: Claude Berthoin Video Dental Concepts, Inc. 110 East Granada Boulevard Suite 207 Ormond Beach, FL 32176 Phone: 800-323-2690
Alternate contact: Sue Williams
General Information
Proprietary or Trade Name: Dentron Sensor
Common/Usual Name: Dental Image Management System
Classification & Regulation Number: Class II, CCD area image sensor; MUH, MQB; 892.1650
- Reason for Premarket Notification: Product manufactured in Louisiana and is new to the market.
The intended device is similar in intended use, material, safety and effectiveness in similar applications to: CEFLA s.l.r.'s MyRay K061114, Air Technique's Accent K050693, and Julie Alliance's QuickRay DSX 730 K990002.
The device is to be distributed by Dentron Systems, LLC in the United States.
The following voluntary standards are utilized in whole or in part:
UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety and Canadian deviations -- see IMQ S.p.A. Test report nº 27SE00094 and CSA/UL certificate 231961;
EN 60601-1-2: 2001 Medical Electrical Equipment -- Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Test, See IMQ S.p.A Test report nº 80SF00347/1 and 80SF000347/2; and
IEC 60601-1-4: 2000 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems, See IMQ S.p.A Test report n° 27SE00094.
The materials in the device are identical to materials used in the identified predicate device.
Comparison of the Dentron Sensor to the legally marketed predicate devices:
Image /page/0/Picture/20 description: The image shows the word "myray" in a bold, sans-serif font. The "m" is stylized with three curved lines underneath it, resembling sound waves or a stylized smile. The rest of the letters, "yray", are in a similar bold font and are connected to the "m". The overall design is simple and modern.
Discovery
Image /page/0/Picture/22 description: The image shows the word "retropan" in a bold, sans-serif font. Above the word is a crescent-shaped design with a textured surface. The text is in black, and the background is white. The overall design appears to be a logo or brand name.
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Image /page/1/Picture/0 description: The image shows the words "Video Detal" in a stylized font. Below the words, it says "RF America". The text is black and white and appears to be a logo or brand name.
110 East Grand a Rouler ard, Suite a Pr Omnonia. Gearth 19 17170 100.325.26 - 1 36. 372 1456 トアイ 386 レビュー 2017
| Comparison
| Table | Dentron Senso | MyRay WDS | Accent | QuickRay |
|---|---|---|---|---|
| K# | TBD | K061114 | K050693 | K990002 |
| Intraoral Sensor | CCD + fiber optic | |||
| plate + scintillator | CCD + fiber optic | |||
| plate + scintillator | CCD + scintillator | CCD + scintillator | ||
| Sensor size | ||||
| (active area) | Size 1: 30x20mm | |||
| Size 2: 34x24mm | Size 1: 20x30mm | |||
| Size 2: 24x34mm | Size 1: 20x30mm | |||
| Size 2: | ||||
| 27.5x36.08mm | 21.4x34mm | |||
| Sensor cable | ||||
| connection | Sealed at the | |||
| factory | sealed at the | |||
| factory | Sealed at the factory | Sealed at the | ||
| factory | ||||
| Theorical | ||||
| resolution | 10 lp/mm | 25 lp/mm | 22.7 lp/mm | 23.8 lp/mm |
| Digitalization / | ||||
| Conversion | ||||
| Resolution | 12 bits (4095 ADU) | 12 bit, 4096 grey | ||
| levels | 12 bit, 4096 grey | |||
| levels | 12 bit, 4096 grey | |||
| levels | ||||
| Connection | Wired, USB to CCU | Wireless, Bluetooth | Wireless, Bluetooth | Wired, USB to CCU |
| Connection | ||||
| medium | CCU with USB | |||
| cable | USB-Bluetooth | |||
| adapter | USB-Bluetooth | |||
| adapter | CCU with USB | |||
| cable | ||||
| Image file format | Greyscale | Greyscale, TWAIN | ||
| compatible | Greyscale, TWAIN | |||
| compatible | Greyscale, | |||
| Proprietary | ||||
| Power supply | Powered through | |||
| USB connection | 3xAA rechargeable | |||
| batteries | 4xAA rechargeable | |||
| batteries | Power applied to | |||
| CCU only via 12V | ||||
| power adapter | ||||
| Sterile product | No | |||
| Existing | ||||
| Commercial | No | No | No | |
| File capturing, | ||||
| management and | ||||
| storage | software (not part | |||
| of the device). | ||||
| DentalEye 510k | ||||
| #K012439 | Commercial | |||
| software (not part | ||||
| of the device) | Commercial | |||
| software (not part of | ||||
| the device) | Commercial | |||
| software (not part | ||||
| of the device) | ||||
| P III 600MHz. | ||||
| PC minimum | ||||
| environment | Windows 2000 / XP | P III 800MHz. | ||
| Windows XP, 256k | ||||
| RAM, 150M HDU, | ||||
| USB2port, | ||||
| 1024x768x16million | ||||
| color display | Intel P IV 2.8 GHz, | |||
| Windows XP pro, 1G | ||||
| RAM, 120G HDU, | ||||
| USB 1.1 port, | ||||
| 1024x768x16million | ||||
| color display | Windows 98SE, XP | |||
| 128K RAM, 10G | ||||
| HDU, 2 x USB ports | ||||
| (unspecified). | ||||
| 1024x768x16million | ||||
| color display |
- concise summary for any performance testing in the submission ●
- The proposed and predicated devices use similar components and are similar in design, ◆ technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file. The porposed and predicated devices are substantially equivalent, similar devices that have been used by dentists int he US since 1989 and well accepted.
Image /page/1/Picture/6 description: The image shows the word "myray" in a bold, sans-serif font. The "m" has a curved line underneath it, resembling a smile or a wave. The letters are closely spaced together, giving the word a compact appearance. The overall design is simple and modern.
Image /page/1/Picture/7 description: The image shows the word "Discovery" in a bold, sans-serif font. The word is slightly distorted, with some blurring and pixelation. There is some additional text or graphics to the right of the word, but it is difficult to make out any details.
Image /page/1/Picture/8 description: The image shows the word "retropan" in a bold, sans-serif font. Above the word is a curved, crescent-shaped design. The text and design are both in black, contrasting with the white background.
2
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol with three blue figures and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The symbol is on the left side of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Dentron Systems. LLC % Mr. Claude D. Berthoin President/Owner Video Dental Concepts. Inc. 11 East Granada Boulevard. Suite 207 ORMOND BEACH FL 32176
AUG 2 3 2013
Re: K080738
Trade/Device Name: Dentron Sensor Regulation Number: 21 CFR 872.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MQB Dated: March 13. 2008 Received: March 18, 2008
Dear Mr. Berthoin:
This letter corrects our substantially equivalent letter of May 13, 2008.
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE
Applicant: Video Dental Concepts, Inc.,
510(k) Number (if known): K080738
Device Name: Dentron Sensor
Indication For Use: The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
Prescription Use _X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Division Sign-Off Office of Device Evaluation
510(k)
Amy M. Wilson
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number