(51 days)
No
The summary describes a digital dental imaging system with a new sensor. While it mentions "image enhancement," there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the sensor technology and image capture/display.
No.
The device is an imaging system designed to capture and display dental X-ray images, not to treat a disease or condition.
No
Explanation: The device is an imaging system used to capture and enhance digital dental images. While these images may be used by a dentist to aid in diagnosis, the device itself performs image capture and enhancement, not diagnosis. It does not provide an interpretation or diagnosis based on the images.
No
The device description explicitly mentions a "new sensor component" and a "CMOS sensor" which are hardware components, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for capturing and processing digital dental images from standard dental X-ray systems. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description focuses on the sensor's function in capturing X-ray images and converting them to digital signals for display. This aligns with the function of a medical imaging device.
- Input Imaging Modality: The input is X-ray, which is a form of medical imaging, not a method used for in vitro diagnostic testing.
- Anatomical Site: The anatomical site is the dentition, jaws, and other oral structures, which are parts of the human body being imaged directly.
IVD devices are used to perform tests on samples taken from the body, not to image the body itself. This device is clearly designed for medical imaging.
N/A
Intended Use / Indications for Use
The EVA SELECT Digital Dental Imaging System is intended to be used with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.
Product codes
MUH
Device Description
The EVA SELECT System (previously named the EVA System) has been modified to incorporate a new sensor component. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent EVA Digital Dental Imaging System. The modifications are limited to changing the sensor from a proprietary design to a commercially available sensor which is already used in at least 2 devices with pre-market clearances (K112380 and K102456). As with the original EVA Sensor, the CMOS sensor when exposed to radiation uses a scintillator to indirectly capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized and sent to a computer via a USB interface. The images are then available for display on a computer monitor screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dentition, jaws and other oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs.
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: Bench Testing and Clinical Testing.
Sample Size: Not Specified.
Key Results: The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates. Clinical images were acquired and evaluated by a qualified dentist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
510(k) Summary 510(k) Number K12 AFP Imaging Corporation dba ImageWorks 250 Clearbrook Road, Suite 240 Elmsford, NY 10523 USA 914.592.6100 - Voice 800.592.6666 - Toll Free 914.592.6148 - Fax Prepared by: James Johnson, Director of Engineering Date Prepared: 23 October 2012
DEC 2 7 2012
Device Name 1.
Proprietary Name: Common/Usual Name: Classification Name: Classification Code:
EVA Select Digital Dental Imaging System Accessory to Extra oral X-Ray System Extra oral Source X-Ray System Accessory MUH
PREDICATE DEVICES 2.
- AFP Imaging EVA Digital Dental Imaging System K030647 .
- Midmark Clearvision K112380 .
- Takara Belmont Belsensor Gold K102456 ●
3. Intended Use
The EVA SELECT Digital Dental Imaging System is intended to be used with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.
Device Description র্বা
The EVA SELECT System (previously named the EVA System) has been modified to incorporate a new sensor component. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent EVA Digital Dental Imaging System. The modifications are limited to changing the sensor from a proprietary design to a commercially available sensor which is already used in at least 2 devices with pre-market clearances (K112380 and K102456). As with the original EVA Sensor, the CMOS sensor when exposed to radiation uses a scintillator to indirectly capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized and sent to a computer via a USB interface. The images are then available for display on a computer monitor screen.
6. Substantial Equivalence and Technological Characteristics
1
| Description
Information | EVA K030647 | Clear Vision
K112380 | BelSensor Gold
K102456 | EVA SELECT |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | AFP Imaging | Mid Mark | Takara Belmont | AFP Imaging dba
ImageWorks |
| Intended Use | The EVA Digital
Dental Imaging
System is intended
to be used with
standard
digital dental X-ray
systems and
computer stations
for system
operation, archive
data storage, input
capture and
enhancement, and
patient data and
support. | ClearVision is
intended to be
used by dentists
and other
qualified
professionals for
producing
diagnostic x-ray
radiographs of
dentition,
jaws and other
oral structures. | The BelSensor GOLD
is a USB-driven digital
sensor which is intended
to acquire dental intra-
oral radiology images.
The BelSensor GOLD
shall be operated by
healthcare professionals,
who are educated and
competent to perform
the acquisition of dental
intra-oral radiographs.
The BelSensor GOLD
can be used either in
combination with
special positioning
devices to facilitate
positioning and
alignment with the x-
ray beam or it may
also be positioned by
hand with the
assistance of a patient. | The EVA
SELECT Digital
Dental Imaging
System is
intended to be
used with
standard dental
X-ray systems
and computer
stations for
system operation,
archive data
storage, digital
dental image
input capture and
enhancement,
and patient data
and support. |
| Number of
Sensors | 2 Sizes | 2 Sizes | 2 Sizes | 2 Sizes |
| Sensor Sizes
(mm) | 19.92mm x 29.97
mm
36.03 mm x 25.83
mm | 19.95 mm x 30.02
mm
36.00 mm x 25.99
mm | 19.95 mm x 30.02 mm
36.00mm x 25.99 mm | 19.95 mm x 30.02
mm
36.00 mm x 25.99
mm |
| Pixel Size | 30 μm | 19 μm | 19 μm | 19 μm |
| Resolution | Resolution
theoretical(optical)
= 16.67 lp/mm
Resolution actual =
12 lp / mm | 26.3 lp/mm
(theoretical)
18.0 lp/mm
(actual) | 26.3 lp/mm
(theoretical)
18.0 lp/mm (actual) | 26.3 lp/mm
(theoretical)
18.0 lp/mm
(actual) |
| Technology | CMOS | CMOS | CMOS | CMOS |
| Scintillation | GadOx | CsI | CsI | CsI |
| Interface with
PC | USB | USB | USB | USB |
| Power source | 5 V (USB) | 5 V (USB) | 5 V (USB) | 5 V (USB) |
| Gray Shades | 4096 | 4096 | 4096 | 4096 |
| Cable Length | 2 m | 3 m | 3 m | 3 m |
:・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
7. Safety and Effectiveness, comparison to predicate device.
The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
2
Summary of Bench Testing Conducted: 8.
Line pair phantoms and step wedge images were evaluated. IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility standards compliance. Risk Analysis and Software validation was conducted in accordance with FDA guidance documents.
9. Summary of Clinical Testing:
Clinical images were acquired and evaluated by a qualified dentist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel.
10. Conclusion:
After analyzing bench, image, and external laboratory testing to applicable standards, it is the conclusion of AFP Imaging Corporation that the EVA SELECT is as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 27,2012
AFP Imaging Corporation c/o Daniel Kamm. P.E. Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
Re: K123419
Trade/Device Name: EVA Select Dental Imaging System Regulation Number: 21 CFR 892.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: Class II Product Code: MUH Dated: Oct. 29, 2012 -Received: Nov. 6, 2012
Dear Mr. Kamm:
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, Trug, 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 I ( 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 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. Yourse of 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
4
Page 2 - Mr. Kamm
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.
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 Diagnostics and Radiological Health 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,
Michael D. O'Hara
Louis M. Vlahos
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K123419
Device Name: EVA Select Digital Dental Imaging System
The EVA SELECT Digital Dental Imaging System is intended to be used Indications for Use: with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)