EVA SELECT DIGITAL DENTAL IMAGING SYSTEM

K123419 · Afp Imaging Corp. · MUH · Dec 27, 2012 · Dental

Device Facts

• Record ID: K123419
• Device Name: EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
• Applicant: Afp Imaging Corp.
• Product Code: MUH · Dental
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

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.

Device Story

EVA SELECT is a digital dental imaging system consisting of a CMOS sensor and software for image capture and enhancement. The device integrates with standard dental X-ray systems; when exposed to radiation, the sensor uses a scintillator to capture images as charge patterns. These signals are digitized and transmitted via USB to a computer station. Operated by dentists or qualified professionals in clinical settings, the system allows for real-time image display, archiving, and enhancement. The output provides diagnostic-quality radiographs, assisting clinicians in evaluating oral structures and supporting clinical decision-making. The system benefits patients by enabling digital imaging with reduced processing time compared to traditional film.

Clinical Evidence

Clinical evaluation involved a qualified dentist reviewing images acquired with the EVA SELECT sensor. The study concluded that the images were as good as or better than those acquired with the predicate panel. Bench testing included line pair phantom and step wedge evaluations, along with electrical safety and electromagnetic compatibility testing per IEC standards.

Technological Characteristics

CMOS sensor with CsI scintillator; USB interface; 5V power source; 4096 gray shades; 19.95mm x 30.02mm and 36.00mm x 25.99mm sensor sizes; 19 μm pixel size; 18.0 lp/mm actual resolution. Operates with standard dental X-ray systems and PC workstations. Software validation conducted per FDA guidance.

Indications for Use

Indicated for use by dentists and qualified professionals for producing diagnostic X-ray radiographs of dentition, jaws, and other oral structures in patients requiring dental imaging.

Regulatory Classification

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.

Predicate Devices

• AFP Imaging EVA Digital Dental Imaging System (K030647)
• Midmark Clearvision (K112380)
• Takara Belmont Belsensor Gold (K102456)

Submission Summary (Full Text)

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K123419

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

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| Description<br>Information | EVA K030647 | Clear Vision<br>K112380 | BelSensor Gold<br>K102456 | EVA SELECT |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | AFP Imaging | Mid Mark | Takara Belmont | AFP Imaging dba<br>ImageWorks |
| Intended Use | The EVA Digital<br>Dental Imaging<br>System is intended<br>to be used with<br>standard<br>digital dental X-ray<br>systems and<br>computer stations<br>for system<br>operation, archive<br>data storage, input<br>capture and<br>enhancement, and<br>patient data and<br>support. | ClearVision is<br>intended to be<br>used by dentists<br>and other<br>qualified<br>professionals for<br>producing<br>diagnostic x-ray<br>radiographs of<br>dentition,<br>jaws and other<br>oral structures. | The BelSensor GOLD<br>is a USB-driven digital<br>sensor which is intended<br>to acquire dental intra-<br>oral radiology images.<br>The BelSensor GOLD<br>shall be operated by<br>healthcare professionals,<br>who are educated and<br>competent to perform<br>the acquisition of dental<br>intra-oral radiographs.<br>The BelSensor GOLD<br>can be used either in<br>combination with<br>special positioning<br>devices to facilitate<br>positioning and<br>alignment with the x-<br>ray beam or it may<br>also be positioned by<br>hand with the<br>assistance of a patient. | The EVA<br>SELECT Digital<br>Dental Imaging<br>System is<br>intended to be<br>used with<br>standard dental<br>X-ray systems<br>and computer<br>stations for<br>system operation,<br>archive data<br>storage, digital<br>dental image<br>input capture and<br>enhancement,<br>and patient data<br>and support. |
| Number of<br>Sensors | 2 Sizes | 2 Sizes | 2 Sizes | 2 Sizes |
| Sensor Sizes<br>(mm) | 19.92mm x 29.97<br>mm<br>36.03 mm x 25.83<br>mm | 19.95 mm x 30.02<br>mm<br>36.00 mm x 25.99<br>mm | 19.95 mm x 30.02 mm<br>36.00mm x 25.99 mm | 19.95 mm x 30.02<br>mm<br>36.00 mm x 25.99<br>mm |
| Pixel Size | 30 μm | 19 μm | 19 μm | 19 μm |
| Resolution | Resolution<br>theoretical(optical)<br>= 16.67 lp/mm<br>Resolution actual =<br>12 lp / mm | 26.3 lp/mm<br>(theoretical)<br>18.0 lp/mm<br>(actual) | 26.3 lp/mm<br>(theoretical)<br>18.0 lp/mm (actual) | 26.3 lp/mm<br>(theoretical)<br>18.0 lp/mm<br>(actual) |
| Technology | CMOS | CMOS | CMOS | CMOS |
| Scintillation | GadOx | CsI | CsI | CsI |
| Interface with<br>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 |

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# 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.

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# 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.

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# 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

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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 [phone]. 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 [phone] or [phone] 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

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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) < 12 3 41 9

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