OP300

K133544 · Palodex Group OY · OAS · Mar 26, 2014 · Radiology

Device Facts

• Record ID: K133544
• Device Name: OP300
• Applicant: Palodex Group OY
• Product Code: OAS · Radiology
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Device Story

OP300 is an extra-oral dental X-ray system producing 2D panoramic, cephalometric, and TMJ images, and 3D cone beam CT volumes. System uses CMOS flat panel detectors to capture X-ray projections during rotation around patient head. Reconstruction software (FBP or ART) processes projections into 3D views. Operated by qualified healthcare professionals in clinical settings. Modified version introduces medium-size CMOS sensor (12x12), expanded FOV options (up to 130x150mm), and modified beam-limiting aperture plate. Includes low-radiation dose mode for follow-up, adjusting voxel size as input parameter. GUI updated for new FOV selections. Output viewed via 3D software to assist dental diagnosis and treatment planning.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing comparing image quality of the modified device against the predicate using anthropomorphic phantoms. Testing confirmed no significant differences in image quality and successful validation of software modifications.

Technological Characteristics

Extra-oral X-ray system; CMOS flat panel detectors; 0.5mm focal spot; 57-90kV (pan), 60-90kV (ceph), 90kV (3D). Reconstruction via Filtered Back Projection (FBP) or Algebraic Reconstruction Technique (ART). Voxel size 80-600 µm. Connectivity via GUI touch screen. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-7, 60601-2-28, 60601-2-32.

Indications for Use

Indicated for dental radiographic examination of teeth, jaw, and TMJ areas in patients requiring 2D panoramic, cephalometric, or 3D cone beam computed tomography imaging. For use by qualified healthcare professionals only.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• OP300 (K122018)

Submission Summary (Full Text)

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**MAR 2 6 2014**

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K133544

# 510(k) Summary

Date: October 25th, 2013 Revised: 4th Febuary, 2014

## Manufacturer:

PaloDEx Group Ov Nahkelantie 160 Tuusula, Finland 04300

Tel: [phone] Fax: [phone]

Contact person: Mr. Terho Turkumäki, Tel [phone]

# Trade Name:

OP300

## Common Name:

Dental panoramic, cephalometric and cone beam computed tomography x-ray device

## Classification Name:

x-ray, tomography, computed, dental (21 CFR § 892.1750, product code OAS)

#### Description:

The Orthopantomograph OP300 is an extra oral source dental x-ray device that is softwarecontrolled which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software.

#### Indication for Use:

The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

#### Intended Use:

The intended use of the OP300 is for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view.

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# Summary of Technological Characteristics:

OP300 is substantially equivalent in design, composition and function to the current OP300 unit.

| | Concept | OP300 (K122018) | OP300 (Modified) |
|----|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 1. | Indications for use | The OP300 dental panoramic,<br>cephalometric and cone beam<br>computed tomography x-ray device is<br>intended for dental radiographic<br>examination of teeth, jaw and TMJ<br>areas by producing conventional 2D x-<br>ray images as well as x-ray projection<br>images of an examined volume for the<br>reconstruction of a 3D view. The<br>device is operated and used by<br>qualified healthcare professionals. | Same |
| 2. | Imaging modes | Panoramic, Cephalometric, TMJ, 3D | Same |
| 3. | X-ray source | 3D mode: 90kV<br>Pan mode: 57-90 kV<br>Ceph mode: 60-90 kV<br>kV accuracy: +/-5kV<br>mA range: 3.2-16 mA<br>3D power mode: pulsed | Same |
| 4. | Focal spot | 0.5mm | Same |
| 5. | Image detector(s) | CMOS Flat Panel<br>+ CMOS for pan/ceph imaging | Same |
| 6. | 3D imaging technique | Reconstruction from 2D images | Same |
| 7. | 3D's Field Of View | 61 x 41 mm<br>61 x 78 mm | 50 x 50 mm<br>61 x 78 mm<br>78 x 78 mm<br>78 x 150 mm<br>130 x 150 mm |
| 8. | 3D's total viewing angle | 200 degrees | Same |
| 9. | Pixel size | CMOS flat panel for 3D: 200 μm<br>CMOS for panoramic imaging: 100 µm | Same |
| 10 | Voxel size | 80-350 µm | 80-600 µm |
| 11 | Reconstruction Software | Filtered Back Projection (FBP) or<br>Algebraic Reconstruction Technique<br>(ART) | Same |
| 12 | 3D's effective exposure time | 2 - 20 sec | Same |
| 13 | 3D Reconstruction Time | 1-3 min | Same |
| 14 | Patient's Position | Standing and wheelchair | Same |
| 15 | System footprint | H161-241cm x D1390cm x W97-193<br>cm | Same |
| 16 | Weight | Pan/3D 205 kg | Same |

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The differences between the Predicate Device OP300 (K122018), and the modified device are the following:

New panel and Field of Views: The small size 3D CMOS flat panel sensor (10x7) used in the Predicate Device OP300 (K122018) is replaced with a medium size CMOS flat panel sensor (12x12), This brings new bigger Field of View (FOV) sizes for the user. The new 3D programs to support the new FOV -sizes are: 50 x 50 mm. 61 x 78 mm (as in the Predicative Device), 78 x 78 mm. 78 x 150 mm and 130 x 150 mm.

Modified beam-limiting device is introduced to support the new FOV -sizes. Sliding aperture plate has been modified to consist of 3 apertures to allow the usage of new FOVs, instead of 1 aperture in the Predicative Device. Control principle remains the same as the predicate device.

The GUI software that is operated through the touch screen control panel has been modified to incorporate the changes to the imaging programs. Each new FOV -size has a new selection button in the updated GUI.

Following the ALARA (As Low As Reasonably Achievable) principle, a very low radiation dose mode for 3D imaging is introduced. The low radiation dose mode can be used for example in treatment follow-up cases where the most accurate image quality is not needed. As the radiation dose is lower, the voxel size needs to be bigger (lower resolution) in order to keep the dose per voxel in adequate level. Voxel size is an input parameter for the 3D reconstruction calculation.

Design verification and validation has been performed to ensure the safety and effectiveness of the device.

#### Performance (bench) Test Data:

In- house Performance (bench) testing has been conducted to compare the image quality and the sensor performance of the proposed OP300 and the predicate OP300 according to the recommendations in the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices". As a result of the performance test it was concluded that there is no significant differences in image quality between the proposed and the predicate device.

The modified OP300 has been tested against FDA Recognized Consensus Standards (IEC60601-1:1988, IEC60601-1-2:2001, IEC 60601-1-3:1994, IEC60601-1-4:1996, IEC 60601-2-7:1998, IEC 60601-2-28:1993 and IEC 60601-2-32:1994). The standards used are the same standards as with the Predicate Device.

Images of an anthropomorphic phantom image for the 3D imaging mode were evaluated for the OP300 device and the predicate to demonstrate the modified device was capable of producing images without severe defects.

The modified OP300 has been successfully verified and validated to ensure the safety and effectiveness of the device.

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K133544
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## Clinical Test Data:

Sample clinical images of patients were not used to support substantial equivalence of the OP300 device because the primary change to the imaging chain was a change in the detector size (other detector characteristics remained the same); the bench performance testing demonstrated that the new detector options had equivalent laboratory image quality performance to the predicate.

#### Conclusion:

Based upon the similar technological/performance characteristics to the predicate device and the successful validation of the OP300 software, the clinical performance of the OP300 is deemed to be substantially equivalent to the predicate devices.

The OP300 has been successfully verified and validated to ensure the safety and effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2014

PaloDex Group Oy % Mr. Terho Turkumäki OA&RA Manager Nahkelantie 160 O4300 Tuusula FINLAND

Re: K133544 Trade/Device Name: OP300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: February 20, 2014 Received: February 24, 2014

Dear Mr. Turkumäki:

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 10 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.

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Page 2-Mr. Turkumäki

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.lda.gov/Medicall.cevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safety/ReportaProblem/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


for

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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# Indications for Use

510(k) Number (if known): K133544

Device Name: OP300

Indications for Use:

The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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)

\$(m,h,7)\$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> K | 33544 510(k) =======================================================================================================================================================================

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