ORTHOPHOS SL
Device Facts
| Record ID | K150217 |
|---|---|
| Device Name | ORTHOPHOS SL |
| Applicant | Sirona Dental Systems GmbH |
| Product Code | OAS · Radiology |
| Decision Date | May 8, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.
Device Story
ORTHOPHOS SL is a dental/maxillofacial X-ray system utilizing cone-beam CT technology. Device captures 2D panoramic, cephalometric, and 3D volume X-ray images. System includes a support stand, height-adjustable sled, motor-driven rotatable ring with X-ray source and direct conversion sensor, and patient fixation (bite blocks, forehead/temple supports). Operator uses control panel for mode/program selection and laser positioning; handheld button triggers exposure. PC software reconstructs 3D volumes and processes 2D images, conveying data to SIDEXIS database for clinician review. Autofocus feature eliminates manual jaw shape preselection. Device provides diagnostic data for hard-tissue assessment in dentistry, ENT, and carpus applications. Benefits include reduced dosage via collimation and improved image quality via direct conversion sensors.
Clinical Evidence
No clinical trials performed. Evidence consists of bench testing, system-level functional testing, and phantom testing to evaluate exposure equality against the predicate ORTHOPHOS XG 3D. DQE and MTF data provided for 3D mode. Sample clinical images were reviewed by an Oral Surgeon, who provided reports asserting the diagnostic quality of the images.
Technological Characteristics
Cone-beam X-ray system; direct conversion sensor; 60-90kV tube voltage; 6-16mA tube current. Features class I laser localizers. Biocompatible materials per ISO 10993-1. Connectivity via SIDEXIS software. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60825-1 (laser), IEC 62304 (software).
Indications for Use
Indicated for patients requiring maxillofacial, dental, pediatric dental, ENT, or carpus hard-tissue diagnostic imaging.
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
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Sirona Dental Systems GmbH % Mr. Kofi Aninakwa Legal Services Engineer Sirona Dental Systems, Inc. 30-30 47th Avenue, Suite 500 LONG ISLAND NY 11101
Re: K150217
Trade/Device Name: ORTHOPHOS SL Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: April 13, 2015 Received: April 17, 2015
Dear Mr. Aninakwa:
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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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) K150217
Device Name ORTHOPHOS SL
Indications for Use (Describe)
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary
For
## Sirona Dental Systems
## ORTHOPHOS SL
#### 1 SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Kofi Aninakwa Telephone: 718-482-2248 Date Prepared: January 19 2015
#### DEVICE NAME 2
ORTHOPHOS SL Proprietary Name: Common/Usual Name: X-Ray, Tomography, Computed, Dental Classification Name: Computed Tomography X-ray system Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system OAS - X-ray, Tomography, Computed, Dental Product Code:
#### 3 PREDICATE DEVICES
- Sirona ORTHOPHOS XG 3D / Ceph (K103711) Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS
- Sirona GALILEOS Comfort Plus (GALILEOS Family K123070) ● Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS
The primary predicate device is ORTHOPHOS XG 3D / Ceph. This is because ORTHOPHOS SL is a further development of ORTHOPHOS XG3D and as such both have very similar functionality. The PC software of ORTHOPHOS SL has similar functions and operations as that of GALILEOS Comfort Plus.
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### 4 INTENDED USE
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.
### 5 DEVICE DESCRIPTION AND FUNCTION
The device comprises image receptors for cephalometric exposures, 2D panoramic radiographs and 3D volume exposures. The combination of sensors in the device varies depending on the installed options and the regions of interest can be altered. The technology behind this is collimation and different start- and end angles of exposure. These allow for a reduced dosage depending on the program selected. This function is available with some volume, cephalometric and panoramic programs.
Class I laser beam light localizers aid in the positioning of a patient's head which may be fixed through the use of bite blocks and adjustable forehead and temple supports.
From the obtained exposures, reconstructed images can be viewed. The reconstructed 3D volumes, simulated projection exposures and panoramic/cephalometric data can be conveyed to SIDEXIS (an FDA approved Sirona software for acquisition, administration, analysis, diagnosis, presentation and transfer of image data for medical/dental use) and stored in the SIDEXIS database.
An operator control panel allows for height adjustment, selection of mode and program, and indication of machine states. A separate handheld push-button serves for exposure release and an optional remote control is available.
#### 5.1 Scientific concept
The underlying scientific concept of the 3D volumes, is the cone-beam x-ray technology. New direct conversion sensors are used to reduce the loss of information along with an autofocus feature that eliminates the need to preselect exact jaw shapes for panoramic exposures. The panoramic and cephalometric exposures are obtained by the standard technology that have been used in dental medicine for a very long time.
#### 5.2 Physical and Performance Characteristics
#### 5.2.1 Design
The ORTHOPHOS SL comprises a support stand to which a height adjustable sled is attached. The sled carries the patient fixation, the operator control panel (easy pad) and
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the motor driven rotatable ring. The X-ray source and image receptor are fixed to the ring. During a scan the device generates an x-ray beam that rotates around the patient´s head at varying angles.
The exposure area is defined by the geometry of the ORTHOPHOS SL. A control panel allows the user to select the exposure modes and the exposure factors, view the machine status information, control the height adjustment and turn on the laser indicator.
The PC software reconstructs the three-dimensional image as well as processes panoramic / cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/ cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS database.
New features include a Direct Conversion Sensor and an autofocus feature that eliminates the need to preselect exact jaw shapes for panoramic exposures. These have been tested in a system test. An Oral Surgeon report provided also covers these features.
# 5.2.2 Materials Used
Materials that come into patient contact intentionally are biocompatible and evaluated according to ISO 10993-1: 2003, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".
#### 5.2.3 Physical Properties
Not applicable.
#### 5.3 Software Level of Concern
The ORTHOPHOS SL software was determined to be of a MODERATE level of concern.
The software of the OTHOPHOS SL has been modified to support the new hardware. Software adaptations have been made to include the new autofocus for panoramic X-ray images, the Acquisition server and the new choice of x-ray programs.
### 6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The ORTHOPHOS SL is a further development of the ORTHOPHOS XG3D (USA 510(k)-K103711).
The ORTHOPHOS SL has a different source to skin distance than the ORTHOPHOS XG3D and the amount of images during an exposure has been increased.
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The ORTHOPHOS SL is capable of a range of x-ray parameters. The tube voltage can vary between 60kV and 90kV. The tube current can vary between 6mA and 12mA with an addition current of 16mA at 66kV. The maximum is 90kV and 12 mA.
A new sensor type is integrated in the ORTHOPHOS SL. It is a direct conversion sensor.
The PC software performs identical functions and algorithms as the GALILEOS. The software has been adapted to the higher number of images.
The ORTHOPHOS SL offers a calculated panoramic view in combination with slices orthogonal to the panoramic curve ('transversal slices') as the predicate GALILEOS for volumes. The GALILEOS family offers nearly the same functionality in viewing slices, projections and volume views for volume exposures.
ORTHOPHOS SL looks similar to the predicate ORTHOPHOS XG 3D, but the color of the operator panel differs. The panel is new, but the main difference is a color change. The offered functions for the operator are nearly the same.
In comparison to ORTHOPHOS XG 3D, ORTHOPHOS SL has an additional class I laser light beam localizer that helps the user identify volume size. The principles of the patient fixation for both devices are the same.
ORTHOPHOS SL has more volume sizes, volume positions and collimations than the predicate devices. This results in more possibilities to get an exposure of relevant dentomaxillofacial areas.
The ORTHOPHOS SL has a higher dose area product than ORTHOPHOS XG 3D due to demand from medical professionals to use with patients with dense bone, patients who are overweight and also due to the larger size of the detector.
### 7 NONCLINICAL TESTING
The ORTHOPHOS SL system functions have been tested in a system test (covers the requirements from the function specification, the risk/hazard analysis and the functionality of the equipment from the user's perspective).
The exposure programs have been tested utilizing test phantoms. The tests evaluate the equality of exposures of proposed ORTHOPHOS SL and predicate device ORTHOPHOS XG 3D.
Additional tests have been performed taking into account FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. Document issued on: August 6, 1999" adapted for image intensifier products. In particular, DQE and MTF data in 3D mode for the Hamamatsu detector mode have been provided to demonstrate substantial equivalence.
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Finally, The ORTHOPHOS SL Device complies with the applicable requirements of the following international and national standards:
- . IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility - Requirements and Tests
- EN 60601-1:2006 + Corr.:2010 + A1:2013 (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.1)
- IEC/EN 60601-1-3:2008 Medical electrical equipment Part 1-3: General . requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- . IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability, (with third edition of 60601-1)
- IEC 60601-2-63:2012 Medical electrical equipment - Part 2-63: Particular Requirements For The Basic Safety And Essential Performance Of Dental Extra-Oral X-Ray Equipment
- IEC 62304: 2006 Medical Devices Software life cycle processes ●
- IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
- . IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots.
- . IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification, requirements and requirements
- IEC 62471:2006, Photobiological safety of lamps and lamp systems ●
- ISO 14971:2007 Medical devices Application of risk management to medical ● devices
- ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation ● and testing within a risk management system
## CLINICAL TESTING 8
Sample clinical images have been provided. These were accompanied with Oral Surgeon reports asserting the general diagnostic quality of the images.
### 9 CONCLUSION
Based on the comparison of intended use, construction, and technical features, Sirona Dental Systems believes that the ORTHOPHOS SL is substantially equivalent to the Sirona ORTHOPHOS XG 3D/CEPH (K103711) and the Sirona GALILEOS (K123070).
