(97 days)
Not Found
No
The document describes image processing and analysis software but does not mention AI, ML, or related concepts like neural networks or deep learning. There is also no information about training or test sets, which are typical for AI/ML development.
No.
The device is described as software for image data management and analysis, predominantly for diagnosis and presentation, not for delivering therapy.
Yes
The "Intended Use / Indications for Use" states that the software offers functions for "diagnosis" of medical image data.
Yes
The device description explicitly states "SIDEXIS 4 is software" and describes its functions related to image data processing and management. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, SIDEXIS 4 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SIDEXIS 4's Intended Use: The intended use of SIDEXIS 4 is for the acquisition, administration, analysis, diagnosis, presentation, and transfer of image data (X-ray images, video recordings) for medical use, predominantly in dentistry. This involves analyzing images of the body, not specimens taken from the body.
Therefore, SIDEXIS 4 falls under the category of medical imaging software, not an IVD.
N/A
-
Intended Use / Indications for Use
SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry. -
Product codes (comma separated list FDA assigned to the subject device)
LLZ -
Device Description
SIDEXIS 4 combines the two Sirona products GALAXIS and SIDEXIS XG and now integrates 2D and 3D functions. New functions have been implemented (e.g. comparison of two volumes, comparison of two 2D projections). SIDEXIS 4 offers similar functions and views as the predicate device Cybermed OnDemand3D (K113543). It offers similar functions to the predicate software parts of SIDEXIS XG and GALAXIS together. All systems (SIDEXIS XG and GALAXIS are always taken into account together) are typical PACS systems with 3D and 2D image-viewing capabilities for dental imaging devices. They have lots of common options to change the display of the images. With adjustment of brightness, contrast and special filters for SIDEXIS 4, the physician can adjust the display to the preferred style. -
Mentions image processing
Yes -
Mentions AI, DNN, or ML
Not Found -
Input Imaging Modality
X-ray images, video recordings -
Anatomical Site
Predominantly in dentistry (Implies dental anatomy) -
Indicated Patient Age Range
Not Found -
Intended User / Care Setting
Medical use, predominantly in dentistry. Intended user is a physician. -
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, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The SIDEXIS 4 system functions have been tested. Additional tests with technicians and physicians have been performed to compare images from SIDEXIS XG/GALAXIS with SIDEXIS 4.
Clinical Testing: Clinical tests have not been performed. -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found -
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cybermed OnDemand3D (K113543), SIDEXIS XG (K013659), GALAXIS cleared with (GALILEOS family K0123070) -
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found -
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510(k) Summary for Sirona Dental Systems SIDEXIS 4
1. SPONSOR
| Sirona Dental Systems GmbH | |
|---|---|
| Fabrikstrasse 31 | |
| D-64625 Bensheim | |
| Germany | |
| Contact Person: | Fritz Kolle |
| Telephone: | +49 6251 16 3294 |
| Date Prepared: | August 30, 2013 |
2. DEVICE NAME
| Proprietary Name: | SIDEXIS 4 |
|---|---|
| Common/Usual Name: | Picture archiving and communications system |
| Classification Name: | System, Image Processing, Radiological |
3. Predicate Devices
- SIDEXIS XG (K013659) .
- GALAXIS cleared with (GALILEOS family K0123070) .
- . Cybermed OnDemand3D (K113543)
4. Intended Use
SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.
Sirona Dental Systems 510(k) SIDEXIS 4
APPENDIX G
Page 1
1
5. Device Description and Function
SIDEXIS 4 combines the two Sirona products GALAXIS and SIDEXIS XG and now integrates 2D and 3D functions. New functions have been implemented (e.g. comparison of two volumes, comparison of two 2D projections).
6. SCIENTIFIC CONCEPT
Not applicable
7. PHYSICAL AND PERFORMANCE CHARACTERISTICS
Not applicable
8. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
SIDEXIS 4 offers similar functions and views as the predicate device Cybermed OnDemand3D (K113543). It offers similar functions to the predicate software parts of SIDEXIS XG and GALAXIS together.
All systems (SIDEXIS XG and GALAXIS are always taken into account together) are typical PACS systems with 3D and 2D image-viewing capabilities for dental imaging devices. They have lots of common options to change the display of the images. With adjustment of brightness, contrast and special filters for SIDEXIS 4, the physician can adjust the display to the preferred style.
9. Non-clinical Testing
The SIDEXIS 4 system functions have been tested.
Additional tests with technicians and physicians have been performed to compare images from SIDEXIS XG/GALAXIS with SIDEXIS 4.
Sirona Dental Systems 510(k) SIDEXIS 4
APPENDIX G
Page 2
2
10. Clinical Testing
Clinical tests have not been performed.
11. Conclusion
ﺮ ﺳﻌﺪ ﺍﻟﻤﻌﺎﺭﺿﺎ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘ
Based on a comparison of intended use, indications, principle of operation, features and technical data, the SIDEXIS 4 is safe and effective to perform its intended use and is substantially equivalent to the predicate devices.
Sirona Dental Systems 510(k) SIDEXIS 4
APPENDIX G
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-0 Silver Spring, MD 20993-0002
December 11, 2013
Sirona Dental Systems GmbH % Mr. Fritz Kolle Fabrikstrasse 31 Bensheim. D-64625 GERMANY
Re: K132773
Trade/Device Name: Sidexis 4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 19, 2013 Received: September 23, 2013
Dear Mr. Kolle:
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
4
Page 2- Mr. Kolle
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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.lda.gov/MedicalDevices/Resourcesfor You/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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132773
Device Name
..............................................................................................................................................................................
SIDEXIS 4
Indications for Use (Describe)
SIDEXIS 4 is software that offers function, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
FORM FDA 3881 (9/13)