(54 days)
syngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools:
Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP)
Basic geometric measurement tools: distance line, polyline, marker, arrow, angle
Basic HU measurement tools: Pixel lens, ROI Circle, ROI freehand, VOI sphere, VOI freehand Dedicated dental visualization tools: Dental panoramic views (curved MPRs) and dental paraxial views (cross-section MPRs) that are calculated based on a manually defined centerline.
A tool to manually outline the mandibular canal.
A tool that allows paraxial and panoramic result images to be saved as dental range series.
True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its actual size on the film sheet.
The specific visualization of panoramic and paraxial views of the dental structures facilitates viewing, manual identification, and marking of dental pathologies and anatomy (for example, the position of the mandibular canal that needs to be preserved during dental interventions, such as dental (implant) surgery). Reporting and documentation of results is facilitated by the creation of ranges and snapshots, True Size (1:1) printing on DICOM printers, and by the use of a reporting tool.
syngo.CT Dental is post-processing image analysis software for computed tomography volume data sets that combines basic and advanced visualization that can be used in pre-surgical planning for dental operations, such as the planning of dental implant surgery. syngo.CT Dental contains image processing tools that allow for easy viewing and manual identification and marking of dental anatomy and pathologies by a physician.
The provided text describes the syngo.CT Dental software, a post-processing image analysis tool for CT scan data. It details the modifications made to a previously cleared predicate device and the testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative acceptance criteria for each feature (e.g., a specific percentage accuracy for a measurement tool). Instead, it states that "The test results show that all of the software specifications have met the acceptance criteria" and "The testing results support that all of the software specifications have met the acceptance criteria."
The reported device performance is described in terms of functionality and successful verification and validation:
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Specifications | All software specifications are met. | All test results met acceptance criteria. |
| Risk Mitigation | Identified hazards are controlled; risk analysis completed. | Risk analysis completed, risk control implemented; testing results support meeting acceptance criteria. |
| Verification & Validation | Device performs as intended; claims of substantial equivalence supported. | Performance tests conducted for functionality; all testing and documentation found acceptable to support claims of substantial equivalence. |
| Safety and Performance Standards | Conformance to listed standards (DICOM, IEC 62304, ISO 14971, IEC 60601-1-6, IEC 60601-1-4). | Siemens claims conformance to these five standards. |
| Cybersecurity | Prevention of unauthorized access, modifications, misuse, etc. | Siemens conforms to cybersecurity requirements by implementing a process for prevention. (Hospital's responsibility to comply with IEC 8001-1-2010). |
| Labeling | Contains instructions, cautions, and warnings for safe/effective use. | Device labeling contains necessary information for safe and effective use. |
| Electrical, Mechanical, Radiation Hazards | Hazards minimized. | Siemens adheres to recognized industry practice and standards for minimization. |
| Comparison to Predicate Device | Performance comparable to predicate device; no new safety risk. | syngo.CT Dental and predicate device have same intended use and operating principle; no significant changes in technological characteristics; non-clinical data supports safety and performs as intended, comparable to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the test set. It mentions "Integration and functional tests were conducted" and "Performance tests were conducted," but provides no numbers of cases or datasets tested.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method:
- Adjudication Method: Not specified. The document does not mention any form of adjudication for establishing ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the software's functionality and safety modifications, comparing it to a predicate device rather than evaluating human reader performance with and without AI assistance.
6. Standalone Performance Study:
- Standalone Study: Yes, a standalone performance study was conducted. The "Nonclinical Testing" section states, "Nonclinical tests were conducted for syngo.CT Dental during product development. The modifications described in this premarket notification were supported with verification and validation testing." "Performance tests were conducted to test the functionality of the subject device, syngo.CT Dental." This indicates direct testing of the algorithm's performance.
7. Type of Ground Truth Used:
- Type of Ground Truth: The document does not explicitly state the type of ground truth used. Given that syngo.CT Dental is a post-processing image analysis software with tools for visualization, measurement, and identification, the ground truth would likely involve expert consensus or reference measurements based on the CT image data itself for features like mandibular canal outlining, measurement accuracy, and proper rendering of dental structures. Pathology or outcomes data are not indicated as the primary ground truth for this type of image analysis software.
8. Sample Size for the Training Set:
- Sample Size: Not specified. The document focuses on verification and validation testing of the product, not its development or training process.
9. How Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not specified. The document does not describe the training set or how its ground truth was established.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2015
Siemens Medical Solutions USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K150785
Trade/Device Name: syngo.CT Dental Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 20, 2015 Received: March 25, 2015
Dear Ms. Davis:
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) K150785
Device Name Syngo.CT Dental
Indications for Use (Describe)
Syngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools:
Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP)
Basic geometric measurement tools: distance line, polyline, marker, arrow, angle
Basic HU measurement tools: Pixel lens, ROI Circle, ROI freehand, VOI sphere, VOI freehand Dedicated dental visualization tools: Dental panoramic views (curved MPRs) and dental paraxial views (cross-section MPRs) that are calculated based on a manually defined centerline.
A tool to manually outline the mandibular canal.
A tool that allows paraxial and panoramic result images to be saved as dental range series.
True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its actual size on the film sheet.
The specific visualization of panoramic and paraxial views of the dental structures facilitates viewing, manual identification, and marking of dental pathologies and anatomy (for example, the position of the mandibular canal that needs to be preserved during dental interventions, such as dental (implant) surgery). Reporting and documentation of results is facilitated by the creation of ranges and snapshots, True Size (1:1) printing on DICOM printers, and by the use of a reporting tool.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the word "SIEMENS" in a large, sans-serif font. The letters are a light blue or teal color. The word is presented in all capital letters and is the only element in the image.
510(k) Summary: syngo.CT Dental
Company: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: May 11, 2015
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
-
- General Information Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Vallev Stream Parkwav Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site:
Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany Owner/Operator No .: 8010024 Establishment Registration No: 3004977335
Contact Person: 2.
Eve Davis Requlatory Affairs Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway, Mail Code D02 Malvern, PA 19355 Phone: (610) 219-7133 Fax: (610) 448-1787 Email: eve.davis@siemens.com
3. Device Name and Classification
| Product Name: | syngo.CT Dental |
|---|---|
| Propriety Trade Name: | syngo.CT Dental |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
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| 4. | Legally Marketed Predicate Device | |
|---|---|---|
| Trade Name: | Dental CT Option | |
| 510(k) #: | K913996 | |
| Clearance Date: | November 22, 1991 | |
| Classification Name: | Computed Tomography X-ray System | |
| Classification Panel: | Radiology | |
| Classification Regulation: | 21 CFR § 892.1750 | |
| Device Class: | II | |
| Product Code: | JAK | |
| Recall Information: | This predicate device has not been thesubject of any design related recalls. | |
| Reference Device | ||
| Trade Name: | syngo.via | |
| 510(k) #: | K123375 | |
| Clearance Date: | November 20, 2012 | |
| Classification Name: | System, Image Processing, Radiological | |
| Classification Panel: | Radiology | |
| Classification Regulation: | 21 CFR § 892.2050 | |
| Device Class: | II | |
| Product Code: | LLZ |
5. Device Description:
syngo.CT Dental is post-processing image analysis software for computed tomography volume data sets that combines basic and advanced visualization that can be used in pre-surgical planning for dental operations, such as the planning of dental implant surgery. syngo.CT Dental contains image processing tools that allow for easy viewing and manual identification and marking of dental anatomy and pathologies by a physician.
The following modifications have been made to the previously cleared predicate device K913996, clearance date November 22, 1991 and are the subject of this 510(k) submission:
-
- A new software version SOMARIS/8 VB10 which supports the following:
- o migration of Dental Option for SOMATOM CT System to the syngo.via client server platform (syngo.via platform cleared in K123375)
- Name change to syngo.CT Dental
- 트 Basic Reading Tools - addition of VRT and MinIP
- Basic Geometric Measurement Tools - addition of polyline, arrow, and angle
- 트 Basic HU Measurement Tools - addition of Pixel lens and VOI
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Image /page/5/Picture/1 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. The word is in all caps.
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. storage of Panoramic and Paraxial Range images to the syngo.via database
o updated graphical user interface -
o Archiving/storage on CD-R and DVD
-
- An extended, more descriptive Indication for Use statement to include details of device functionality
6. Indications for Use:
svngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools:
- · Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP)
- · Basic geometric measurement tools: distance line, polyline, marker, arrow, angle
- · Basic HU measurement tools: Pixel lens, ROI Circle, ROI polygonal, ROI freehand, VOI sphere, VOI freehand
- · Dedicated dental visualization tools: Dental panoramic views (curved MPRs) and dental paraxial views (cross-section MPRs) that are calculated based on a manually defined centerline.
- · A tool to manually outline the mandibular canal.
- A tool that allows paraxial and panoramic result images to be saved as dental range series.
- · True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its actual size on the film sheet.
The specific visualization of panoramic and paraxial views of the dental structures facilitates viewing, manual identification, and marking of dental pathologies and anatomy (for example, the position of the mandibular canal that needs to be preserved during dental interventions, such as dental (implant) surgery). Reporting and documentation of results is facilitated by the creation of ranges and snapshots, True Size (1:1) printing on DICOM printers, and by the use of a reporting tool.
-
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Dental software package has the same intended use and operating principle as the predicate device, Dental CT Option (K913996, clearance date 11/22/1991). syngo.CT Dental device is a post-processing application that will operate on the multi-user syngo.via client/server platform.
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
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syngo.CT Dental does not have significant changes in technological characteristics when compared to the predicate device. The indications for use and fundamental scientific technology are similar. The subject device and predicate device are the same in regards to:
- Anatomic Region ●
- Dedicated Dental Visualization Tools o
- Outlining of the Mandibular Canal ●
- Reporting (True Size printing) ●
- DICOM compatible Communication o
The subject device and the reference device (K123375) are the same in regards to:
- Basic Reading Tools (VRT, MinIP) .
- Basic Geometric Measurement Tools (polyline, arrow, angle) ●
- Basic HU Measurement Tools (Pixel Lens, ROI, Circle, ROI o polygonal, ROI freehand, VOI sphere, VOI freehand)
The following table shows the differences in technological characteristics between the subject device and the predicate device.
| Differences in Technological Characteristics of the Subject Device Compared tothe Predicate Device | |||
|---|---|---|---|
| Feature | Subject Devicesyngo.CT Dental | PredicateDeviceDental CTOption(K913996) | Comparison |
| BasicReadingTools | MPR, MIP, VRT,MinIP | MPR, MIP | Volume Rendering Technique (VRT)and Minimal Intensity Projection(MinIP) reading is available on thesubject device with the migration to thesyngo.via platform (K123375).Verification and Validation testingsupports this modification. |
| BasicGeometricMeasurementTools | Manualmeasurement ofdistance line,polyline, reviewmarker, arrow andangle | Manualmeasurementof distanceline andreview marker | Manual measurement of polyline,arrow, and angle are available on thesubject device with the migration to thesyngo.via platform (K123375).Verification and Validation testingsupports this modification. |
| Basic HUMeasurementTools | Manualmeasurement ofpixel lens, ROIcircle, ROIpolygonal, ROIfreehand, VOIsphere, and VOI | ROI | Manual measurement of Pixel Lens,Region of Interest (ROI) Circle, ROIpolygonal, ROI freehand, Volume ofInterest (VOI) sphere, and VOIfreehand are available on the subjectdevice with the migration to thesyngo.via platform (K123375). |
| Differences in Technological Characteristics of the Subject Device Compared tothe Predicate Device | |||
| Feature | Subject Devicesyngo.CT Dental | PredicateDeviceDental CTOption(K913996) | Comparison |
| freehand | Verification and Validation testingsupports this modification. | ||
| Panoramicand ParaxialRangeSaving | Generated imagesare stored to thesyngo.viadatabase | Generatedimages arestored onmagneticdisks | The image results will now besaved to the syngo.via database,however the purpose of thoseimages remains the same. Fromthe syngo.via database, the imagescan be further distributed to eitherthe PACS or to disk. Verificationand Validation testing supports thismodification. |
| Workstation,OperatingSoftwarePlatform | syngo.via:Windows XP,Windows Vista orWindows 7 systems.The syngo.viaframework is amultiuser HW/SWarchitecture withclient/serversupport. | syngo classic:SOMATOMCT standardHW/SW | Siemens syngo.via platform is aclient/server multi-user framework andis a further development of syngoclassic. It runs on updated Windowssystems, and can support multipleusers. |
| UserInterface | syngo.via basedGUI | SOMATOMCTWorkstation | The user interface has been adaptedfrom syngo Classic to the currentsyngo.via framework. Verification andValidation testing supports thismodification. |
| Archiving /Storing | MOD, CD-R, film;DVD | MOD, film | The subject device has the additionalability to store images on CD-R orDVD as compared to the predicate.Verification and Validation testingsupports this modification. |
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SIEMENS
8. Nonclinical Testing:
Nonclinical tests were conducted for syngo.CT Dental during product development. The modifications described in this premarket notification were supported with verification and validation testing. Siemens claims conformance to the following five safety and performance standards for syngo.CT Dental:
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| Title of Standard | ReferenceNumber and Date | PublicationDate | StandardsDevelopmentOrganization |
|---|---|---|---|
| Digital Imaging and Communications inMedicine (DICOM) Set | PS 3.1 – 3.18 | 03/16/2012 | NEMA |
| Medical device software - Software lifecycle processes | 62304 First edition2006-05 | 08/20/2012 | IEC |
| Medical devices - Application of riskmanagement to medical devices | 14971 SecondEdition 2007-03-01 | 08/20/2012 | ISO |
| Medical electrical equipment -- Part 1-6: General requirements for basicsafety and essential performance --Collateral Standard: Usability | 60601-1-6 Edition3.0 2010-01 | 01/30/2014 | IEC |
| Medical electrical equipment - Part 1-4:General requirements for safety --Collateral standard: Programmableelectrical medical systems, edition 1.1 | 60601-1-4:2000,Consol. Ed. 1.1 | 09/08/2009 | IEC |
Verification and Validation
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Integration and functional tests were conducted for syngo.CT Dental during product development.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The test results show that all of the software specifications have met the acceptance criteria.
The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all of the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. It is the hospital's responsibility to comply with IEC 8001-1-2010.
Summary
Performance tests were conducted to test the functionality of the subject device, syngo.CT Dental. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
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General Safety and Effectiveness Concerns: 9.
SIEMENS
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
Conclusion as to Substantial Equivalence 10.
The modifications made to the predicate device add basic reading and viewing functionality. There is no new clinical functionality.
The predicate device was cleared based on non-clinical supportive information. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that syngo.CT Dental performs as intended. The non-clinical test data demonstrates that syngo.CT Dental device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens is of the opinion that the syngo.CT Dental does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.