(111 days)
The syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. The software combines following digital image processing and visualization tools:
- multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
- geometric measurement tools (distance line, polyline, marker, arrow, angle)
- HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI freehand, VOI sphere)
- curved MPR visualization (unfolded ribs and spine views), cross-section MPRs
- tools for creation and editing of anatomical centerline paths
- tools for creation and editing of anatomical labels
The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures. Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.
syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems.
syngo.CT Bone Reading combines basic and advanced digital image processing and visualization tools for easy manual identification, marking and reporting of pathologies such as bone lesions or fractures.
The software combines following digital image processing and visualization tools:
- multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
- geometric measurement tools (distance line, polyline, marker, arrow, angle)
- HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI freehand, VOI sphere)
- curved MPR visualization (unfolded ribs and spine views), cross-section MPRs
- tools for creation and editing of anatomical centerline paths
- tools for creation and editing of anatomical labels
Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.
Thereby, the user is always free to decide when or whether to apply particular tools. Accordingly, the user can operate the application in basic reading mode only and use conventional navigation on 2D and 3D views. Furthermore, during the whole reading process, the reading clinician has full control on the reported measurements, text and images.
The provided 510(k) submission for syngo.CT Bone Reading does not contain acceptance criteria or detailed results from a study proving the device meets said criteria in a manner that allows for a direct comparison table.
The submission focuses heavily on establishing substantial equivalence to predicate devices based on functional similarity and adherence to general medical device standards. It lacks specific performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with acceptance criteria for a diagnostic aid that provides quantitative output or automated detection.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states: "Non clinical tests were conducted for syngo.CT Bone reading software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria." However, it does not specify what those acceptance criteria were or how the device performed against them.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document does not describe a clinical test set, its sample size, or its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available in the provided text. Since no specific clinical test set is described, there's no information on experts or ground truth establishment for such a set.
4. Adjudication Method for the Test Set
Not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
Not available in the provided text. The submission focuses on the device's tools for manual identification and marking of pathologies, rather than automated detection or assistance that would be evaluated in a comparative effectiveness study.
6. Standalone Performance Study (Algorithm Only)
Not available in the provided text. The device is described as "image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems." It provides tools for manual identification and marking, implying human interaction is central to its intended use, rather than standalone algorithm performance.
7. Type of Ground Truth Used
Not available in the provided text for any specific performance claims. The document mentions "manual identification and marking of pathologies such as bone lesions or fractures" but doesn't define how ground truth for these pathologies would be established in a formal validation study for the software itself.
8. Sample Size for the Training Set
Not available in the provided text. The submission describes the software's functionality and its comparison to predicate devices, but does not discuss machine learning models, training data, or training set sizes.
9. How Ground Truth for the Training Set Was Established
Not available in the provided text. As no training set or machine learning components are discussed, this information is absent.
Summary of the Study (Based on Provided Text):
The submission describes "Non clinical tests were conducted for syngo.CT Bone reading software package during product development." These tests aimed to ensure the software met its specifications and that risk control measures were implemented. The testing "supports that all the software specifications have met the acceptance criteria" and "verification and validation of the device was found acceptable to support the claims of substantial equivalence."
However, this is a general statement about software development and testing, not a detailed report of a clinical performance study with specific acceptance criteria and results. The 510(k) strategy for syngo.CT Bone Reading appears to be based on demonstrating substantial equivalence through similar technological characteristics, indications for use, and safety/performance standards adherence to already cleared predicate devices, rather than through a novel clinical effectiveness study with quantitative performance metrics.
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Traditional 510(k) Submission: syngo.CT Bone Reading
510(K) SUMMARY FOR SYNGO.CT BONE READING
MAR 1 2 2013
Submitted by:
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355
Date Prepared: February 26, 2013
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.
1. Contact Person:
Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com
2. Device Name and Classification
Product Name: syngo.CT Bone Reading Propriety Trade Name: syngo.CT Bone Reading Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class Class II Product Code: 901AK
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KI23584
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Image /page/1/Picture/1 description: The image shows the word "SIEMENS" in a stylized, outlined font. Each letter is clearly defined with a double-line border, giving it a bold and distinct appearance. The font style is consistent throughout the word, creating a uniform and recognizable logo or brand name.
Substantial Equivalence: 3.
Siemens syngo.CT Bone Reading post processing software package is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device Name | FDA ClearanceNumber | FDA Clearance Date |
|---|---|---|
| Siemens syngo.CT Vascular Analysis | K112020 | 08/18/2011 |
| Siemens syngo MultimodalityWorkplace | K072728 | 04/22/2008 |
| Siemens SOMATOM Definition Edge | K120579 | 05/23/2012 |
4. Device Description:
syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems.
syngo.CT Bone Reading combines basic and advanced digital image processing and visualization tools for easy manual identification, marking and reporting of pathologies such as bone lesions or fractures.
The software combines following digital image processing and visualization tools:
- . multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
- geometric measurement tools (distance line, polyline, marker, ◆ arrow, angle)
- HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI . freehand, VOI sphere)
- curved MPR visualization (unfolded ribs and spine views), cross-. section MPRs
- . tools for creation and editing of anatomical centerline paths
- . tools for creation and editing of anatomical labels
Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.
Thereby, the user is always free to decide when or whether to apply particular tools. Accordingly, the user can operate the application in basic
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reading mode only and use conventional navigation on 2D and 3D views. Furthermore, during the whole reading process, the reading clinician has full control on the reported measurements, text and images.
In the following sections we list all tools and explain in detail how different tools are operated, and which steps are to be followed in order to complete and report a clinical diagnosis.
5. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Bone Reading software package is designed to be operated on syngo via VA20 platform in a single or multi user environment.
syngo.CT Bone Reading software package provides similar evaluation, reporting, and visualization tools and functionality as the predicate devices syngo MultiModality Workplace (K072728, clearance date April 22, 2008) and syngo.CT Vascular Analysis (K112020, clearance date August 18, 2011). syngo MultiModality Workplace contains visualization tools such as Curved Mode (in 3D application), Panoramic, and Paraxial Views.
These tools can be used to generate reformatted MPR images which are equivalent to the curved and cross-section MPRs in syngo.CT Bone Reading. Predicate device svngo.CT Vascular Analysis also has equivalent visualization tools. Predicate device SOMATOM Definition Edge (K120579, clearance date May 23, 2012) includes similar image processing and visualization tools such as curved MPRs for ribs and spine as well as suggested labeling of ribs and spine.
syngo.CT Bone Reading has similar indications for use and technological characteristics when compared to the predicate devices; therefore Siemens believes that syngo.CT Bone Reading is substantially equivalent to the predicate devices.
6. Nonclinical Testing:
syngo.CT Bone Reading is designed to fulfill the requirements of following standards:
- t IEC 60601-1-6 : 2006; Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 62304 Ed. 1.0, "Medical Device Software Software Lifecycle . Processes"
- ISO 14971:2007; Medical devices Application of risk management to . medical devices
- DICOM (Digital Imaging and Communications in Medicine) Standard: . . 2008 DICOM conformity is fully covered by syngo.via implementations.
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Non clinical tests were conducted for syngo.CT Bone reading software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all 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.
7. Indications for Use:
The syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. The software combines following digital image processing and visualization tools:
- multiplanar reconstruction (MPR) thin/thick, maximum intensity . projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
- geometric measurement tools (distance line, polyline, marker, . arrow, angle)
- HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI . freehand, VOI sphere)
- . curved MPR visualization (unfolded ribs and spine views), crosssection MPRs
- tools for creation and editing of anatomical centerline paths .
- tools for creation and editing of anatomical labels .
The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures.
Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots
8. General Safety and Effectiveness Concerns:
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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
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Traditional 510(k) Submission: syngo.CT Bone Reading
9. Conclusion as to Substantial Equivalence
In summary, Siemens is of the opinion that the syngo.CT Bone Reading software package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2013
Siemens Medical Solutions, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway D-02 MALVERN PA 19355
Re: K123584
Trade/Device Name: Syngo.CT Bone Reading Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: February 8, 2013 Received: February 15, 2013
Dear Ms. Mangum:
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.
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
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Page 2 - Ms. Mangum
CFR Part 807): labeling (21 CFR Part 801): medical device 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.
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 (301) 796-5450. 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely yours,
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Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
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Indications for Use
510(k) Number (if known):
Device Name: syngo.CT Bone Reading
Indications for Use:
The syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging The software combines following digital image processing and systems. visualization tools:
- multiplanar reconstruction (MPR) thin/thick, maximum intensity ◆ projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
- geometric measurement tools (distance line, polyline, marker, ● arrow, angle)
- HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI freehand, VOI sphere)
- curved MPR visualization (unfolded ribs and spine views), cross-. section MPRs
- . tools for creation and editing of anatomical centerline paths
- . tools for creation and editing of anatomical labels
The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures. Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.
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 OF NEEDED)
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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) K123584
§ 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.