(43 days)
Not Found
No
The summary describes image viewing, manipulation, contouring, and segmentation tools, but does not mention any AI or ML capabilities. The focus is on porting existing, cleared segmentation tools to a new software architecture.
No
The device is an accessory to a linear accelerator system and a medical application for viewing, manipulating, and exporting medical images and structures for use in radiation therapy planning. It does not directly deliver therapy but assists in the planning.
No
The device is described as an accessory to a linear accelerator system for therapeutic treatment planning of cancer, not for diagnostic purposes. Its functions involve viewing, manipulating, contouring, and exporting medical image data for radiation therapy planning, which is a therapeutic process, even though it uses diagnostic images.
Yes
The device is described as a "licensable plug-in" to existing software architecture and its function is solely based on software tools for image viewing, manipulation, contouring, and data conversion. There is no mention of any associated hardware components being part of this specific device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The syngo® RT Interface is described as an accessory to a linear accelerator system used for radiation therapy planning. Its primary functions involve viewing, manipulating, contouring, and exporting medical images (DICOM data) for use in treatment planning. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states its role in the planning for the delivery of radiation therapy, not in the diagnosis of disease through in vitro testing.
- Device Description: The description focuses on image processing, segmentation tools, and integration with other medical imaging software, all related to treatment planning and image management, not in vitro testing.
Therefore, the syngo® RT Interface falls under the category of medical imaging software and treatment planning tools, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The syngo® RT Interface is as an accessory to the linear accelerator system to provide input to the planning for the delivery of x-ray photon and electron radiation for the therapeutic treatment of cancer where indicated.
The syngo® RT Interface supports the oncology workflow as a medical application for viewing, manipulation, contouring, 3D visualization and comparison of medical images from multiple imaging modalities.
This application allows the user to convert, store and export volume of interest (VOI) structures in DICOM® RT format for use in radiation therapy planning.
Product codes (comma separated list FDA assigned to the subject device)
MUJ, LLZ
Device Description
The syngo® RT Interface offers the segmentation tools, which are currently cleared in the Virtual Simulation [VSIM] module of the syngo® Dosimetrist v2.7 workspace, to be available from the RT Connect workflow on the MM Oncology Reading pane. The syngo® RT Interface software is based on the currently cleared SIEMENS syngo.via software's client /server architecture and is intended to be marketed as a licensable plug-in to the currently cleared syngo.via MM Oncology™ workspace. The basic design, safety features and function of the segmentation tools supported within the syngo® RT Interface remain unchanged from their currently cleared intended use and functions, however, the segmentation tools have been modified to run on the syngo.via architecture.
The syngo® RT Interface supports the RT Connect workflow application within the MM Oncology Reading pane that provides access to patient imaging data. The clinician can view and make clinical assessments of the area of medical interest (findings) using a variety of digital diagnostic radiographic [DDR] and other imaging modality images such as PET, CT, MR, and SPECT that conform to the DICOM standard.
The RT Connect workflow on the MM Oncology workspace supports the segmentation tools for use on a three dimensional view allowing for a virtual setup of the patient's preliminary treatment planning. A variety of segmentation tools are supplied to assist in the delineation of structures for contouring and placement on target organ(s) or findings prior to the data transfer for use by the third party treatment planning systems [TPS].
Additionally, the segmentation tools available through the syngo® RT Interface supports a workflow that enables the user to delineate, edit, or delete contours, and automatically convert them to DICOM RT structures. The DICOM RT Structure objects can be transfer to a currently cleared and commercial DICOM compatible treatment planning system to be used in the development of the treatment plan by the clinician or archived.
The syngo® RT Interface software utilizes the SIEMENS proprietary syngo.via software client/server architecture and allows for a standardized graphical user interface across SIEMENS medical products. The syngo.via -based software design consists of a unified user interface with clinical focused workflow options (clinically based engines) allowing for a selection and use of modules of common software applications for image acquisition, reconstruction, post-processing, display, and archiving across the Siemens Healthcare imaging and radiation therapy product lines.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital diagnostic radiographic [DDR], PET, CT, MR, SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician / Not Found
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)
Not Found
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.
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K120363
Siemens Medical Solutions USA, Inc. Radiation Oncology
MAR 2 0 2012
Section 5
510(k) Summary
Siemens Medical Solutions USA, Inc. Submitter: Radiation Oncology 4040 Nelson Avenue Concord, CA 94520
Contact: Christine Dunbar Senior Manager, Regulatory Affairs
Phone: (925)602-8157 (925)602-8008 Fax: Email: christine.dunbar@siemens.com
Proprietary Name: syngo® RT Interface
System, Planning, Radiation Therapy Treatment (accessory to) Common Name:
Classification: 892.5050
Product Code: MUJ
Substantial Equivalence Claimed To:
| PRODUCT | Clearance | Claim of Equivalence For: |
|---|---|---|
| Syngo® Dosimetrist v2.7 | ||
| Segmentation and | ||
| contouring features on | ||
| "syngo classic:". | K101119 | syngo® RT Interface supports the RT Connect |
| features which includes: | ||
| Segmentation, (contours) | ||
| Image fusion, | ||
| Plan review | ||
| Conversion to DICOM® RT Structure Sets. | ||
| Syngo® PET & CT | ||
| application (market name: | ||
| MM Oncology) – Software | ||
| Pkg | K093621 | syngo® RT Interface as a plug-in into the MM |
| Oncology Reading feature and clinically focused | ||
| image review applications including syngo TrueD™, | ||
| Findings Navigator and Image post processing | ||
| applications. | ||
| Syngo®.X (market name | ||
| syngo®.via) | K092519 | Syngo® classic to the Syngo.via software |
| development for client / server architecture. |
The syngo® RT Interface as described in this premarket notification has similar intended use and fundamental scientific technical characteristics as the predicate devices listed above.
510(k) for SIEMENS syngo® RT Interface
Page Sect. 5/1
1
Description Summary for the syngo® RT Interface:
Technological Characteristics:
. The syngo® RT Interface offers the segmentation tools, which are currently cleared in the
Virtual Simulation [VSIM] module of the syngo® Dosimetrist v2.7 workspace, to be available from the RT Connect workflow on the MM Oncology Reading pane. The syngo® RT Interface software is based on the currently cleared SIEMENS syngo.via software's client /server architecture and is intended to be marketed as a licensable plug-in to the currently cleared syngo.via MM Oncology™ workspace. The basic design, safety features and function of the segmentation tools supported within the syngo® RT Interface remain unchanged from their currently cleared intended use and functions, however, the segmentation tools have been modified to run on the syngo.via architecture.
The syngo® RT Interface supports the RT Connect workflow application within the MM Oncology Reading pane that provides access to patient imaging data. The clinician can view and make clinical assessments of the area of medical interest (findings) using a variety of digital diagnostic radiographic [DDR] and other imaging modality images such as PET, CT, MR, and SPECT that conform to the DICOM standard.
The RT Connect workflow on the MM Oncology workspace supports the segmentation tools for use on a three dimensional view allowing for a virtual setup of the patient's preliminary treatment planning. A variety of segmentation tools are supplied to assist in the delineation of structures for contouring and placement on target organ(s) or findings prior to the data transfer for use by the third party treatment planning systems [TPS].
Additionally, the segmentation tools available through the syngo® RT Interface supports a workflow that enables the user to delineate, edit, or delete contours, and automatically convert them to DICOM RT structures. The DICOM RT Structure objects can be transfer to a currently cleared and commercial DICOM compatible treatment planning system to be used in the development of the treatment plan by the clinician or archived.
Syngo.via:
ﻧﺔ
The syngo® RT Interface software utilizes the SIEMENS proprietary syngo.via software client/server architecture and allows for a standardized graphical user interface across SIEMENS medical products. The syngo.via -based software design consists of a unified user interface with clinical focused workflow options (clinically based engines) allowing for a selection and use of modules of common software applications for image acquisition, reconstruction, post-processing, display, and archiving across the Siemens Healthcare imaging and radiation therapy product lines.
Refer to Section 11- Design Description, for the System and Sub-System Requirements Specifications regarding these specific requirements.
510(k) for SIEMENS syngo® RT Interface
Page Sect. 5/2
2
Siemens Medical Solutions USA, Inc. Radiation Oncology
General Safety and Effectiveness:
The device labeling contains instructions for use, on-line help and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards. SIEMENS adheres to recognized and established industry practice and relevant international standards.
Intended Use:
The syngo® RT Interface is as an accessory to the linear accelerator system to provide input to the planning for the delivery of x-ray photon and electron radiation for the therapeutic treatment of cancer where indicated.
The syngo® RT Interface supports the oncology workflow as a medical application for viewing, manipulation, contouring, 3D visualization and comparison of medical images from multiple imaging modalities.
This application allows the user to convert, store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning.
Summarv:
In summary, SIEMENS is of the opinion that the syngo® RT Interface update does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.
Page Sect. 5/3
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christine Dunbar Senior Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Radiation Oncology 4040 Nelson Avenue CONCORD CA 94520
MAR 2 0 2012
Re: K120363
Trade/Device Name: syngo® RT Interface Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, LLZ Dated: January 31, 2012 Received: February 6, 2012
Dear Ms. Dunbar:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 Diagnostic Device Evaluation and Safety 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/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.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Siemens Medical Solutions USA, Inc. Radiation Oncology
Section 4
Indication For Use Statement
510(k) Number (if known): K12 0363
Device Name: syngo® RT Interface
Indications for Use:
The syngo® RT Interface is as an accessory to the linear accelerator system to provide input to the planning for the delivery of x-ray photon and electron radiation for the therapeutic treatment of cancer where indicated.
The syngo® RT Interface supports the oncology workflow as a medical application for viewing, manipulation, contouring, 3D visualization and comparison of medical images from multiple imaging modalities.
This application allows the user to convert, store and export volume of interest (VOI) structures in DICOM® RT format for use in radiation therapy planning.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) on of Aactological D Office of In Vitra OR Over-the-Counter Use_ Prescription Use (Per 21 CFR 801.109)
510(k) for SIEMENS syngo® RT Interface
Page Sec 4/1