(19 days)
Not Found
No
The document describes automated and assisted anatomical volume definition and image co-registration, which are common image processing techniques, but does not explicitly mention or imply the use of AI or ML algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
This device is used for planning and simulation of radiotherapy treatment, not for delivering the treatment itself. It prepares data for dosimetry planning, which is a precursor to therapy.
No
The device is used for preparing geometric and anatomical data for radiotherapy treatment planning, not for diagnosing a medical condition. It supports treatment planning by defining anatomical volumes and optimizing field coverage, which occurs after a diagnosis has been made.
Unknown
The provided text describes the functionality of the device, which is software-based image processing and treatment planning. However, it also mentions "relations with the following external systems: Data Export, Marking Systems, RT Data Import, Hardcopy, Archiving." While these could be software interfaces, "Marking Systems" and "Hardcopy" could potentially imply hardware components or direct control over hardware, making it unclear if the device is exclusively software. The summary does not explicitly state it is software-only.
Based on the provided information, no, 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. They are used to provide information for diagnosis, monitoring, or screening.
- AdvantageSim MD Function: The description of AdvantageSim MD clearly states its purpose is to "prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning." It uses medical imaging data (CT, MR, PET, SPECT) to define anatomical volumes and plan treatment fields.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. Its function is based on processing and visualizing medical images.
Therefore, AdvantageSim MD falls under the category of medical imaging software or radiotherapy planning software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
Product codes
KPQ
Device Description
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
The GE Advantage Sim MD has to ensure relations with the following external systems:
Data Export
Image, volume and plan data are exported in accordance with DICOM V3.0 with all radiotherapy specific data included in a DICOM V3.0 object - including RT Plan and RTSS- Structure Set. Implementation profile is available on request. NOTE: Any treatment planning system connected to AdvantageSim MD must be NOTE: Any a compatible and capable of reading the AdvantageSim MD radiotherapy DICOM V3.0 -including RT Plan and RTSS- object Structure Set. Export of treatment plan data to any external system, and its correct interpretation by that system must be fully validated before use.
Marking Systems
AdvantageSim MD stores isocenter coordinates and user defined marker coordinates onto an external accessible directory using a published protocol readable by external mobile laser controller. Currently supports Gammex and LAP formats.
Laser shifts sent to the external laser systems can be corrected for table deflection by identifying the fiducial landmark location within the image volume.
RT Data Import
Image, volume and plan data can be imported in accordance with the RT objects of the DICOM Standard. Import of treatment plan data from an external system, of the DICOM banomal import over and must be validated before use.
Hardcopy
Hardcopy of all displays and plan data can be made at selected magnification on Tardeopy of an enspire analy. Users can print DRR to film at user defined SID if paper of trailSparency material. SockstationTM compatible Laser camera**, with the appropriate AW Laser Camera Interface. (AW Option). Hardcopy of beam we appropriate AW DESC. Cancillates, using IEC standard, can be made on an optional Postscript printer
Archiving
AdvantageSim MD can save DICOM images and DICOM RT objects on singlesession DICOM CD R using an optional CD ROM writer.
Configuration Requirements
AdvantageSim MD is compatible with Advantage Windows WorkstationTM 4.1 or higher
Mentions image processing
Yes, "Image, volume and plan data are exported in accordance with DICOM V3.0", "Image, volume and plan data can be imported in accordance with the RT objects of the DICOM Standard.", "Hardcopy of all displays and plan data can be made at selected magnification", "AdvantageSim MD can save DICOM images and DICOM RT objects"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, PET, SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
K021780, K032915, K010336, K041521
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
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.
0
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are solid black, creating a strong contrast against the white background.
K05 23 45
GE Healthcare
Advantage Sim MD 510 (k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in
ternation of the county of a for CPD Ro-4807 87 (b) Tuts 310(K) Summary of St Surville of 21 CFR Part 807.87 (h)
-
- Identification of submitter: Larry A. Kroger, Ph.D. Senior Regulatory Program Manager 3000 N. Grandview Blvd Waukesha, 53188 USA Telephone: 262-544-3894 Fax: 262-548-4768 Date Prepared: May 10, 2005
-
- Identification of Product:
| Device name | Advantage Sim MD. |
|---|---|
| Classification name | Radiation therapy simulation system |
| per 21CFR Section 892 5840 | |
| Manufacturer/ | |
| Distributor | General Electric Medical Systems |
| 283, Rue de la Minière | |
| 78533 BUC Cedex France |
3. Marketed Devices
Advantage Sim MD is substantially equivalent to the devices listed below:
| Model: | Advantage Sim 6.0 |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K021780 |
| Model: | Advantage 4D option |
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K032915 |
| Model: | Advantage Windows CT/PET Fusion |
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K010336 |
1
GE Healthcare
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, creating a strong contrast against the white background.
Volume Viewer Plus Model: General Electric Medical Systems Manufacturer: K041521 510 (k):
4. Device Description :
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
The GE Advantage Sim MD has to ensure relations with the following external systems:
Data Export
Image, volume and plan data are exported in accordance with DICOM V3.0 with all radiotherapy specific data included in a DICOM V3.0 object - including RT Plan and RTSS- Structure Set. Implementation profile is available on request. NOTE: Any treatment planning system connected to AdvantageSim MD must be NOTE: Any a compatible and capable of reading the AdvantageSim MD radiotherapy DICOM V3.0 -including RT Plan and RTSS- object Structure Set. Export of treatment plan data to any external system, and its correct interpretation by that system must be fully validated before use.
Marking Systems
AdvantageSim MD stores isocenter coordinates and user defined marker coordinates onto an external accessible directory using a published protocol readable by external mobile laser controller. Currently supports Gammex and LAP formats.
Laser shifts sent to the external laser systems can be corrected for table deflection by identifying the fiducial landmark location within the image volume.
2
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
RT Data Import
Image, volume and plan data can be imported in accordance with the RT objects of the DICOM Standard. Import of treatment plan data from an external system, of the DICOM banomal import over and must be validated before use.
Hardcopy
Hardcopy of all displays and plan data can be made at selected magnification on Tardeopy of an enspire analy. Users can print DRR to film at user defined SID if paper of trailSparency material. SockstationTM compatible Laser camera**, with the appropriate AW Laser Camera Interface. (AW Option). Hardcopy of beam we appropriate AW DESC. Cancillates, using IEC standard, can be made on an optional Postscript printer
Archiving
Arculving
AdvantageSim MD can save DICOM images and DICOM RT objects on singlesession DICOM CD R using an optional CD ROM writer.
Configuration Requirements
AdvantageSim MD is compatible with Advantage Windows WorkstationTM 4.1 or higher
5. Indications for Use
Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the additional CT, MR, FET of St LCT Studios Lich data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-The geometric parameded of a propos of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined unages, or on a vean of the display of digitally reconstructed radiograph
-
- Comparison with Predicate Device
3
Image /page/3/Picture/1 description: The image shows a logo of General Electric (GE). The logo consists of the letters 'GE' intertwined and enclosed within a circle. The logo is black and white, with the letters and the circle being black and the background being white.
Advantage Sim MD, and all of its predicates are software options that operate on Advantage Workstation 4.2 (some predicates on 4.0 and 4.1 as well). The functional features of Advantage Sim MD software package are substantially equivalent to that of the following devices:
| Device Name | FDA Clearance Number |
|---|---|
| Advantage Sim 6.0 | K021780 |
| Advantage 4D option | K032915 |
| Advantage Windows CT/PET Fusion | K010336 |
| Volume Viewer Plus | K041521 |
7. Adverse Effects on Health
Auverse Encels on freat."
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- Software Development, Validation and Verification Process to ensure . performance to specifications, Federal Regulations and user requirements.
- Adherence to industry and international standards. .
8. Conclusions
The Advantage Sim MD does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the performs & wen as dovivalent to those of Advantage Sim 6.0 (K021780), Advantage 4D option, Advantage Windows CT/PET Fusion (K010336) and Volume Viewer Plus (K041521).
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 18 2012
GE Healthcare % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K052345
Trade/Device Name: Advantage SIM MD Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: KPQ Dated: August 22, 2005 Received: August 26, 2005
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of September 14, 2005,
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 (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
5
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
hMD D'A fon
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): K052345
510(k) Number (if known):
Device Name: ADVANTAGE SIM MD
Indications for Use:
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosiments planning. Anatomical
proposed external beam radiotherapy treatment prior to dosimensions using a set of CT proposed external beam radiously or manually in three dimensions using a set of CT
volumes can be defined automatically or manualizes most position of the volumes can be defined avions in the proposed reading position. Definition of the images acquired with the patient in the propose and PPT or SPECT studies that anatomical volumes may be assisted by additionally, CT & PET data from a
have been co-registered with the planning CT scan. Additionally, CT & PET data from a have been co-registered with me praining & I sear to define the target or
respiratory tracked examination may be used to allow the user to define the target or respiratory fracked oximilation arange of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-The geometric parameters of a proposed connect included anatomical stuctures and dosimetric treatment fields are displayed on transverse images, on reformatted sagittal, geometric treatment neids, on 3 D views created from the mages, or on a beam eye's s
coronal or oblique images, on 3 D views created from the mages, or on a beam eye's coronal or obligue mages, on > D views created from the mages,
view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052345