(60 days)
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No
The document describes standard medical imaging and planning software functionalities without mentioning AI or ML.
No
The device is used to prepare geometric and anatomical data for radiotherapy treatment planning, not to administer treatment itself. It's a pre-treatment planning tool.
No
This device is used to prepare geometric and anatomical data for radiotherapy treatment planning. It helps visualize and optimize treatment fields but does not diagnose diseases or conditions.
No
The device description explicitly states that Advantage Sim 6.0 can be installed only on validated Advantage Workstation, which is a hardware platform. It also mentions the need for a compatible Laser camera and an optional Postscript printer for hardcopy, indicating reliance on specific hardware components beyond just software.
Based on the provided information, the Advantage Sim 6.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Advantage Sim 6.0's Function: The description clearly states that Advantage Sim 6.0 is used to "prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning." It works with CT images of the patient's body to define anatomical volumes and plan treatment fields.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is based on processing and visualizing medical images.
Therefore, Advantage Sim 6.0 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
Advantage Sim 6.0 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 in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. 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 CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.
Product codes (comma separated list FDA assigned to the subject device)
90 KPO
Device Description
Advantage Sim 6.0. 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 in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. 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 CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display of defined structures with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.
The GE Advantage Sim 6.0 has to ensure relations with the following external systems:
Data Export
Image, volume and plan data are exported in accordance with DICOM V3.0.
Implementation profile is available on request. NOTE: Any treatment planning system connected to Advantage Sim 6.0. must be DICOM 3.0 compatible and capable of reading DICOM RT Plan and RT Structure Set.
Export of treatment plan data to any external system, and its correct interpretation by that system, must be fully validated before use. Advantage Sim 6.0 stores isocenter coordinates and user defined marker coordinates onto an external accessible directory using a published protocol readable bv external mobile laser controller.
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, and its correct interpretation by Advantage Sim 6.0, must be validated before use.
Hardcopy
Hardcopy of all displays and plan data can be made at selected magnification on paper or transparency material. Users can print DRR to film at user defined SID if equipped with an Advantage Workstation 6.0. compatible Laser camera (Laser camera must be adequate for scaled printing), with the appropriate AW Laser Camera Interface. (AW Option). Hardcopy of beam parameters and of isocenter coordinates, using IEC standard, can be made on an optional Postscript printer
Archiving
Advantage Sim 6.0 can save DICOM images and DICOM RT objects on single-session DICOM CD R using an optional CD ROM writer.
Configuration Requirements
Advantage Sim 6.0 can be installed only on validated Advantage Workstation with single or dual color monitor.
The GE Advantage Sim 6.0 is designed and produced by GE Medical Systems and has been previously submitted to PMN (K951830).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT images
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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JUL 2 9 2002
ರೈ
General Electric Medical Systems
Attachment 3 pg 1 of 4
Advantage Sim 6.0 510 (k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements 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: 262-544-3863 Date Prepared: February 26. 2002
2. Identification of Product:
| Device name | Advantage Sim 6.0. |
|---|---|
| Classification name | Radiation therapy simulation system |
| per 21CFR Section 892 5840 | |
| Manufacturer/ | General Electric Medical Systems |
| Distributor | 283, Rue de la Minière |
| 78533 BUC Cedex France |
3. Marketed Devices
Advantage Sim 6.0 is substantially equivalent to the device listed below:
| Model: | Advantage Sim 1.2 |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K951830 |
4. Device Description :
Advantage Sim 6.0. 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 in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The
1
Attachment 3 page 2 of 4
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 CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display of defined structures with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.
The GE Advantage Sim 6.0 has to ensure relations with the following external systems:
Data Export
Image, volume and plan data are exported in accordance with DICOM V3.0.
Implementation profile is available on request. NOTE: Any treatment planning system connected to Advantage Sim 6.0. must be DICOM 3.0 compatible and capable of reading DICOM RT Plan and RT Structure Set.
Export of treatment plan data to any external system, and its correct interpretation by that system, must be fully validated before use. Advantage Sim 6.0 stores isocenter coordinates and user defined marker coordinates onto an external accessible directory using a published protocol readable bv external mobile laser controller.
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, and its correct interpretation by Advantage Sim 6.0, must be validated before use.
Hardcopy
Hardcopy of all displays and plan data can be made at selected magnification on paper or transparency material. Users can print DRR to film at user defined SID if equipped with an Advantage Workstation 6.0. compatible Laser camera** (** Laser camera must be adequate for scaled printing), with the appropriate AW Laser Camera Interface. (AW Option). Hardcopy of beam parameters and of isocenter coordinates, using IEC standard, can be made on an optional Postscript printer
Archiving
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Affar Life Light on the many
Advantage Sim 6.0 can save DICOM images and DICOM RT objects on single-session DICOM CD R using an optional CD ROM writer.
Configuration Requirements
Advantage Sim 6.0 can be installed only on validated Advantage Workstation with single or dual color monitor.
The GE Advantage Sim 6.0 is designed and produced by GE Medical Systems and has been previously submitted to PMN (K951830).
5. Indications for Use
Advantage Sim 6.0 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 in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. 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 CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.
6. Comparison with Predicate Device
The GE Advantage Sim 6.0 is substantially equivalent to the following device:
Advantage Sim 1.2 Manufacturer: GE Medical Systems 510(k): K951830
Both of Advantage Sim 6.0 and Advantage Sim 1.2 provides complete volume definition and geometric beam placement capability for radiotherapy. It is then able to compute a DRR for any type of patient set-up and fully replaces a classic simulator
7. Conclusions
The entire potential new hazards has been studied and controlled by a Risk Management Plan:
- · A hazard analysis/ Risk Management Summary
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Artach ment 3 lg : 4 of 4
- A software development and validation process
- A software verification plan
Advantage Sim 6.0 provides images comparable to the predicate device.
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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K021780
Trade/Device Name: Advantage SIM 6.0 Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPO Dated: July 15, 2002 Received: July 16, 2002
Dear Mr. Gmelin:
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 CFR Part 807); labeling (21 CFR Part 801); 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,
5
This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/0 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.
Attachment 1
STATEMENT OF INTENDED USE
Device name: Advantage Sim 6.0
Indication For Use:
Advantage Sim 6.0 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 in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. 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 CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -OR-Over-The-Counter Use (Per 21 CFR 801.109) (Division Sian-Off) Division of Reproductive, and Radiological De 510(k) Number 1/1PAGENOMFICHIER