(64 days)
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 or PET 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.
AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist, nuclear medicine physicians and trained healthcare professional) to assist treatment planning.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) Premarket Notification Submission Summary for "GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options." It describes the device, its intended use, and its classification, and notes that the software complies with voluntary standards and underwent quality assurance measures like risk analysis, design reviews, and various testing (integration, performance, safety).
Crucially, under "Summary of Clinical Tests," it explicitly states:
"The subject of this premarket submission, AdvantageSim MD with CT Atlas-based Contouring and Re-planning Options software did not require clinical studies to support substantial equivalence since the two new features have triggered this 510(k) notification, CT atlas-based contouring and CT based re-planning options are part of Mirada’s FDA cleared product."
This indicates that no new clinical study was conducted for this specific 510(k) submission to demonstrate performance against acceptance criteria. Instead, substantial equivalence was established by referencing features already part of an FDA-cleared predicate device (Mirada's product).
Therefore, I cannot provide the requested information from the given text as it explicitly states that clinical studies were not required and thus, no such study demonstrating device performance against acceptance criteria is detailed.
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Image /page/0/Picture/0 description: The image shows a document with the text "K132045 Page 1 of 2" written on it. The text is handwritten in black ink and is located at the top of the page. Below the text is a circular logo with the letters "GE" inside. The logo is also in black ink and appears to be a stamp or seal.
GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 25, 2013 |
|---|---|
| Submitter: | GE Hungary Kft.Akron utca 22040 Budörs, Hungary |
| Primary ContactPerson: | Peter UhlirRegulatory Affairs LeaderTel: 00 36 23 410121Fax: (262) 364 2506 |
| SEP 0 4 2013 | |
| Secondary ContactPerson: | Stephen G. Slavens, RACRegulatory Affairs DirectorGE HealthcareTel: (262) 548 4992Fax: (262) 364 2506 |
| Device Trade Name: | AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options |
| Common/Usual Name: | AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options |
| Classification Names: | 21CFR 892.5840, Radiology |
| Product Code: | KPQ |
| Predicate Device(s): | K052345 - AdvantageSim™ MDK130393 - RTx (Mirada Medical Ltd. LLC) |
| Device Description /Intended Use: | AdvantageSim™ MD is a CT/MR/PET oncology application used byclinicians (radiologist, radiation oncologist, medical oncologist,nuclear medicine physicians and trained healthcare professional) toassist treatment planning. |
| Indications for Use: | AdvantageSim™ MD is used to prepare geometric and anatomicaldata relating to a proposed external beam radiotherapy treatmentprior to dosimetry planning. Anatomical volumes can be definedautomatically or manually in three dimensions using a set of CTimages acquired with the patient in the proposed treatmentposition. |
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Image /page/1/Picture/0 description: The image shows the text "K132045 Page 2 of 2" in a handwritten style. Below the text is the GE logo, which is a circular emblem with the letters "GE" intertwined in the center. The logo is black and white and appears to be a stamp or seal.
GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options 510(k) Premarket Notification Submission
| Definition of the anatomical volumes may be assisted by additionalCT, MR or PET studies that have been co-registered with theplanning CT scan. Additionally, CT & PET data from a respiratorytracked examination may be used to allow the user define thetarget or treatment volume over a defined range of the respiratorycycle.The geometric parameters of a proposed treatment field areselected to allow non-dosimetric, interactive optimization of fieldcoverage. Defined anatomical structures and geometric treatmentsfields 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 ofdefined structures with or without the display of digitallyreconstructed radiograph. | ||
| Technology: | The AdvantageSim MD with CT Atlas-based Contouring and Re-planning Options software employs the same fundamentalscientific technology as that of the AdvantageSim MD on itspredicate devices. | |
| Determination of | Summary of Non-Clinical Tests: | |
| SubstantialEquivalence: | The AdvantageSim MD with CT Atlas-based Contouring and Re-planning Options software complies with voluntary standards asdetailed in Section 9, 11 and 16 of this premarket submission. Thefollowing quality assurance measures were applied to thedevelopment of the system:Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Performance testing (Bench testing, verification) Safety testing (Verification) | |
| Summary of Clinical Tests: | ||
| The subject of this premarket submission, AdvantageSim MD withCT Atlas-based Contouring and Re-planning Options software didnot require clinical studies to support substantial equivalence sincethe two new features have triggered this 510(k) notification, CTatlas-based contouring and CT based re-planning options are partof Mirada's FDA cleared product. | ||
| Conclusion: | GE Healthcare considers the AdvantageSim MD with CT Atlas-basedContouring and Re-planning Options software application to be assafe, as effective, and performance is substantially equivalent tothe predicate devices. |
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2013
GE Hungary Kft. % Mr. Stephen Slavens Regulatory Affairs Director GE Medical Systems - dba GE Healthcare 3000 N. Grandview Blvd. WAUKESHA WI 53188
Re: K132045
Trade/Device Name: AdvantageSim™ MD with CT Atlas-based Contouring and Replanning Options Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: 11 Product Code: KPQ Dated: June 25, 2013 Received: July 5, 2013
Dear Mr. Slavens:
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 or any with all the Act's requirements, including, but not limited to: registration and listing (2 l 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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Page 2-Mr. Slavens
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicallDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Melvin D. Dixon
for
Janine M. Morris 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): K132045
Device Name: AdvantageSim™ MD with CT Atlas-based Contouring and Replanning Options
Indications for Use:
AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a . proposed external beam radiotherapy treatment pror to dosimetry planning. Anotomical 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 or PET studies that have been coregistered with the planning CT scan. Additionally CT & PET data from a respratory tracked examination may be used to allcw the user define the target or treatment volume cver o 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 aecmetric treatments fields are displayed on transverse images. In reformatted sagittal. coronal or obligue images. on 3D 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 radicgraph.
Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In I'itro Diagnostic and Radiological Health
510(k)_K132045
Page 1 of
§ 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.