(64 days)
Not Found
Unknown
The document mentions "automatic or manual" definition of anatomical volumes and "atlas-based contouring," which could potentially involve AI/ML, but the summary does not explicitly state or describe the use of AI/ML algorithms. The "Not Found" for mentions of AI, DNN, or ML further supports this ambiguity.
No.
AdvantageSim™ MD is used for planning external beam radiotherapy treatment by preparing geometric and anatomical data prior to dosimetry planning. It is a tool for clinicians to assist treatment planning rather than directly delivering or performing therapy.
No
The device is used for treatment planning in external beam radiotherapy, not for diagnosing disease. It prepares geometric and anatomical data for dosimetry planning and optimizes field coverage, rather than identifying or characterizing medical conditions.
Yes
The device description explicitly states it is a "CT/MR/PET oncology application," indicating it is software. The intended use and performance studies focus on software functionalities and verification, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning." This is a pre-treatment planning tool, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces its use as a "CT/MR/PET oncology application used by clinicians... to assist treatment planning." Again, this points to a planning and visualization tool, not a diagnostic test.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological samples in this way.
The device is a medical imaging software used for radiotherapy treatment planning, which falls under a different regulatory category than IVD devices.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
KPQ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians (radiologist, radiation oncologist, medical oncologist, nuclear medicine physicians and trained healthcare professional)
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)
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.
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
§ 892.5840 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/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 2 | |
| 2040 Budörs, Hungary | |
| Primary Contact | |
| Person: | Peter Uhlir |
| Regulatory Affairs Leader | |
| Tel: 00 36 23 410121 | |
| Fax: (262) 364 2506 | |
| SEP 0 4 2013 | |
| Secondary Contact | |
| Person: | Stephen G. Slavens, RAC |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Tel: (262) 548 4992 | |
| Fax: (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™ MD |
| K130393 - RTx (Mirada Medical Ltd. LLC) | |
| Device Description / | |
| Intended Use: | 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. | |
| 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. |
1
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 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. | |
| Technology: | The AdvantageSim MD with CT Atlas-based Contouring and Re-
planning Options software employs the same fundamental
scientific technology as that of the AdvantageSim MD on its
predicate devices. | |
| Determination of | Summary of Non-Clinical Tests: | |
| Substantial
Equivalence: | The AdvantageSim MD with CT Atlas-based Contouring and Re-
planning Options software complies with voluntary standards as
detailed in Section 9, 11 and 16 of this premarket submission. The
following quality assurance measures were applied to the
development 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 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. | |
| Conclusion: | GE Healthcare considers the AdvantageSim MD with CT Atlas-based
Contouring and Re-planning Options software application to be as
safe, as effective, and performance is substantially equivalent to
the predicate devices. | |
2
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.
3
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
4
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
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