(197 days)
There are no Reference Device(s) K/DEN numbers listed in the text. The "Reference Device(s)" section explicitly states "Not Found".
No
The document describes the use of a proprietary collapsed cone convolution superposition (CCCS) algorithm for dose calculation and image comparison for patient alignment, but does not mention AI or ML.
No
This device is described as a "quality assurance tool" and "analysis tool meant solely for quality assurance (QA) purposes" in radiation therapy. It does not directly treat or diagnose patients.
No
The intrinsic function of a diagnostic device is to diagnose a disease or condition, which is not what this device does. This device is a quality assurance tool for radiation therapy, verifying treatment plans and patient alignment, and analyzing anatomy. It does not identify or characterize diseases.
Yes
The device description explicitly states "Being a software-only QA tool, Mobius3D never comes into contact with patients." and describes its function as an analysis tool that operates on data from other systems. It does not mention any associated hardware components that are part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Mobius3D's Function: Mobius3D is a software tool used for quality assurance and treatment plan verification in radiation therapy. It analyzes radiation dose calculations and patient alignment based on medical images (CT and CBCT) and treatment plan data.
- Lack of Specimen Analysis: Mobius3D does not examine any biological specimens from the human body. Its analysis is based on digital data derived from imaging and treatment planning systems.
- Purpose: Its purpose is to verify the accuracy of radiation treatment plans and patient positioning, not to diagnose a disease or monitor a patient's biological state through specimen analysis.
Therefore, Mobius3D falls under the category of a medical device used in the context of radiation therapy treatment planning and quality assurance, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
Product codes
IYE
Device Description
Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.
Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm.
Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.
Compared to the previously cleared Mobius3D v 1.3.2 (K140660), Mobius3D v 2.0.0 contains the additional intended use of performing quality assurance of a patient's alignment and anatomy analysis. This analysis is based on comparison of Cone Beam Computed Tomography (CBCT) images taken immediately before treatment to the images used for treatment planning, which are typically acquired using standard Computed Tomography (CT). This analysis is presented to the end user in an add-on software module within Mobius3D called CBCT Checks.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography, cone beam computed tomography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained radiation oncology personnel
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
Bench testing was performed and is presented in a report titled: Mobius3D CBCT Module Evaluation - Patient Positioning / Anatomical Changes Bench Testing. The report was generated by performing a full suite of tests utilizing anonymized data from 22 different patients over 163 different fractions with varying treatment sites.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Bench Testing
Sample size: anonymized data from 22 different patients over 163 different fractions
Key results: The report demonstrates the Mobius3D CBCT module's ability to notify users to a potential patient positioning or anatomical difference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Mobius Medical Systems, LP % Mr. Stan Eshelman COO 5012 Tamarisk Street BELLAIRE TX 77401
Re: K153014 Trade/Device Name: Mobius3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 7, 2016 Received: April 8, 2016
Dear Mr. Eshelman:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Michael D.'Hara
For
Robert Ochs, Ph.D. 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)
Device Name Mobius3D
Indications for Use (Describe)
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5 510(K) Summary
5.1 510(K) Owner
Mobius Medical Systems, LP 5012 Tamarisk St Bellaire, TX 77401 Tel: (888) 263-8541 Fax: (888) 263-8541
5.2 Contact Person
Stan Eshelman
5.3 Preparation Date
April 7, 2016 (revised from original October 14, 2015 submission)
5.4 Trade Name
Mobius3D
5.5 Common Name
Secondary Check QA Software
5.6 CLASSIFICATION NAME
Accelerator, Linear, Medical 21 CFR 892.5050 Product Code - IYE
5.7 PREDICATE DEVICES
Primary Predicate:
-
o K140660 Mobius3D (Mobius Medical Systems, LP)
Secondary Predicates: -
K090531 RadCalc Software (Lifeline Software, Inc.) o
-
K081076 VelocityAIS (Velocity Medical Solutions, LLC) o
5.8 Device Description
Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes
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when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.
Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm.
Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.
Compared to the previously cleared Mobius3D v 1.3.2 (K140660), Mobius3D v 2.0.0 contains the additional intended use of performing quality assurance of a patient's alignment and anatomy analysis. This analysis is based on comparison of Cone Beam Computed Tomography (CBCT) images taken immediately before treatment to the images used for treatment planning, which are typically acquired using standard Computed Tomography (CT). This analysis is presented to the end user in an add-on software module within Mobius3D called CBCT Checks.
5.9 Intended Use
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
5.10 TECHNOLOGICAL CHARACTERISTICS SUMMARY
The principle technological characteristic of Mobius3D is to perform quality assurance evaluations on the radiation treatment planning system (TPS) and radiation delivery systems (e.g. linear accelerators). Mobius3D (v 2.0.0) adds the technical characteristic of performing comparative analysis between patient images acquired at different times using different image modalities.
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Detailed technological characteristics and indications for use presented within the full set of submitted documentation for this 510(k) application support the claim that Mobius3D is substantially equivalent to the predicate devices.
5.11 Testing Summary
Software development, verification, and validation have been carried out in accordance with FDA quidelines. The software was tested against the established Software Design Specifications and passed all required tests. A Risk Management Report was completed which identified and verified the mitigation of all required hazards.
In addition, bench testing was performed and is presented in a report titled: Mobius3D CBCT Module Evaluation - Patient Positioning / Anatomical Changes Bench Testing. The report was generated by performing a full suite of tests utilizing anonymized data from 22 different patients over 163 different fractions with varying treatment sites to validate each portion of the analysis. The report demonstrates the Mobius3D CBCT module's ability to notify users to a potential patient positioning or anatomical difference.
5.12Conclusions
Based on the evidence presented in this 510k submission, Mobius Medical Systems believes that Mobius3D is substantially equivalent to its predicate devices both in terms of its indications for use and its technical characteristics, and that Mobius3D is a safe and effective medical device for its intended users.