(64 days)
Not Found
No
The document describes a software that performs calculations and comparisons based on measured and theoretical dose distributions. It explicitly states it does not provide conclusions or interpretation criteria, and there is no mention of AI, ML, or training/test sets for such algorithms. The algorithms mentioned (Pencil Beam, Convolution/Superposition "Collapsed Cone") are traditional physics-based dose calculation methods.
No.
The device is described as a "quality control software" and "analysis tool meant solely for quality assurance purposes," not for direct treatment or therapy.
No
Explanation: The device is explicitly stated to be a "quality control software" and an "analysis tool meant solely for quality assurance purposes." It checks the correctness of x-ray treatment plans and compares calculated dose to intended planned dose. It does not provide conclusions, criteria for interpreting results, or make diagnoses; instead, it provides data for an experienced radiological physicist to reevaluate a treatment plan.
Yes
The device description explicitly states, "Being a software only quality control tool, Dosimetry Check never comes into contact with patients or persons." and "Dosimetry Check is a standalone software product". While it processes data from hardware devices, the device itself is solely software.
Based on the provided text, Dosimetry Check is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Dosimetry Check's Function: Dosimetry Check analyzes radiation fields measured by various devices and calculates theoretical dose distributions based on patient imaging data. It compares this calculated dose to the planned dose.
- No Human Specimens: The device does not interact with or analyze any specimens taken from the human body. Its inputs are radiation measurements and medical images.
- Quality Control Tool: The text explicitly states that Dosimetry Check is a "quality control software" and an "analysis tool meant solely for quality assurance purposes." It is used to check the correctness of radiation treatment plans and delivery, not to diagnose or monitor a patient's condition through analysis of bodily fluids or tissues.
Therefore, Dosimetry Check falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dosimetry Check quality control software uses the x-ray radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
Product codes
IYE
Device Description
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the calculated dose to the patient from the measured radiation fields that is intended to be used as a quality control tool tothen be compared to the intended planned dose. This product is to be used as a quality control check for the treatment planning system and delivery system. Dosimetry Check is not a treatment planning system. It does not design or transmit instructions to a delivery device, nor does it control any other medical device. Being a software only quality control tool, Dosimetry Check never comes into contact with patients or persons. Dosimetry Check is an analysis tool meant solely for quality assurance purposes when used by trained medical professionals.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, fan line detector array, CT or other image set
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
experienced radiological physicist
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)
Study Type: Internal testing consisted of internal testing with and without the Graphic Processing Unit for the comparison of the results obtained using the Pencil Beam (PB) algorithm in the 510(k) cleared version of Dosimetry Check to the results obtained using the Convolution/Superposition "Collapsed Cone" Algorithm (CC) added in Dosimetry Check Version 5 Release 1 as well as regression testing.
Sample Size: Not Found
Key Results: Successful testing was accomplished with internal testing. No issues were identified that required external beta testing. The successful testing demonstrates the safety and effectiveness of the Dosimetry CheckVersion 5 Release 1 when used for the defined indications for use demonstrates that the device for which this 510(k) is submitted perform as well as or better than the legally marketed predicate devices.
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
§ 892.5050 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
Math Resolutions, LLC % Mr. Wendel Renner President 5975 Gales Lane COLUMBIA MD 21045
Re: K162577
Trade/Device Name: Dosimetry Check Version 5 Release 1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 17, 2016 Received: September 20, 2016
Dear Mr. Renner:
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.
1
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
2
Indications for Use
510(k) Number (if known) K162577
Device Name
Dosimetry Check Version 5 Release 1
Indications for Use (Describe)
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for Dosimetry Check Version 5 Release 1
| Submitter's Name
Address | Math Resolutions, LLC
5975 Gales Lane
Columbia, MD USA 21045 |
|--------------------------------------|--------------------------------------------------------------------|
| Establishment
Registration Number | 1833314 |
| Summary Date | 16 Nov 2016 |
| Telephone Number | (410) 997-9578 |
| Email | WDRenner@MathResolutions.com |
| Contact Person | Wendel Dean Renner, President |
| Name of the Device | Common or Usual Name | Classification Name |
|---|---|---|
| Dosimetry Check version 5 release 1 | Standalone Software Quality Control System | Medical Charged-particle |
| Radiation Therapy Systems, 21 CFR 892.5050 | ||
| Product Code IYE |
| Identification of the Legally Marketed Devices (Predicate Devices) | |
|---|---|
| Dosimetry Check Version 4 Release 1, K132605 | Mobius3D, K140660 |
Indications for Use
Dosimetry Check Version 5 Release 1 (Modified Device) ●
Dosimetry Check quality control software uses the x-ray radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. The product can only be used with photons (high energy x-rays) and cannot be used with electron or proton therapy. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
4
. Dosimetry Check Version 4 Release 1. K132605 (Predicate Device)
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the dose to the patient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system.
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
. Mobius3D, K140660 (Predicate Device)
Mobius3D software is used for quality assurance and treatment plan verification 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. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
DEVICE DESCRIPTIONS
Dosimetry Check version 5 release 1 (Modified Device) .
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the calculated dose to the patient from the measured radiation fields that is intended to be used as a quality control tool tothen be compared to the intended planned dose. This product is to be used as a quality control check for the treatment planning system and delivery system. Dosimetry Check is not a treatment planning system. It does not design or transmit instructions to a delivery device, nor does it control any other medical device. Being a software only quality control tool, Dosimetry Check never comes into contact with patients or persons. Dosimetry
5
Check is an analysis tool meant solely for quality assurance purposes when used by trained medical professionals.
6
510(k) Summary continued
● Dosimetry Check version 4 release 1, K132605 (Predicate Device)
System 2100 for which 510(k) K993530 was cleared by the FDA on December 15, 1999 that is a medical image display system serves as a foundation that provides basic image display functionality for Dosimetry Check.
Dosimetry Check is a software program that will compute the dose and dose distribution to the patient from a measurement of the radiation fields that are applied to the patient. The dose so computed serves as a means to verify the correctness of the radiation treatment and to serve as a final sanity check. The radiation fields are measured with media such as x-ray film or electronic devices that will measure over the area of the field, such as electronic portal imaging devices (EPID), or diode or ion chamber arrays.
To extend Dosmetry Check to support the TomoTherapy machine, the device uses the data measured by the fan beam radiation detector that is part of the TomoTherapy machine. The detectors capture the radiation intensity periodically at predetermined gantry angles and couch positions, known as control points, from the treatment plan. The detector only measures the intensity across the center of the radiation beam in the transverse plane. A prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map. The radiation field map is then applied as a stationary beam at the center gantry angle and couch position for the integration period (between two control points), from which the dose to the patient is computed. The patient dose is then summed up from all such radiation field maps
● Mobius3D, K140660 (Predicate Device)
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 OA 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 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 (COS) 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.
7
Device Comparison Table
| Features | Predicate
Dosimetry Check
Version 4 Release 1
K132605 | Predicate
Mobius3D
K140660 | Modified Device
Dosimetry Check
Version 5
Release 1 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pre-treatment images | Yes | No | Yes |
| Exit images | Yes | No | Yes |
| Pencil beam dose algorithm | Yes | No | Yes |
| Convolution/superposition "collapsed cone"
algorithm (CC). Additional technical comparison
information regarding this added CC algorithm is
provided above. | No | Yes | Yes |
| Compute dose to patient | Yes | Yes | Yes |
| Compare to planning system dose | Yes | Yes | Yes |
| Used for verifying the correctness of radiation
therapy treatments | Yes | Yes | Yes |
| TomoTherapy: Uses a line in the transverse plane
through the radiation field measurement provided to
Dosimetry Check. A prior measured longitudinal
profile is applied to each detector signal to complete
the radiation field. | Yes | No, uses
linac log
files | Yes |
| Generates a report as described in the Dosimetry
Check manual using either the auto-report feature,
or the user may construct their own report using the
evaluate tools. | Yes | Provides a
report in
their
format | Yes |
| Installed by downloading the software from the
Math Resolutions web site at
http://www.mathresolutions.com/downlprg.htm | Yes | unknown | Yes |
| Photons (x-ray) | Yes | Yes | Yes |
| Electrons | No | unknown | No |
| Protons | No | unknown | No |
| Ability to use measured radiation field for
conventional linac in a pretreatment dry run without
the patient and measured radiation fields taken
during treatment. | yes | No, uses
linac log
files | yes |
| Ability to use the TomoTherapy detector data
measured in a pretreatment dry run without the
patient and the detector data taken during treatment | Yes | No, uses
linac log
files | Yes |
| Features | Predicate
Dosimetry Check
Version 4 Release 1
K132605 | Predicate
Mobius3D
K140660 | Modified Device
Dosimetry Check
Version 5
Release 1 |
| Operating Systems | Microsoft Windows
XP, Windows Vista,
Windows 7, 10,and
Ubuntu 14.04 LTS
(Linux) | unknown | Microsoft
Windows XP,
Windows Vista,
Windows 7,
10,and Ubuntu
14.04 LTS
(Linux) |
| Hardware | - Open GL capable
graphics card is
required with 24
true color and a
depth buffer.
- For added
stereoscopic three
dimensional
displays, an Nvidia
Quadro fx card that
supports stereo is
needed with a single
monitor capable of
120 Hertz refresh
rate or the Planar
Mirror System with
two monitors. | Graphics
processing
unit | - Open GL
capable graphics
card is required
with 24 true
color and a depth
buffer. - For added
stereoscopic
three
dimensional
displays, an
Nvidia Quadro fx
card that supports
stereo is needed
with a single
monitor capable
of 120 Hertz
refresh rate or the
Planar Mirror
System with two
monitors. - Graphics
processing unit |
8
9
510(k) Summary continued
Description and Conclusion of Testing
Testing
Testing consisted of internal testing with and without the Graphic Processing Unit for the comparison of the results obtained using the Pencil Beam (PB) algorithm in the 510(k) cleared version of Dosimetry Check to the results obtained using the Convolution/Superposition "Collapsed Cone" Algorithm (CC) added in Dosimetry Check Version 5 Release 1 as well as regression testing. Successful testing was accomplished with internal testing. No issues were identified that required external beta testing.
Conclusion:
The successful testing demonstrates the safety and effectiveness of the Dosimetry CheckVersion 5 Release 1 when used for the defined indications for use demonstrates that the device for which this 510(k) is submitted perform as well as or better than the legally marketed predicate devices.