(86 days)
Not Found
No
The summary describes a software product that performs theoretical dose calculations based on measured radiation fields and patient imaging data. It does not mention any AI or ML techniques for analysis, prediction, or decision support. The core function is a deterministic calculation and comparison.
No.
The device is described as quality control software that checks the correctness of x-ray treatment plans and computes dose from measured radiation fields, but it does not provide any treatment or therapeutic function itself.
No
Explanation: The device is explicitly stated to be a quality control software for checking the correctness of x-ray treatment plans and not a treatment planning system. It computes the dose to the patient from measured radiation fields and compares it to the planned dose, but "does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results." This indicates it does not diagnose patient conditions or diseases.
Yes
The device description explicitly states "Dosimetry Check is a software program" and the intended use describes it as a "standalone software product". While it utilizes data from various hardware sources (x-ray film, EPID, etc.), the device itself is the software that processes this data and performs calculations. The predicate device is also a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Dosimetry Check's Function: Dosimetry Check is a software product used for quality control of radiation therapy treatment plans. It uses measurements of radiation fields and patient imaging data (like CT scans) to calculate and compare dose distributions.
- No Biological Samples: The process described does not involve analyzing biological samples from a patient. It focuses on the physical aspects of radiation delivery and its theoretical impact on the patient's anatomy based on imaging.
Therefore, Dosimetry Check falls under the category of medical device software used in radiation oncology, but not as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYE
Device Description
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.
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, patient specific 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)
Nonclinical Testing: Nonclinical testing included modular testing, regression testing, verification of the risk control measures implemented in the software, verification of successful installation and performance testing.
External Validation: The external validation was performed at two (2) sites in Europe, three (3) sites in the US. All aspects of using Dosimetry Check for quality control for TomoTherapy were tested during the beta testing. The conclusions of the beta test results submitted demonstrated the safety and performance of the Dosimetry Check software for its intended use and that it can be used by its intended users to compute the dose from the TomoTherapy detector as a quality tool for radiation treatments on that machine.
Conclusion: The successful non-clinical testing and external validation demonstrates the safety and effectiveness of the Dosimetry Check Version 4 Release 1 when used for the defined indications for use and demonstrates that the device for which this 510(k) is submitted performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dosimetry Check version 3 release 1, K101503
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.
0
K132605
Page 1 of 5
510(k) Summary for Dosimetry Check Version 4 Release 1
| Submitter's Name | Math Resolutions, LLC |
|---|---|
| Address | 5975 Gales Lane |
| Columbia, MD USA 21045 | |
| Establishment | |
| Registration | |
| Number | 1833314 |
| Date of Summary | September 17, 2013 |
| Telephone | |
| Number | (410) 997-9578 |
| WDRenner@MathResolutions.com | |
| Contact Person | Wendel Dean Renner |
| Name of the | |
| Device | Dosimetry Check version 4 release 1 |
| Common or Usual | |
| Name | Standalone Software Quality Control System |
| Classification | |
| Name | Quality Control for Medical Charged-particle Radiation Therapy Systems. 21 CFR |
| 892.5050 | |
| Indications for | |
| Use | 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. |
| | NOV 1 4 2013 |
1
Indications for Use This product is not a treatment planning system and is not to be used as onc. cont.
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.
| Identification of the
Legally Marketed
Device (Predicate
| Device) | Dosimetry Check version 3 release 1, K101503 |
|---|---|
| Device | |
| Description | 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.
2
Intended Use for Predicate Device: Dosimetry Check version 3 release 1
Dosimetry Check with Exit Dose is a software program intended to provide a means for testing the dosimetry of radiation therapy treatments applied to a patient using high energy x-rays. This test is performed from measurements made during treatment of the patient by measuring the radiation fields after they have passed through the patient with a suitable imaging device such as an electronic portal imaging device or other measuring devices or media. The following software functions are then performed:
- I. The patient's CT scan treatment plan image set is traced to provide the water equivalent path to points on the measured exit dose plane.
-
- A deconvolution process is performed with a kernel that is a function of radius and the thickness transversed to convert the exit images back to x-ray intensity in air fluence prior to patient entry. The kernel is derived prior from phantom measurements with the same imaging device or media.
-
- The derived in air fluence is now the same starting point as when the radiation fields are measured directly prior to patient entry.
Intended Use for Modified Device: Dosimetry Check version 4 release 1
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 xray 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 TomoTheraov, a fan line detector arrav, 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.
3
Device Comparison Table
·
| Features | Predicate
Dosimetry Check
version 3 release 1
K101503 | Modified Device
Dosimetry Check
version 4 release 1
K132605 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pre-treatment images | Yes | Yes |
| Exit images | Yes | Yes |
| Compute dose to patient | Yes | Yes |
| Compare to planning system dose | Yes | Yes |
| Used for verifying the correctness of radiation therapy
treatments | Yes | Yes |
| 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. | No | 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 | Yes |
| Installed by downloading the software from the Math
Resolutions web site at
http://www.mathresolutions.com/downlprg.htm | Yes | Yes |
| Photons (x-ray) | Yes | Yes |
| Electrons | No | No |
| Protons | No | No |
| Ability to use the TomoTherapy detector data measured in
a pretreatment dry run without the patient and the detector
data taken during treatment | No | Yes |
| Operating Systems | Microsoft Windows XP.
Windows Vista. Windows
7. and Ubuntu 9.04
(Linux) | Microsoft Windows XP.
Windows Vista. Windows
7. and Ubuntu 9.04 (Linux) |
| Hardware needed but not provided | Open GL capable
graphics card is required
with 24 true color and a
depth buffer. For added
stereoscoptic 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 | Open GL capable graphics
card is required with 24
true color and a depth
buffer. For added
stereoscoptic 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 |
.
4
K132605
page 5 of 5
Description and Conclusion of Testing
Nonclinical Testing:
Nonclinical testing included modular testing, regression testing, verification of the risk control measures implemented in the software, verification of successful installation and performance testing.
External Validation:
The external validation was performed at two (2) sites in Europe, three (3) sites in the US. All aspects of using Dosimetry Check for quality control for TomoTherapy were tested during the beta testing. The conclusions of the beta test results submitted demonstrated the safety and performance of the Dosimetry Check software for its intended use and that it can be used by its intended users to compute the dose from the TomoTherapy detector as a quality tool for radiation treatments on that machine.
Conclusion:
The successful non-clinical testing and external validation demonstrates the safety and effectiveness of the Dosimetry Check Version 4 Release 1 when used for the defined indications for use and demonstrates that the device for which this 510(k) is submitted performs as well as or better than the legally marketed predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2013
Math Resolutions, LLC % Mr. Wendel Dean Renner President 5975 Gales Lane COLUMBIA MD 21045
Re: K132605
Trade/Device Name: Dosimetry Check Version 4 Release 1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: Sep. 17, 2013 Received: Sep. 24, 2013
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 cither 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 I outlar Bither 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
6
Page 2 - Mr. Renner
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.
If 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/Resources/orYou/Industrv/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/Satety/ReportalProblem/default.html 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Richard D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
7
Indications for Use
510(k) Number (if known): K132605
Device Name: Dosimetry Check Version 4 Release 1
Indications for Use:
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 palient 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 computed tomography (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 point as compared to the patient specific radiation treatment plan.
This product is not a treatment planning system and is not to be used as one. This product only checks the This produce is not a treatinon planning by each x-ray field applied to the patient and provided in an apported file, and a theoretical calculation. This product does not provide any quality assurance that the caported inc. and a theirenen and correctly aligned with the patient anatomy as planned. In nelds are in and correctly approc to display the above dose on other fused image sets which could addition, the product may be asse to anspire in the user regarding the correctness of treatment.
× Prescription Use (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. Oliva
(Division Sign-off)
Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health (OIR) K 132605 210(k)
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