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510(k) Data Aggregation
K Number
K990833Device Name
DOSE CALC, MODEL VS. 1.02
Manufacturer
INTEGRITY MEDICAL SOFTWARE, INC.
Date Cleared
1999-06-08
(88 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
INTEGRITY MEDICAL SOFTWARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DoseCalc is a program utilized in a radiation therapy department for the determination of monitor units. The Monitor Unit is a quantity used by a treatment machine for determining the length of time that it should remain on in order to deliver a prescribed amount of radiation to a point. Most of the time, a radiation treatment planning system is used to define the location and dose distribution of the radiation. Radiation therapy planning systems typically calculate the monitor units needed to deliver the desired amount of reduction to a point of reference and this produce the desired dose distribution within the patient. On occasion, a hand calculation will be performed in order to determine the number of monitor units needed to deliver the prescribed amount of radiation. DoseCalc is a program which allows the user to input data by hand through the use of the mouse or keyboard or electronically from the primary radiation therapy planning system. From this data, it will then determine the number of monitor units needed to be given to a patient. The process of calculating the monitor units involves DoseCalc automatically looking up the data parameters from previously inputed data and then calculating the monitor units from these values. This process greatly increases the speed at which a calculation can be performed and also eliminates many errors that occur from manually looking up the data. DoseCalc's monitor unit calculation can then be used to validate the monitor units previously determined by hand or by the primary radiation therapy planning system. It is not the intention of DoseCalc to replace the calculation performed by the primary radiation therapy planning computer but to validate its calculation as a means of quality assurance. The practice of performing a secondary check is recommended by the American Association of Physicists in Medicine (AAPM) Task Group 40 as part of good quality assurance program. This practice is an important aspect in providing quality patient care. DoseCalc is not only being submitted to perform this secondary function but to also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. For this situation, it is important to accurately determine the monitor units needed for a patient's treatment. DoseCalc provides this operation. It has many built in checks that will check for many common errors that occur when calculating monitor units as well as checking that the inputted parameters are within predefined limits for the treatment machine. The use of DoseCalc in this manner provides a means for accurately determining the monitor units. A physicist can then visually examine the inputted data for accuracy and verify the computed parameters to be sure that they are correct.
DoseCalc also allows for the transfer of the treatment planning data from the primary radiation therapy planning computer to DoseCalc and then to the facility's Verify and Record system. This will reduce the number of errors that occur as a result of manually inputting this data. This feature merely transfers information from one system to another without performing any calculations.
Device Description
DoseCalc is a software program that is designed to operate on a PC in a Windows environment on either a stand alone PC or on a server. It does not control any radiation hardware device but does interface with the primary radiation therapy planning software and verify and record software. The device performs monitor unit calculations for photon beams which can be used to validate monitor units calculated by the primary radiation therapy planning system or to simply provide the monitor units needed to treat a patient when a radiation therapy plan is not prescribed by the physician. DoseCalc determines the monitor units through the process looking data up from previously inputted tables.
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