(89 days)
Not Found
No
The description states that the software determines monitor units or dose by "looking data up from previously input tables or data curves," which indicates a deterministic, rule-based approach rather than AI/ML. There is no mention of learning, training data, or adaptive algorithms.
No.
The device is a software program used for quality assurance and validation of monitor units and dose calculations in radiation therapy planning, not for directly delivering or performing therapy.
No.
The document states that RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. It is used to validate calculations from a primary radiation therapy planning system or as the primary means of calculating monitor units. It does not diagnose a disease or condition.
Yes
The device is described as "RadCalc Software" and explicitly states it is a "stand-alone program or operating from a server". It also clarifies that it "does not control any radiation hardware device". While it interfaces with other software systems, the core device itself is presented as a software application.
Based on the provided information, the RadCalc Software is not an In Vitro Diagnostic (IVD) 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.
- RadCalc's Function: RadCalc Software is used in a radiation therapy department to calculate and validate monitor units and dose for external beam radiation therapy and brachytherapy treatments. It works with treatment planning systems and verify and record systems, not with biological specimens.
- Intended Use: The intended use clearly describes its role in radiation therapy planning and quality assurance, not in analyzing biological samples.
- Device Description: The device description reinforces its function as a software tool for radiation dose calculations and data transfer within a radiation therapy workflow.
Therefore, RadCalc Software falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the RadCalc Software is a means of validating the monitors units or radiation dose to points that have been calculated by the primary radiation therapy planning system for external beam radiation therapy and/or brachytherapy treatments. In addition to this, RadCalc Software can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy plan.
RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.
RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning.
RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
The RadCalc Software is a stand-alone program or operating from a server that provides determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. RadCalc is designed to work on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. The program makes the task of performing independent Monitor Unit validations much faster, easier, and more accurate. RadCalc determines the monitor units or dose through the process of looking data up from previously input tables or data curves.
RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.
RadCalc allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data. The software does not control any radiation hardware device, but does interface with the primary radiation therapy planning software and the Verify and Record software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. Software testing was conducted using a brachytheraphy treatment planning system and RadCalc to verify nonclinical testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. Software testing was conducted using a brachytheraphy treatment planning system and RadCalc to verify nonclinical testing. The testing results supports that the software specification are met for the acceptance of each module and interaction of processes. The RadCalc Software passed all testing and supports the claims of substantial equivalence.
Clinical Testing: There is no clinical testing required to support the additional indication for use of the submission. The supporting information is addressed by the non-clinical testing and beta-site testing. The verification and validation testing of the software passed all the testing and supports the claims of substantial equivalence.
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
510(k) Summary
MAY 27 2009
For
RadCalc Software
1. Sponsor Information
LifeLine Software, Inc. 311 Hines Crossing Bullard, TX 75757 Phone: (903) 207.4298 x13 Fax: (903) 207.4298 Contact: Craig Laughton, CEO
2. Applicant Information
Emergo Group 1705 S. Capital of Texas Highway Suite 500 Austin, TX 78746 Phone: (512) 326.9997 Fax: (512) 326.9998 Contact: Richard Vincins, Senior Consultant OA/RA
3. Date Prepared
February 20, 2009
4. Device Name
Trade/Proprietary Name: RadCalc Software Common/Usual Name: RadCalc Classification Name: Medical Charged Particle Radiation Therapy System - Accessory Classification Regulation: 892.5050
5. Predicate Devices
MuCheck - Monitor Unit/Dose Program K061152 RadCalc, Model V4.0 K010464
1
6. Device Description
The RadCalc Software is a stand-alone program or operating from a server that provides determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. RadCalc is designed to work on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. The program makes the task of performing independent Monitor Unit validations much faster, easier, and more accurate. RadCalc determines the monitor units or dose through the process of looking data up from previously input tables or data curves.
RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.
RadCalc allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data. The software does not control any radiation hardware device, but does interface with the primary radiation therapy planning software and the Verify and Record software.
7. Intended Use
The intended use of the RadCalc Software is a means of validating the monitors units or radiation dose to points that have been calculated by the primary radiation therapy planning system for external beam radiation therapy and/or brachytherapy treatments. In addition to this, RadCalc Software can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy plan.
8. Technological Characteristics and Substantial Equivalence
The RadCalc Software is similar in design and function to the RadCalc Model v4.0 and muCheck Monitor Unit/Dose Program. These devices all have the same intended use and indications for use as the RadCalc Software. This submission is adding LDR, HDR, and Permanent Implant brachytherapy treatment plans to the indications for use. These are two recent predicate devices cleared for market by the FDA.
2
The RadCalc Software and the predicate devices are used on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. Their function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. The RadCalc, Model v4.0 and RadCalc Software can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.
The RadCalc Software and the predicate devices are similar in technical characteristics and performance.
9. Non-Clinical Testing
The software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. Software testing was conducted using a brachytheraphy treatment planning system and RadCalc to verify nonclinical testing. The testing results supports that the software specification are met for the acceptance of each module and interaction of processes. The RadCalc Software passed all testing and supports the claims of substantial equivalence.
10. Clinical Testing
There is no clinical testing required to support the additional indication for use of the submission. The supporting information is addressed by the non-clinical testing and beta-site testing. The verification and validation testing of the software passed all the testing and supports the claims of substantial equivalence.
11. Conclusion
The RadCalc Software has the same intended use and technological characteristics as the predicate devices.
The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the circular emblem.
Public Health Service
MAY 2 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LifeLine Software, Inc. % Mr. Richard Vincins Senior Consultant QA/RA Emergo Group 1705 S. Capital of Texas Hwy., Suite 500 AUSTIN TX 78746
Re: K090531
Trade/Device Name: RadCalc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: February 26, 2009 Received: March 3, 2009
Dear Mr. Vincins:
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 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 (OS) 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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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx (240) 276-0115 (Gastroenterology/Renal/Urology) 21 CFR 884.xxx (Obstetrics/Gynecology) (240) 276-0115 21 CFR 892.xxx (Radiology) (240) 276-0120 Other (240) 276-0100
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Not Assigned. K 0 7 0 5 3 /
Device Name: RadCalc
Indications for Use:
RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan.
RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning.
RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ______________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Off) | |
Division of Reproductive, Abdominal and | |
Radiological Devices | |
510(k) Number | K090531 |