(26 days)
Not Found
Not Found
No
The provided text describes a software device for secondary dose calculation verification in radiation therapy, data import/export, and primary MU calculation in specific scenarios. It focuses on traditional calculation methods, comparisons (point dose, Gamma analysis, DVH), and interoperability with external dose calculation engines. There is no mention of AI, ML, deep learning, or any related concepts in the intended use or the "Mentions AI, DNN, or ML" section.
No.
The device's primary function is to perform secondary dose calculation verification for quality assurance and error reduction in radiation therapy planning, not to directly provide therapy or affect the structure/function of the body. While it supports therapeutic processes, it is a calculation and verification tool, not a therapeutic device itself.
No
The device is used for secondary dose calculation verification and monitor unit calculation in radiation therapy, which are quality assurance and treatment planning functions, not diagnostic functions.
Unknown
The provided text only describes the intended use of the device. It does not contain a device description, which is necessary to determine if the device is software-only or includes hardware components.
Based on the provided information, RadCalc is likely an In Vitro Diagnostic (IVD).
Here's why:
-
Intended Use 1, 3, and 4: These intended uses describe RadCalc performing calculations related to radiation dose for patient treatment. Specifically, it calculates or verifies "monitor units" (MU) which directly relate to the amount of radiation delivered to a patient. While it's primarily a secondary verification tool, its ability to act as a primary calculation tool in emergency situations (Intended Use 3) and its verification of brachytherapy calculations (Intended Use 4) strongly suggest it's involved in determining or verifying information used for patient diagnosis or treatment.
-
Focus on Dose Calculation and Verification: The core function of RadCalc is to calculate and verify radiation dose. This is a critical step in radiation therapy, which is a medical treatment.
Why it fits the definition of an IVD (generally):
While the provided text doesn't explicitly state it's an IVD, the functions described align with the general definition of an IVD, which often includes devices used to provide information for the diagnosis, monitoring, or treatment of a disease or condition. In this case, RadCalc provides crucial information (radiation dose) that directly impacts the treatment of cancer or other conditions treated with radiation therapy.
Why it might not be a traditional IVD (but still likely falls under the broader regulatory scope):
Traditional IVDs often involve analyzing biological samples. RadCalc does not appear to do this. However, regulatory bodies often classify software and devices that provide critical information for medical treatment as medical devices, and the regulatory framework for these can overlap with or be similar to that for IVDs, especially when they directly impact patient care decisions and outcomes.
In summary:
Given its role in calculating and verifying radiation dose for patient treatment, RadCalc's intended uses strongly indicate it is a medical device that falls under regulatory oversight, and based on the nature of its function, it is likely classified as an In Vitro Diagnostic or a similar category of medical device that provides information for patient treatment.
N/A
Intended Use / Indications for Use
RadCalc has the following intended uses:
-
RadCalc performs a secondary dose calculation verification on the treatment plan done by the treatment planning software. This is RadCalo's primary function. Radiation therapy systems typically calculate the monitor units needed to deliver the desired amount of radiation to a point of reference within the patient. In this situation, RadCale will serve to validate those monitor units computed by the primary radiation therapy planning system. Additional verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. It is not the intention of RadCalc 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 Physicis in Medicine (AAPM) Task Group 40 as part of a good quality assurance program. This practice is an important aspect in providing quality patient care.
-
Import data from the treatment planning software and export the treatment planning system to the verify and record system, which is the device that actually controls the radiation beam. This will reduce the number of errors that occur as a result of manually inputting this data.
-
In addition to performing the secondary dose verification calculation, RadCalc can 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. RadCalc can independently calculate the amount of radiation the beam should produce (called the MU or monitor unit) to deliver to the patient the radiation dose the doctor recommends. This function is usually only used in urgent, emergency situations.
-
In addition, RadCalc performs brachytherapy-type calculations. For brachytherapy calculations, High Dose Rate (HDR), Low Dose Rate (LDR), and Permanents can be verified. Verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. RadCalc is not used as a primary means of calculating patient dose for brachytherapy treatments.
-
Analysis of fluence and dose maps can be percentage difference, distance to agreement, or gamma analysis methodologies.
-
Interoperability with external dose calculation engines (EDCE) by sending them treatment plans and associated information in their necessary format so that the EDCE can perform a 3D dose calculation using its dose calculation algorithm. The computed dose volume is received back and the 3D analysis tools described above are used to compare against the treatment planning system.
Product codes
MUJ, IYE
Device Description
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
December 31, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LifeLine Software, Inc. % Mr. Craig A. Laughton Chief Executive Officer 3304 S Broadway Avenue, Suite 200 TYLER TX 75701
Re: K193381
Trade/Device Name: RadCalc Software, Version 7.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ, IYE Dated: December 2, 2019 Received: December 5, 2019
Dear Mr. Laughton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193381
Device Name RadCalc Software, Version 7.1
Indications for Use (Describe) RadCalc has the following intended uses:
-
RadCalc performs a secondary dose calculation verification on the treatment plan done by the treatment planning software. This is RadCalo's primary function. Radiation therapy systems typically calculate the monitor units needed to deliver the desired amount of radiation to a point of reference within the patient. In this situation, RadCale will serve to validate those monitor units computed by the primary radiation therapy planning system. Additional verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. It is not the intention of RadCalc 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 Physicis in Medicine (AAPM) Task Group 40 as part of a good quality assurance program. This practice is an important aspect in providing quality patient care.
-
Import data from the treatment planning software and export the treatment planning system to the verify and record system, which is the device that actually controls the radiation beam. This will reduce the number of errors that occur as a result of manually inputting this data.
-
In addition to performing the secondary dose verification calculation, RadCalc can 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. RadCalc can independently calculate the amount of radiation the beam should produce (called the MU or monitor unit) to deliver to the patient the radiation dose the doctor recommends. This function is usually only used in urgent, emergency situations.
-
In addition, RadCalc performs brachytherapy-type calculations. For brachytherapy calculations, High Dose Rate (HDR), Low Dose Rate (LDR), and Permanents can be verified. Verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. RadCalc is not used as a primary means of calculating patient dose for brachytherapy treatments.
-
Analysis of fluence and dose maps can be percentage difference, distance to agreement, or gamma analysis methodologies.
-
Interoperability with external dose calculation engines (EDCE) by sending them treatment plans and associated information in their necessary format so that the EDCE can perform a 3D dose calculation using its dose calculation algorithm. The computed dose volume is received back and the 3D analysis tools described above are used to compare against the treatment planning system.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."