(29 days)
No
The description focuses on a Monte Carlo dose calculation algorithm for quality assurance, with no mention of AI or ML techniques.
No.
The device is used for quality assurance of a radiotherapy dose, not for directly treating a condition or disease.
No
The device is described as a quality assurance software for radiotherapy doses, recalculating and comparing doses. It is not used to diagnose a medical condition or disease in a patient.
Yes
The device description explicitly states "SciMoCa is a standalone software product". The summary does not mention any associated hardware components that are part of the device itself.
Based on the provided information, SciMoCa is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. SciMoCa's intended use is to perform quality assurance of radiotherapy doses calculated by a treatment planning system. It works with dose calculations and potentially patient imaging data (though not explicitly mentioned as input imaging modality, it's implied for dose calculation), but it does not analyze biological specimens like blood, urine, or tissue.
- The intended use clearly states it's for quality assurance of radiotherapy dose calculations. This is a quality control function within the radiotherapy treatment process, not a diagnostic test performed on a patient sample.
- The device description reinforces its role in recalculating and comparing doses. This is a computational task related to treatment planning, not an in vitro analysis.
Therefore, SciMoCa falls outside the definition of an In Vitro Diagnostic device. It is a software tool used in the field of radiation oncology for quality assurance purposes.
N/A
Intended Use / Indications for Use
SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses.
SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Product codes
IYE
Device Description
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
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
trained radiation oncology personnel
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)
Validation testing involved simulated clinical workflows and environment, as well as algorithm testing. These are described in detail in section 18. The product was deemed fit for clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K140660 Mobius3D, K161946 Model 1217028 DoseCHECK
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.
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April 4, 2018
Radialogica LLC % Ms. Debra Vigil Director of Quality Assurance and Regulatory Affairs 511 N. Garrison Avenue SAINT LOUIS MO 63103
Re: K180595
Trade/Device Name: SciMoCa Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 1, 2018 Received: March 6, 2018
Dear Ms. Vigil:
We have reviewed vour 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 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.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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
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Indications for Use
510(k) Number (if known)
Device Name SCiMoCa
Indications for Use (Describe)
SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses.
SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
| 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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510(k) Summary Statement
510(K) Owner
Radialogica, LLC 511 N Garrison Ave. St. Louis, MO 63101 Tel: (800) 515-9132 Fax: (888) 788-5946
Contact person
Debra Vigil debra@radialogica.com Ph: (800) 515-9132, ext. 301
Preparation Date
1 March 2018
Trade Name
SciMoCa
Common Name
Secondary Check QA Software
Classification Name
Accelerator, Linear, Medical 21 CFR 892.5050 Product Code: IYE
Class II
©Radialogica LLC 2018 All rights reserved
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Predicate Devices
- o K140660 Mobius3D (Mobius Medical Systems, LP)
- . K161946 Model 1217028 DoseCHECK (Sun Nuclear Corporation)
Device Description:
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Intended Use:
SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses.
SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Technological Characteristics:
The primary technological components of SciMoCa and its predicate devices are an independent dose calculation algorithm and functionality that allows comparison between an independently-calculated dose and a dose generated by a treatment planning system, all for quality assurance purposes. The technological characteristics are believed to be substantially equivalent to the predicate devices.
Performance Testing Summary:
Validation testing involved simulated clinical workflows and environment, as well as algorithm testing. These are described in detail in section 18. The product was deemed fit for clinical use.
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Non-Clinical Testing Summary:
Verification tests were written and executed, focused on verifying that the product performed to specifications and works as designed. Over 700 tests procedures were executed, including tests to verify requirements for functionality, tests to ensure risk mitigations function as intended, and regression tests to ensure the safety and effectiveness of functionality. SciMoCa passed verification testing and was deemed safe and effective for its intended use.
Conclusion:
SciMoCa is believed to be substantially equivalent to the predicate devices in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates substantial equivalence to the predicate devices. It is in the opinion of Radialogica, LLC that the medical device, SciMoCa, is as safe, is as effective, and performs as well as the predicate devices.