SciMoCa

K180595 · Radialogica, LLC · IYE · Apr 4, 2018 · Radiology

Device Facts

• Record ID: K180595
• Device Name: SciMoCa
• Applicant: Radialogica, LLC
• Product Code: IYE · Radiology
• Decision Date: Apr 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

SciMoCa is standalone software for radiotherapy quality assurance; performs independent dose recalculation to verify treatment planning system (TPS) output. Operates via client-server architecture; clinicians submit calculation requests to central server. Uses Monte Carlo algorithm for independent dose verification; compares recalculated dose against TPS-generated dose. Used in clinical settings by trained radiation oncology personnel. Output allows clinicians to validate treatment plan accuracy; facilitates clinical decision-making regarding plan suitability for radiation delivery. Benefits patient by ensuring radiation dose accuracy and reducing potential for treatment planning errors.

Clinical Evidence

No clinical data. Bench testing only. Validation included simulated clinical workflows, environment testing, and algorithm testing. Over 700 verification test procedures executed, including functional requirements, risk mitigation verification, and regression testing.

Technological Characteristics

Standalone software; service-oriented client-server architecture. Core technology is an independent Monte Carlo dose calculation algorithm. Functionality includes dose recalculation and comparison against primary treatment planning system output. Designed for clinical quality assurance workflows.

Indications for Use

Indicated for quality assurance of radiotherapy treatment plans by trained radiation oncology personnel. Not for use as a treatment planning system or radiation delivery device.

Regulatory Classification

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.

Predicate Devices

• Mobius3D (K140660)
• Model 1217028 DoseCHECK (K161946)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K180595

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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary Statement

# 510(K) Owner

Radialogica, LLC 511 N Garrison Ave. St. Louis, MO 63101 Tel: [phone] Fax: [phone]

## Contact person

Debra Vigil [e-mail] Ph: [phone], 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.