MU2net

K191944 · Dosisoft · IYE · Oct 24, 2019 · Radiology

Device Facts

• Record ID: K191944
• Device Name: MU2net
• Applicant: Dosisoft
• Product Code: IYE · Radiology
• Decision Date: Oct 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

Treatment plan verification System by double Monitor Units calculation and in vivo verifications management. MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets. It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions. MU2net is dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.

Device Story

MU2net is a standalone software for secondary monitor unit (MU) or dose calculation and in vivo dosimetry management. Input: DICOM RT Plan data sets from Radiotherapy Treatment Planning Systems (TPS). Operation: Performs secondary dose computations at a local workstation using measured physical beam data and tabular databases; supports 3D CRT, IMRT, and VMAT techniques. Output: Verified dose/MU calculations and in vivo measurement management reports. Used in medical facilities by radiation oncologists, medical physicists, and dosimetrists. Web-based interface allows multi-user access to patient calculation information. Benefits: Provides independent verification of treatment plans to ensure accuracy before patient treatment; assists in managing in vivo measurements during treatment fractions.

Clinical Evidence

Bench testing only. Performance, functional, and algorithmic testing were conducted under clinically representative conditions. Validation activities confirmed the device meets user needs and intended use requirements. No clinical trial data presented.

Technological Characteristics

Standalone software; Linux-based; web-based interface. Performs secondary dose/MU calculations using measured tabular beam data. Supports DICOM RT Plan import. Cybersecurity includes secure login with layered authorization. Major Level of Concern software. Algorithms based on ESTRO formalism booklet 3 and NCS Report 12.

Indications for Use

Indicated for quality assurance of conventional and IMRT (static or rotational) radiotherapy treatment plans and management of in vivo measurements during treatment fractions for cancer patients of any age (child, adult, elderly) undergoing external beam radiotherapy.

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

• IMSure OA Software (K031975)

Submission Summary (Full Text)

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October 24, 2019

DOSIsoft SA % Mr. Luc Diot Quality Director 45/47, Avenue Carnot 94230 Cachan FRANCE

Re: K191944

Trade/Device Name: MU2net Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 10, 2019 Received: July 30, 2019

Dear Mr. Diot:

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/cfpmn/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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K191944

Device Name MU2net

Indications for Use (Describe)

Treatment plan verification System by double Monitor Units calculation and in vivo verifications management.

MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets.

It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions.

MU2net is dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.

| 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)

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Image /page/3/Picture/0 description: The image shows the word "DOSI" in bold, black font, followed by a blue butterfly outline, and the word "soft" in a thin, black font. The butterfly is positioned between the two words, creating a logo-like appearance. The overall design is clean and simple, with a focus on the text and the butterfly symbol.

Image /page/3/Picture/1 description: The image is a logo for ISO certification. The logo is a blue circle with the word "iSO" in white letters in the center. There are two red arrows on either side of the word "iSO", pointing towards it. The number "73485" is printed at the bottom of the circle.

# Premarket Notification 510(k) Summary

[as required by 21 CFR 807.92]

K191944

## 510(k) Summary

- 1. Date the Summary was prepared: 2019-07-10
#### 2. Submitter:

| Company Name: | DOSIsoft SA |
|---------------|-----------------------------------------------|
| Address: | 45-47, Avenue Carnot<br>94230 CACHAN – France |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| Contact Name: | Mr. Marc USZYNSKI |

#### 3. Device Information:

| Proprietary Name: | MU2net |
|----------------------|----------------------------------------------------------------------------------------------------|
| Trade Names: | MU2net |
| Common Name: | Standalone software quality control system |
| Classification Name: | Medical charged-particle radiation therapy system<br>(21 CFR 892.5050, Class II, Product Code IYE) |

#### 4. Predicate Device:

K031975 - IMSure OA Software - Standard Imaging, Inc. (Prodigm, Inc.)

# Executive Summary

### 5. Product Description:

MU2net is a standalone software designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems.

MU2net is also designed to manage in vivo measurements performed by skin dose detectors (diode in vivo dosimetry).

### 6. Intended Use and User profiles:

Treatment plan verification System by double Monitor Units calculation and in vivo verifications management.

MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets.

It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions.

MU2net is dedicated to be used by high qualified professionals in medical oncology and/or medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.

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Image /page/4/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly-shaped design with red arrows pointing towards it. The word "soft" is written in a thin, sans-serif font to the right of the butterfly. The text and butterfly design appear to be part of a logo or branding element.

Image /page/4/Picture/1 description: The image shows a blue circular logo with the text "iSO" in the center. The text "CERTIFIED" is written in a smaller font size above the "iSO" text, and the number "73485" is written below it. There are two small red arrows pointing towards the "iSO" text from the left and right sides.

# 7. Technological Characteristics:

The table below compares the technological characteristics and the features of MU2net and its predicate IMSure QA Software.

| Device name | | IMSure QA Software<br>(predicate) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (this submission) | |
| 510(k) number | This filing | K031975 |
| Company | DOSIsoft SA | Standard Imaging, Inc. (Prodigm, Inc.) |
| Intended use | is intended to be used as a quality<br>assurance software for secondary<br>monitor-unit (MU) or secondary dose<br>computations from DICOM RT Plans<br>provided by TPS.<br>It is also intended for in vivo dose<br>measurements management. | Independent dose and fluence map<br>verification software for Intensity<br>Modulated Radiation Therapy based on<br>Linear accelerator plans containing multi-<br>leaf collimator leaf sequence data and<br>fluence maps from primary IMRT<br>treatment planning systems.<br>Independent dose computation software<br>for standard, simple geometry radiation<br>therapy treatment planning and<br>verification of monitor units based on<br>Linear Accelerator parameters and<br>physician prescribed dose information. |
| Indication for<br>use | is indicated for use as a quality<br>assurance software to verify conventional<br>and IMRT (static or rotational) treatment<br>plans provided by Radiotherapy<br>Treatment Planning Systems and<br>transferred as DICOM RT Plan data sets.<br>It is also indicated for use as a quality<br>assurance software to manage in vivo<br>measurements performed during patient<br>treatment fraction. | IMSure is indicated for use as a quality<br>assurance tool to verify IMRT treatment<br>plans developed on any radiation therapy<br>treatment planning system with the<br>appropriate transfer format. IMSure will<br>also perform primary monitor unit<br>calculations from measured physics data<br>for plans of known geometry. |
| Target<br>population | is used to validate a plan for any<br>population (child, adult and elderly<br>people) having a diagnosed cancer and<br>following an External Beam Radiotherapy. | Same |
| Anatomical<br>sites | is used for human medical field. is used<br>to validate a plan for any tumor sites. | Same |
| Where used | is installed in medical facilities. | Same |
| Human factors | It is used by qualified users such as<br>radiation oncologists, medical physicists<br>and medical dosimetrists. | Same |
| Design | Dose computations are performed at local<br>workstation. Multiple simultaneous dose<br>calculations. | Same |
| Performances | | |
| Algorithm - map<br>verification | No | Single Source model |
| Dose / MU<br>calculation<br>Algorithm | Commissioning based on formalism<br>booklet3 - Monitor Unit Calculation for<br>High Energy Photon Beams from ESTRO<br>and Report 12 from Netherlands<br>Commission on Radiation Dosimetry<br>(NCS).<br>Inspired from J. H. Kung and al. "A<br>monitor unit verification calculation in<br>intensity modulated radiotherapy as a<br>dosimetry quality assurance" Medical | 3DCRT: Khan (classical)<br>IMRT/VMAT: Single Source model,<br>Clarkson scatter algorithm based on<br>Stanford University method |

| DOSISOFT SA<br>45/47, avenue Carnot<br>94230 Cachan - France | <br>[phone]<br><br>[phone] | [e-mail]<br>www.dosisoft.com | RCS Créteil 443 195 433 | Page 2/4 |
|--------------------------------------------------------------|------------------------------------------------------|---------------------------------------|-------------------------|----------|
|--------------------------------------------------------------|------------------------------------------------------|---------------------------------------|-------------------------|----------|

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Image /page/5/Picture/0 description: The image shows the word "DOSI" in large, bold, black font, followed by a blue butterfly-shaped design with red arrows pointing towards it. The word "soft" is written in a smaller, thinner, black font to the right of the butterfly. The text and butterfly design together form a logo or brand name.

Image /page/5/Picture/1 description: The image is a blue and white circular logo that says "CERTIFIED" at the top and has the letters "iSO" in the center. There are two red arrows on either side of the letters. The number "73485" is at the bottom of the circle.

| Device name | (this submission) | IMSure QA Software (predicate) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | Physics 2000 October; 27(10):2226-30. | |
| Patient Geometry Specifications | Dose computing: Large parallelepipedic water phantom.<br>Calculation point position and depth:<br>external/internal/support outlines and<br>electron density from DICOM RT StructureSet for VMAT plans | Two dimensional, graphical user interface based |
| Machines supported | Commercially available Linear<br>Accelerators.<br>Supports MR-Linacs. | Commercially available Linear<br>Accelerators. |
| Calculation point for MU calculations | Off-Axis and depth specified distances<br>required for dose calculation (dose point<br>coordinates) using measured physical<br>beam data.<br>Dose verification is performed using a list<br>of points of interest given in the RT Plan<br>file. | Same |
| Physics Data | Measured, tabular database stored. | Measured, tabular database stored,<br>multiple linear allowed. |
| Scatter table | Processed | Measured. |
| Import plan data | DICOM RT | DICOM RT<br>RTP link |
| Supported treatment technics | 3D CRT, IMRT, VMAT | Same |
| TPS supported | DOSIsoft/Isogray,<br>Varian/Eclipse,<br>Philips/Pinnacle,<br>Elekta/Xio, Monaco<br>Nucletron/Oncentra<br>RaySearch/RayStation | Same |
| Database | Provides easy access to patient<br>information allowing you to verify, change<br>calculations or change the status of the<br>plan. | Provides easy access to patient<br>information allowing you to verify, change<br>or copy calculations. |
| | Gives multiple user access to all patient<br>calculation information using a web-based<br>interface. | Gives multiple user access to all patient<br>calculation information from a network<br>server. |
| Import in vivo dose data | Automatic or manual import of detector<br>measurements. | The software allows a simple interface to<br>enter the collected data and computes the<br>expected diode reading for each<br>treatment field. |
| Dose calibration method(s) | Apply to all beams with isocentric or fixed<br>SSD calibration | Isocentric or fixed SSD calibration<br>distance. |
| Export data | Results can be printed out or saved as<br>Portable Document Format (PDF) files.<br>The original DICOM RT Plan provided by<br>the TPS is never modified and can be<br>forwarded to the R&V system. | Paper documentation<br>DICOM RT<br>RTP Link |
| Cybersecurity | Secure login with layered authorization<br>model. | Secure login with layered authorization<br>model. |
| Traceability | The user can see the chronological<br>account of events from the file import to<br>the current status. | Not available |
| Review interface | Web based interface | Windows based interface |
| Operating system | Linux operating system | Microsoft Windows operating system |

DOSISOFT SA 45/47, avenue Carnot 94230 Cachan - France

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Image /page/6/Picture/0 description: The image shows the word "DOSIsoft" in a stylized font. The first four letters, "DOSI", are in a bold, serif font, while the "soft" part of the word is in a thinner, sans-serif font. Between the "I" and "soft" is a blue butterfly-shaped design, which appears to be part of the logo.

### 8. Performance Testing - Bench:

MU2net was designed and documented in accordance with the recommandations of FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for software devices identified as Major Level of Concern.

MU2net was submitted to performance, functional and algorithmic testing, risk management assessment and validation activities under clinically representative conditions.

The results of performance, functional and algorithmic testing, risk management and validation activities under clinically representative conditions demonstrate the safety and effectiveness of MU2net.

MU2net meets the requirements of the device, its user needs and intended use, which are demonstrated to be substantially equivalent to those of the predicate device.

### 9. Conclusions

The substantial equivalence discussion sustains that MU2net intended use, clinical and technical (principles of operation, functionalities and critical performances) characteristics are the same as for the predicate device IMSure OA Software legally marketed in the U.S. (K031975).

The differences on some functional features do not significantly affect, or may not significantly affect, safety or effectiveness.

The results of verification and validation activities demonstrate the safety and effectiveness of MU2net. MU2net meets the requirements of the device, its user needs and intended use, which are demonstrated to be substantially equivalent to those of the predicate device.

In summary, DOSIsoft therefore considers that, in its opinion, MU2net is substantially equivalent to and is at least as safe and effective as the predicate device.

- France

[phone] 26 28

RCS Créteil 443 195 433

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