(94 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as performing calculations and managing data, without mentioning any learning or adaptive capabilities.
No.
The device is a quality assurance software designed to verify treatment plans and manage in vivo measurements, not to deliver therapy itself.
No
This device is a quality assurance software used to verify radiotherapy treatment plans and manage in vivo measurements. It is not used for diagnosing medical conditions; rather, it ensures the accuracy of treatment plans.
Yes
The device description explicitly states "MU2net is a standalone software designed to perform secondary monitor unit (MU) or dose calculation" and "MU2net is also designed to manage in vivo measurements performed by skin dose detectors". It does not describe any hardware components included with the device. While it interacts with external systems (Radiotherapy Treatment Planning Systems and skin dose detectors), the device itself is presented as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: MU2net is a software used for quality assurance of radiotherapy treatment plans and management of in vivo measurements. It processes data from treatment planning systems (DICOM RT Plan) and manages data from skin dose detectors.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. Its function is related to the planning and verification of a medical treatment, not the diagnosis or monitoring of a condition through sample analysis.
Therefore, MU2net falls under the category of a medical device used in the treatment process, specifically for quality assurance in radiotherapy, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
IYE
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM RT Plan data sets
Anatomical Site
is used for human medical field. is used to validate a plan for any tumor sites.
Indicated Patient Age Range
is used to validate a plan for any population (child, adult and elderly people) having a diagnosed cancer and following an External Beam Radiotherapy.
Intended User / Care Setting
is dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.
is installed in medical facilities.
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)
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.
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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]
510(k) Summary
-
- Date the Summary was prepared: 2019-07-10
2. Submitter:
| Company Name: | DOSIsoft SA |
|---|---|
| Address: | 45-47, Avenue Carnot |
| 94230 CACHAN – France | |
| Phone No.: | +33 1 41 24 26 26 |
| Fax No.: | +33 1 41 24 26 28 |
| 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 |
| (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.
4
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
(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
assurance software for secondary
monitor-unit (MU) or secondary dose
computations from DICOM RT Plans
provided by TPS.
It is also intended for in vivo dose
measurements management. | Independent dose and fluence map
verification software for Intensity
Modulated Radiation Therapy based on
Linear accelerator plans containing multi-
leaf collimator leaf sequence data and
fluence maps from primary IMRT
treatment planning systems.
Independent dose computation software
for standard, simple geometry radiation
therapy treatment planning and
verification of monitor units based on
Linear Accelerator parameters and
physician prescribed dose information. |
| Indication for
use | is indicated for use as a quality
assurance software to verify conventional
and IMRT (static or rotational) 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 patient
treatment fraction. | IMSure is indicated for use as a quality
assurance tool to verify IMRT treatment
plans developed on any radiation therapy
treatment planning system with the
appropriate transfer format. IMSure will
also perform primary monitor unit
calculations from measured physics data
for plans of known geometry. |
| Target
population | is used to validate a plan for any
population (child, adult and elderly
people) having a diagnosed cancer and
following an External Beam Radiotherapy. | Same |
| Anatomical
sites | is used for human medical field. is used
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
radiation oncologists, medical physicists
and medical dosimetrists. | Same |
| Design | Dose computations are performed at local
workstation. Multiple simultaneous dose
calculations. | Same |
| Performances | | |
| Algorithm - map
verification | No | Single Source model |
| Dose / MU
calculation
Algorithm | Commissioning based on formalism
booklet3 - Monitor Unit Calculation for
High Energy Photon Beams from ESTRO
and Report 12 from Netherlands
Commission on Radiation Dosimetry
(NCS).
Inspired from J. H. Kung and al. "A
monitor unit verification calculation in
intensity modulated radiotherapy as a
dosimetry quality assurance" Medical | 3DCRT: Khan (classical)
IMRT/VMAT: Single Source model,
Clarkson scatter algorithm based on
Stanford University method |
| DOSISOFT SA
45/47, avenue Carnot
94230 Cachan - France |
+33 (0)1 41 24 26 26
+33 (0)1 41 24 26 28 | info@dosisoft.com
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. | |
| Calculation point position and depth: | ||
| external/internal/support outlines and | ||
| electron density from DICOM RT StructureSet for VMAT plans | Two dimensional, graphical user interface based | |
| Machines supported | Commercially available Linear | |
| Accelerators. | ||
| Supports MR-Linacs. | Commercially available Linear | |
| Accelerators. | ||
| Calculation point for MU calculations | Off-Axis and depth specified distances | |
| required for dose calculation (dose point | ||
| coordinates) using measured physical | ||
| beam data. | ||
| Dose verification is performed using a list | ||
| of points of interest given in the RT Plan | ||
| file. | Same | |
| Physics Data | Measured, tabular database stored. | Measured, tabular database stored, |
| multiple linear allowed. | ||
| Scatter table | Processed | Measured. |
| Import plan data | DICOM RT | DICOM RT |
| RTP link | ||
| Supported treatment technics | 3D CRT, IMRT, VMAT | Same |
| TPS supported | DOSIsoft/Isogray, | |
| Varian/Eclipse, | ||
| Philips/Pinnacle, | ||
| Elekta/Xio, Monaco | ||
| Nucletron/Oncentra | ||
| RaySearch/RayStation | Same | |
| Database | Provides easy access to patient | |
| information allowing you to verify, change | ||
| calculations or change the status of the | ||
| plan. | Provides easy access to patient | |
| information allowing you to verify, change | ||
| or copy calculations. | ||
| Gives multiple user access to all patient | ||
| calculation information using a web-based | ||
| interface. | Gives multiple user access to all patient | |
| calculation information from a network | ||
| server. | ||
| Import in vivo dose data | Automatic or manual import of detector | |
| measurements. | The software allows a simple interface to | |
| enter the collected data and computes the | ||
| expected diode reading for each | ||
| treatment field. | ||
| Dose calibration method(s) | Apply to all beams with isocentric or fixed | |
| SSD calibration | Isocentric or fixed SSD calibration | |
| distance. | ||
| Export data | Results can be printed out or saved as | |
| Portable Document Format (PDF) files. | ||
| The original DICOM RT Plan provided by | ||
| the TPS is never modified and can be | ||
| forwarded to the R&V system. | Paper documentation | |
| DICOM RT | ||
| RTP Link | ||
| Cybersecurity | Secure login with layered authorization | |
| model. | Secure login with layered authorization | |
| model. | ||
| Traceability | The user can see the chronological | |
| account of events from the file import to | ||
| 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
6
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
+33 (0)1 41 24 26 26 24 26 28
RCS Créteil 443 195 433
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