(131 days)
Not Found
No
The summary describes image processing, segmentation, registration, and dosimetry calculations, but does not mention AI, ML, or related terms.
No.
This device is a software for image processing and analysis, assisting in diagnosis, treatment analysis, and therapy response assessment. It does not directly provide therapy or interact with the patient in a therapeutic manner.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is intended "to assist in medical diagnosis" and "to assist in treatment analysis and in therapy response assessment," which are all diagnostic functions. The "Device Description" also mentions it is a "medical diagnosis aid."
Yes
The device description explicitly states "PLANET Onco Dose is a software platform" and "PLANET Onco Dose is a modular software suite composed of three elements". The intended use and device description focus entirely on software functionalities for image processing, analysis, and dosimetry calculations, without mentioning any accompanying hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that PLANET Onco Dose is a software that processes, displays, and analyzes medical image series (PET, SPECT, CT, MRI, XA). It assists in medical diagnosis, treatment analysis, therapy response assessment, and contouring for radiotherapy.
- No Sample Analysis: The device does not perform any analysis on biological samples taken from the patient. Its input is medical imaging data.
Therefore, while it is a medical device used in the diagnostic and treatment process, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medical medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy.
PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology.
The medical modalities of these medical imaging systems include CT. MRI, SPECT, PET. XA, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format.
PLANET Onco Dose provides the user with the means to segment structures in medical image volumes by providing dedicated delineation, contouring and propagation tools for both tumors and normal tissues (i.e. Regions of Interest (ROI)).
PLANET Onco Dose provides tools to display, co-register (including deformable registration), compute Standardized Uptake Value (SUV) and import / export results (contours and dosimetries) to / from Treatment Planning Systems (TPS) and PACS devices for assessment and response of patients undergoing a course of oncology treatment.
PLANET Onco Dose provides the user with the means to assist in the assessment quantification of radiation doses received by tissues as a result of administering a radionuclide (e.g. Permanent Yttrium-90 microsphere implants).
PLANET Onco Dose provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 (Y90) microspheres:
-
3D liver-lung shunt assessment;
-
Local Deposition Model;
-
Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1]:
-
Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series;
-
Compatible with PET images acquired with another radioisotope instead of Y90 when Y90 acquisitions are not supported by the scanner (correction of branching ratio and decay parameters).
For Y90 microspheres. PLANET Onco Dose cannot be used to prescribe the radionuclide activity to be administered to the patient for the therapy. The user has to provide the parameters (e.g. activity) in order for PLANET Onco Dose to estimate the radiation doses that the tissues received as a result of the administration.
PLANET Onco Dose should only be used for the retrospective determination of dose and not for the case where is a need for retreatment using Y90 microspheres.
[1] Bolch WE et al. MIRD pamphlet no. 17: the dosimetry of nonuniform activity distributions-Radionuclide S values at the voxel level. J Nucl Med, 1999, 40:11S-36S
Product codes
LLZ
Device Description
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
PLANET Onco Dose is a modular software suite composed of three elements:
- PLANET: Core System: license controller, reviewing of multi-modal molecular image series -(PET/CT, SPECT/CT, PET/MRI, SPECT/MRI): fusion and registration;
- -PLANET Onco: Oncology Module: contouring of region of interest, turnor segmentation, tumoral activity monitoring, therapy response assessment;
- -PLANET Dose: Dosimetry Module: internal dosimetry computation for the Targeted Radionuclide Therapy (TRT).
Mentions image processing
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, SPECT, CT, MRI, XA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals in Molecular Imaging, and/or Medical Oncology
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)
PLANET Onco Dose 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.
PLANET Onco Dose 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 assessment and validation activities under clinically representative conditions demonstrate the safety and effectiveness of PLANET Onco Dose.
PLANET Onco Dose 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
March 6, 2019
DOSIsoft % Mr. Luc Diot Quality Director 45/47, Avenue Carnot Cachan, 94230 FRANCE
Re: K182966
Trade/Device Name: PLANET Onco Dose Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 8, 2019 Received: February 21, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.'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
2
Indications for Use
510(k) Number (if known) K182966
Device Name PLANET Onco Dose
Indications for Use (Describe)
PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medical medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy.
PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology.
The medical modalities of these medical imaging systems include CT. MRI, SPECT, PET. XA, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format.
PLANET Onco Dose provides the user with the means to segment structures in medical image volumes by providing dedicated delineation, contouring and propagation tools for both tumors and normal tissues (i.e. Regions of Interest (ROI)).
PLANET Onco Dose provides tools to display, co-register (including deformable registration), compute Standardized Uptake Value (SUV) and import / export results (contours and dosimetries) to / from Treatment Planning Systems (TPS) and PACS devices for assessment and response of patients undergoing a course of oncology treatment.
PLANET Onco Dose provides the user with the means to assist in the assessment quantification of radiation doses received by tissues as a result of administering a radionuclide (e.g. Permanent Yttrium-90 microsphere implants).
PLANET Onco Dose provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 (Y90) microspheres:
-
3D liver-lung shunt assessment;
-
Local Deposition Model;
-
Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1]:
-
Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series;
-
Compatible with PET images acquired with another radioisotope instead of Y90 when Y90 acquisitions are not supported by the scanner (correction of branching ratio and decay parameters).
For Y90 microspheres. PLANET Onco Dose cannot be used to prescribe the radionuclide activity to be administered to the patient for the therapy. The user has to provide the parameters (e.g. activity) in order for PLANET Onco Dose to estimate the radiation doses that the tissues received as a result of the administration.
PLANET Onco Dose should only be used for the retrospective determination of dose and not for the case where is a need for retreatment using Y90 microspheres.
[1] Bolch WE et al. MIRD pamphlet no. 17: the dosimetry of nonuniform activity distributions-Radionuclide S values at the voxel level. J Nucl Med, 1999, 40:11S-36S
3
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4
Image /page/4/Picture/0 description: The image shows the word "DOSIsoft" with a butterfly image in between "DOSI" and "soft". The word "DOSI" is in a bold, serif font, and the word "soft" is in a thinner, sans-serif font. The butterfly image is blue and has red arrows pointing to it from the words on either side.
Image /page/4/Picture/1 description: The image is a logo with a blue circle and the letters "iSO" in the center. The word "CERTIFIED" is written in blue around the top of the circle. There are two red arrows on either side of the circle, pointing towards the center. The number "73485" is written in blue around 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: 2018-10-17
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: | PLANET Onco Dose |
|---|---|
| Trade Names: | PLANET Onco, PLANET Dose, PLANET Onco Dose |
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Image Processing, Radiological |
| (21 CFR 892.2050, Class II, Product Code LLZ) |
4. Predicate Device:
K173636 - Velocity - Varian Medical Systems, Inc.
Executive Summary
5. Product Description:
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
PLANET Onco Dose is a modular software suite composed of three elements:
- PLANET: Core System: license controller, reviewing of multi-modal molecular image series -(PET/CT, SPECT/CT, PET/MRI, SPECT/MRI): fusion and registration;
- -PLANET Onco: Oncology Module: contouring of region of interest, turnor segmentation, tumoral activity monitoring, therapy response assessment;
- -PLANET Dose: Dosimetry Module: internal dosimetry computation for the Targeted Radionuclide Therapy (TRT).
6. Intended Use and User profiles:
PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medicine and other digital mage series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy.
PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology.
The medical modalities of these medical imaging systems include CT, MRI, SPECT, PET, XA, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format.
5
Image /page/5/Picture/0 description: The image shows the word "DOSIsoft" in a stylized font. The words "DOSI" and "soft" are in black, while the "I" is replaced with a blue butterfly-like shape. The text is horizontally aligned and the font is sans-serif.
Image /page/5/Picture/1 description: The image is a blue circular logo with the text "CERTIFIED" at the top. Inside the circle is the text "iSO" in a sans-serif font. Below the text "iSO" is the number "73485" with a bullet point on either side. There are two red arrows on either side of the text "iSO".
PLANET Onco Dose provides the user with the means to segment structures in medical image volumes by providing dedicated delineation, contouring and propagation tools for both tumors and normal tissues (i.e. Regions of Interest (ROI)).
PLANET Onco Dose provides to display, co-register (including deformable registration), compute Standardized Uptake Value (SUV) and import / export results (contours and dosimetries) to / from Treatment Planning Systems (TPS) and PACS devices for assessment and response of patients undergoing a course of oncology treatment.
PLANET Onco Dose provides the user with the means to assessment quantification and verification of radiation doses received by tissues as a result of administering a radionuclide (e.g. Permanent Yttrium-90 microsphere implants).
PLANET Onco Dose provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 (Y90) microspheres:
- ー 3D liver-lung shunt assessment;
- । Local Deposition Model;
- Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1]; ।
- Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series; ।
- Compatible with PET images acquired with another radioisotope instead of Y90 when Y90 acquisitions are not supported by the scanner (correction of branching ratio and decay parameters).
For Y90 microspheres, PLANET Onco Dose cannot be used to prescribe the radionuclide activity to be administered to the patient for the therapy. The user has to provide the radionuclide parameters (e.g. activity) in order for PLANET Onco Dose to estimate the radiation doses that the tissues received as a result of the administration.
PLANET Onco Dose should only be used for the retrospective determination of dose and not for the case where there is a need for retreatment using Y90 microspheres.
[1] Bolch WE et al. MIRD pamphlet no. 17: the dosimetry of nonuniform activity distributions-Radionuclide S values at the voxel level. J Nucl Med, 1999, 40:11S-36S
7. Technological Characteristics:
4230 Cachan - France
The table below compares the technological characteristics and the features of PLANET Onco Dose and its predicate Velocity K173636.
| PLANET Onco Dose (This submission) | Velocity K173636 (Predicate) |
|---|---|
| Indications for Use / Intended Use | |
| PLANET Onco Dose is a standalone software | |
| intended to be used with PET or SPECT hybrid | |
| imaging systems in order to manage, process, | |
| display and analyze nuclear medicine and other | |
| digital medical image series, to assist in medical | |
| diagnosis, to assist in treatment analysis and in | |
| therapy response assessment, to assist in the | |
| contouring of region of interest for radiotherapy. | |
| PLANET Onco Dose is dedicated to be used by | |
| qualified medical professionals in Molecular Imaging, | |
| and/or Medical Oncology. | Velocity is a software package that provides the |
| physicians a means for comparison of medical data | |
| including imaging data that is DICOM compliant. | |
| It allows the display, annotation, volume operation, | |
| volume rendering, registration and fusion of medical | |
| images as an aid during use by diagnostic radiology, | |
| oncology, radiation therapy planning and other | |
| medical specialties. | |
| Velocity is not intended for mammography. | |
| Device Type | |
| Standalone software | Standalone software |
| Users | |
| Qualified medical professionals in Molecular | |
| Imaging, and/or Medical Oncology | Physicians |
| Cybersecurity | |
| DOSISOFT SA | |
| 45/47, avenue Carnot | +33 (0)1 41 24 26 26 |
| info@dosisoft.com | |
| Page 2/5 | |
| PLANET Onco Dose (This submission) | Velocity K173636 (Predicate) |
| Limits software access to trusted users only | Limits software access to trusted users only |
| Workflow | Workflow |
| Oncology workflow automation | Oncology workflow automation |
| Receive, store and retrieve digital DICOM medical | |
| images from a variety of sources and modalities | |
| PET/SPECT/CT/MRI | Receive, store and retrieve digital DICOM medical |
| images from a variety of sources and modalities | |
| PET/SPECT/CT/MRI | |
| Digital medical images patient's structured database | Organize data into a logical overview of a patient's |
| imaging history | |
| Image and registered image data export as DICOM | |
| series | Image and registered image data export as DICOM |
| series | |
| Structure Import, Save & Export as DICOM RT | |
| Object | Structure Import, Save & Export as DICOM RT |
| Object | |
| Dose data Import, Save & Export as DICOM RT | |
| Object | Dose data Import, Save & Export as DICOM RT |
| Object | |
| Reports can be exported as DICOM files | Reports can be exported as print sessions |
| Image Management Tools | Image Management Tools |
| Support of 4D series | Support of 4D series with breathing cine mode |
| Advanced visualization and navigation features | Advanced visualization and navigation features |
| Management of multi-time point image | |
| series | Management of multi-time point image |
| series | |
| Manual registration methods including landmarks | Manual registration method |
| Automatic rigid image registration and fusion of | |
| medical series from multiple modalities | Automatic rigid image registration and fusion of |
| medical series from multiple modalities | |
| Automatic deformable image registration and fusion | |
| of medical images from multiple modalities | Automatic deformable image registration and fusion |
| of medical images from multiple modalities | |
| Combines images from different modalities for | |
| enhanced volume definition | Combines images from different modalities for |
| enhanced volume definition | |
| Visualization Tools | Visualization Tools |
| General image viewer with view layout selection and | |
| toolbars | General image viewer with view layout selection and |
| toolbars | |
| 2D visualization (Multi-planar) | 2D visualization (Multi-planar) |
| 3D volume rendering | 3D volume rendering |
| Image fusion | |
| Anatomical and functional series | Image fusion |
| Anatomical and functional series | |
| Image analysis tools | Image analysis tools |
| General Contouring Features | General Contouring Features |
| Multi-modality manual contouring tools | Multi-modality manual contouring tools |
| Contour transformation tools | Contour transformation tools |
| Semi-automatic advanced contouring tools | Contouring with automated scripting |
| Automated structure of interest segmentation tools | Atlas auto-segmentation |
| Propagates contours from one time point to another | Propagates contours from one time point to another |
| Contour transformation (interpolation, | |
| margining) between modalities | - |
| Functional Segmentation Tools | - |
| PLANET Onco Dose (This submission) | Velocity K173636 (Predicate) |
| Assessment Aid and Patient Follow-up Tools | |
| Visualization and analytical monitoring of disease | |
| progression or response to treatment or therapy | |
| using multiexam comparison and correlation | Visualization and analytical monitoring of disease |
| progression or response to treatment or therapy | |
| using multiexam comparison and correlation | |
| Quantification of metabolic activity and volume | |
| measurement of segmented tumors on PET modality | Volume operations |
| Biological effective dose (BED) scaling | |
| Measure Standard Uptake Value - SUV | Measure Standard Uptake Value - SUV |
| Advanced Tumor SUV Statistics | - |
| Patient's follow up analysis with volumetric graphs | Patient's follow up analysis with volumetric graphs |
| Allows generation of RECIST 1.1 & PERCIST 1.0 | |
| format reports. | - |
| Dose Distribution Import and Estimation Tools | |
| The dose distribution can be imported from any | |
| system such as radiation therapy planning systems | |
| using DICOM RT Dose format | The dose distribution can be imported from any |
| system such as radiation therapy planning systems | |
| using DICOM RT Dose format | |
| Intended for post-treatment absorbed dose | |
| calculation and evaluation | Intended for post-treatment absorbed dose |
| calculation and evaluation | |
| Compatible with Y90 PET and SPECT image types | Compatible with Y90 PET and SPECT image types |
| Use the Local Deposition Model for dose calculation | Use the Local Deposition Model for dose calculation |
| Use the Voxel S Value approach based on the | |
| schema in MIRD Pamphlet 17 ([1]) | - |
| Dosimetry Analysis Tools | |
| Display of the dose distribution in patient tissues | Display of the dose distribution in patient tissues |
| Dose Volume Histogram statistics display | Dose Volume Histogram statistics display |
| Table of dose to organs | Table of dose to organs |
| Simultaneous display of two dose distributions and | |
| comparison tools | - |
| Addition of multiple treatment stages: internal | |
| dosimetry and/or external beam radiotherapy | Addition of multiple treatment stages: internal |
| dosimetry and/or external beam radiotherapy | |
| Operating System | |
| Linux operating system | Microsoft Windows and Apple macOS operating |
| systems |
RCS Créteil 443 195 433
+33 (0)1 41 24 26 28 |
6
Image /page/6/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 visual break. The overall design is simple and clean, with a focus on the text and the butterfly symbol.
Image /page/6/Picture/1 description: The image is a logo for ISO certification. The logo is a blue circle with the letters "iSO" in white in the center. There are two red arrows on either side of the letters. The number "73485" is printed in black at the bottom of the circle. The word "CERTIFIED" is printed in white at the top of the circle.
DOSISOFT SA 45/47, avenue Carnot 94230 Cachan - France
7
Image /page/7/Picture/0 description: The image shows the word "DOSI" in bold, black font, followed by a blue butterfly outline. The word "soft" is written in a thin, black font to the right of the butterfly. The image appears to be a logo or brand name.
Image /page/7/Picture/1 description: The image is a logo with the letters "iSO" in a white circle with a light blue background. The word "CERTIFIED" is written in blue letters above the circle, and the number "73485" is written in blue letters below the circle. There are two small red arrows on either side of the circle, pointing towards the letters "iSO".
8. Performance Testing - Bench:
PLANET Onco Dose 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.
PLANET Onco Dose 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 assessment and validation activities under clinically representative conditions demonstrate the safety and effectiveness of PLANET Onco Dose.
PLANET Onco Dose 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.
DOSISOFT SA 45/47, avenue Carnot 94230 Cachan - France
+33 (0)1 41 24 26 26 |
+33 (0)1 41 24 26 28 |
8
Image /page/8/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly outline, and the word "soft" in a thin, sans-serif font. The butterfly is positioned between the two words, creating a logo-like appearance. The overall design is clean and modern.
Image /page/8/Picture/1 description: The image is a circular logo with the text "CERTIFIED" at the top and ".73485." at the bottom. The letters "iSO" are in the center of the circle in a sans-serif font. There are two arrows on either side of the letters "iSO" pointing towards the center. The logo is light blue and white.
9. Conclusions
The substantial equivalence discussion sustains the claim that PLANET Onco Dose intended use, clinical and technical (principles of operation, functionalities and critical performances) characteristics are the same as for the predicate device Velocity legally marketed in the U.S. (K173636).
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 PLANET Onco Dose.
PLANET Onco Dose 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, PLANET Onco Dose is substantially equivalent to and is at least as safe and effective as the predicate device.
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