(56 days)
Not Found
No
The description focuses on traditional image processing, dose conversion models, prediction models, and gamma-index analysis, without mentioning AI or ML techniques. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
Explanation: This device is a Quality Assurance (QA) tool used to verify that radiation dose delivered to the patient is as intended. It does not directly treat or diagnose a medical condition; instead, it assists in reducing clinical risk by detecting errors in radiation therapy delivery prior to treatment. Therefore, it is not a therapeutic device.
No.
The device is described as a Quality Assurance (QA) device and a pre-treatment verification tool to detect errors in the delivery of radiation therapy, not to diagnose a medical condition in a patient.
Yes
The device is explicitly described as a "software framework" and a "modular software suite" that processes data acquired from an existing hardware device (EPID) but does not include or modify the hardware itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ThinkQA's Intended Use: ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device. Its purpose is to verify that the radiation dose delivered to a patient during cancer treatment is as intended. It does this by analyzing data from an Electronic Portal Imaging Device (EPID) during a test irradiation without the patient present.
- No Human Specimens: The device does not collect, prepare, or examine any specimens taken from the human body. It works with data acquired from a medical device (EPID) during a simulated treatment delivery.
- Focus on Equipment Performance: The primary function is to detect errors in the delivery of radiation therapy, such as issues with the linear accelerator or the transfer of plan data. It's a quality control tool for the treatment equipment and process, not a diagnostic tool for a patient's condition.
Therefore, ThinkQA falls under the category of a medical device used in the delivery of radiation therapy, specifically for quality assurance purposes, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended.
The Epibeam module contained in ThinkQA is intended to be used as follows:
Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
Epibeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
Epibeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
Epibeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
ThinkQA is a modular software suite composed of the module Epibeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams.
The EPIbeam verification module integrated to the ThinkOA software platform is a Quality Assurance tool in external beam radiation therapy, used in combination with the electronic portal imaging device (EPID) and dedicated to the irradiation beam pre-treatment verifications, particularly for IMRT and VMAT techniques.
EPIbeam principle is based on the comparison of two images expressed in terms of absolute dose: on the one hand, a RT Plan defined in the TPS is used for the acquisition of a real portal image (test image) with the EPID directly irradiated (without attenuating medium); on the same RT Plan is used to compute a theoretical portal image (reference image). Specific models and algorithms are applied to express both images in the same absolute dose terms.
The dose images obtained from the same RT Plan, one by the conversion model of the acquired raw EPID images and the other by the prediction model, can be quantitatively compared through dose difference mappings or 2D gamma-index. Both models are based on dosimetric data provided from the TPS.
Mentions image processing
The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
EPIbeam principle is based on the comparison of two images expressed in terms of absolute dose: on the one hand, a RT Plan defined in the TPS is used for the acquisition of a real portal image (test image) with the EPID directly irradiated (without attenuating medium); on the same RT Plan is used to compute a theoretical portal image (reference image). Specific models and algorithms are applied to express both images in the same absolute dose terms.
The dose images obtained from the same RT Plan, one by the conversion model of the acquired raw EPID images and the other by the prediction model, can be quantitatively compared through dose difference mappings or 2D gamma-index. Both models are based on dosimetric data provided from the TPS.
Ability to view test and reference images
Ability to view superimposed test/reference dose profiles
Ability to view 2D gamma index distribution
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electronic Portal Imaging Device (EPID)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
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)
ThinkQA software was submitted to performance, functional and algorithmic testing.
The results of performance, functional and algorithmic testing demonstrate that ThinkOA meets the requirements of the device, which are demonstrated to be substantially equivalent to those of the predicate device.
ThinkQA software underwent unit, integration and system tests. All test cases were documented with the results showing that acceptance criteria were met.
Validation of the system under clinically representative conditions has been performed. Results from verification and validation testing demonstrate that conformance to applicable technical design specification has been met and that safety and effectiveness have been achieved.
Regression testing was also successfully performed.
All product requirements can be traced to the test results.
The conclusions of the verification and validation activities are that the safety, performances and benefit / risk ratio under normal conditions of use met device requirements.
The substantial equivalence discussion and the performance testing conclusions demonstrate that ThinkQA is substantially equivalent to and performs at least as safely and effectively as its 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.
0
March 13, 2018
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DOSIsoft S.A. % Mr. Luc DIOT Quality Director 45/47, avenue Carnot 94230 Cachan FRANCE
Re: K180106
Trade/Device Name: ThinkOA Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 29, 2017 Received: January 16, 2018
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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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
2
Indications for Use
510(k) Number (if known) K180106
Device Name ThinkQA
Indications for Use (Describe)
ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended.
The Epibeam module contained in ThinkQA is intended to be used as follows:
Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
Epibeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
Epibeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
Epibeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly logo, and the word "soft" in a thin, sans-serif font. The word "DOSI" is in black, and the word "soft" is in gray. The butterfly logo is blue with red arrows pointing towards it.
Image /page/4/Picture/1 description: The image is a blue circular seal that says "CERTIFIED" at the top and has the number "73485" at the bottom. The letters "iSO" are in the center of the seal in a sans-serif font. There are two red arrows on either side of the letters "iSO".
Premarket Notification 510(k) Summary
[as required bv 21 CFR 807.92]
510(k) Summary
1. Date the Summary was prepared: 2017-12-08
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: | ThinkQA |
|---|---|
| Trade Names: | ThinkQA, EPIbeam |
| Common Name: | Standalone software quality control system |
| Classification Name: | Medical charged-particle radiation therapy system |
| (Class II, 21 CFR 892.5050, Product Code IYF) |
4. Predicate Device:
K133572 - ARIA Radiation Therapy Management - "Enhanced Portal Dosimetry gamma evaluation" feature - Varian Medical Systems, Inc.
Executive Summary
5. Product Description:
ThinkQA is a modular software suite composed of the module Epibeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams.
The EPIbeam verification module integrated to the ThinkOA software platform is a Quality Assurance tool in external beam radiation therapy, used in combination with the electronic portal imaging device (EPID) and dedicated to the irradiation beam pre-treatment verifications, particularly for IMRT and VMAT techniques.
EPIbeam principle is based on the comparison of two images expressed in terms of absolute dose: on the one hand, a RT Plan defined in the TPS is used for the acquisition of a real portal image (test image) with the EPID directly irradiated (without attenuating medium); on the same RT Plan is used to compute a theoretical portal image (reference image). Specific models and algorithms are applied to express both images in the same absolute dose terms.
The dose images obtained from the same RT Plan, one by the conversion model of the acquired raw EPID images and the other by the prediction model, can be quantitatively compared through dose difference mappings or 2D gamma-index. Both models are based on dosimetric data provided from the TPS.
6. Intended Use and User profiles:
ThinkQA is a modular software suite composed of the module EPIbeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams.
The intended Use for the EPIbeam module contained in ThinkQA product is as follows:
EPIbeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
4230 Cachan - France
+33 (0)1 41 24 26 26
+33 (0)1 41 24 26 28
5
Image /page/5/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly outline, and then the word "soft" in a thin, sans-serif font. The butterfly is positioned between the two words, acting as a visual element that connects them. The overall design is clean and modern, with a focus on typography and a simple color palette.
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 arrows on either side of the letters "ISO". At the bottom of the logo is the number "73485" with a dot on either side of the number.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the presence of the patient and subsequently processed data is compared with data calculated by the EPIbeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
EPlbeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
EPIbeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
EPIbeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
7. Technological Characteristics Summary:
The detailed technological characteristics and the substantial equivalence discussion as included in the body of the 510(k) submission support the claim that ThinkQA and its EPIbeam module technological characteristics and indication for use are substantially equivalent to that of its predicate device ARIA Radiation Therapy Management – "Enhanced Portal Dosimetry gamma evaluation" feature – K133572.
The table below compares the device functionalities of ThinkOA / EPIbeam and Portal Dosimetry component of ARIA Radiation Therapy Management product (K133572).
| Functionality | Think QA
EPIbeam
DOSIsoft SA
(this submission) | Portal Dosimetry
Varian Medical Systems |
|---------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------|
| FDA Control Number | - | K133572 |
| CE Marked | Yes | Yes |
| Pretreatment check | Yes | Yes |
| Independent software | Yes | Only compatible with Varian
hardware and software |
| Pretreatment images | Yes | Yes |
| Algorithm for computing predicted reference
dose image | Yes | Yes (Eclipse TPS - PDIP) |
| Algorithm for converting acquired portal
image into dose image | Yes | Yes |
| Compares measured dose image to the
reference dose image according to gamma-
index analysis | Yes | Yes |
| Generates a report for the reviewer | Yes | Yes |
| Results include gamma agreement index
per beam | Yes | Yes |
| Results include significant statistic gamma
index values per beam | Yes | Yes |
| Ability to view test and reference images | Yes | Yes |
| Ability to view superimposed test/reference
dose profiles | Yes | Yes |
| Ability to view 2D gamma index distribution | Yes | Yes |
| Patient control database | Yes | Yes (ARIA database) |
| User defined Alert Criteria for out of
tolerance analysis | Yes | Yes |
4230 Cachan - France
- +33 (0)1 41 24 26 26 | +33 (0)1 41 24 26 28 |
info@dosisoft.com www.dosisoft.com
Page 2/3
6
Image /page/6/Picture/0 description: The image shows the word "DOSIsoft" with a butterfly image in between the two words. The word "DOSI" is in a bold, serif font, while the word "soft" is in a thinner, sans-serif font. The butterfly image is a simple outline of a butterfly, with a blue fill and a darker blue outline.
Image /page/6/Picture/1 description: The image is a blue and white circular logo that says "CERTIFIED ISO" in a circular pattern. The word "ISO" is in the center of the circle in a sans-serif font. There are two red arrows on either side of the word "ISO". The number "73485" is at the bottom of the circle.
| Import Approved Plan data from Treatment
| Planning System | Yes | Yes (ARIA database) |
|---|---|---|
| Import Portal Images from pretreatment | ||
| fraction | Yes | Yes |
| Analysis performed automatically offline | Yes | Yes |
| Multiple treatment techniques | Static, IMRT, VMAT | IMRT, VMAT (RapidARC) |
| EPID panel Calibration required for | ||
| commissioning | Yes | Yes |
| TPS results for dose data reference | Yes | Yes |
The substantial equivalence discussion sustains the claim that ThinkQA software and its EPIbeam module intended use, clinical, technical (principles of operation, functionalities and critical performances) and biological characteristics are the same as for the predicate device Portal Dosimetry component of ARIA Radiation Therapy Management product CE marked and legally marketed in the U.S. (K133572).
In summary, DOSIsoft therefore considers that, in its opinion, ThinkOA / EPIbeam is substantially equivalent and is as safe and effective as the predicate device.
8. Performance Testing - Bench:
ThinkQA software was submitted to performance, functional and algorithmic testing.
The results of performance, functional and algorithmic testing demonstrate that ThinkOA meets the requirements of the device, which are demonstrated to be substantially equivalent to those of the predicate device.
ThinkQA software underwent unit, integration and system tests. All test cases were documented with the results showing that acceptance criteria were met.
Validation of the system under clinically representative conditions has been performed. Results from verification and validation testing demonstrate that conformance to applicable technical design specification has been met and that safety and effectiveness have been achieved.
Regression testing was also successfully performed.
All product requirements can be traced to the test results.
Performance Testing Conclusions:
The conclusions of the verification and validation activities are that the safety, performances and benefit / risk ratio under normal conditions of use met device requirements.
The substantial equivalence discussion and the performance testing conclusions demonstrate that ThinkQA is substantially equivalent to and performs at least as safely and effectively as its predicate device.
+33 (0)1 41 24 26 26 | (0)1 41 24 26 28