(66 days)
No
The description focuses on rule-based analysis of log files and does not mention AI or ML techniques.
No.
This device is software that monitors the performance of a radiation therapy machine. It does not directly treat or diagnose patients.
Yes
This device is a diagnostic device because it analyzes radiation therapy machine performance using log files to alert personnel to potential machine delivery issues that can affect treatment quality, which is a form of diagnosis for the machine's function.
Yes
The device is explicitly described as "stand-alone software" and a "standalone software product" that analyzes log files from existing hardware (linear accelerators). The description focuses solely on the software's functionality and analysis capabilities, with no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software analyzes radiation therapy machine performance using log files. It is used to alert trained personnel to potential machine delivery issues. This is related to the performance of a medical device (linear accelerator) and not to the examination of specimens derived from the human body.
- Device Description: The description details the analysis of log files from linear accelerators, focusing on parameters related to the machine's operation during radiation treatment. It does not mention analyzing biological samples or providing diagnostic information about a patient's health status.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological specimens
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological specimens.
The software's function is to monitor and assess the performance of a radiation therapy machine, which is a medical device used in treatment. This falls under the category of quality assurance or performance monitoring for a therapeutic device, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.
QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.
Product codes
IYE
Device Description
QualiFormeD LINACWATCH / LINACVIEW is a standalone software product analyzes logfiles generated by Varian and Elekta linear accelerators during radiation treatments. Logfile analysis can be with respect to the "prescription" DICOM radiotherapy (RT) Plan or with respect to the first logfile in a series of logfiles for each treatment and each beam. Initial logfiles that may be created for pre-treatment intensity-modulated radiation therapy (IMRT) quality assurance (QA) can be excluded from treatment session analysis.
The preferred method of running QualiFormeD LINACWATCH / LINACVIEW is in "batch" mode. In this mode, QualiFormeD LINACWATCH / LINACVIEW automatically processes logfiles and analyzes them, sending emails to designated staff for non-compliant results over an internet connection.
QualiFormeD LINACWATCH / LINACVIEW allows the user to verify for every treatment, in real time, with email notifications on alert or failure, the following parameters:
- The position of each moving multi-leaf collimator (MLC) leaf; ●
- The position of MLC carriages and jaws;
- The percentage of monitor units (MUs) delivered; ●
- The gantry rotation angle; ●
- The collimator rotation angle;
- The beam on/off statistics; and
- . The reconstructed integrated fluence.
Additionally, after any number of treatments has been analyzed, QualiFormeD LINACWATCH / LINACVIEW allows the user to create RT Plans that can simulate the composite behavior of the analyzed logfiles. These RT Plans can be imported into the treatment planning system (TPS) to compare intended doses with those actually delivered, although this estimated dose does not include dosimetric changes due to patient setup or geometric changes. Adobe Acrobat® PDF reports documenting machine performance can be created at any point during treatment.
At the end of a course of treatment when the treatment series is closed, a composite RT Plan is automatically created that summarizes the composite behavior of all analyzed logfiles as well as two (2) final reports, a short and a comprehensive report, that documents all aspects of the treatment course.
Step and Shoot, Sliding Window, and Volumetric Modulated Arc Therapy (VMAT) IMRT techniques are supported.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained radiation oncology personnel
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
Software QualiFormeD LINACWATCH / LINACVIEW contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with • FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; • FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99: • FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; • FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14; and · IEC 62304: 2006, Medical device software - Software life cycle processes. Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications and the applicable standard. Performance Testing QualiFormeD LINACWATCH / LINACVIEW was tested in accordance – Bench with internal specifications: Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of QualiFormeD LINACWATCH / LINACVIEW. The results of these activities demonstrate that QualiFormeD LINACWATCH / LINACVIEW is as safe, as effective, and performs as well as or better than the predicate device. Therefore, QualiFormeD LINACWATCH / LINACVIEW is considered substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 27, 2017
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
QualiFormeD Sarl % Mr. Thomas Kroenke Principal Consultant Speek To Market. Inc. PO Box 3018 NEDERLAND CO 80466
Re: K172534
Trade/Device Name: QualiFormeD Sarl LINACwatch/LinacView Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 21, 2017 Received: August 22, 2017
Dear Mr. Kroenke:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Robert Ochs
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172534
Device Name
QualiFormeD Sarl LINACwatch/LinacView
Indications for Use (Describe)
QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.
QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
5 510(k) Summary
4
510(k) Summary provided in accordance with 21 CFR §807.92(C)
| Submission Date: | 21 August 2017 | ||
|---|---|---|---|
| Submitter: | QualiFormeD Sarl | ||
| 14 rue de la Vieille Horloge | |||
| 85000 La Roche Sur Yon, France | |||
| Submitter Contact: | Mr. Stéphane Beaumont | ||
| Technical Director | |||
| Phone: +011 33 9 77 00 91 29 | |||
| Fax: +011 33 2 51 24 85 79 | |||
| Email: stephane.beaumont@qualiformed.com | |||
| Application | |||
| Correspondent: | Thomas Kroenke | ||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | QualiFormeD Sarl | ||
| 14 rue de la Vieille Horloge | |||
| 85000 La Roche Sur Yon, France | |||
| Trade Name: | QualiFormeD LINACWATCH / LINACVIEW | ||
| Classification Name: | Accelerator, Linear, Medical | ||
| Classification | |||
| Regulation: | 21 CFR §892.5050 | ||
| Product Code: | IYE | ||
| Substantially | |||
| Equivalent Devices: | New | ||
| QualiFormeD | |||
| Model | Predicate | ||
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| QualiFormeD | |||
| LINACWATCH / | |||
| LINACVIEW | K140660 | ||
| K141800 | Mobius Medical Systems Mobius3D | ||
| Sun Nuclear Corporation Model 1215 | |||
| PerFRACTION |
5
510(k) Summary provided in accordance with 21 CFR §807.92(C)
Device Description: QualiFormeD LINACWATCH / LINACVIEW is a standalone software product analyzes logfiles generated by Varian and Elekta linear accelerators during radiation treatments. Logfile analysis can be with respect to the "prescription" DICOM radiotherapy (RT) Plan or with respect to the first logfile in a series of logfiles for each treatment and each beam. Initial logfiles that may be created for pre-treatment intensity-modulated radiation therapy (IMRT) quality assurance (QA) can be excluded from treatment session analysis.
The preferred method of running QualiFormeD LINACWATCH / LINACVIEW is in "batch" mode. In this mode, QualiFormeD LINACWATCH / LINACVIEW automatically processes logfiles and analyzes them, sending emails to designated staff for non-compliant results over an internet connection.
QualiFormeD LINACWATCH / LINACVIEW allows the user to verify for every treatment, in real time, with email notifications on alert or failure, the following parameters:
- The position of each moving multi-leaf collimator (MLC) leaf; ●
- The position of MLC carriages and jaws;
- The percentage of monitor units (MUs) delivered; ●
- The gantry rotation angle; ●
- The collimator rotation angle;
- The beam on/off statistics; and
- . The reconstructed integrated fluence.
Additionally, after any number of treatments has been analyzed, QualiFormeD LINACWATCH / LINACVIEW allows the user to create RT Plans that can simulate the composite behavior of the analyzed logfiles. These RT Plans can be imported into the treatment planning system (TPS) to compare intended doses with those actually delivered, although this estimated dose does not include dosimetric changes due to patient setup or geometric changes. Adobe Acrobat® PDF reports documenting machine performance can be created at any point during treatment.
At the end of a course of treatment when the treatment series is closed, a composite RT Plan is automatically created that summarizes the composite behavior of all analyzed logfiles as well as two (2) final reports, a short and a comprehensive report, that documents all aspects of the treatment course.
Step and Shoot, Sliding Window, and Volumetric Modulated Arc Therapy (VMAT) IMRT techniques are supported.
6
510(k) Summary provided in accordance with 21 CFR §807.92(C)
Intended Use: QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine. It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.
QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.
Technology QualiFormeD LINACWATCH / LINACVIEW employs the same Comparison: technological characteristics as the predicate device.
| Characteristic | Mobius Medical
Systems Mobius3D
plus FX
(K140660) | Sun Nuclear
PerFraction
(K141800) | QualiFormeD
LINACWATCH /
LINACVIEW |
|-------------------------------------|------------------------------------------------------------|-----------------------------------------|------------------------------------------|
| Desktop software | Mobius3D:
Yes
MobiusFX:
No | No | Yes |
| IMRT/VMAT
Analysis | Mobius3D:
Yes
MobiusFX:
Yes | Yes | Yes |
| Logfile-based
analysis | Mobius3D:
Yes
MobiusFX:
Yes | No | Yes |
| All fractions
analyzed | Mobius3D:
No
MobiusFX:
No | Yes | Yes |
| Analysis in real-
time | Mobius3D:
No
MobiusFX:
No | No | Yes |
| Automatic process | Mobius3D:
Yes
MobiusFX:
No | Yes | Yes |
| Dashboard results
for therapists | Mobius3D:
No
MobiusFX:
No | No | Yes |
| Dashboard results
for physicists | Mobius3D:
Yes
MobiusFX:
Yes | Yes | Yes |
7
510(k) Summary provided in accordance with 21 CFR §807.92(C)
Summary of Performance Testing:
Software QualiFormeD LINACWATCH / LINACVIEW contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with • FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; • FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99: • FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; • FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14; and · IEC 62304: 2006, Medical device software - Software life cycle processes. Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications and the applicable standard. Performance Testing QualiFormeD LINACWATCH / LINACVIEW was tested in accordance – Bench with internal specifications: Test results indicated that QualiFormeD LINACWATCH / LINACVIEW complies with predetermined specifications. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of QualiFormeD LINACWATCH / LINACVIEW. The results of these activities demonstrate that QualiFormeD LINACWATCH / LINACVIEW is as safe, as effective, and performs as well as or better than the predicate device. Therefore, QualiFormeD LINACWATCH / LINACVIEW is considered substantially equivalent to the predicate device.