LINACwatch, LinacView

K172534 · Qualiformed Sarl · IYE · Oct 27, 2017 · Radiology

Device Facts

• Record ID: K172534
• Device Name: LINACwatch, LinacView
• Applicant: Qualiformed Sarl
• Product Code: IYE · Radiology
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Standalone software analyzing linear accelerator (LINAC) performance via machine-generated log files; supports Step and Shoot, Sliding Window, and VMAT IMRT techniques. Inputs: log files from Varian/Elekta LINACs; compares against DICOM RT Plan or initial log files. Outputs: real-time alerts (via email) for non-compliant parameters (MLC leaf/carriage/jaw positions, MU delivery, gantry/collimator angles, beam statistics, reconstructed integrated fluence); generates PDF reports and composite RT Plans for TPS import. Used in clinical radiation oncology settings by physicists/therapists. Benefits: enables automated, real-time monitoring of machine delivery performance to ensure treatment quality and workflow efficiency.

Clinical Evidence

Bench testing only. Software verification and validation conducted per IEC 62304 and FDA guidance. Results confirm compliance with predetermined specifications and performance requirements.

Technological Characteristics

Standalone software; processes Varian and Elekta LINAC log files. Features include real-time analysis, automated batch processing, and email alert system. Supports IMRT/VMAT techniques. Software development follows IEC 62304 standards. No hardware components.

Indications for Use

Indicated for use by trained radiation oncology personnel to analyze linear accelerator performance for each radiation therapy fraction using machine-generated log files to identify potential delivery issues.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Mobius Medical Systems Mobius3D (K140660)
• Sun Nuclear Corporation Model 1215 PerFRACTION (K141800)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

"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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{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<br>14 rue de la Vieille Horloge<br>85000 La Roche Sur Yon, France | | |
| Submitter Contact: | Mr. Stéphane Beaumont<br>Technical Director<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Application<br>Correspondent: | Thomas Kroenke<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 | | |
| Manufacturing Site: | QualiFormeD Sarl<br>14 rue de la Vieille Horloge<br>85000 La Roche Sur Yon, France | | |
| Trade Name: | QualiFormeD LINACWATCH / LINACVIEW | | |
| Classification Name: | Accelerator, Linear, Medical | | |
| Classification<br>Regulation: | 21 CFR §892.5050 | | |
| Product Code: | IYE | | |
| Substantially<br>Equivalent Devices: | New<br>QualiFormeD<br>Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | QualiFormeD<br>LINACWATCH /<br>LINACVIEW | K140660<br>K141800 | Mobius Medical Systems Mobius3D<br>Sun Nuclear Corporation Model 1215<br>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<br>Systems Mobius3D<br>plus FX<br>(K140660) | Sun Nuclear<br>PerFraction<br>(K141800) | QualiFormeD<br>LINACWATCH /<br>LINACVIEW |
|-------------------------------------|------------------------------------------------------------|-----------------------------------------|------------------------------------------|
| Desktop software | Mobius3D:<br>Yes<br>MobiusFX:<br>No | No | Yes |
| IMRT/VMAT<br>Analysis | Mobius3D:<br>Yes<br>MobiusFX:<br>Yes | Yes | Yes |
| Logfile-based<br>analysis | Mobius3D:<br>Yes<br>MobiusFX:<br>Yes | No | Yes |
| All fractions<br>analyzed | Mobius3D:<br>No<br>MobiusFX:<br>No | Yes | Yes |
| Analysis in real-<br>time | Mobius3D:<br>No<br>MobiusFX:<br>No | No | Yes |
| Automatic process | Mobius3D:<br>Yes<br>MobiusFX:<br>No | Yes | Yes |
| Dashboard results<br>for therapists | Mobius3D:<br>No<br>MobiusFX:<br>No | No | Yes |
| Dashboard results<br>for physicists | Mobius3D:<br>Yes<br>MobiusFX:<br>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.