MOSAIQ Oncology Information System

K183034 · Elekta, Inc. · IYE · Dec 4, 2018 · Radiology

Device Facts

• Record ID: K183034
• Device Name: MOSAIQ Oncology Information System
• Applicant: Elekta, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: - Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. - Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. - Import, view, annotate, adjust, enhance, manage and archive images. - Compare radiation treatment plans and evaluate dose coverage. - Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators. - Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. - View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions. - Record actual delivered radiation values in an electronic chart to track treatment. - Use stereotactic localization to calculate set-up coordinates for treatments. - Observation of Intrafractional motion with real time image overlay. MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

Device Story

MOSAIQ is an image-enabled electronic medical record (EMR) system for oncology departments; manages clinical/administrative workflows. Inputs: patient data, treatment plans (DICOM/DICOM RT), medication orders, and real-time machine settings/images. Operation: system compares imported treatment plans against actual machine settings; alerts users to mismatches; supports stereotactic localization and intrafractional motion observation via real-time image overlay. Output: electronic patient charts, treatment setup instructions, and recorded delivered radiation values. Used in clinics/hospitals by physicians, nurses, and technicians. Benefits: ensures treatment plan adherence, streamlines clinical documentation, and facilitates safe radiation delivery by preventing machine-plan mismatches.

Clinical Evidence

No clinical trials performed. Evidence based on non-clinical verification and validation testing. System passed simulated clinical workflow testing and regression testing to ensure safety and functionality as designed.

Technological Characteristics

Standalone software system running on Windows OS. Features DICOM/DICOM RT connectivity, electronic charting, CPOE, and machine communication interfaces. Implements rule-based verification of treatment parameters against machine constraints. Security features for HIPAA compliance. No hardware components; software-only device.

Indications for Use

Indicated for oncology workflow management, treatment planning, and delivery support in patients 18+ (medical oncology dose calculations). Contraindicated for diagnostic use.

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

• MOSAIQ Oncology Information System (K141572)

Reference Devices

• ViewRay (MRIdian) Linac System (K162393)

Submission Summary (Full Text)

{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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

December 4, 2018

Elekta, Inc % Ms. Faiza Ahmed Regulatory Affairs Specialist 100 Mathilda Place 5th Floor SUNNYVALE CA 94086 US

Re: K183034

Trade/Device Name: MOSAIQ Oncology Information System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: October 30, 2018 Received: November 1, 2018

Dear Ms. Ahmed:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. 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) K183034

#### Device Name MOSAIQ Oncology Information System

#### Indications for Use (Describe)

MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy are prescribed.

Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:

- · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
- · Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.
- · Import, view, annotate, adjust, enhance, manage and archive images.
- · Compare radiation treatment plans and evaluate dose coverage.
- · Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators.
- · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine

constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.

- · View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions.
- · Record actual delivered radiation values in an electronic chart to track treatment.
- · Use stereotactic localization to calculate set-up coordinates for treatments.
- · Observation of Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

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.

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."

{3}------------------------------------------------

October 30, 2018

# MOSAIQ Oncology Information System Premarket Notification (510(k)) Summary of Safety and Effectiveness

## INTRODUCTION

This document summarizes the safety and effectiveness information within the MOSAIQ Oncology Information System 510(k). The Summary of Safety and Effectiveness contains of trade secret information and is intended for full public disclosure and distribution.

## PREMARKET NOTIFICATION INFORMATION

- 1. Product Information:
- a. Product Trade Name
- b. Release Version Number
- 2. Classification Information:
- a. Classification Name
- b. Common/Usual Name
- c. Product Classification
- d. Product Code
- e. Reference
- f. Review Panel

Medical charged-particle radiation therapy system Radiation Treatment Planning System Class II

- IYE
MOSAIQ

Release 2.65

- 21 CFR 892.5050
- Radiology

{4}------------------------------------------------

#### Establishment Information: 3.

| a. | Submitter | Elekta, Inc. |
|----|----------------------|----------------------------------------------------|
| b. | Submitter Address | 100 Mathilda Place 5th Floor<br>Sunnyvale CA 94086 |
| c. | Establishment Number | 2950347 |
| d. | Contact | Faiza Ahmed, RA Specialist |
| e. | Contact Phone | 408-830-8920 |
| f. | Contact Fax | 208-830-8003 |
| g. | Contact | Faiza Ahmed, RA Specialist |
| h. | Contact Phone | 408-830-8920 |
| i. | Contact Fax | 408-830-8003 |

## PREDICATE DEVICE INFORMATION

The MOSAIQ Oncology Informaiton System is substantially equivalent to the Food and Drug Administration (FDA) has cleared for distribution and is currently being actively marketed in the United States. MOSAIQ is substantially equivalers in intended use and safety and effectiveness.

MOSAIQ Oncology Information System IMPAC Medical Systems, Inc. K141572

## REFERENCE DEVICE INFORMATION

The MOSAIQ Oncology Information is using the following device to demonstrate intended use and technical similarities. The Food and Drug Administration (FDA) has cleared the reference device for distribution and is currently being actively marketed in the United States.

The ViewRay (MRIdian) Linac System ViewRay Incorporated

MOSAIQ Oncology Information Systems 510(k), Elekta, Inc ©2018— All Rights Reserved

{5}------------------------------------------------

### K162393

## MOSAIQ INTENDED USE/INDICATIONS FOR USE

MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy are prescribed.

Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:

- Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
- Generate and keep medication formulary lists and calculate medication dosages for medical oncology. ●
- Import, view, annotate, adjust, enhance, manage and archive images,
- Compare radiation treatment plans and evaluate dose coverage. ●
- Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators. ●
- Make sure radiation treatment planning systems agree with treatment machine constraints. MOSAIQ® ● reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the actual machine settings, the system warns the user.
- . View reference images to setup treatment. MOSAQ® refers to predelined settings to help treatment machine setup, and communicates patient and machine setup instructions.
- Record actual delivered radiation values in an electronic chart to track treatment. ●
- Use stereotactic localization to calculate set-up coordinates for treatments. ●
- Observation of Intrafractional motion with real time image overlay. ●

MOSAQ® is not intended for use in diagnosis dose calculation functions are designed for use with patients 18 years or older only.

## OVERVIEW OF MOSAIQ

The MOSAIQ Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilities efficient patient care. It can be configured for Medical Oncology, or both.

{6}------------------------------------------------

The Medical Oncology (MO) configuration is a medical oncology charting solution that includes customizable regimens (Care Plans) that automate chemotherapy orders for labs, procedures, and appointment views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and druglallergy interactions. MOSAIQ also performs standard calculations such as Body Sufface Area Under the Curve (AUC). The Medical Administration Record (MAR) supports all information related to chemotherapy and blood product administration, clinical trial study drugs, dose amounts, infusion time, multiple sites of administration, etc. MOSAQ's Medical Oncology functions are . It is labeled accordingly and calculates all doses accordingly.

The Radiation Oncology configuration is also a charting solution with computerized physician order entry (CPOE) capability, along with added features for image management, patient setup and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAQ's Radiation Can be used to support a wide variety of treatment modalities including INRT. IGRT, particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from TPS systems via DICOM import DICOM RT import.

# LEVEL OF CONCERN

ltem 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Software Contained in Medical Devices asks, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems... " The record and vithin MOSAQ does not directly control the machine that delivers the radiation. However, it does interface with the linear accelerator and is responsible for detecting potential mismatchine settings and alerting the user. A failure in MOSAIQ can result, thus, we believe it is a major level of concern.

# SUMMARY OF CLINICAL TESTING

Clinical trials were not performed as part of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effective can be performed such that no human subjects are exposed to risk. Validation testing involved simulated clinical workflows, described in section 16.8. The product was deemed fit for clinical use.

# SUMMARY OF NON-CLINICAL TESTING

Ventification tests were written and executed to ensure that the system is working as designed use executed, including tests to verify requirements for new product functionality, tests to ensure that instion as intended, and regression tests to ensure continued safety and existing functionality. MOSAQ passed testing and was deemed safe and effective for its intended use.

{7}------------------------------------------------

{8}------------------------------------------------

| Substantial Equivalence to Legally Marketed Products | MOSAIQ with new<br>features | Predicate<br>Device<br>MOSAIQ<br>(K141572) | Reference Device<br>The ViewRay (MRIdian)<br>Linac System<br>(K162393) | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------|-----|-----|-----|----------------------------------------------------|-----|-----|-----|-----------------------------------------------------------------------------------------|-----|-----|----|
| Intended Use Comparison | | | | | | | | | | | | | | | |
| Ability to define leaf plans for use with radiotherapy treatment machines<br>equipped with multileaf collimator | Yes | Yes | Yes | | | | | | | | | | | | |
| Ability to import, view, annotate, manipulate, enhance, manage and<br>archive images | Yes | Yes | Yes | | | | | | | | | | | | |
| Allows users to create, view, and edit geometric information associated<br>with treatment field definitions, including the MLC accessory. | Yes | Yes | Yes | | | | | | | | | | | | |
| Checks radiation treatment plans against treatment machine constraints,<br>provides the capability to notify clinicians of actions that need to take place<br>prior to treatment, displays reference images for setup purposes, and<br>facilitates treatment machine setup according to predefined settings. | Yes | Yes | Yes | | | | | | | | | | | | |
| Verification against imported radiation treatment plans | Yes | Yes | Yes | | | | | | | | | | | | |
| Recording of actual delivered treatment values | Yes | Yes | Yes | | | | | | | | | | | | |
| Record-only interfaces for appropriate treatment machines | Yes | Yes | N/A - not a standalone V&R<br>system | | | | | | | | | | | | |
| Integrated electronic patient charting functionality | Yes | Yes | N/A - not a standalone<br>charting system | | | | | | | | | | | | |
| Administrative functions for practice management (e.g., scheduling, billing) | Yes | Yes | No | | | | | | | | | | | | |
| Medical oncology management including care plans, calculation of<br>medication dosage & dose delivery tracking | Yes | Yes | No | | | | | | | | | | | | |
| Dose Volume Histogram (DVH) Statistics creation and display | Yes | Yes | Yes | | | | | | | | | | | | |
| Intrafractional motion with real time image overlay | Yes | No | Yes | | | | | | | | | | | | |
| Technological Characteristics Comparison | | | | Comparison of multiple radiation treatment plans | Yes | Yes | Yes | Radiation treatment plan summation and subtraction | Yes | Yes | Yes | Includes ability to evaluate brachytherapy & external beam radiation<br>treatment plans | Yes | Yes | No |
| Technological Characteristics Comparison | | | | | | | | | | | | | | | |
| Comparison of multiple radiation treatment plans | Yes | Yes | Yes | | | | | | | | | | | | |
| Radiation treatment plan summation and subtraction | Yes | Yes | Yes | | | | | | | | | | | | |
| Includes ability to evaluate brachytherapy & external beam radiation<br>treatment plans | Yes | Yes | No | | | | | | | | | | | | |

MOSAIQ Oncology Information Systems 510(k), Elekta, Inc
©2018— All Rights Reserved

{9}------------------------------------------------

| Isodose & beam display | Yes | Yes | Yes |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------------------------------------------------------------|
| Supports frame-based stereotactic localization | Yes | Yes | No |
| Contouring, optimization and dose calculation. | No | No | Yes |
| Support for IMRT | Yes | Yes | Yes |
| Support for IGRT | Yes | Yes | Yes |
| Support for adaptive therapy | Yes | No | Yes |
| Patient positioning using volumetric images | Yes | Yes | Yes |
| Motion management within the MR-Linac environment includes continuous<br>stream of MR images during treatment, refreshing multiple times per<br>second. | Yes | No | Yes |
| Motion management within the MR-Linac environment includes automatic<br>gating in response to patient motion | No | No | Yes |
| Integrated software & treatment delivery hardware:<br>Radiation software for image guidance and linear accelerator to deliver<br>radiation therapy | MOSAIQ is a<br>separate,<br>standalone software<br>device, with image<br>guidance function<br>designed for use<br>with the MR Linac<br>and tested<br>accordingly. | N/A | K162393 addresses both<br>treatment hardware and<br>software. |
| Security features to enable customer HIPAA compliance | Yes | Yes | Yes |
| DICOM connectivity with compatible systems | Yes | Yes | Yes |
| Software runs on Windows operating system | Yes | Yes | Yes |