MOSAIQ ONCOLOGY INFORMATION SYSTEM

K123230 · Impac Medical Systems, Inc. · IYE · Dec 12, 2012 · Radiology

Device Facts

• Record ID: K123230
• Device Name: MOSAIQ ONCOLOGY INFORMATION SYSTEM
• Applicant: Impac Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 12, 2012
• 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 and/or chemotherapy 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 through the 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. MOSAIO® 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. . 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 integrated software suite for oncology facilities; manages electronic patient charts, treatment plans, and billing. Inputs include patient data, diagnostic test orders, medication prescriptions, and radiation treatment plan parameters; interfaces with linear accelerators to read machine settings. System compares planned values against actual machine settings; alerts users to mismatches. Includes 'Evaluate' module for calculating and displaying dose volume histograms (DVHs). Used by clinicians in oncology departments to support treatment planning, verify setup, and record delivered radiation. Benefits include streamlined information flow, improved treatment plan verification, and automated tracking of radiation delivery. Does not directly control radiation delivery; functions as a record-and-verify system.

Clinical Evidence

No clinical trials performed. Bench testing conducted using simulated clinical workflows and actual patient data to verify system requirements and risk mitigations. Over 100 test procedures executed, including exploratory, functional, and regression testing. System deemed fit for clinical use based on successful verification results.

Technological Characteristics

Integrated software suite; operates as a record-and-verify system interfacing with linear accelerators. Features include image management, MLC leaf plan design, and DVH calculation. Software-based; major level of concern due to interface with radiation delivery systems. Connectivity via machine communication interface for setting verification.

Indications for Use

Indicated for oncology workflow management in radiotherapy and chemotherapy settings. Medical oncology dose calculation functions are indicated for patients 18 years or older. Not intended 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 (K120067)
• Mobile MIM (K112930)

Submission Summary (Full Text)

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KI 23230

DEC 1 2 2012

October 12, 2012

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

## INTRODUCTION

This document summarizes the safety and effectiveness information contained within the MOSAIQ Oncology Information System 510(k). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution.

#### PREMARKET NOTIFICATION INFORMATION

| 1. | Product Information: | | |
|----|-----------------------------|-------------------------------|------------------------------------------------------|
| | a. | Product Trade Name | MOSAIQ |
| | b. | Release Version Number | Release 2.50 |
| 2. | Classification Information: | | |
| | a. | Classification Name<br>system | Medical charged-particle radiation therapy |
| | b. | Common/Usual Name | Oncology Information System |
| | c. | Product Classification | Class II |
| | d. | Product Code | IYE |
| | e. | Reference | 21 CFR 892.5050 |
| | f. | Review Panel | Radiology |
| 3. | Establishment Information: | | |
| | a. | Submitter | IMPAC Medical Systems, Inc. |
| | b. | Submitter Address | 100 Mathilda Place, 5th Floor<br>Sunnyvale, CA 94086 |
| | c. | Establishment Number | 2950347 |
| | d. | Contact | Kathryn Stinson, RA Specialist |
| | e. | Contact Phone | 314-993-0003 |
| | f. | Contact Fax | 314-993-0075 |

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#### PREDICATE DEVICE INFORMATION

The MOSAIQ Oncology Information System is substantially equivalent to the following devices that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. MOSAIQ is substantially equivalent to these products in intended use and safety and effectiveness.

- 1. MOSAIQ Oncology Information System IMPAC Medical Systems, Inc. K120067
- 2. Mobile MIM MIM Software Inc. K112930

#### 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 and/or chemotherapy 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 through the 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. MOSAIO® 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. .

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

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#### DESCRIPTION OF THE PRODUCT

MOSAIQ is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for medical and radiation oncology facilities. For both medical and radiation oncology users, MOSAIQ provides image-enabled electronic patient charting and record management as well as medical transcription and billing functionality. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery.

This Premarket Notification addresses the addition of the "Evaluate" module, which calculates and displays dose volume histograms (DVHs) for the purpose of review and evaluation of radiation treatment plans.

#### LEVEL OF CONCERN

The FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005, Table 1, item 4b states, "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 verify function within MOSAIO does not directly control the machine that delivers the radiation. However, it does interface with the linear accelerator and is responsible for detecting potential mismatches between planned and actual machine settings and alerting the user. Thus, it is a major level of concern function.

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#### SUMMARY OF CLINICAL TESTING

Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Bench testing was performed, as described in Section 16.8, using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data. The product was deemed fit for clinical use.

#### SUMMARY OF NON-CLINICAL TESTING

Verification tests were written and executed to ensure that the system is working as designed. Over 100 test procedures were executed, including exploratory tests, tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Pass/fail criteria for this testing effort was equivalent to past testing efforts for the previous versions of MOSAIQ. MOSAIQ passed testing and was deemed safe and effective for its intended use.

5-4

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized wing shapes.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 12, 2012

IMPAC Medical Systems, Inc. C/O Ms. Kathryn Stinson Regulatory Affairs Specialist 100 Mathilda Place, 5th Floor SUNNYVALE, CA 94086

Re: K123230

Trade/Device Name: MOSAIQ Oncology Informaiton System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 12, 2012 Received: November 6, 2012

Dear Ms. Stinson:

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 (reporting of medical device-related adverse evénts) (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

# Janine MAMorris -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K123230

#### Device Name: MOSAIQ Oncology Information System

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 and/or chemotherapy 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 through the 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. .

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

| Prescription Use | X |
|----------------------|---|
| AND/OR | |
| Over-The-Counter Use | |

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.11 14:38:44 -05'00' /

> (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

#### K123230 510(k)

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