(33 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard EMR and workflow management functionalities.
No
The device is an oncology information system used to manage workflows for treatment planning and delivery, not directly administering therapy.
No.
Explanation: The Intended Use/Indications for Use section explicitly states, "MOSAIQ® is not intended for use in diagnosis."
No
The device description explicitly states it is an "image-enabled electronic medical record system" and mentions importing, viewing, and managing images, as well as interacting with radiotherapy treatment machines. This indicates it includes or interacts with hardware components beyond just software.
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 MOSAIQ is an "oncology information system used to manage workflows for treatment planning and delivery." It focuses on managing patient information, treatment plans, prescriptions, and machine settings. It explicitly states, "MOSAIQ® is not intended for use in diagnosis."
- Device Description: The description reinforces its function as an "image-enabled electronic medical record system" for managing clinical and administrative workflows in oncology. It details features related to charting, medication management, image handling, and treatment delivery support.
- Lack of Diagnostic Function: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. MOSAIQ does not perform any such analysis of biological specimens. Its function is centered around managing and facilitating the treatment process based on existing diagnostic information and treatment plans.
Therefore, MOSAIQ falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
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 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.
Product codes
IYE
Device Description
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
Intended User / Care Setting
healthcare facility 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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
-
- Product Information:
- a. Product Trade Name
- b. Release Version Number
-
- 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 |
| 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
features | Predicate
Device
MOSAIQ
(K141572) | Reference Device
The ViewRay (MRIdian)
Linac System
(K162393) | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------|-----|-----|-----|----------------------------------------------------|-----|-----|-----|-----------------------------------------------------------------------------------------|-----|-----|----|
| Intended Use Comparison | | | | | | | | | | | | | | | |
| Ability to define leaf plans for use with radiotherapy treatment machines
equipped with multileaf collimator | Yes | Yes | Yes | | | | | | | | | | | | |
| Ability to import, view, annotate, manipulate, enhance, manage and
archive images | Yes | Yes | Yes | | | | | | | | | | | | |
| Allows users to create, view, and edit geometric information associated
with treatment field definitions, including the MLC accessory. | Yes | Yes | Yes | | | | | | | | | | | | |
| Checks radiation treatment plans against treatment machine constraints,
provides the capability to notify clinicians of actions that need to take place
prior to treatment, displays reference images for setup purposes, and
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
system | | | | | | | | | | | | |
| Integrated electronic patient charting functionality | Yes | Yes | N/A - not a standalone
charting system | | | | | | | | | | | | |
| Administrative functions for practice management (e.g., scheduling, billing) | Yes | Yes | No | | | | | | | | | | | | |
| Medical oncology management including care plans, calculation of
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
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
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 | |||
| stream of MR images during treatment, refreshing multiple times per | |||
| second. | Yes | No | Yes |
| Motion management within the MR-Linac environment includes automatic | |||
| gating in response to patient motion | No | No | Yes |
| Integrated software & treatment delivery hardware: | |||
| Radiation software for image guidance and linear accelerator to deliver | |||
| radiation therapy | MOSAIQ is a | ||
| separate, | |||
| standalone software | |||
| device, with image | |||
| guidance function | |||
| designed for use | |||
| with the MR Linac | |||
| and tested | |||
| accordingly. | N/A | K162393 addresses both | |
| treatment hardware and | |||
| 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 |