(50 days)
No
The document describes a comprehensive electronic medical record system for oncology workflow management. While it handles images and performs complex tasks like treatment planning and verification, there is no mention of AI or ML technologies being used for any of its functions. The description focuses on standard software functionalities and comparisons to predefined values.
No.
MOSAIQ is primarily an electronic medical record system and workflow management tool for oncology, which supports administrative functions, treatment planning, and verification. While it is involved in the overall treatment process by ensuring correct settings and recording delivered values, it does not directly apply or provide therapy itself.
No
The "Intended Use / Indications for Use" section explicitly states, "MOSAIQ is not intended for use in diagnosis."
Yes
The device is described as a "multi-functional, integrated software suite" and explicitly states it "includes the ViewStation, MLC Fit and SEQUENCER software applications as well as other applications". While it interacts with hardware (treatment machines), the device itself is presented as a software product.
Based on the provided text, MOSAIQ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "MOSAIQ is not intended for use in diagnosis." IVD devices are specifically intended for use in the diagnosis of disease or other conditions.
- Focus on Workflow Management and Treatment: The description of MOSAIQ's functions centers around managing oncology workflows, creating care plans, ordering tests (but not performing them), prescribing medications, managing images for treatment planning and verification, and verifying and recording treatment delivery. These are all related to the management and execution of patient care, not the diagnostic process itself.
- No Mention of In Vitro Testing: The text does not describe any functionality related to testing biological samples (blood, urine, tissue, etc.) outside of the body, which is the core characteristic of in vitro diagnostics.
Therefore, while MOSAIQ is a medical device used in a healthcare setting, its intended use and functionality do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users:
- Supply electronic patient charts and assemble care plans, order diagnostic . tests, and prescribe medications.
- Import, view, annotate, manipulate, enhance, and archive images. .
- Import, keep, and export information related to patient treatments to ● monitor treatment progress from a central location. This includes orders, documents, lab information, and other related information from compatible programs.
- Generate and keep medication and formulary lists and calculate applicable . medication dosages for medical oncology.
- Design leaf plans for operation with radiotherapy treatment machines that . have multileaf collimators. Users can give, view and change geometric data related to treatment fields, including the MLC accessory.
- Ensure plans imported from treatment planning systems agree with . treatment machine constraints.
Additionally, MOSAIQ:
- . Supplies other administrative functionality necessary to operate medical and radiation oncology departments.
- . Shows reference images for setup purposes, refers to predefined settings to help treatment machine setup, and tells clinicians of necessary steps before treatment.
- Reads actual settings from the treatment machine through the machine's ● communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system inhibits treatment.
- . Verifies the actual treatment against radiation treatment plans. At applicable points during the treatment, it records the actual delivered values to provide treatment tracking.
MOSAIQ supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. 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 (comma separated list FDA assigned to the subject device)
IYE
Device Description
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.
Previously, three of the components within MOSAIQ were cleared through the 510(k) process individually. The ViewStation software (K011694) provides the ability to to import, view, annotate, manipulate, enhance, manage and archive medical images and includes patient positioning functionality. The MLC Fit software (K991133) allows users to define MLC leaf shapes for radiation treatment plans. The SEQUENCER software (K981313) connects to the treatment unit (e.g. linear accelerator) and compares its setup to the predefined treatment field in the treatment chart. SEOUENCER inhibits treatment if errors are detected, records actual treatment unit parameters, and allows this information to be stored and/or printed as part of the treatment record.
MOSAIQ includes the ViewStation, MLC Fit and SEQUENCER software applications as well as other applications that were not classified as medical devices when considered as individual products.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
Intended User / Care Setting
healthcare facility personnel, wherever radiotherapy and/or chemotherapy are prescribed.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K043412, K981313, K991133, K093527
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
January 6, 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 2.40 | |
| 2. Classification Information: | |||
| a. | Classification Name 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 | |
| Sunnyvale, CA 94086 | |||
| c. | Establishment Number | 2950347 | |
| d. | Contact | Kathryn Stinson, RA Specialist | |
| e. | Contact Phone | 314-993-0003 | |
| f. | Contact Fax | 314-993-1175 |
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PREDICATE DEVICE INFORMATION
The MOSAIO 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.
MOSAIQ INTENDED USE
MOSAIO is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users:
- Supply electronic patient charts and assemble care plans, order diagnostic . tests, and prescribe medications.
- Import, view, annotate, manipulate, enhance, and archive images. .
- Import, keep, and export information related to patient treatments to ● monitor treatment progress from a central location. This includes orders, documents, lab information, and other related information from compatible programs.
- Generate and keep medication and formulary lists and calculate applicable . medication dosages for medical oncology.
- Design leaf plans for operation with radiotherapy treatment machines that . have multileaf collimators. Users can give, view and change geometric data related to treatment fields, including the MLC accessory.
2
-
Ensure plans imported from treatment planning systems agree with . treatment machine constraints.
Additionally, MOSAIQ: -
. Supplies other administrative functionality necessary to operate medical and radiation oncology departments.
-
. Shows reference images for setup purposes, refers to predefined settings to help treatment machine setup, and tells clinicians of necessary steps before treatment.
-
Reads actual settings from the treatment machine through the machine's ● communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system inhibits treatment.
-
. Verifies the actual treatment against radiation treatment plans. At applicable points during the treatment, it records the actual delivered values to provide treatment tracking.
MOSAIQ INDICATIONS FOR USE
MOSAIO supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. MOSAIQ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
DESCRIPTION OF THE PRODUCT
MOSAIO 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. MOSAIO 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.
Previously, three of the components within MOSAIQ were cleared through the 510(k) process individually. The ViewStation software (K011694) provides the ability to to import, view, annotate, manipulate, enhance, manage and archive medical images and includes patient positioning functionality. The MLC Fit software (K991133) allows users to define MLC leaf shapes for radiation treatment plans. The SEQUENCER software (K981313) connects to the treatment unit (e.g. linear accelerator) and compares its setup
3
to the predefined treatment field in the treatment chart. SEOUENCER inhibits treatment if errors are detected, records actual treatment unit parameters, and allows this information to be stored and/or printed as part of the treatment record.
MOSAIQ includes the ViewStation, MLC Fit and SEQUENCER software applications as well as other applications that were not classified as medical devices when considered as individual products. This section of the Premarket Notification provides a description of the functional units within MOSAIQ.
LEVEL OF CONCERN
Because MOSAIQ includes many different pieces of functionality, we conclude that the level of concern for the device as a whole must be equivalent to that of the function with the highest level of concern, namely, the verify and record functionality.
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.
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.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathryn Stinson Regulatory Affairs Specialist IMPAC Medical Systems, Inc. 100 Mathilda Place, 5th Floor SUNNYVALE CA 94086-6076
FEB 2 8 2012
Re: K120067
Trade/Device Name: MOSAIQ Oncology Information System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 6, 2012 Received: January 9, 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120067
Device Name: MOSAIQ Oncology Information System
Indications for Use:
MOSAIQ supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Diagnostic Devices (OIVD)
Page 1 of 1
Mary Scott
Division of Radio Office of In Vitro Diagnostic Device
510K K120067