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
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.
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.
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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 (800) 638 2041 or (301) 796-7100 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)
Page 1 of
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
