The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy. two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

contouring
image manipulation
simulation
image fusion
plan optimization
QA and plan review

Device Description

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179) and again when Dynamic Conformal Arc planning was added (K110730). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images.

Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of beam modifiers between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

AI/ML Overview

Acceptance Criteria and Study for Monaco RTP System

The Monaco RTP System is a radiation treatment planning system. The provided document focuses on demonstrating its substantial equivalence to previously cleared devices rather than defining specific performance acceptance criteria against a new clinical standard. The "acceptance criteria" in this context are implicitly that the device performs comparably to its predicate devices for the stated intended uses and technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are not explicit numerical targets but rather a demonstration of substantial equivalence to predicate devices across various features and functionalities. The "reported device performance" is the assertion that the Monaco RTP System with new features meets or exceeds these characteristics.

Acceptance Criteria (Implicit for Substantial Equivalence)	Monaco RTP System (K132971) Performance
Intended Use & Indications for Use:
- Contouring capabilities	Yes
- Dose Calculation capabilities	Yes
- Plan Optimization capabilities	Yes
- Image Manipulation & Fusion capabilities	Yes
- CT Simulation capabilities	Yes
- QA/Plan Review capabilities	Yes
- Brachytherapy support	No (Consistent with predicate Monaco K110730 and ERGO++ K080601)
Technological Characteristics:
- Dose Calculation Algorithms	Monte Carlo (electron & photon), Collapsed Cone (photon), Pencil Beam (optimization only) - Expanded from predicate Monaco (K110730) which only had Monte Carlo (photon) & Pencil Beam.
- Calculation and display of standardized uptake value for contouring on PET images	Yes (New feature, aligned with Eclipse TPS K102011)
- Local Biological Measure Optimization	Yes (Consistent with predicate Monaco K110730 and Eclipse TPS K102011)
- MLC Support	Yes
- Support for Other Treatment Aids	Yes (New feature, aligned with ERGO++ K080601, Eclipse TPS K102011, Oncentra K121448)
- Support for Dynamic Delivery Methods	Yes
- Operating System	Windows (Consistent with predicate Monaco K110730, Eclipse TPS K102011, Oncentra K121448)
- DICOM RT Support	Yes
- Modalities Supported: Full RTP Workflow	Photon & Electron (Expanded from predicate Monaco K110730 which was Photon Only, aligned with Eclipse TPS K102011, Oncentra K121448)
- Modalities Supported: Partial Workflow* (e.g., image fusion, contouring, simulation)	Electron, Photon, Proton (Expanded from predicate Monaco K110730 which was Photon, Proton, Electron, and aligned with Eclipse TPS K102011, Oncentra K121448)
- Can be used for stereotactic treatment planning	Yes
- Stereotactic Localization	No (Consistent with predicate Monaco K110730, aligned with Oncentra K121448)
- Support for Cone-Based Stereotactic	Yes (New feature, aligned with ERGO++ K080601, Eclipse TPS K102011)
Safety and Effectiveness:
- Risk Mitigation functions as intended	Passed testing demonstrating that risk mitigations function as intended.
- Continued safety and effectiveness of existing functionality (regression testing)	Passed regression tests.
- Accuracy of dose calculation functions	Validated through algorithm testing using a simulated clinical setup.
- System working as designed for new product functionality (verification tests > 500)	Verification tests for new product functionality were written and executed, and the system "passed testing and was deemed safe and effective for its intended use." (Implied successful completion of all >500 tests, including those for new features).

2. Sample Size Used for the Test Set and the Data Provenance

The document states: "Validation testing involved simulated clinical workflows, and algorithm testing, described in detail in section 20, which validated the accuracy of dose calculation functions using a simulated clinical setup."

Sample Size for Test Set: Not explicitly stated. The phrase "simulated clinical workflows, and algorithm testing" suggests a variety of test cases, but the exact number or type of "simulated clinical setups" or specific test patients/scenarios is not quantified in the provided text.
Data Provenance: The data is generated from "simulated clinical workflows" and "algorithm testing using a simulated clinical setup." This indicates the data is synthetic or derived from controlled test environments, not from real patient data. There is no mention of country of origin as it's not real-world data. The nature of the testing is retrospective in the sense that it's against predefined test cases and expected outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. However, the document notes that "Dosimetrist or Medical Physicist" are the users who create treatment plans and qualified clinicians review and approve them. It is implied that any "ground truth" for simulated scenarios would be established by similarly qualified professionals or based on established physics principles and industry standards.

4. Adjudication Method for the Test Set

Not specified. The testing involved "verification tests" and "algorithm testing" against "simulated clinical workflows" and "simulated clinical setup." This implies that the correctness of the output was compared against expected results, likely determined by established physics models or known solutions for the simulations, rather than requiring expert adjudication of discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "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." This confirms that no human reader studies (MRMC or otherwise) were conducted.

Effect Size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes. The validation testing included "algorithm testing, described in detail in section 20, which validated the accuracy of dose calculation functions using a simulated clinical setup." This specifically refers to the performance of the algorithm itself in dose calculation. Additionally, "Over 500 test procedures were executed, including tests to verify requirements for new product functionality" and "regression tests," which would inherently involve evaluating the algorithm's output against expected results in a standalone manner.

7. The Type of Ground Truth Used

The ground truth for the algorithm and verification testing appears to be based on:

Established physics principles and models: Given that the device calculates radiation dose, the ground truth for dose calculation functions would be derived from known physics equations and simulated or theoretical benchmarks.
Engineering specifications and requirements: The "over 500 test procedures" and "requirements for new product functionality" suggest that many ground truths were the expected behavior and output defined by the device's design specifications.
Expected outcomes from simulated clinical setups/workflows: This implies a comparison against a "correct" or "ideal" treatment plan result for a given simulated patient scenario.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. The Monaco RTP System is a software system based on physics models and algorithms for radiation treatment planning, not a system that is "trained" on a dataset in the typical machine learning sense. Therefore, this information is not applicable.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for machine learning. The "ground truth" for the device's underlying physics models and algorithms would be established through principles of radiation physics, mathematical derivations, and prior validation of these computational methods.

Summary

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NOV 2 0 2013

K13297/

September 20, 2013

Monaco RTP System Premarket Notification (510(k)) Summary of Safety and Effectiveness

INTRODUCTION

This document summarizes the safety and effectiveness information contained within the Monaco RTP 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

l . Product Information:
- a. Product Trade Name
- b. Release Version Number
1. Classification Information:
- a. Classification Name system
- b. Common/Usual Name
- Product Classification c.
- d. Product Code
- Reference e.
- ﯾﺖ Review Panel
1. Establishment Information:
- a. Submitter
- b. Submitter Address
Monaco Release 5.0
Medical charged-particle radiation therapy

Radiation Treatment Planning Svstem Class II MUJ 21 CFR 892.5050 Radiology

IMPAC Medical Systems, Inc. 13723 Riverport Dr., Suite 100 Maryland Heights, MO 63043

c. Establishment Number
d. Contact
e. Contact Phone
ি Contact Fax

1937649 Kathryn Stinson, RA Specialist 314-993-0003

314-993-0075

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24. 11. 15 PREDICATE DEVICE INFORMATION

The Monaco RTP 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. Monaco is substantially equivalent to these products in intended use and safety and effectiveness.

1. Monaco RTP System IMPAC Medical Systems, Inc. K110730
1. ERGO++ IMPAC Medical Systems, Inc. K080601
1. Eclipse Treatment Planning System Varian Medical Systems, Inc. K102011
1. Oncentra Nulcetron Corporation K121448

MONACO INTENDED USE/INDICATIONS FOR USE

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

· contouring
· image manipulation
· simulation
· image fusion
· plan optimization
· QA and plan review

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: 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DESCRIPTION OF THE PRODUCT

LEVEL OF CONCERN

Item 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Premarket Submissions for 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 ... " Monaco does not directly control the linear accelerator that delivers the radiation. Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place. There is no automatic link between the Monaco software and the linear accelerator. However, should a flaw in the treatment plan escape the notice of the qualified professionals using the Monaco system, serious injury or death could result. Therefore, we believe Monaco to be of major level of concern.

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. Validation testing involved simulated clinical workflows. and algorithm testing, described in detail in section 20, which validated the accuracy of dose calculation functions using a simulated clinical setup. The product was deemed fit for clinical use.

SUMMARY OF NON-CLINICAL TESTING

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-- Verification tests were written and executed to ensure that the system is working as designed. Over 500 test procedures were executed, including 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. Monaco passed testing and was deemed safe and effective for its intended use.

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	Monaco w/newfeatures	Monaco(K110730)	ERGO++(K080601)	Eclipse TPS(K102011)	Oncentra(K121448)
Intended Use and Indications for Use
Contouring	Yes	Yes	Yes	Yes	Yes
Dose Calculation	Yes	Yes	Yes	Yes	Yes
Plan Optimization	Yes	Yes	Yes	Yes	Yes
Image Manipulation & Fusion	Yes	Yes	Yes	Yes	Yes
CT Simulation	Yes	Yes	No	Yes	Yes
QA/Plan Review	Yes	Yes	Yes	Yes	Yes
Brachytherapy	No	No	No	Yes	Yes
Technological Characteristics
Dose Calculation Algorithms	Monte Carlo(electron &photon),Collapsed Cone(photon), PencilBeam(optimizationonly)	Monte Carlo(photon) &Pencil Beam(optimizationonly)	Pencil Beam(electron)	Pencil Beam,Monte Carlo(electron)Acurus XB &AAA (photon),proton eyealgorithm	Monte Carlo(electron), CollapsedCone (photon),Pencil Beam
Calculation and display of standard izeduptake value for contouring on PET images	Yes	No	No	Yes	No
Local Biological Measure Optimization	Yes	Yes	No	Yes	No
MLC Support	Yes	Yes	Yes	Yes	Yes
Support for Other Treatment Aids	Yes	No	Yes	Yes	Yes
Support for Dynamic Delivery Methods	Yes	Yes	Yes	Yes	Yes
Operating System	Windows	Windows	Linux	Windows	Windows
DICOM RT Support	Yes	Yes	Yes	Yes	Yes
Modalities Supported: Full RTP Workflow	Photon &Electron	Photon Only	Photon Only	Electron,Photon, Proton	Electron, Photon
						くことここで、
Modalities Supported: Partial Workflow*	lectron, PhotonProton	Photon, ProtorElectron,	N/A	Same as above	N/A
Can be used for stereotactic treatmentplanning	Yes	Yes	Yes	Yes	No
Stereotactic Localization	No	No	Yes	Yes	No
Support for Cone-Based Stereotactic	Yes	No	Yes	Yes	No
. It is nessble to configure Manchoolity such as image fusion, contantine and simulation, not including MIRT optimization or dose

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: It is posible to configure Nonality such as image fusion, contouring and initials, not intiding to taledning MNK opimized or dose • --------

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem. The logo is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO6 Silver Spring, MD 20993-0002

November 20, 2013

IMPAC Medical Systems, Inc. % Ms. Kathryn Stinson Regulatory Affairs Specialist 13723 Riverport Drive. Suite 100 MARYLAND HEIGHTS MO 63043

Re: K132971

Trade/Device Name: Monaco RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: September 20, 2013 Received: September 23, 2013

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 events) (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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Page 2-Ms. Stinson

.. ·· ······

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/Medicall.covices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

michal D.

for

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): K 132971

Device Name: Monaco RTP System

Indications For Use:

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays. on-screen and in hard-copy: two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation reading . It uses generally accepted methods for:

· contouring
· image manipulation
· simulation
· image fusion
· plan optimization
· QA and plan review

Prescription Use (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 Center for Devices and Radiological Health (CDRH)

Michael D.'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological HealthPage 1 of __1

510(k) ___K 132971

Regulation Number and Section

§ 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.