The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient for a given treatment plan setup.

The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

Device Description

Monaco uses local biological measures for optimization to create intensity modulated radiation therapy (IMRT) plans using Multileaf Collimators. With the addition of VMAT planning capability, Monaco also allows users to creatment plans in which the devices that aim and shape the beam are in motion while the beam is on.

AI/ML Overview

The provided text describes the Monaco RTP System - VMAT Option, a software used for radiation treatment planning. It states that "Clinical trials were not performed as part of the development of this product." Instead, "Clinically oriented validation test cases were written and executed in-house by Customer Support personnel in a simulated clinical environment. Algorithm testing was also performed by qualified Medical Physicists using measured data from clinical facilities."

However, the document does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set or data provenance.
Number or qualifications of experts used to establish ground truth.
Adjudication methods.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
Specific details on standalone algorithm performance.
Type of ground truth used (beyond "measured data").
Sample size for the training set.
How ground truth for the training set was established.

Therefore,Based on the provided text, a comprehensive description of acceptance criteria and the study proving the device meets them cannot be fully constructed for many of the requested categories. The document explicitly states that "Clinical trials were not performed."

Here's what can be extracted and what is missing:

Acceptance Criteria and Study Details:

Information Category	Details from K091179
1. Table of Acceptance Criteria and Reported Performance	Acceptance Criteria: Not explicitly stated as a table. The document mentions "Pass/fail requirements" for verification testing and that "Monaco with the VMAT option successfully passed both testing efforts and was deemed fit for clinical use." Reported Device Performance: The text states, "Monaco with the VMAT option successfully passed both testing efforts and was deemed fit for clinical use." No quantitative performance metrics (e.g., accuracy, precision, dose deviation thresholds) are provided in this summary.
2. Sample size for test set and data provenance	Sample Size: Not specified. The document mentions "Clinically oriented validation test cases" and "measured data from clinical facilities" but does not give a number of cases or patients. Data Provenance: "measured data from clinical facilities." Specific countries or retrospective/prospective nature are not mentioned.
3. Number and qualifications of experts for ground truth	Number of Experts: Not specified. Qualifications: "qualified Medical Physicists" performed algorithm testing. For clinically oriented validation, "Customer Support personnel in a simulated clinical environment" executed tests. No specific experience or board certifications are provided for either group.
4. Adjudication method for the test set	Not documented.
5. MRMC comparative effectiveness study	No. The document explicitly states: "Clinical trials were not performed as part of the development of this product."
6. Standalone (algorithm only) performance study	Yes, to some extent. "Algorithm testing was also performed by qualified Medical Physicists using measured data from clinical facilities." This suggests an assessment of the algorithm's output against known measured data, which is a form of standalone performance evaluation. However, detailed results or metrics are not provided in this summary.
7. Type of ground truth used	"Measured data from clinical facilities." This implies physical measurements of radiation dose distributions that the system's calculations were compared against.
8. Sample size for the training set	Not applicable/Not specified. This is a radiation treatment planning system that calculates dose distributions, not a machine learning model that would typically have a "training set" in the conventional sense. The "algorithm" was developed, and then tested.
9. How ground truth for the training set was established	Not applicable/Not specified (see point 8).

Summary of Study (as described in the document):

The Monaco RTP System - VMAT Option underwent two main types of testing:

Clinically oriented validation test cases: These were executed in-house by Customer Support personnel within a simulated clinical environment. The specific nature of these "test cases" (e.g., number of plans, complexity) is not detailed.
Algorithm testing: This was performed by qualified Medical Physicists. The testing involved comparing the algorithm's outputs against "measured data from clinical facilities." The report states that "Test reports are included in section 20 of this submission," but these details are not provided in the summary.

Both testing efforts were successfully passed, leading the device to be deemed "fit for clinical use." Verification tests, with associated pass/fail requirements, were also conducted to ensure the system functioned as designed, and these were also successfully passed.

Crucially, no clinical trials involving human subjects were performed or deemed necessary for this premarket notification, as the manufacturer argued that "testing can be performed such that no human subjects are exposed to risk" and that clinical testing was "not advantageous in demonstrating substantial equivalence or safety and effectiveness." The device's safety and effectiveness were established through comparison to predicate devices and the non-clinical testing described above.

Summary

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K091179

JUL 1 6 2009

April 22, 2009

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

INTRODUCTION

This document summarizes the safety and effectiveness information contained within the Monaco VMAT Premarket Notification (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
- b. Release Version Number

Classification Information:

a. Classification Name system
b. Common/Usual Name
Product Classification c.
d. Product Code
Reference e.
f. Review Panel
1. Establishment Information:
- a. Submitter
- b. Submitter Address
- c. Establishment Number
- d. Contact
- e. Contact Phone
- f. Contact Fax

VMAT functionality added in release 2.0.0

Monaco RTP System

Medical charged-particle radiation therapy

Radiation Treatment Planning System Class II MUJ 21 CFR 892.5050 Radiology

Computerized Medical Systems, Inc. 13723 Riverport Dr. . Suite 100 Maryland Heights, MO 63043 1937649 Kathryn Stinson, RA Associate 314-993-0003 314-993-0075

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PREDICATE DEVICE INFORMATION

ﻤﻰ ﺑ

The Monaco RTP System is substantially equivalent to the following device(s) 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 product(s) in intended use and safety and effectiveness.

1. Monaco RTP System Computerized Medical Systems. Inc. K071938
1. ERGO++ 3D Line Medical Systems K080601
1. Eclipse Treatment Planning System Varian Medical Systems K073020

MONACO INTENDED USE

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

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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 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. Clinically oriented validation test cases were written and executed inhouse by Customer Support personnel in a simulated clinical environment. Algorithm testing was also performed by qualified Medical Physicists using measured data from clinical facilities. Test reports are included in section 20 of this submission.

Monaco with the VMAT option successfully passed both testing efforts and 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. Pass/fail requirements and results of this testing can be found in the Monaco Verification Test Report, which is included in section 18 of this submission.

Monaco with the VMAT option successfully passed verification testing.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2009

Ms. Kathryn Stinson Regulatory Affairs Associate Computerized Medical Systems, Inc. 13723 Riverport Dr., Suite 100 MARYLAND HEIGHTS MO 63043

Re: K091179

Trade/Device Name: Monaco RTP System - VMAT Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 22, 2009 Received: April 23, 2009

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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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.

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours ride Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko91179

Statement of Indication for Use · Monaco RTP System - VMAT Option 510(k)

Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)

Prescription Use X

OR Over the Counter Use per 21 CFR 801.109

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

4-I

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.