IMSURE

K031975 · Prodigm, Inc. · IYE · Aug 29, 2003 · Radiology

Device Facts

• Record ID: K031975
• Device Name: IMSURE
• Applicant: Prodigm, Inc.
• Product Code: IYE · Radiology
• Decision Date: Aug 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

IMSure is intended for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics for plans of known geometry.

Device Story

IMSure is a software-based quality assurance tool for radiation therapy. It imports IMRT treatment plans, including fluence maps and multi-leaf collimator (MLC) sequence data, from primary treatment planning systems. The software performs an independent verification of the IMRT plan by calculating dose and fluence maps, then comparing these results against the original plan to identify discrepancies. Additionally, it computes primary monitor unit (MU) calculations for standard radiation therapy beams (open, blocked, wedged). Used in clinical settings by medical physicists or radiation therapists, the software operates on Windows-based PCs. By providing an independent second check of treatment parameters, the device helps ensure the accuracy of radiation delivery, potentially reducing the risk of treatment errors and improving patient safety during radiation therapy.

Clinical Evidence

No clinical data. The device relies on bench testing and physics-based validation of its dose calculation algorithms (three-source model and Clarkson scatter) against measured physical data to demonstrate substantial equivalence.

Technological Characteristics

Software-based dose calculation and verification tool. Operates on Windows 2000/XP platforms (min. Pentium III). Uses a three-source model for IMRT dose calculation and Clarkson scatter algorithm (Stanford method) for scatter tables. Supports linear accelerators with 52, 80, and 120-leaf MLCs. Features three-level password-protected user security. Data input via RTP link; output via paper or Word documentation.

Indications for Use

Indicated for quality assurance verification of IMRT treatment plans and primary monitor unit calculations for radiation therapy planning. Applicable to patients undergoing radiation therapy where independent verification of treatment plans or monitor units is required.

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.

Predicate Devices

• RadCalc V4.0 (K010464)

Submission Summary (Full Text)

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KO31975

# AUG 2 9 2003

#### Premarket Notification [510(k)] Summary Tab 4

Date Prepared:

April 24, 2003

IMSure Trade Name:

IMRT QA Device and Monitor Unit Calculator Common Name:

Classification Name: Medical Linear Accelerator

Manufacturer's Name: Address:

Prodiam. Inc. 585 Manzanita Ave. Chico, CA 95926

Suzanne Wild

Corresponding Official: Title: Telephone: Fax:

Director of Quality Assurance/ Regulatory Affairs 530-897-0937 530-897-0934

Predicate:

K010464 RadCalc V4.0

Device Description:

IMSure is a software program designed to provide a second, independent verification of IMRT plans created on primary radiation therapy treatment planning systems. After independently calculating the imported plan and fluence maps, IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan.

IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.

Intended Use:

IMSure is intended for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics for plans of known geometry.

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Technological Characteristics: The New Device has the same intended use and safety characteristics as the predicate device.

| System<br>Component | Device | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LifeLine Software, Inc.<br>RadCalc, Model V.4.0 | Prodigm, Inc.<br>IMSure |
| K number | K010464 | This filing. |
| Application (Use) | Utilized for determination of<br>monitor units or dose. Serves<br>to validate those monitor units<br>computed by the primary<br>radiation therapy planning<br>system. Primary means of<br>calculating monitor units in<br>situations where the physician<br>does not order the user of a<br>radiation therapy treatment<br>plan. | Independent dose and<br>fluence map verification<br>software for Intensity<br>Modulated Radiation Therapy<br>based on Linear accelerator<br>plans containing multi-leaf<br>collimator leaf sequence data<br>and fluence maps from<br>primary IMRT treatment<br>planning systems.<br>Independent dose<br>computation software for<br>standard, simple geometry<br>radiation therapy treatment<br>planning and verification of<br>monitor units based on Linear<br>Accelerator parameters and<br>physician prescribed dose<br>information. |
| Platform | Minimum Pentium II processor,<br>MFS network enabled | Minimum Pentium III<br>processor, MFS network<br>enabled |
| Operating system | Any MS Windows | Windows 2000 and XP |
| Algorithm - map<br>verification | Single Source model | Single source model |
| Algorithm - IMRT<br>dose Calculation | Single Source model, Clarkson<br>scatter algorithm based on<br>University of Chicago method | Three Source model,<br>Clarkson scatter algorithm<br>based on Stanford University<br>method |
| MU Calculation<br>Dose Algorithm | Khan (classical) | Khan (classical) |
| Patient Geometry<br>Specifications | Two dimensional, graphical<br>user interface based, based | Two dimensional, graphical<br>user interface based |
| Machines<br>supported | Commercially available Linear<br>Accelerators with multi-modality<br>energies and both photon and<br>electron particles, including<br>field blocking and linear wedge<br>applicators for photon fluence<br>modulation, and with 52,80 and<br>120 leaf Multi-leaf collimators | Commercially available<br>Linear Accelerators with<br>multi-modality energies and<br>photon and electron particles,<br>including field blocking and<br>linear wedge applicators for<br>photon fluence modulation,<br>and with 52,80 and 120 leaf<br>Multi-leaf collimators |
| System<br>Component | Device | |
| | LifeLine Software, Inc.<br>RadCalc, Model V.4.0 | Prodigm, Inc.<br>IMSure |
| Calculation point<br>for IMRT QA | Fixed, iso-centric | Off-Axis calculation points<br>incorporating modeled head<br>scatter information and<br>measured fluence<br>perturbations |
| Calculation point<br>for MU<br>Calculations | Off-Axis and depth specified<br>calculation points using<br>measured physical data | Off-Axis and depth specified<br>calculation points using<br>measured physical data |
| Physics Data | Measured, tabular database<br>stored, multiple linear<br>accelerators allowed | Measured, tabular, flat file<br>storage, multiple linear<br>accelerators allowed |
| Scatter table | Measured | Measured and modeled (3-<br>source model, Yang, et. al ) |
| Import data | RTP link, Dicom RT for IMRT<br>QA and MU Calculations | RTP link for IMRT QA<br>Graphical User Interface for<br>MU Calculations |
| Calibration<br>method(s) | Iso-centric or fixed Calibration<br>Distance | Iso-centric or fixed Calibration<br>Distance |
| Export data | RTP link, Dicom RT, Paper<br>documentation | Paper or Word<br>documentation |
| User security | Two levels of user, password<br>enabled | Three levels of user,<br>password enabled |

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Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight, composed of three parallel lines that curve upwards and to the right. The bird is enclosed within a circle, and the words "U.S. Department of Health & Human Services" are arranged around the circumference of the circle. The logo is rendered in black and white, with a simple and clean design.

Food and Drug Administration 0 Corporate Boulevard kville MD 20850

AUG 2 9 2003

Prodigm, Inc. % Mr. Juergen Welte Program Manager TUV Rheinland of North America 1279 Quarry Lane, Suite A Pleasanton, CA 94566

Re: K031975

Trade/Device Name: IMSure (IMRT QA Device and Monitor Unit Calculator) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: August 15, 2003 Received: August 18, 2003

Dear Mr. Welte:

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 enactnient 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 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); 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Tab 3

### Indications For Use

510(k) Number (if known): Ko31975

Device Name: IMSure

### Indications for Use:

IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031975

Prescription Use Y (per 21 CFR 801.109)

OR

Over-The-Counter Use