MU PLUS

K992689 · Rad Therapy Solutions, Inc. · IYE · Feb 10, 2000 · Radiology

Device Facts

• Record ID: K992689
• Device Name: MU PLUS
• Applicant: Rad Therapy Solutions, Inc.
• Product Code: IYE · Radiology
• Decision Date: Feb 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the MU Plus! monitor unit calculation verification program is the same as for the predicate devices: to calculate monitor unit or timer settings for the purpose of validating a monitor unit or timer setting previously calculated by a radiation treatment planning system or hand calculation. MU Plus! also calculates an expected diode reading which is used to verify proper delivery of radiation therapy treatment.

Device Story

MU Plus! is a software-based quality assurance tool for radiation oncology; operates on Windows-based PCs; functions independently of radiation treatment planning systems; does not control radiation hardware. Input: clinical data entered by user. Operation: performs mathematical calculations for monitor unit settings for accelerator-produced photons and electrons using established physics formalisms; calculates expected diode readings. Output: verified monitor unit/timer settings and expected diode readings. Usage: clinical setting; operated by medical physicists, dosimetrists, or radiation therapists. Benefit: provides independent verification of treatment planning or hand-calculated settings to ensure accurate radiation delivery.

Clinical Evidence

Bench testing only. Comparison of monitor unit calculations between MU Plus! and predicate devices (Prowess, PC Setup Program) using standard test cases. Additional validation performed by comparing software outputs against manual lookup calculations. All test results matched closely.

Technological Characteristics

Software-based monitor unit calculation verification program. Operates on IBM-compatible PCs (Windows 95/NT 4.0 or higher). Uses mathematical formalisms for photon and electron dose calculation (TMR, Sp, Sc, WF, TF, OAF, ISF, Output factors). Standalone application; no hardware connectivity or control. No specific materials or sterilization required.

Indications for Use

Indicated for use in radiation oncology clinics as a quality assurance tool to verify monitor unit or timer settings for linear accelerators and to predict expected diode readings for radiation therapy delivery. Used by medical physicists, dosimetrists, and radiation therapists.

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

• K&S Associates, PC Setup Program (K914698)
• SSGI, Prowess Pro-Sim (K980379)

Submission Summary (Full Text)

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FEB 1 0 2000

K992689
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# 510(k) Summary

| Submitter: | Rad Therapy Solutions, Inc.<br>738 Alden Drive<br>Ormond Beach, FL 32176<br>Tel. [phone]<br>Email: [e-mail] |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact:<br>Date: | Steve Gruse, President<br>August 7. 1999 |
| Trade Name: | MU Plus! |
| Common Name: | Monitor Unit Calculation Verification Program |
| Classification Panel: | Radiology |
| Classification Name: | Medical Charged Particle Radiation Therapy<br>System (Accessory)<br>21 CFR 892.5050 (class II) |
| Substantial Equivalence: | K&S Associates, PC Setup Program<br>510(k) K914698<br>SSGI, Prowess Pro-Sim<br>510(k) K980379 |

#### Description:

The MU Plus! monitor unit calculation verification program is designed to operate on an IBM compatible personal computer using Windows 95. Windows NT 4.0, or higher operating system. It is designed to operate independently of any radiation treatment planning system. It does not connect to or control any radiation hardware device. It is designed to verify monitor unit calculations for accelerator produced photons and electrons. It also calculates expected diode readings based on clinical data entered by the user.

#### Intended Use:

The intended use of the MU Plus! monitor unit calculation verification program is the same as for the predicate devices: to calculate monitor unit or timer settings for the purpose of validating a monitor unit or timer setting previously calculated by a radiation treatment planning system or hand calculation. MU Plus! also calculates an expected diode reading which is used to verify proper delivery of radiation therapy treatment.

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#### Technological Characteristics:

MU Plus! calculates monitor unit settings in a fashion similar to Prowess for photon calculations. MU Plus! calculates monitor unit settings for photons using the following formalism:

Calculated Dose MU = TMR * Sp * Sc * WF * TF * OAFx * OAFy * ISF * Output (cGy/MU)

Prowess calculates monitor settings for photons using the following formalism:

Calculated Dose MU = TMR * OF * (PSF'/PSF) * WF * TF * ISF * Output (cGy/MU)

where: OF * (PSF'/PSF) = Sp * Sc

MU Plus! calculates monitor unit settings in a fashion similar to PC Setup Program for electrons. MU Plus! calculates monitor unit settings for photons using the following formalisms:

Calculated Dose MU = Cone Output Factor * SSD Output Factor * Isodose Prescription

#### OR

MU = Calculated Dose Calibration Factor * Isodose Prescription

PC Setup Program calculates monitor unit settings for electrons using the following formalism:

Calculated Dose MU = Cone Output Factor * Modifier Factor * Isodose Prescription

Although terms in these formalism may differ slightly, the formalism is essentially the same for both MU Plus! and PC Setup Program.

#### Non-clinical tests:

Non-clinical tests were conducted using the predicate devices and MU Plus!. Standard test cases were used on both systems. The test results matched very closely which supports the claim of substantial equivalence. See Appendixes A and B for a comparison summary.

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In addition monitor unit settings calculated by MU Plus! were compared against those performed by manual lookup to verify that the program was performing monitor unit calculations correctly. All tests matched very closely. See Appendixes C and D for a comparison summary.

### Conclusions:

Based on the technological characteristics, intended use, non-clinical tests, as well as clinical tests, MU Plus! is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.

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Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 0 2000

Steve Gruse, M.S., DABR President Rad Therapy Solutions, Inc. 738 Alden Drive Ormond Beach, Florida 32176 Re:

K992689

MU Plus ! Dated: November 12, 1999 Received: November 18, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

#### Dear Mr. Gruse:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications of Use

Applicant: Rad Therapy Solutions. Inc.

15992689 510(k) Number: N/A

Device Name: MU Plus!

Indications For Use:

MU Plus! is a quality assurance tool for monitor unit calculations performed in radiation oncology clinics. MU Plus! is designed to be used as a verification of treatment planning derived monitor unit settings or hand generated monitor unit settings. Monitor unit calculations for linear accelerators are performed by various staff of radiation oncology clinics, including medical physicists, dosimetrists, and radiation therapists. MU Plus! also contains a diode measurement verification program which predicts an expected diode reading based on a formalism similar to the monitor unit calculations.

Prescription Use (Per 21 CFR 801.109)

David A. Segerson
(Division Sign Off)

vision Sign-Off vision of Reproductive, Abdomi d Radiological De 510(k) Number