MUCHECK V7.0

K061152 · Oncology Data Systems, Inc. · LHN · May 10, 2006 · Radiology

Device Facts

• Record ID: K061152
• Device Name: MUCHECK V7.0
• Applicant: Oncology Data Systems, Inc.
• Product Code: LHN · Radiology
• Decision Date: May 10, 2006
• 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

The intended use for the BrachyCheck module is to calculate dose and dwell times for the purpose of validating a dose previously calculated by a primary brachytherapy treatment planning system . The intended use is as a quality assurance tool only and not as a treatment planning device.

Device Story

BrachyCheck is an optional software module within the MuCheck system; operates on a Windows-based PC. It functions as a secondary quality assurance tool to validate dose and dwell times calculated by a primary brachytherapy treatment planning system. Input data includes treatment plan parameters; device performs independent dose calculations to specified anatomical points. It does not control radiation hardware. Used by medical dosimetrists or physicists in clinical settings to ensure accuracy of primary treatment plans, adhering to AAPM Task Group 43 recommendations. Output allows clinicians to verify primary calculations, reducing risk of treatment errors and improving patient safety.

Clinical Evidence

No clinical data. Substantial equivalence and safety/effectiveness were demonstrated through non-clinical bench testing, including verification and validation test plans, hazard analysis, and comparison of software calculations against primary treatment planning systems and manual calculations.

Technological Characteristics

Software-based dose validation tool; operates on Windows PC environment; utilizes keyboard and mouse input. Performs independent dose calculations for brachytherapy. No hardware connectivity or control. Developed in accordance with GMP regulations.

Indications for Use

Indicated for use in radiation therapy departments to verify monitor unit or dose calculations generated by a primary brachytherapy treatment planning system for patients undergoing brachytherapy procedures (implants using radioactive sources).

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

• Plato Brachytherapy (BPS v14.0) (K983343)
• MuCheck - Monitor Unit Validation Program (K980904)
• MuCheck - Monitor Unit/Dose Validation Program (K012227)

Submission Summary (Full Text)

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VAY 10 1 0 1 1

| | K061152 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Oncology Data Systems, Inc.<br>1601 S.W 89th, Ste. E-100<br>Oklahoma City, Ok. 73159<br>tel. [phone]<br>fax [phone] |
| Contact: | Gregory G. Miller |
| Date: | March 24, 2006 |
| Trade Name: | MuCheck - Monitor Unit/Dose Validation Program |
| Common Name: | MuCheck |
| Classification Panel: | Radiology |
| Classification Name: | Medical Charged Particle Radiation Therapy<br>System(Accessory)<br>21 CFR 892.5050 (class II) |
| Performance Standards: | none established under section 514 |

# 510(k) Safety and Effectiveness Summary

#### Substantial Equivalence:

| Device Name | 510(k) # |
|------------------------------------------------|----------|
| Plato Brachytherapy (BPS v14.0) | K983343 |
| MuCheck - Monitor Unit Validation Program | K980904 |
| MuCheck - Monitor Unit/Dose Validation Program | K012227 |

#### Description:

The BrachyCheck Dose Validation module is an optional software module that is part of the MuCheck software. MuCheck is designed to operate on a personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of any brachytherapy treatment planning system or to import plans from a brachytherapy treatment planning system. It does not connect to or control any radiation hardware device. BrachyCheck performs dose calculations to verify the dose calculated by the primary radiation brachytherapy treatment planning system.

# Substantial Equivalence Summary:

#### Intended Use:

The intended use for the BrachyCheck module is to calculate dose and dwell times for the purpose of validating a dose previously calculated by a primary brachytherapy treatment

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planning system . The intended use is as a quality assurance tool only and not as a treatment planning device.

In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary dose calculation is part of good treatment protocol as well being a recommendation by AAPM Task Group 43. BrachyCheck provides this very important quality assurance function.

## Safety and Effectiveness:

The staff at Oncology Data Systems includes a certified medical dosimetrist with over 34 years of clinical experience. The computer programming and design has been provided by a programming staff with combined experience of over 48 years in the design and development of systems. The combined expertise as well as conformance to the GMP regulations helped to insure that the finished product is safe and effective to use.

A comprehensive users manual provides extensive documentation for the user. Optional system startup and training is provided as part of the service provided by Oncology Data Systems.

## Technological Characteristics:

The technological characteristics are the same as for the predicate devices. BrachyCheck was designed to operate in a windows environment using both mouse and keyboard.

## Non-clinical tests:

Verification and validation test plans were completed in accordance with Oncology Data Systems procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate. All system specifications were met and testing performed to demonstrate substantial equivalence. The non-clinical tests were conducted using a brachytherapy treatment planning system or hand calculations and BrachyCheck. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.

## Summary of Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness.

## Conclusions:

Based upon the technological characteristics, intended use, and non-clinical tests, BrachyCheck is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Oncology Data Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

#### Re: K061152

Trade/Device Name: MuCheck - Monitor Unit/Dose Validation Software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: LHN, JAO, and KXK Dated: April 21, 2006 Received: April 26, 2006

MAY 1 0 2006

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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.

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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toH-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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# Indications for Use

510(k) Number (if known): _ Қобыл >2

## Device Name: MuCheck - Monitor Unit/Dose Validation Software

Indications for Use:

In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated.

The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system.

The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated.

The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

Prescription Use 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

d Radiological Devices

10(k) Number

page 1 of 1

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,