MUCHECK V8

K091602 · Oncology Data Systems, Inc. · IYE · Jun 18, 2009 · Radiology

Device Facts

• Record ID: K091602
• Device Name: MUCHECK V8
• Applicant: Oncology Data Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 18, 2009
• 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 Gamma-Knife QA Check program is the same as for the predicate devices: to calculate a dose for the purpose of validating a dose previously calculated by a the primary GammaKnife treatment planning system The intended use is as a quality assurance tool only and not as a treatment planning device.

Device Story

MuCheck Gamma-Knife QA Check is a software program operating on an IBM-compatible PC in a Windows environment. It functions as an independent quality assurance tool for radiation therapy. The device imports treatment plans from the Gamma-Knife treatment planning system or operates in a standalone mode. It performs independent dose calculations to verify the accuracy of the primary system's dose calculations. It does not connect to or control any radiation hardware. The software is used by medical physicists in radiation therapy departments to fulfill quality assurance protocols, such as those recommended by Task Group 40. By providing a secondary check of the primary dose calculation, the device assists in ensuring the accuracy of patient treatment plans, thereby supporting safe radiation therapy delivery.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation test plans were completed in accordance with Oncology Data Systems procedures and GMP guidelines. System specifications were met, and test results demonstrated close agreement between the Gamma-Knife treatment planning system and the Gamma-Knife QA Check software.

Technological Characteristics

Software-based dose validation tool. Operates on IBM-compatible PC in Windows environment. User interface utilizes mouse and keyboard. Standalone or integrated via plan import. No hardware connectivity. Verification and validation performed per GMP guidelines.

Indications for Use

Indicated for independent verification of monitor unit or dose calculations performed by a primary radiation treatment planning system for Gamma-Knife procedures. Used for single or multiple points as determined by a physicist. Not for use as a primary treatment planning device.

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

• MuCheck Monitor Unit Validation (V4 for IMRT) (K012227)
• MuCheck Monitor Unit Validation (V7 for Brachy) (K061152)
• Leksell GammaPlan (K061540)

Submission Summary (Full Text)

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K091602

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# JUN 18 2009

## 510(k) Safety and Effectiveness Summary

| 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:<br>Date: | Vince Ruminer<br>May 18, 2009 |
| Trade Name: | Mucheck Gamma-Knife QA Check |
| Common Name: | Dose Validation Software |
| 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 |

## Substantial Equivalence:

| Device Name | 510(K) Number |
|-------------------------------------------------|---------------|
| MuCheck Monitor Unit Validation (V4 for IMRT) | K012227 |
| MuCheck Monitor Unit Validation (V7 for Brachy) | K061152 |
| Leksell GammaPlan | K061540 |

#### Description:

The Gamma-Knife QA Check Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to onerate either in a stand alone mode independent of the Gammaknife treatment planning grown or to import plans from the GammaKnife treatment planning system. It does not connect to a control any radiation hardware device. Gamma Knife QA Check performs dose calculations to verify the dose calculated by the primary GammaKnife radiation treatment planning system.

# Substantial Equivalence Summary:

#### Intended Use:

The intended use for the Gamma-Knife QA Check program is the same as for the predicate devices: to calculate a dose for the purpose of validating a dose previously calculated by a the

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K09/602

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primary GammaKnife treatment 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 Task Group 40. Gamma Knife QA Check provides this very important quality assurance function.

#### Technological Characteristics:

The technological characteristics are the same as for the predicate devices. Gamma-Knife OA Check 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 the GammaKnife treatment planning system and Gamma-Knife QA Check. 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, Gamma Knife QA Check is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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JUN 18 2009

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

Re: K091602

Trade/Device Name: MuCheck V8 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 1, 2009 Received: June 3, 2009

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. Insting 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/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/cdrl/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Larry Morris

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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# Indications for Use

99/607 510(k) Number (if known):

Device Name: MuCheck V8

Indications For Use:

MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.

The intended use of the MuCheck software has been extended to include an optional module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Camufo Rorxes

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