TOMOTHERAPY TREATMENT SYSTEM

K112446 · Tomotherapy Incorporated · MUJ · Oct 7, 2011 · Radiology

Device Facts

• Record ID: K112446
• Device Name: TOMOTHERAPY TREATMENT SYSTEM
• Applicant: Tomotherapy Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Oct 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, nonrotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

Device Story

TomoTherapy Treatment System integrates radiation therapy planning, dose calculation, and delivery. Device utilizes megavoltage CT imaging for IGRT functionality; delivers radiation via rotational (helical) or fixed beam methods. System is prescription-only; operated by clinical staff in radiation oncology settings. Device does not diagnose disease or recommend treatment regimens; imaging is not for diagnostic use. Physician approves treatment plan; system delivers radiation accordingly. Enhancements improve dose rate consistency compared to predicate. Benefits include precise radiation delivery to tumors while sparing healthy tissue.

Clinical Evidence

Bench testing only. Verification and validation tests, including imaging and radiation delivery functionality, confirmed performance within design specifications. No clinical tests were required.

Technological Characteristics

Integrated radiation therapy system; megavoltage x-ray source; helical/rotational and fixed beam delivery; megavoltage CT imaging for IGRT. Includes independent dose monitoring and interlock systems. Design, materials, and energy sources are substantially similar to predicate.

Indications for Use

Indicated for patients requiring radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues. Used for delivery of megavoltage x-ray radiation in rotational, non-rotational, modulated (IMRT), or non-modulated formats per physician-approved plan.

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

• TomoTherapy Hi-Art System (modified) (K082005)

Submission Summary (Full Text)

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OCT - 7 2011

# erapy

#### Section 2 510(k) Summary

# Applicant:

TomoTherapy, Inc. 1209 Deming Way Madison, WI 53717-1954 Phone: [phone] Fax: [phone] Contact:

| | Gregory G. Bange |
|-------|--------------------|
| | [e-mail] |
| ared: | August 19, 2011 |

Date Prepared:

## Device Identification:

| Device Name: | TomoTherapy Treatment System |
|-------------------------|---------------------------------------------------|
| Trade Names | Hi-Art® and TomoHD ^TM |
| Common Name: | Radiation Therapy System |
| Classification: | System, Planning, Radiation Therapy Treatment |
| Product Code: | MUJ, IYE |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Description: | Medical charged particle radiation therapy system |

## Predicate Device:

TomoTherapy Hi-Art System (modified) K082005

# Description:

The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprchensive system.

The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, rccommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.

## Intended Use:

The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, nonrotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

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#### Technological Characteristics:

The technological characteristics of the TomoTherapy Treatment System are substantially equivalent to the predicate. The TomoTherapy Treatment System consists of the same primary subassemblies, is comparable in key safety and effectiveness features, utilizes substantially similar design, construction, materials, energies, and it has an intended use that is identical to that of the predicate device. It is important to note that while this addition addresses consistency of dose output, the operation of the independent dose monitoring/interlock system is completely unchanged. Therefore the dose monitoring/interlocks operation is identical to pre-existing functionality and performance limits.

Enhancements to the radiation delivery system improve the consistency of the dose rate of the TomoTherapy Treatment System in comparison to the predicate device. This does not alter the performance claims for the product. These technological enhancements do not raise new type of safety or effectiveness questions.

### Performance Data:

The TomoTherapy Treatment System was tested and demonstrated to conform to the requirements of applicable recognized consensus standards for medical devices. Results of verification and validation tests, including extensive tests of imaging and radiation delivery functionality, confirm the TomoTherapy Treatment System performance is within design specifications. No clinical tests were required to establish substantial equivalence. These performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device.

#### Summary:

The TomoTherapy Treatment System is substantially equivalent to the predicate device. The intended use, major technological characteristics, and principles of operation of the TomoTherapy Treatment System are identical to those of the predicate device. Minor technological differences do not raise new types of safety or effectiveness questions. Performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human form, with three curved lines extending upwards from the body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Mr. Greg Bange Manager of Regulatory Submissions and Standards TomoTherapy, Inc. 1240 Deming Way MADISON WI 53717-1954

OCT - 7 2011

Re: K112446

Trade/Device Name: TomoTherpy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 19, 2011 Received: August 24, 2011

Dear Mr. Bange:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5100k) 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 Parts 801 and 1 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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.

Mary Patel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

#### Enclosure

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#### Section 1 Indications for Use Form

510(k) Number (if known):

KI12446

Device Name:

TomoTherapy Treatment System

Indications for use:

The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician prescribed and approved plan.

Prescription Use X (Per 21 CFR 801 subpart D)

AND/OR

Over-the-Counter Use (Per 21 CFR 801 subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)

Muhaf D.O.H
Division Sign Off

Division Sign-Off Office of In-Vitro Diagnostic Device Evaluation and Safety

510(k) K112446

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