TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER

K112776 · Tomotherapy Incorporated · MUJ · Dec 22, 2011 · Radiology

Device Facts

• Record ID: K112776
• Device Name: TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
• Applicant: Tomotherapy Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Dec 22, 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, non-rotational, 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 megavoltage CT imaging for IGRT; delivers rotational/fixed-beam radiation. Modification (Fast Optimizer) adds GPU hardware and revised software to accelerate treatment planning and dose calculation. System is prescription-only; operated by clinical staff in radiation oncology settings. Device does not diagnose or recommend treatment; provides output based on physician-approved plans. Benefits include precise radiation delivery to tumors while sparing healthy tissue; increased efficiency in planning workflow.

Clinical Evidence

Bench testing only. Verification and validation tests confirmed performance is within design specifications and meets applicable consensus standards. No clinical tests were required.

Technological Characteristics

Radiation therapy system with integrated planning, dose calculation, and MV CT imaging. Modification adds GPU hardware for accelerated optimization and dose calculation. Energy source: megavoltage x-ray. Connectivity: integrated system. Software: revised for GPU-based optimization. Sterilization: N/A (not applicable to system hardware).

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 (K082005)

Submission Summary (Full Text)

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K112776

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DEC 2 2 2011

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#### 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]

Date Prepared:

October 25, 2011 (with corrected device name)

#### Device Identification:

| Device Name: | TomoTherapy Treatment System |
|-------------------------|---------------------------------------------------|
| Trade Names | Hi-Art® and TomoHD™ |
| Common Name: | Radiation Therapy System |
| Classification: | System, Planning, Radiation Therapy Treatment |
| Product Code: | MUJ |
| 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 comprehensive 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, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.

The TomoTherapy Treatment System with Fast Optimizer is a modification that allows for increased efficiency and speed during the treatment planning process through the use of modified hardware and software. The device name remains unchanged as "TomoTherapy Treatment System", and the modification itself is referred to as TomoTherapy Treatment System Fast Optimizer.

#### 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

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# TomoTherapy.

delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

#### Technological Characteristics:

The technological characteristics of the TomoTherapy Treatment System Next Generation Fast Optimizer are substantially equivalent to the predicate. The TomoTherapy Treatment System Next Generation Fast Optimizer introduces new hardware, a Graphics Processing Unit (GPU), and revised software to accommodate this new hardware to allow for substantially increased speed and efficiency during the performance of optimization and dose calculation processes. All other primary subassemblies remain unchanged, and therefore this modification 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.

As the modification is limited to faster operation of the Planning sub-system with unchanged dose accuracy constraints, and the changes do not affect the radiation delivery system, this modification does not alter the performance claims for the product. These technological enhancements do not raise new types of safety or effectiveness questions.

### Performance Data:

The TomoTherapy Treatment System Next Generation Fast Optimizer was tested and it was demonstrated that there are no changes to the conformance to the requirements of applicable recognized consensus standards for medical devices. Results of verification and validation tests confirm the TomoTherapy Treatment System Next Generation Fast Optimizer performance is within design specifications. No clinical tests were required to establish substantial equivalence. These performance data demonstrate the TomoTherapy Treatment System Next Generation Fast Optimizer is as safe, as effective, and performs as well as the predicate device.

#### Summary:

The TomoTherapy Treatment System Next Generation Fast Optimizer is substantially equivalent to the predicate device. The intended use, major technological characteristics, and principles of operation of the TomoTherapy Treatment System Fast Optimizer 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 Fast Optimizer 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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting something, often interpreted as representing health and well-being.

# 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. Gregory Bange Manager of Regulatory Submissions and Standards TomoTherapy, Inc. 1209 Deming Way MADISON WI 53717-1954

DEC 2 2 2011

Re: K112776

Trade/Device Name: TomoTherapy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 10, 2011 Received: November 14, 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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to eonimered processified 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 r roase be active and in that your device complies with other requirements of the Act that I Drimas Intacted and regulations administered by other Federal agencies. You must or any I vith 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 medical device-lefated adverse events) (21 CFR Part 820), and 2010 (21 CFR Part 820). This letter requirements as set form in the quality by with ( <<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<< will anow you to begil marketing your device of your device to a legally marketed notification. The I DAY miding of oubsitification 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 II you desire specific advice for your don't of the Diagnostic Device Evaluation and Safety at (31) 796-807), please contact the regulation entitled, "Misbranding by reference to premarket 5430. Also, please note the regarding the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 CFR Pac 000), presso go of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may other built built general informational 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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#### Indications for Use Form Section 1

KII 2776 510(k) Number (if known):

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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)

continue on another page if PLEASE DO NOT WRITE BELOW THIS LINE. NEEDED.

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

Muchel D'Ollum

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

510(k) K112776

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