TOMOTHERAPY TREATMENT SYSTEM

K121934 · Accuray Incorporated · IYE · Aug 29, 2012 · Radiology

Device Facts

• Record ID: K121934
• Device Name: TOMOTHERAPY TREATMENT SYSTEM
• Applicant: Accuray Incorporated
• Product Code: IYE · Radiology
• Decision Date: Aug 29, 2012
• 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, (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. Device delivers radiation via rotational or fixed-beam delivery; supports IMRT and non-modulated conformal therapy. Used in clinical settings by physicians and trained staff to treat tumors or targeted tissues. System operates based on physician-approved treatment plans; does not diagnose disease or recommend regimens. Megavoltage CT imaging is for IGRT, not diagnostic use. Enhancements include asymmetric beam positioning and dynamic motion of primary beam-limiting device. Output allows clinicians to deliver precise radiation doses to target volumes while minimizing exposure to healthy tissue, facilitating targeted cancer treatment.

Clinical Evidence

No clinical tests were required to establish substantial equivalence. Performance data based on bench testing and verification/validation activities confirming compliance with recognized consensus safety standards.

Technological Characteristics

Integrated radiation therapy system; megavoltage x-ray source; helical/rotational and fixed-beam delivery; megavoltage CT imaging for IGRT; software-controlled asymmetric beam positioning and dynamic motion of primary beam-limiting device.

Indications for Use

Indicated for planning and delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or targeted tissues in patients requiring radiation treatment, while sparing healthy tissue.

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 Treatment System (K112776)

Submission Summary (Full Text)

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# K121934

ACCURAY®

TomoTherapy* A wholly owned subsidiary of Accuray

#### 510(k) Summary Section 2

## AUG 2 9 2012

### Applicant:

Accuray Incorporated 1240 Deming Way Madison, WI 53717-1954 Phone: [phone] Fax: [phone]

| Contact: | Gregory G. Bange |
|----------------|------------------|
| Date Prepared: | June 29, 2012 |

#### Device Identification:

| Device Name: | TomoTherapy Treatment System |
|-------------------------|---------------------------------------------------|
| Trade & Brand Names: | Hi-Art® and TomoHDTM |
| 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 Treatment System (K112776)

#### 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.

#### 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, (IMRT), or non-modulated (non-IMRT/three dimensional modulated 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 physical properties of the device are identical to the predicate. Enhancements to software allow for the planning and delivery of radiation therapy that utilize asymmetric positions and dynamic motion of the primary beam limiting device.

#### Performance Data:

The TomoTherapy Treatment System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm the TomoTherapy Treatment System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The 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 the 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## 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

AUG 2 9 2012

Mr. Gregory G. Bange Manager of Regulatory Submissions and Standards Accuray Incorporated 1209 Deming Way MADISON WI 53717

Re: K121934

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: IYE and MUJ Dated: June 29, 2012 Received: July 2, 2012

Dear Mr. Bange:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfed in the encreativent of the enactment date of the Medical Device Amendments, or to conimered print to May 20, 1978, in occordance 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 r ou may, distore, mains 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 If your device Is classified (300 a00 regulations affecting your device can be found in Title 21, additions: Controls: Existing major 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 Flease be advised that I DA 3 issumes or a race complies with other requirements of the Act that IDA has made a dolormistion and regulations administered by other Federal agencies. You must of any I cuchares and regaratis 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 mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality of since & described in your Section 510(k) premarket will anow you to begin mading of substantial equivalence of your device to a legally marketed notification. The I Drivin 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 If you desire specific ad rice tor your live Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise 1100, premo 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 Tou may 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,

Janine M. Morris

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): K121934

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 The megavoltage x-ray radiation is delivered in a healthy tissue. rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician 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)

Division Sign Off

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

510(k) Kia1934

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