MODIFICATION TO HI-ART TREATMENT SYSTEM

K082005 · Tomotherapy Incorporated · MUJ · Aug 25, 2008 · Radiology

Device Facts

• Record ID: K082005
• Device Name: MODIFICATION TO HI-ART TREATMENT SYSTEM
• Applicant: Tomotherapy Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Aug 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TomoTherapy HI-ART 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

Integrated radiation therapy system; performs treatment planning, dose calculation, megavoltage CT (MVCT) imaging for image-guided radiation therapy (IGRT), and helical radiation delivery. Modification adds capability for fixed-beam treatments from multiple user-defined angles. System uses linear accelerator for photon-mode radiation delivery. Operated by clinical staff in a radiation oncology setting. Physician approves treatment plan; system delivers radiation in rotational, non-rotational, modulated (IMRT), or non-modulated (3D conformal) formats. MVCT provides patient positioning verification. Benefits include precise targeting of tumors while sparing healthy tissue; elimination of beam blocks; and gantry shielding for patient safety.

Clinical Evidence

Bench testing only. Validation performed on system functionality including planning, imaging, delivery, database management, and DICOM communications using IMRT phantoms, ion chambers, and other test phantoms.

Technological Characteristics

Radiation therapy system; linear accelerator (photon mode only); helical and fixed-beam delivery; MVCT imaging. Complies with IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-32, IEC 60601-2-44, IEC 61217, EN ISO 14971:2007, and IEC TR 62266. Connectivity includes DICOM communications.

Indications for Use

Indicated for patients requiring radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues. No specific age or gender restrictions noted.

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 (K060912)
• Varian Clinac 600 (K026321)

Submission Summary (Full Text)

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Korzoos

AUG 2 5 2008

# Section 4 510(k) Safety and Effectiveness Summary

# 4.1 General Information

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

| Contact Person: | Robert Bovy<br>TomoTherapy, Inc.<br>1240 Deming Way<br>Madison, WI 53717-1954 |
|----------------------|-------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Date: | July 7, 2008 |
| Device Trade Name: | HI-ART System (modified) |
| Common Name: | Radiation Therapy System |
| Classification Name: | Medical Charged Particle Radiation Therapy<br>System |
| Predicate Devices: | TomoTherapy Hi-Art System<br>K060912 |
| | Varian Clinac 600<br>K026321 |

# 4.2 Intended Use

The TomoTherapy HI-ART 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.

# 4.3 Description

The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning for IGRT functionality, and helical radiation therapy treatment capabilities into a single comprehensive system. The megavoltage CT image is not for diagnostic use. This modification provides a licensable option that adds the capability for fixed beam treatments from multiple user defined angles as well.

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## Safety Considerations 4.4

The HI-ART System has several inherent characteristics that promote its safety - no beam blocks are used that can fall off onto the patient; the rotating gantry is covered so that the patient cannot contact moving gantry parts; the linear accelerator operates in photon mode only so inadvertent electron exposure is eliminated; MVCT allows for reliable patient positioning. This modification introduces no new fundamental technical characteristics or safety concerns.

#### Standards Compliance 4.5

The HI-ART System is designed to comply with relevant sections of the IEC 60601-1. 1EC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-32, IEC 60601-2-44, IEC 61217, EN ISO 14971:2007, and IEC TR 62266 safety standards.

## 4.6 Validation

The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc. Test tools utilized in this testing included IMRT phantoms, ion chambers and other test phantoms.

## 4.7 Conclusion

Validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2008

Mr. Robert Bovy Director of Regulatory Affairs TomoTherapy Incorporated 1240 Deming Way MADISON WI 53717-1954

Re: K082005

Trade/Device Name: TomoTherapy HI-ART System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: July 8, 2008 Received: July 14, 2008

# Dear Mr. Bovy:

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 (PMA), 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use Form Section 3

- 510(k) Number (if known)
Ko82005

Device Name:

TomoTherapy HI-ART System

- Indications for use:
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and The Tomor Horapy TIT THEF Uystein is tereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage xray 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109)

OR

Over-the-Counter Use

Arge Mmhly
(Division Sign-Off)

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

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