MODIFICATION TO: HI-ART SYSTEM

K060912 · Tomotherapy Incorporated · IYE · Apr 19, 2006 · Radiology

Device Facts

• Record ID: K060912
• Device Name: MODIFICATION TO: HI-ART SYSTEM
• Applicant: Tomotherapy Incorporated
• Product Code: IYE · Radiology
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use. When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.

Device Story

Integrated radiation therapy system; combines planning, dose calculation, megavoltage CT (MVCT) imaging, and helical delivery. Inputs: diagnostic CT images (DICOM) or onboard MVCT scans. Operation: 6 MV linear accelerator mounted on rotating gantry; patient couch moves axially through bore. Multi-leaf collimator (MLC) with 64 tungsten leaves modulates beam intensity; helical delivery pattern. Used in clinical settings by physicians/oncologists for prescription/planning and therapists for treatment implementation. MVCT confirms patient positioning prior to therapy. Output: conformal radiation dose to target tissue; minimized dose to healthy tissue. Benefits: precise tumor targeting; reduced healthy tissue exposure; integrated image-guided positioning.

Clinical Evidence

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

Technological Characteristics

6 MV linear accelerator; rotating gantry; 64-leaf tungsten multi-leaf collimator (MLC); patient couch. Standards: IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4, EN ISO 14971:2000. Helical delivery mode. DICOM connectivity.

Indications for Use

Indicated for patients requiring intensity modulated radiation therapy (IMRT), stereotactic radiotherapy, or stereotactic radiosurgery for tumors or targeted tissues.

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 (K042739)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image is a black and white photograph that appears to be of low quality. The image is grainy and has a lot of noise, which makes it difficult to see any details. The image is mostly black, with some white areas. The black areas are concentrated in the upper left corner of the image, while the white areas are concentrated in the lower right corner.

(page 1/3)

Image /page/0/Picture/2 description: The image shows the logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol appears to be a circular shape with a section removed, creating a dynamic and somewhat incomplete form. Below the symbol, the word "TomoTherapy" is prominently displayed in a bold, sans-serif font, with the trademark symbol to the right. Underneath "TomoTherapy", the word "INCORPORATED" is written in smaller, uppercase letters.

Kobo912

Safety and Effectiveness Summary 1.4

# GENERAL INFORMATION

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

| Contact Person: | Kenneth D. Buroker<br>TomoTherapy Incorporated<br>1240 Deming Way<br>Madison, WI 53717-1954 |
|----------------------|---------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Date: | March 31, 2006 |
| Device Trade Name: | HI-ART System (modified) |
| Common Name: | Radiation Therapy System |
| Classification Name: | Medical Charged Particle Radiation Therapy<br>System |
| Predicate Device: | TomoTherapy Hi-Art System<br>K042739 |

# INTENDED USE

The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.

The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use.

When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.

1240 Deming Way

Madison, WI 53717-1954

608.824.2800

fax [phone]

.tometherapy.com

012

{1}------------------------------------------------

#### DESCRIPTION

K060912

(page 2/3)

The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning, and helical radiation therapy treatment capabilities into a single comprehensive IMRT system.

The HI-ART System's planning station or operator station is used by the physician to prescribe and enter the radiation therapy plan. A diagnostic CT image imported via a DICOM protocol from another diagnostic CT device or a TomoImage (MVCT) scan is used as the basis for the plan. The regions of interest, regions to avoid, and other prescribing information are entered in a manner that is similar to other commercially available planning systems.

The HI-ART System utilizes a 6 MV linear accelerator as the radiation source. The linear accelerator along with the primary collimator, multi-leaf collimator (MLC), detector, various control devices and power supplies are mounted on a rotating gantry, much like a CT gantry. During treatment or imaging, the patient is positioned on the couch support, and the couch moves axially through the bore of the gantry, and the radiation is delivered in a helical pattern.

The primary collimator and the MLC control the beam dimensions during radiation delivery so that the range of collimated beam size can vary from 0 to 400 mm wide by 5 to 50 mm at the isocenter. The MLC is constructed of 64 tungsten leaves that open and close as determined by the radiation therapy plan. The intensity of the radiation beam is proportional to the length of time that a particular leaf is open. The opening and closing of various leaves as the radiation is delivered in this helical pattern allows for an IMRT plan to be delivered with precise control. The result is a highly conformal dose to the region of interest with low doses to surrounding healthy tissue.

Because the HI-ART System is operating in a helical mode similar to CT systems, it inherently has the ability to obtain a CT image. The system utilizes the linear accelerator to obtain a megavoltage (MVCT) scan of the region of interest prior to the delivery of radiation therapy. This MVCT image is then used to ascertain that the patient is correctly positioned prior to treatment. The radiation dose to the patient from an MVCT scan is comparable to diagnostic CT or portal imaging.

#### SAFETY CONSIDERATIONS

The HI-ART System has several 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 virtually eliminated; MVCT allows for reliable pattent positioning.

Also, the HI-ART System consists of components similar to those already commercially marketed, including the 6 MV linear accelerator, rotating gantry, patient couch and CT imaging devices.

013

{2}------------------------------------------------

## STANDARDS COMPLIANCE

Kobo9112 (page 3/3)

The HI-ART System is designed to comply with relevant sections of the IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4 safety standards and EN ISO 14971:2000.

## 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.

## CONCLUSION

Validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use. The HI-ART System with modifications is substantially equivalent to the HI-ART system.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, overlaid on three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the logo.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 9 2006

Mr. Kenneth D. Buroker Vice President of Regulatory Affairs TomoTherapy, Inc. 1240 Deming Way MADISON WI 53717-1954

Re: K060912

Trade/Device Name: TomoTherapy HI-ART System® (modified) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: March 31, 2006 Received: April 3, 2006

Dear Mr. Buroker:

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 cither class II (Special Controls) or class III (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating the years 1906-2006. The logo features the letters "FDA" in a bold, stylized font at the center. Below the letters, the word "Centennial" is written in a cursive font. Three stars are aligned beneath the word "Centennial". The logo is surrounded by text that curves along the circle's edge.

ting Public .

{4}------------------------------------------------

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 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" (21 CFR 807.97). 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

Enclosure

{5}------------------------------------------------

#### 1.3 Indications for Use Form

- 510(k) Number (if known)
K040912

Page 1 of 1

Device Name:

TomoTherapy HI-ART System® (modified)

- Indications for use:
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

The HI-ART System's planning station or operator station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.

The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This Tomolmage (MVCT) will confirm that the patient's position is correct for the radiation therapy. as nell as assist in patient re-positioning when necessary. The Tomolmage (MVCT image) is not for diagnostic use.

When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy treatment, stereotactic radiotherapy, or stereotactic radiosurgery in accordance with the physician approved plan delivered in a helical tomographic pattern.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 810.109)
OR
Over-the-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
arbological Devices
Number K060912