MODIFICATION TO: HI-ART SYSTEM

K033347 · Tomotherapy Incorporated · IYE · Nov 12, 2003 · Radiology

Device Facts

• Record ID: K033347
• Device Name: MODIFICATION TO: HI-ART SYSTEM
• Applicant: Tomotherapy Incorporated
• Product Code: IYE · Radiology
• Decision Date: Nov 12, 2003
• 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) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue. The HI-ART System's planning 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 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 in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.

Device Story

Integrated radiation therapy system; combines planning, dose calculation, megavoltage CT (MVCT) imaging, and helical IMRT delivery. Physician uses planning station to prescribe treatment based on imported diagnostic CT images; system calculates plan. Therapist uses operator station to implement plan; performs pre-treatment MVCT scan using onboard 6 MV linear accelerator to verify patient positioning. System delivers radiation via rotating gantry in helical pattern; 64-leaf tungsten multi-leaf collimator (MLC) modulates beam intensity based on plan. Used in clinical settings by oncologists and therapists. Benefits include precise tumor targeting and minimized dose to healthy tissue; MVCT provides non-diagnostic image guidance for accurate positioning.

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 tools.

Technological Characteristics

6 MV linear accelerator; rotating gantry; 64-leaf tungsten MLC; xenon detector; helical delivery pattern; DICOM connectivity; IEC 60601-1, 60601-2-1, 60601-1-2, 60601-1-4 compliance.

Indications for Use

Indicated for the treatment of cancer in patients requiring intensity modulated radiation therapy (IMRT).

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 (K013673)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image is a black and white photograph. The top portion of the image is mostly black, with a white circle in the upper left corner. The bottom portion of the image is mostly white, with some black speckling. The bottom of the image has a black rectangle.

1.4

1240 Deming Way Madison, WI 53717-1954 608.824.2800

fax [phone]

ww.tomotherapy.con

NOV 1 2 2003

Ko33347

Image /page/0/Picture/6 description: The image contains the text "Safety and Effectiveness Summary" in a bold, sans-serif font. The text is centered horizontally and appears to be the title or heading of a document or section. The words are stacked on top of each other, with "Safety and Effectiveness" on the first line and "Summary" on the second line.

# 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: | October 17, 2003 |
| 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>K013673 |

## 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) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue.

The HI-ART System's planning 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 TomoImage (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 in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.

Image /page/0/Picture/15 description: The image shows the logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol is a circular shape with a section cut out, and a star-like element is visible within the cutout. The text "TomoTherapy" is in a bold, sans-serif font, with "INCORPORATED" in a smaller font size below it.

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1240 Deming Way Madison, WI 53717-1954 608.824.2800 fax [phone]

Image /page/1/Picture/2 description: The image is a black and white photograph. The majority of the image is black, with a large white circle in the upper left corner. The white circle is slightly irregular in shape, and it appears to be a light source. The black background is uniform and featureless, except for a few small white specks. The image is simple and abstract, with a strong contrast between the black and white elements.

www.tomotherapy.com

KC333477

Image /page/1/Picture/5 description: The image is a logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol appears to be a three-dimensional shape with a curved, circular element and a pointed extension, creating a dynamic and modern look. The company name, "TomoTherapy," is printed in a bold, sans-serif font, with "INCORPORATED" in a smaller font size below.

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 is used by the physician to prescribe and enter the radiation therapy plan. The patient's diagnostic CT image is imported via a DICOM protocol from another diagnostic CT device. 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), xenon 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 in a non-diagnostic mode 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

DESCRIPTION

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 patient 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.

### STANDARDS COMPLIANCE

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.

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Image /page/2/Picture/0 description: The image is a black and white photograph. The top portion of the image is mostly black, with a white circle in the upper left corner. The bottom portion of the image is mostly white, with some black speckling. There is a black rectangle at the very bottom of the image.

1240 Deming Way Madison, WI 53717-1954 608.824.2800

fax [phone]

www.tomotherapy.com

Image /page/2/Picture/4 description: The image shows a conclusion statement. The conclusion states that 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.

VALIDATION

phantoms.

K033347

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

Image /page/2/Picture/5 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 cut-out section, giving it a dynamic and modern look. The text "TomoTherapy" is in a bold, sans-serif font, with "INCORPORATED" in a smaller font size below it.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Mr. Kenneth D. Buroker Director, Regulatory Affairs & Quality TomoTherapy Incorporated 1240 Deming Way MADISON WI 53717

Re: K033347

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: 90 IYE and MUJ Dated: October 17, 2003 Received: October 20, 2003

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 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.

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.

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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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

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#### 1.3 Indications for Use Form

Page 1 of 1

. 510(k) Number (if known)

KU33347

. 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) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue.

The HI-ART System's planning 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 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 in accordance with the physician approved plan using IMRT techniques 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

Nancy C. Brogdon

510(k) Num