FOCUS RADIATION TREATMENT PLANNING SYSTEM

K020027 · Computerized Medical Systems, Inc. · MUJ · Oct 8, 2002 · Radiology

Device Facts

• Record ID: K020027
• Device Name: FOCUS RADIATION TREATMENT PLANNING SYSTEM
• Applicant: Computerized Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Oct 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons).

Device Story

FOCUS Radiation Treatment Planning System (RTP) assists clinicians in planning radiation therapy. Inputs: patient diagnostic images (CT, MR, film) and dosimetry data from linear accelerators. Operation: Dosimetrist/Medical Physicist defines target volumes and critical structures; creates treatment scenarios (beam type, number, position, energy, and treatment aids like wedges/blocks). System calculates and displays 2D/3D radiation dose distributions. Output: hard-copy plan for patient file. Benefit: enables selection of optimal plan to maximize target dose while minimizing healthy tissue exposure. Proton planning capability added via algorithm developed with Massachusetts General Hospital (MGH) based on Harvard Cyclotron Lab experience.

Clinical Evidence

No clinical testing performed. Safety and effectiveness demonstrated via non-clinical algorithm validation using test cases and comparison to measured dose data at the Harvard Cyclotron Laboratory.

Technological Characteristics

Software-based radiation treatment planning system; runs on UNIX-based OS with off-the-shelf hardware (computers, digitizing tablets, printers/plotters). Adds proton beam dose calculation module to existing electron/photon planning system. Algorithm developed in collaboration with MGH.

Indications for Use

Indicated for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

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

• Varian ProtonVision (K000922 & K002312)

Submission Summary (Full Text)

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## K 020027 FOCUS Radiation Treatment Planning System Proton Planning 510(k) Summary of Safety and Effectiveness

| Submitter Name: | Computerized Medical Systems, Inc. |
|--------------------------|-----------------------------------------------------------------------------|
| Submitter Address: | 1145 Corporate Lake Drive<br>St. Louis, MO 63132-1716 |
| Submitter Phone: | 314 993 0003 |
| Submitter Fax: | 314 993-0075 |
| Contact Person: | Michael A. Parsons - Director - Quality Assurance<br>and Regulatory Affairs |
| Date Summary Prepared: | December, 2001 |
| Device Trade Name: | FOCUS Radiation Treatment Planning System |
| Device Common Name: | Radiation Treatment Planning System |
| Device Classification: | System, Simulator, Radiation Therapy per<br>21CFR892.5840 |
| Substantial Equivalence: | Varian ProtonVision (K000922 & K002312) |

Device Description: The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images.

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## Kozoozz

### FOCUS Radiation Treatment Planning System Proton Planning 510(k) Summary of Safety and Effectiveness Page 2 of 3

Based on the prescribed dose, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The FOCUS system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one which maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file.

Previously, for situations where external beam therapy was to be used, either Electron and/or Photon radiation beams could be selected.. These were delivered by a linear accelerator whose output characteristics are input to the treatment planning system prior to beginning planning.

This Premarket Notification addresses the addition of a third type of radiation beam -Proton. The algorithm for calculating dose was provided by the Massachusetts General Hospital (MGH), based on their years of experience at the Harvard Cyclotron Lab. In addition to providing the algorithm, MGH also worked with CMS in its implementation. Software developers at MGH were trained on the CMS software development process to permit them to create code directly for use in FOCUS. As the final step, MGH provided the verification testing to assure the algorithm had been implemented correctly, measuring calculated dose against measures. A FOCUS RTP System with proton planning capability is now in clinical use at the Northeast Proton Therapy Center.

Device Intended Use: The FOCUS RTP System with will continue to be used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan sct-up.

Summary of Technological Characteristics Compared to Predicate Devices: The Proton Planning algorithm described in this 510(k) consists of modules "added-on" to the existing FOCUS Radiation Treatment Planning System previously cleared under K915691 in February, 1995, K973936 in June, 1998 and K002147 in October, 2000.

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Kozouzą FOCUS Radiation Treatment Planning System Proton Planning 510(k) Summary of Safety and Effectiveness Page 3 of 3

Summary of Clinical Testing: Actual testing in a clinic was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device.

Summary of Non-Clinical Testing: Algorithm test cases were written and executed to assure the system is calculating dose correctly for proton treatment plans. The results of testing on the Proton Algorithm feature can be found in the Validation of the CMS Proton Treatment Planning System for Treatments In Large Field Beam Line at the Harvard Cyclotron Laboratory (HCL) authored by Skip Rosenthal of MGH. This document is included in Tab 15 of this 510(k).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, composed of three curved lines.

#### Public Health Service

OCT 0 8 2002

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Parsons Director, Quality Assurance and Regulatory Affairs Computerized Medical Systems, Inc.™ 1145 Corporate Lake Drive ST LOUIS MO 63132

- Re: K020027 Trade/Device Name: FOCUS Radiation Treatment Planning System with Proton Planning Capability Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: August 22, 2002 Received: August 23, 2002
Dear Mr. Parsons:

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 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 (OS) 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 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:

| 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" (21 CFR Part 807.97). 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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Statement of Indication for Use

# 510(k) Number: Ko20027

Device Name: FOCUS Radiation Treatment Planning System with Proton Planning Canability

Indication for use: The FOCUS RTP System consists of CMS-developed software running on UNIX-based operating systems and off the shelf hardware including computers and various computer peripherals (digitizing tablet, printer/plotter, etc.).

The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons)..

> Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)

Prescription Use

OR per 21 CFR 801.109 Over the Counter Use

David A. Heymann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

Computerized Medical Systems Inc. - FOCUS RTP System with Proton Planning - Indications For Use Statement