FOCUS RTP SYSTEM

K973936 · Computerized Medical Systems, Inc. · IYE · Jun 1, 1998 · Radiology

Device Facts

• Record ID: K973936
• Device Name: FOCUS RTP SYSTEM
• Applicant: Computerized Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Stereotactic Radiosurgery system is to be used to create a treatment plan for any patient with single or multiple lesions of the brain and for whom radiation therapy 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 set-up.

Device Story

FOCUS Stereotactic Radiosurgery Treatment Planning System is an add-on to existing radiation treatment planning software; accepts patient diagnostic imaging (CT/MR) and linear accelerator dosimetry data; allows dosimetrists/physicists to define target volumes and treatment scenarios (beam number, position, energy); uses BRW headframe for patient coordinate system; performs coordinate transformation between headframe and imaging data; calculates and displays 2D/3D radiation dose distributions; output used by clinicians to select optimal treatment plan; hard-copy output for patient files; used in hospital/clinic office settings; benefits patients by enabling precise planning for single-session radiosurgery.

Clinical Evidence

No clinical data. Bench testing only. Seven categories of non-clinical tests performed: CT/MR image transfer, coordinate transformation algorithm verification, fiducial marker localization, ruler/pixel size accuracy, target point verification, isodose alignment, and dose calculation algorithm accuracy. Results met all pre-defined criteria.

Technological Characteristics

Software add-on for existing FOCUS system; runs on UNIX-based RISC workstations; supports 2D/3D planning; utilizes Ratio Tissue Air Ratio (RTAR) dose calculation algorithm; supports BRW headframe for coordinate transformation; no image fusion capability; no physical connection to radiation source.

Indications for Use

Indicated for patients with single or multiple brain lesions requiring radiation therapy. No specific age or gender restrictions.

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

• ADAC Pinnacle3 APEX Stereotactic Radiosurgery Planning System (K951581)
• Nucletron PLATO SRS Stereotactic Radiosurgery System (K940001)
• RSA XKNIFE3 Stereotactic Radiosurgery System (K953482)

Submission Summary (Full Text)

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K 973936

#### JUN 1 1998

## 510(k) Summary of Safety and Effectiveness Data FOCUS Stereotactic Radiosurgery Treatment Planning System

| Submitter Name: | Computerized Medical Systems, Inc. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 1195 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 and<br>Regulatory Affairs |
| Date Summary Prepared: | September, 1997 |
| Device Trade Name: | FOCUS Stereotactic Radiosurgery Treatment Planning<br>System |
| Device Common Name: | Radiation Treatment Planning System |
| Device Classification: | System, Simulator, Radiation Therapy per 21 CFR<br>892.5840 (Class II) |
| Substantial Equivalence: | ADAC Pinnacle3 APEX Stereotactic Radiosurgery<br>Planning System - K951581<br>Nucletron PLATO SRS Stereotactic Radiosurgery<br>System - K940001<br>RSA XKNIFE3 Stereotactic Radiosurgery System -<br>K953482 |

Device Description: The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT or MR scans or from films and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to

Computerized Medical Systems Inc. - Premarket Notification - FOCUS Stereotactic Radiosurgery Page 3-1

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### 510(k) Summary of Safety and Effectiveness Data FOCUS Stereotactic Radiosurgery Treatment Planning System Page 2 of 3

define a target volume to be treated based on these diagnostic images. Based on the prescribed dose, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the 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 dose 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.

The software addition to add stereotactic radiosurgery treatment planning capability to FOCUS was developed at the Mallinckrodt Institute of Radiology of the Washington University School of Medicine in St. Louis, Missouri. The addition of Stereotactic Radiosurgery Therapy Planning capability to the system is a logical extension of the original intended use of the system. Stereotactic Radiosurgery is actually a sub-set of standard treatment planning in that it accepts the same inputs in the same formats as that for general planning. One significant, simplifying difference is that, in Stereotactic Radiosurgery Therapy, there are no treatment aids between the source and the patient. All therapy is performed using what are referred to as "open fields". A second difference is the introduction of "headframes" which, as the name implies, attach to the patients head and provide a unique patient coordinate system. The significant issue introduced here is one of coordinate transformation between the headframe and the patient diagnostic imaging data from the CT or MR machine. The system has been validated and marketed to support only the BRW headframe for CT or MR scans.

Device Intended Use: The Stereotactic Radiosurgery system is to be used to create a treatment plan for any patient with single or multiple lesions of the brain and for whom radiation therapy 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 set-up.

Summary of Technological Characteristics Compared To Predicate Devices: The Stereotactic Radiosurgery Treatment Planning capability described in this 510(k) has been designed as an "add-on" to the existing FOCUS Radiation Treatment Planning System previously cleared under K915691 in February, 1995. The FOCUS System with Stereotactic Radiosurgery Planning capability incorporates no technological characteristics not currently existent in the predicate Stereotactic Radiosurgery devices.

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### 510(k) Summary of Safety and Effectiveness Data FOCUS Stereotactic Radiosurgery Treatment Planning System Page 3 of 3

The FOCUS System supports all Linear Accelerators, has 3-D visualization capabilities and can perform both 2-D and 3-D treatment planning. Beam's Eye View (BEV) presentation is available as is a Time/MU calculator. All predicate systems, and FOCUS, use some form of the Ratio Tissue Air Ratio (RTAR) Algorithm to calculate dose. Likewise, all systems run under UNIX on a RISC-based processor workstation. The FOCUS System, unlike most of the predicate devices, has been validated only for use with the Brown-Roberts-Wells (BRW) headframe (there are at least four more on the market) and it does not have image fusion capabilities (the ability to map a MR scan onto a CT scan to obtain better imaging data of soft tissue).

Summary of Non-clinical Tests: Seven categories of tests were performed to evaluate the performance of the system: 1) Transfer of CT and MR Images, 2) Verification of Coordinate Transformation Algorithm, 3) Fiducial Marker Localization Verification, 4) Verification of Accuracy of Linear and Spherical Rulers and Checking of Image Pixel Size Detection, 5) Verification of Target Points In Different Software Modules of the System, 6) Verify Alignment of Isodoses with Image Anatomy and 7) Verification of Accuracy of the Dose Calculation Algorithm. This last test was performed by verifying system outputs against calculated and measured data collected especially for this project. The Coordinate Transformation verification was performed against a current marketed device.

Conclusions From Non-Clinical Tests: All testing provided results which met the criteria set. The system has been judged to be substantially equivalent to predicate devices and safe and effective for clinical use in the planning of Stereotactic Radiosurgery therapy situations using the BRW headframe. Normal QA of treatment planning activities, including review of the plans by a Medical Physicist and a Radiation Oncologist/Neurosurgeon prior to their use, is recommended.

Summary of Clinical Tests: Clinical testing was not performed as part of the development of this feature by the Mallinckrodt Institute of Radiology of the Washington University School of Medicine in St. Louis, MO. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness.

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Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a human figure, possibly representing a family or individual, with arms outstretched.

JUN 12:08

Michael A. Parsons Director, Quality Assurance & and Regulatory Affairs Computerized Medical Ssytem (CMS) 1195 Corporate Lake Drive St. Louis, MO 63132

Re:

K973936 FOCUS Stereotactic Radiation Treatment Planning System Dated: October 8, 1997 Received: October 15, 1997 Regulatory class: II Procode: IYE 90, CFR 892.5050

Dear Mr. Parsons:

ﻨﺎ

We have reviewed your Section 5100%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Feceral Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odch/dsmaldsmamain.html".

Sincerely yours,

Kilian Yu

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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JUN 1 1998

#### Statement of Indication for Use

# 510(k) Number: K973936

#### Device Name: FOCUS Stereotactic Radiosurgery Treatment Planning System

Purpose: To calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient diagnosed as having single or multiple brain lesions based on user-defined radiation treatment plan parameters.

Function: The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT or MR scans or from films and b) "source" dosimetry data for a linear accelerator. The system then permits the user to define a target volume to be treated based on these diagnostic-images. Knowing the prescribed dose, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment seenarios involving the number, position(s), shape (achieved by use of treatment aids such as wedges, blocks, and ports between the source of radiation and the patient) and energy of the radiation beams. The FOCUS System then produces a display of radiation dose distribution within the patient, indicating not only dose 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 tumor 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.

The addition of Stereotactic Radiosurgery Therapy Planning capability to the system is a logical extension of the original intended use of the system. Stereotactic Radiosurgery is actually a sub-set of standard treatment planning in that it accepts the same inputs in the same formats as that for general planning. One significant difference is that, in Stereotactic Radiosurgery There are no treatment aids between the source and the patient. All therapy is performed using what are referred to as "open fields". One new item is the introduction of "headframes" which, as the name implies, attach to the patients head, enhance target immobilization, and provide a unique patient coordinate system. The significant issue introduced here is one of coordinate transformation between the headframe and the patient diagnostic imaging data from the CT or MR machine. The system has been validated and marketed to support only the Brown .-. Roberts-Wells (BRW) headframe for CT or MR scans.

One difference in delivery of treatment between Stereotactic Radiosurgery and other Treatment Planning is the number of therapy sessions required to deliver the presectbed dose. In stereotactic radiosurgery, the total prescribed dose is typically delivered in a single treatment. For therapy to target volumes in other locations of the anatomy, treatment is typically broken into multiple (20-30) fractions. While this change in therapy delivery introduces no significant change in the treatment planning system, it does increase the amount of patient risk resulting from an incorrect treatment plan. For

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### Statement of Indication for Use (continued from Page 5-1)

patients receiving fractionated therapy, checks of dose received by the patient are made weekly and any mistake in the plan or delivery may be corrected by raising or lowering the delivered dose over the remaining fractions of therapy. For patients undergoing only one session of radiation, once a mistake is made involving lesion overdose, it cannot be adjusted.

Target Population: The Stereotactic Radiosurgery system is to be used to create a treatment plan for any patient with single or multiple lesions of the brain and for whom radiation therapy has been prescribed. Patient demographics are not an issue in creating the treatment plan.

Intended Environment for Use: The System is typically used in an office setting within a hospital/clinic. It is not located in the same room as the Linear Accelerator or other source of radiation. There is no need for physical connection between the source of the radiation and the Treatment Planning System.

Claims for the device: The FOCUS Stereotactic Radiosurgery Treatment Planning System will provide displays, both on-screen and in hard-copy format, of the radiation dose distributions for a given beam set-up(s) defined by the treatment planner. No claims of dose calculation accuracy, accuracy for CT localization, or center of radiation versus actual center of the lesion is indicated.

Substantial Equivalence: The system is substantially equivalent to at least three currently legally marketed devices. It is a subset of these devices, having no features not already found on one or more of the systems. See Section 7 of this Premarket Notification for details of Substantial Equivalence determination.

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

Thrid b. Jysom

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .

Prescription Use ... V.. Over the Counter Use OR per 21 CFR 801.109