MLC FIT

K962335 · Impac Medical Systems, Inc. · IYE · Feb 6, 1997 · Radiology

Device Facts

• Record ID: K962335
• Device Name: MLC FIT
• Applicant: Impac Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The primary function of MLC Fit is to provide a means to define multileaf collimator leaf plans based on a user defined shape of a desired treatment area for use with a cancer radiotherapy treatment machines equipped with a multileaf collimator manufactured by Siemens Medical Systems and Varian Associates. Users may create, view, and edit MLC leaf data as well as other geometric parameters associated with treatment field definitions.

Device Story

Software tool for radiotherapy treatment planning; inputs user-defined treatment field shapes; calculates multileaf collimator (MLC) leaf positions; eliminates manual hand calculations; outputs hardcopy reports and database files containing leaf plans and geometric parameters; used in cancer therapy departments by clinical staff; does not control radiotherapy machine hardware or leaf movement; improves efficiency and reduces manual setup errors.

Clinical Evidence

Bench testing only. Software developed per internal Software Development Standard and Good Manufacturing Practices (GMP). Hazard analysis performed to evaluate potential operational risks.

Technological Characteristics

Software-based treatment planning tool; standalone application; generates geometric parameters and leaf positions for Siemens and Varian MLC systems; no physical hardware components; developed under documented software requirements and design specifications.

Indications for Use

Indicated for use in cancer radiotherapy departments to define multileaf collimator (MLC) leaf positions and geometric parameters for treatment field planning on Siemens and Varian radiotherapy machines.

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

• Philips MLC Prescription Entry System

Submission Summary (Full Text)

{0}

MLC Fit - 510(K)/NOTIFICATION
K962335
11/6/96
FEB - 6 1997

# MLC Fit Non-Confidential
## Summary of Safety and Effectiveness

The primary function of MLC Fit is to provide a means to define multileaf collimator leaf plans based on a user defined shape of a desired treatment area for use with a cancer radiotherapy treatment machines equipped with a multileaf collimator manufactured by Siemens Medical Systems and Varian Associates. Users may create, view, and edit MLC leaf data as well as other geometric parameters associated with treatment field definitions. An intended use statement for MLC Fit is contained in Exhibit 2a of this submission.

The goal of MLC Fit is to provide the leaf positions for a given treatment shape in a manner that eliminates the slow and error prone method of hand calculating the position for each leaf and manually setting up the leaf plans. MLC Fit allows the users to define treatment field shapes and generate multileaf collimator leaf plans based on that input shape. Leaf positions and other geometric parameters can be adjusted to meet the user’s clinical requirements. MLC Fit is not capable of moving the leaves or other parameters to the calculated positions; it only provides the definition of the treatment field as a hardcopy and to a database file.

The primary functions of MLC Fit are, in effect, the same as those of the Philips MLC Prescription Entry System (see Exhibit 3b). Both systems supplement the MLC treatment field definition process only, and do not attempt to control the movement of the defined parameters.

IMPAC Medical Systems, Inc., has gained a reputation of providing high quality software products which serve the cancer therapy community. One reason we have earned this reputation is that we strive to provide end-user process oriented solutions with our products. Another reason is that software development for cancer therapy is our only business. This allows us to stay focused on administering development processes designed specifically for a software business. Strict adherence to these processes will assure that MLC Fit is a safe and effective product suitable for use as intended in a cancer therapy department.

MLC Fit was developed according to IMPAC Medical Systems, Inc.’s approved Software Development Standard (Exhibit 9). This standard governs the process by which systems and software development are to be defined, implemented, tested, released, installed, and supported. In addition, this standard outlines how IMPAC conforms to the Good Manufacturing Practices (GMP) requirement required by the Safe Medical Devices Act of 1990.

Per the guidelines set forth in the Software Development Standard, MLC Fit was developed per Software Requirements Specifications and documented with Software Design Descriptions. Samples of these are shown in Exhibits 4 and 5 for your review.

In addition, a Hazard Analysis was performed to determine and evaluate the areas which represent potentials hazards during MLC Fit operation. For hazards within the scope of the MLC

IMPAC Medical Systems, Inc. - Proprietary/Confidential - Copyright 1996 - All Rights Reserved

{1}

Fit product, the hazard, effect, and protection implemented were documented and reviewed. The System Hazard Analysis is included in Exhibit 6.

IMPAC Medical Systems, Inc. - Proprietary/Confidential - Copyright 1996 - All Rights Reserved