(234 days)
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No
The description focuses on automating a manual calculation process based on user-defined shapes, not on learning from data or using AI/ML algorithms. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device primarily aids in defining and generating treatment field plans for multileaf collimators. It does not directly perform any therapeutic action on the patient (e.g., delivering radiation, affecting the body's structure or function). It is a planning tool, not a therapeutic device.
No
The device's primary function is to define multileaf collimator leaf plans for radiotherapy treatment, not to diagnose a disease or condition. It helps in planning treatment by calculating leaf positions based on a user-defined shape and provides these definitions as hardcopy or data, but it does not analyze patient data for diagnostic purposes.
Yes
The device description explicitly states that 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." This indicates that the device's function is purely computational and data output, without any physical hardware interaction or control of the radiotherapy machine.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that MLC Fit's primary function is 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." It generates data for radiotherapy treatment planning.
- No Biological Samples: There is no mention of the device interacting with or analyzing any biological samples from a patient.
- Focus on Treatment Planning: The entire description revolves around the process of creating and adjusting parameters for a radiotherapy treatment plan, not diagnosing or monitoring a condition through biological analysis.
Therefore, MLC Fit falls under the category of a medical device used in the planning and delivery of radiotherapy treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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
47
1
THE STATE OF THE FORT THE FORM OF THE FOR
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