(88 days)
K/DEN number: Not Found
Not Found
No
The description focuses on the mechanical and control aspects of the device (collimator, motor drives, control console) and does not mention any AI or ML algorithms for decision-making, control, or data processing. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a component (Dynamic Wedge system) of a linear accelerator used for external beam radiotherapy, specifically designed to shape the radiation field. It is not directly therapeutic itself but modifies the output of a therapeutic device (linear accelerator) to achieve an effective isodose curve.
No
The device is described as a system for external beam radiotherapy, designed to create effective isodose curves and replace traditional hard wedges in treatment delivery. It modifies the radiation field during treatment and does not perform any diagnostic function.
No
The device description explicitly lists multiple hardware components including the collimator, motor drive unit (MDU), local control equipment (LCE), control console, and data management equipment (DME).
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 Dynamic Wedge system is described as a component used with linear accelerators for external beam radiotherapy. Its purpose is to shape the radiation beam to create effective isodose curves, replacing traditional physical wedges. This is a treatment delivery system, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use clearly states it's for use with linear accelerators to provide effective isodose curves and replace hard wedges, which is a function related to radiation therapy treatment planning and delivery.
Therefore, the Dynamic Wedge system falls under the category of a medical device used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Dynamic Wedge system is intended to be used with MLC and Mitsubishi linear accelerators with computerized consoles to provide the effective isodose curve and replace the need for traditional hard wedges.
Product codes
Not Found
Device Description
This submission is intended to be applicable to the Dynamic Wedge system which can be used with multileaf collimator system on Mitsubishi linear accelerators for external beam radiotherapy. The Dynamic Wedge system is designed to create effective isodose curve by using collimator leaf drive during irradiation. The Dynamic Wedge system consists of the collimator, motor drive unit (MDU), local control equipment (LCE) located in the treatment room, control console, and data management equipment (DME).
The collimator consists of two sets of jaws which determines the field size and shape. The upper jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The upper jaws move in tandem and determine the field length.
The lower set of jaws consist of 31 pairs of leaves (62 leaves).
Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
EXL series of Mitsubishi Linear Accelerators
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
a da m
510 (k) SUMMARY
MITSUBISHI LINEAR ACCELERATORS EXL SERIES
MAY 1 2 1997
1. Submitter:
The 510 (k) is submitted by Mr. Hideyuki Kawakami, Sales Manager, Medical Systems Division, Mitsubishi Electronics America, Inc., Two Tower Bridge, 1 Fayette Street, Suite 100. Conshohocken, PA 19428. This 510 (k) summary was prepared on February 6, 1997.
2. Device Name:
The 510 (k) submission is for Mitsubishi Dynamic Wedge system, an additional function to Mitsubishi multileaf collimator (MLC) as well as the conventional monoblock collimator.
The predicate device is legally marketed, having been found to be substantially equivalent through the 510 (k) premarket notification process.
3. Predicate device:
The devices described in this submission are considered to be substantially equivalent to the EXL series of Mitsubishi Linear Accelerators utilizing klystron and magnetron power supplies and conventional hard-wired control consoles. The predicate device are legally marketed, having been found to be substantially equivalent through the 510 (k) premarket notification process.
4. Device description:
This submission is intended to be applicable to the Dynamic Wedge system which can be used with multileaf collimator system on Mitsubishi linear accelerators for external beam radiotherapy. The Dynamic Wedge system is designed to create effective isodose curve by using collimator leaf drive during irradiation. The Dynamic Wedge system consists of the collimator, motor drive unit (MDU), local control equipment (LCE) located in the treatment room, control console, and data management equipment (DME).
The collimator consists of two sets of jaws which determines the field size and shape. The upper jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The upper jaws move in tandem and determine the field length.
The lower set of jaws consist of 31 pairs of leaves (62 leaves).
Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
5. Intended use:
The Dynamic Wedge system is intended to be used with MLC and Mitsubishi linear accelerators with computerized consoles to provide the effective isodose curve and replace the need for traditional hard wedges.
1
- Comparison of technological characteristics:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This submission describes the modification of existing Mitsubishi MLC system by adding data management equipment (DME) to transfer treatment data for Dynamic Wedge. Monoblock type collimator can also be used by simply deleting functions to control lower leaves for MLC system.