(88 days)
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No
The summary does not mention AI, ML, or related concepts, and the device description focuses on mechanical and control components typical of a traditional multileaf collimator.
Yes
The device is intended for use in radiation therapy, which is a therapeutic medical procedure.
No
Explanation: The device is described as a Multileaf collimator for radiation therapy, which is a treatment delivery device, not a diagnostic one.
No
The device description explicitly lists hardware components such as the collimator assembly, accessory tray, electron applicators, and the accelerator radiation head.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "radiation therapy." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a device used to shape and control radiation beams for treating patients, which is consistent with radiation therapy equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on delivering radiation for treatment.
N/A
Intended Use / Indications for Use
The Saturne Multileaf collimator is intended to be used for radiation therapy.
Product codes
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Device Description
The Multileaf collimator consists of the collimator assembly, a collimator accessory tray and electron applicators, collimator control and display functions on the Saturne operator console, and a Treatment Preparation Console and film digitizer. The accelerator radiation head and Multileaf collimator are assembled in a rotating gantry fastened to a wall. The existing treatment couch is used to support and position the patient.
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
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Key Metrics
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Predicate Device(s)
Multileaf collimators produced by Varian Associates and Philips Medical Systems
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are decorative swirls around the outside of the circle.
GE Medical Svstems
Genera! Electric Company 20 Box 414 Milwaukee. WI 53201
APR 25 1997
SUMMARY OF SAFETY AND EFFECTIVENESS January 9, 1997
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Contact: Larry A. Kroger, Ph.D. Phone - 414-544-3894 Fax - 414-544-3863
Identification of Product The Multileaf Collimator Option is a versatile therapy beam collimation system designed for use on GE Saturne medical charged-particle radiation therapy systems. It is manufactured by GE Medical Systems Europe, 283 Rue de la Miniere, 78530 Buc. France and is distributed by GE Medical Systems, Milwaukee, WI.
Marketed Devices The current family of Saturne therapy systems uses rectangular field collimators in combination with external beam blockers to contour the treatment field to the desired shape. The Multileaf collimator will permit the use of irregular treatment field shapes to better conform the treatment field to the desired shape without external beam blockers for some treatments.
Device Description The Multileaf collimator consists of the collimator assembly, a collimator accessory tray and electron applicators, collimator control and display functions on the Saturne operator console, and a Treatment Preparation Console and film digitizer. The accelerator radiation head and Multileaf collimator are assembled in a rotating gantry fastened to a wall. The existing treatment couch is used to support and position the patient.
Indications for Use The Saturne Multileaf collimator is intended to be used for radiation therapy.
Comparison with Predicate Saturne Multileaf collimators perform the same function as Multileaf collimators produced by Varian Associates and Philips Medical Systems, Other device characteristics are either the same or comparable for the various collimator systems.
Conclusion It is the opinion of GE Medical Systems that Saturne Multileaf collimators are substantially equivalent to the named predicate devices based on the similarities in operation and intended use. The Saturne Multileaf collimators are as safe and perform as well as the predicate devices and raise no new questions of safety or effectiveness.
100 Years of Radiology
100 Years of Radiology 1895 - 1995