(84 days)
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No
The description focuses on manual input and geometric manipulation, with no mention of AI/ML terms or learning processes.
No
The device, MLC Beam Shaper software, is an accessory that helps create and edit geometric information for radiation treatment fields. It is used to generate treatment field shapes for the Siemens Digital MEVATRON radiation treatment system but does not directly deliver therapy itself. Therefore, it is not a therapeutic device.
No
This device is used to shape radiation treatment fields based on existing geometric information, not to diagnose medical conditions or identify diseases. It's an accessory for a radiation treatment system.
No
The device description explicitly mentions a "digitizer tablet for inputting leaf positions," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is used to "create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes." This describes a tool for planning and shaping radiation therapy, which is a treatment process, not a diagnostic process performed in vitro (outside the body).
- Device Description: The description details how the software uses a digitizer tablet to input leaf positions based on x-ray film or paper diagrams to generate Multileaf Collimator leaf plans. This is related to treatment planning and delivery, not in vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro tests.
The device is an accessory to a radiation treatment system and is used for shaping the radiation beam for therapeutic purposes. This falls under the category of a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system.
Product codes
RA 90 IXI
Device Description
Beam Shaper consists of a digitizer tablet for inputting leaf positions based on field shapes traced from an x-ray film or paper diagram to generate Multileaf Collimator leaf plans. In specifying field geometry, Beam Shaper utilizes leaf, jaw collimator, and gantry position information.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray film
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
Performance tests were conducted and the results indicated that the levice consistently performed within the design parameters and equivalently to the predicate levice.
Key Metrics
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Predicate Device(s)
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
K9619C
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter's Information: | Dated: May 13, 1996 |
|---|---|
| AUG - 8 1996 | |
| Siemens Medical Systems | |
| Oncology Care Systems Group | |
| 4040 Nelson Avenue | |
| Concord, CA 94520 | |
| Contact Person: | Kenneth R. Michael, Pharm.D. |
| Vice President Regulatory Affairs and Quality Assurance | |
| Common or Usual Name: | Radiation therapy beam shaping block |
| Proprietary Name: | Siemens Multileaf Collimator Beam Shaper |
| Classification Names: | Radiation therapy beam shaping block - 21 CFR § 892.5710 |
| Class II, Product Code: RA 90 IXI | |
| Predicate Device: | Siemens Multileaf Collimator Hand Control |
| K953894 |
Description of Device: Beam Shaper consists of a digitizer tablet for inputting leaf positions based on field shapes traced from an x-ray film or paper diagram to generate Multileaf Collimator leaf plans. In specifying field geometry, Beam Shaper utilizes leaf, jaw collimator, and gantry position information.
Statement of intended use: The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system.
The intended use is the same the predicate device.
Statement of technological characteristics: The Siemens Multileaf Collimator Beam Shaper software does not have significant change in materials, energy source or performance characteristics compared to the predicate devices.
The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
Differences: The minor configuration and specification differences between the Siemens Multileaf Collimator Beam Shaper software and that of the MLC hand control does not alter the intended use or affect the safety and effectiveness of the Siemens Multileaf Collimator Beam Shaper when used as labeled.
?erformance Evaluation: Performance tests were conducted and the results indicated that the levice consistently performed within the design parameters and equivalently to the predicate levice.
dical Systems, Inc.
tems
4040 Nelson Avenue Concord, CA 94520
Tel: (510) 246-8200 FAX (510) 246-8284