(171 days)
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No
The summary describes a treatment planning software for brachytherapy that calculates dose distribution and dwell times based on applicator placement and imaging data. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The functionality described is typical of traditional treatment planning systems.
No
The device is a software application for dose distribution planning, not a device that directly administers therapy. It works with a therapeutic device (VariSource High Dose Rate Remote Afterloader) but is not therapeutic itself.
No.
The device is described as a treatment planning system for radiation therapy, specifically designed to shape dose distribution and calculate dwell times for an afterloader. It does not identify or diagnose a disease or condition.
Yes
The device is described as a "Windows NT software application" and its function is treatment planning and dose calculation, which are software-based tasks. While it works with a hardware device (the VariSource Remote Afterloader), the 510(k) summary focuses solely on the software's capabilities and does not describe any hardware components of the CADPLAN BT itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow the dose distribution of an applicator to be individually shaped for each patient" and "allow for calculation of the dwell time of the catheter." This is a treatment planning function, not a diagnostic function.
- Device Description: It's a software application designed to work with a remote afterloader for radiotherapy. This further reinforces its role in treatment delivery planning.
- Input Imaging Modality: While it uses radiograph imaging, this imaging is used for planning the delivery of radiation therapy, not for diagnosing a disease or condition from a biological sample.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not analyze any biological samples.
In summary, CADPLAN BT is a medical device used for radiotherapy treatment planning, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient.
Product codes
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Device Description
CADPLAN BT is a Windows NT software application that is designed to work together with the VariSource High Dose Rate Remote Afterloader. It allows for applicator placement for up to 20 channels, and allows dose distribution of an applicator to be individually shaped for each patient. It also allows for calculation of the dwell time of the catheter.
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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
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- Submitter: Varian Oncology Systems MAR 1 5 1996 911 Hansen Way Palo Alto, CA 94304 (415) 424-5036 Contact: Charles H. Will, Manager Regulatory Compliance & Safety Prepared: September 15, 1995 2. Device Name: CADPLAN BT 3. Predicate Varian VariSource Treatment Planning System Device: 510(k) Notification 945383 (Varian VariSource High Dose Rate Remote Afterloader) Cleared February 15, 1995 4. Device CADPLAN BT is a Windows NT software application that is designed to work together with the VariSource High Dose Rate Remote Afterloader. It allows for applicator placement for up to 20 channels, and allows dose distribution of an applicator to be individually shaped for each patient. It also allows for calculation of the dwell time of the catheter. 5. Intended Use: CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient. 6. Technological Both CADPLAN BT and VariSource Treatment Planning Characteristics System have plan and multiple plan dose calculation. radiograph imaging definition that support's stereoshifted and orthogonal films and a linear source model for IR-192. Natural dose volume histogram can be calculated manually from normal dose volume histogram in both systems. CADPLAN BT calculates the geometricallyoptimal dwell times through the software, whereas with the VariSource Treatment Planning System these dwell times must be calculated manually.