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This document contains the 510(k) premarket notification summary for the OsteoCool RF Ablation System, detailing its intended use, device description, submission information, and equivalency to predicate
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How to fill out osteocool rf ablation system
How to fill out OsteoCool RF Ablation System 510(k) Summary
01
Gather relevant preclinical and clinical data supporting the efficacy and safety of the OsteoCool RF Ablation System.
02
Outline the description of the device, including its intended use and technological characteristics.
03
Include comparisons to legally marketed devices, highlighting similarities and differences.
04
Provide labeling information, including instructions for use, indications, contraindications, warnings, and precautions.
05
Document the manufacturing information, including the facilities involved and their compliance with quality system regulations.
06
Prepare a risk analysis to identify and mitigate potential hazards associated with the device.
07
Compile and summarize all data in a clear and concise summary format as specified by FDA requirements.
Who needs OsteoCool RF Ablation System 510(k) Summary?
01
Medical device manufacturers seeking clearance for the OsteoCool RF Ablation System.
02
Healthcare professionals and stakeholders involved in the development and assessment of medical devices.
03
Regulatory affairs specialists responsible for preparing and submitting 510(k) summaries to the FDA.
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People Also Ask about
What is OsteoCool ablation?
Medtronic OsteoCool™ RF ablation is a minimally invasive procedure that allows your doctor to deliver ablation energy to the precise size and location of your tumor. It uses alternating, low power current to generate heat during the procedure.
What is RF ablation system?
Radiofrequency ablation, or RFA, is a minimally invasive technique that shrinks the size of tumors, nodules or other growths in the body. RFA is used to treat a range of conditions, including benign and malignant tumors, chronic venous insufficiency in the legs, as well as chronic back and neck pain.
What is the downside of radiofrequency ablation?
Complete Guide To Radiofrequency Ablation Cost With the average cost ranging between $10,000-$15,000, it is a typically more affordable procedure. The procedure involves inserting a thin needle that acts as an electrode; it is inserted under the guidance of an X-ray, Ultrasound, or CT Scan.
What is an osteocool procedure?
The Osteocool procedure is a minimally invasive treatment for painful bone tumors that offers several benefits over traditional surgery. It uses heat to destroy cancer cells in the tumor while leaving surrounding healthy tissue unharmed, and has a low risk of complications.
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What is OsteoCool RF Ablation System 510(k) Summary?
The OsteoCool RF Ablation System 510(k) Summary is a document submitted to the FDA that outlines the safety and effectiveness of the OsteoCool RF Ablation System, which is used for palliative treatment of pain from bone metastatic disease.
Who is required to file OsteoCool RF Ablation System 510(k) Summary?
Any manufacturer or sponsor of the OsteoCool RF Ablation System intending to market the device in the United States is required to file the 510(k) Summary with the FDA.
How to fill out OsteoCool RF Ablation System 510(k) Summary?
To fill out the OsteoCool RF Ablation System 510(k) Summary, the manufacturer must provide detailed information about the device, including descriptions of the device, intended use, technological characteristics, and data demonstrating safety and effectiveness.
What is the purpose of OsteoCool RF Ablation System 510(k) Summary?
The purpose of the OsteoCool RF Ablation System 510(k) Summary is to demonstrate to the FDA that the device is substantially equivalent to a legally marketed predicate device, thereby allowing for its clearance to be marketed in the United States.
What information must be reported on OsteoCool RF Ablation System 510(k) Summary?
The information that must be reported includes device identification, intended use, description of the device, any performance testing results, summaries of preclinical and clinical studies, and comparisons to predicate devices.
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