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This document summarizes the 510(k) premarket notification for the modified MammoSite Radiation Therapy System, detailing its intended use, technological characteristics, and substantial equivalence

How to fill out mammosite radiation formrapy system

How to fill out MammoSite Radiation Therapy System 510(k) Summary

1. Begin by gathering all necessary documentation and information related to the MammoSite Radiation Therapy System.
2. Review the FDA guidelines for 510(k) submissions to ensure compliance.
3. Clearly identify the device and its intended use in the summary.
4. Describe the technological characteristics and intended performance of the MammoSite system.
5. Provide information on the predicate device to demonstrate substantial equivalence.
6. Include data from clinical studies or literature if available to support safety and effectiveness.
7. Outline any potential risks associated with the device and how they are mitigated.
8. Detail the manufacturing process and quality control measures in place.
9. Compose a summary that clearly addresses all the required sections of the 510(k) application.
10. Review the completed summary for accuracy and submit it to the FDA as per their submission protocols.

Who needs MammoSite Radiation Therapy System 510(k) Summary?

1. Healthcare providers who administer radiation therapy.
2. Medical device manufacturers seeking FDA clearance for similar devices.
3. Regulatory affairs professionals involved in device submission processes.
4. Patients considering their treatment options involving MammoSite therapy.

People Also Ask about

What is MammoSite radiation?

(MA-moh-site) A system used to deliver internal radiation therapy to cancer patients after surgery to remove their cancer. MammoSite targets only the part of the where the cancer was found.

Is MammoSite still used?

Ten-year survival rates were 79.0% for low-risk (n = 120), 59.9% for intermediate-risk (n = 430) and 56.8% for high-risk patients (n = 986). A higher age, higher comorbidity score, active smoking and Gleason score ≥8 had a statistically significant negative impact on overall survival at multivariable analysis.

What is the success rate of MammoSite radiation?

This study reports on a single-institution prospective experience of 36 female cancer patients treated with the MammoSite RTS. At a median follow-up of 42 months, there were no in- tumor recurrences. At last follow-up, cosmetic outcome was rated as good or excellent in 94 % of the patients.

What is the success rate of radiation therapy for cancer after mastectomy?

it's completely safe as the radiation is highly targeted, no other organs or tissue is ever at risk. The cosmetic results are tremendous, you don't need new or reconstruction surgery. And when detected early has a 95% success rate.

For pdfFiller’s FAQs

What is MammoSite Radiation Therapy System 510(k) Summary?

The MammoSite Radiation Therapy System 510(k) Summary is a document submitted to the FDA that outlines the device's safety and effectiveness for delivering localized radiation therapy to breast cancer patients via a balloon catheter.

Who is required to file MammoSite Radiation Therapy System 510(k) Summary?

Manufacturers of the MammoSite Radiation Therapy System are required to file the 510(k) Summary with the FDA to demonstrate that their device is safe and effective compared to similar devices already on the market.

How to fill out MammoSite Radiation Therapy System 510(k) Summary?

To fill out the MammoSite Radiation Therapy System 510(k) Summary, manufacturers must follow FDA guidelines, providing detailed specifications about the device, its intended use, technological characteristics, performance data, and any clinical information relevant to supporting the device's safety and effectiveness.

What is the purpose of MammoSite Radiation Therapy System 510(k) Summary?

The purpose of the MammoSite Radiation Therapy System 510(k) Summary is to provide the FDA with necessary information to assess whether the device is substantially equivalent to a predicate device, ensuring it meets safety and effectiveness standards before being marketed.

What information must be reported on MammoSite Radiation Therapy System 510(k) Summary?

The 510(k) Summary must report information such as device description, intended use, technological characteristics, performance testing results, labeling, and any clinical studies that demonstrate the device's safety and efficacy.