Get the free 510(k) Summary for STERIS® 5085 SRT - accessdata fda
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This document summarizes the 510(k) premarket notification for the STERIS® 5085 SRT surgical table, detailing its intended use, safety, and regulatory compliance.
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How to fill out 510k summary for steris
How to fill out 510(k) Summary for STERIS® 5085 SRT
01
Gather product information: Collect details about the STERIS® 5085 SRT, including its intended use, design specifications, and labeling.
02
Determine the predicate device: Identify a legally marketed device that is similar to the STERIS® 5085 SRT and can serve as a predicate for comparison.
03
Provide device description: Include a description of the STERIS® 5085 SRT, highlighting its features, functionality, and intended patient population.
04
Summarize technological characteristics: Detail the technological characteristics of the STERIS® 5085 SRT and compare them with those of the predicate device.
05
Assess performance testing: Document any performance testing conducted, including the methods used, results obtained, and their relevance to safety and effectiveness.
06
Include labeling: Provide copies of the proposed labeling for the STERIS® 5085 SRT, including instructions for use, indications, and contraindications.
07
Compile information for submission: Organize all compiled information into a clear and concise format, ready for submission to the FDA as part of the 510(k) application.
Who needs 510(k) Summary for STERIS® 5085 SRT?
01
Manufacturers of the STERIS® 5085 SRT must submit a 510(k) Summary as part of the premarket notification process to the FDA.
02
Healthcare providers and professionals who use the STERIS® 5085 SRT may benefit from understanding the 510(k) Summary for safety and efficacy.
03
Regulatory affairs specialists and compliance officers involved in medical device approvals need the 510(k) Summary to ensure the product meets regulatory standards.
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What is 510(k) Summary for STERIS® 5085 SRT?
The 510(k) Summary for STERIS® 5085 SRT is a document submitted to the FDA that demonstrates that the device is safe and effective for its intended use. It provides a summary of the device's characteristics, performance, and any clinical data that may support its regulatory status.
Who is required to file 510(k) Summary for STERIS® 5085 SRT?
The manufacturer or the importer of the STERIS® 5085 SRT is required to file the 510(k) Summary. This includes any entity that intends to market the device in the United States.
How to fill out 510(k) Summary for STERIS® 5085 SRT?
To fill out the 510(k) Summary for STERIS® 5085 SRT, the applicant must follow the FDA's guidelines for format and content, including device description, intended use, performance testing results, and any comparison to predicate devices. Templates provided by the FDA can be utilized for this process.
What is the purpose of 510(k) Summary for STERIS® 5085 SRT?
The purpose of the 510(k) Summary is to provide evidence to the FDA that the STERIS® 5085 SRT is substantially equivalent to a legally marketed device, ensuring that it meets safety and effectiveness requirements for public health.
What information must be reported on 510(k) Summary for STERIS® 5085 SRT?
The information that must be reported on the 510(k) Summary includes device identification, regulatory information, intended use, device description, performance data, labeling information, and any clinical data supporting the claims made about the device.
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