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This document provides a 510(k) summary for the SYSTEM IE Liquid Chemical Sterilant Processing System, detailing its intended use, device description, and safety and equivalence to predicate devices.

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How to fill out SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary

1. Gather all relevant data regarding the SYSTEM IE Liquid Chemical Sterilant Processing System.
2. Ensure that you have clinical data and any preclinical data required for the submission.
3. Fill out the 510(k) summary form with specific details about the product, including its intended use and a description of the device.
4. Include information about the device’s materials, design, and how it operates.
5. Insert a table comparing the SYSTEM IE to predicate devices, highlighting similarities and differences.
6. Provide summaries of any performance testing results, including efficacy and safety data.
7. Attach labeling and promotional materials that will be used with the product.
8. Review the summary for accuracy and completeness before submission.

Who needs SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary?

1. Manufacturers of liquid chemical sterilants seeking FDA clearance for marketing.
2. Regulatory affairs professionals responsible for product submissions.
3. Healthcare facilities looking to adopt new sterilization technologies.
4. Quality assurance teams ensuring compliance with regulatory standards.

People Also Ask about

What is the chemical sterilant used in the STERIS method of sterilizing?

VHP sterilization technology from STERIS utilizes Vaprox® Hydrogen Peroxide Sterilant to achieve product and package surface sterilization, validated to SAL 10-6 in ance with ISO14937. Vaprox Hydrogen Peroxide Sterilant is a specially formulated, stabilized, high-purity, 35% aqueous hydrogen peroxide solution.

What is the liquid chemical sterilization method?

Liquid chemical sterilization involves a two-part process: Devices are treated with a liquid chemical germicide (LCG). The processed devices are rinsed with water to remove the chemical residues.

What type of sterilant is used in the STERIS sterilization system?

VHP sterilization technology from STERIS utilizes Vaprox® Hydrogen Peroxide Sterilant to achieve product and package surface sterilization, validated to SAL 10-6 in ance with ISO14937. Vaprox Hydrogen Peroxide Sterilant is a specially formulated, stabilized, high-purity, 35% aqueous hydrogen peroxide solution.

What is liquid chemical sterilant processing?

Liquid chemical sterilization (LCS) is used to liquid chemically sterilize heat-sensitive, immersible, reusable medical devices. When a device is liquid chemically sterilized, it is completely immersed in an active sterilant solution for a prescribed period of time at a controlled temperature and concentration.

What is the most common chemical sterilant?

Although Ethylene Oxide is the most commonly used chemical for sterilization of devices, other chemicals are also used, and novel methodologies are being developed.

What type of sterilant is used in the STERIS sterilization system?

The SYSTEM 1 endo Processor ensures that S40 Sterilant use dilution reaches all parts of medical devices, including port surfaces commonly shielded from germicide contact in Automated Endoscope Reprocessors (AERs) with tight-fitting adapters.

How long does liquid chemical sterilization take?

Liquid Chemicals The indicated contact times range from 3 hours to 12 hours. However, except for a few of the products, the contact time is based only on the conditions to pass the AOAC Sporicidal Test as a sterilant and not on simulated use testing with devices.

What is the chemical sterilant used in the STERIS method of sterilizing?

The SYSTEM 1 endo Processor ensures that S40 Sterilant use dilution reaches all parts of medical devices, including port surfaces commonly shielded from germicide contact in Automated Endoscope Reprocessors (AERs) with tight-fitting adapters.

For pdfFiller’s FAQs

What is SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary?

The SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary is a document submitted to the FDA that provides information about a specific medical device, which in this case is the SYSTEM IE Liquid Chemical Sterilant Processing System. The summary includes details about the device's intended use, technological characteristics, and performance testing.

Who is required to file SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary?

Manufacturers or companies that intend to market the SYSTEM IE Liquid Chemical Sterilant Processing System are required to file the 510(k) Summary with the FDA. This is part of the premarket notification process for medical devices.

How to fill out SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary?

To fill out the SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary, manufacturers should provide relevant information including device identification, proposed labeling, intended use, descriptions of technological characteristics, and results of any performance testing. They must adhere to FDA guidelines for formatting and content.

What is the purpose of SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary?

The purpose of the SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary is to demonstrate to the FDA that the device is safe and effective for its intended use and is substantially equivalent to a legally marketed device.

What information must be reported on SYSTEM IE Liquid Chemical Sterilant Processing System 510(k) Summary?

The information that must be reported includes the device's name, trade name, manufacturer details, intended use, description of the technology, labeling, summary of safety and effectiveness, and any clinical or non-clinical performance data.