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This document serves as a summary for the 510(k) premarket notification regarding the 0.9% Sodium Chloride Flush Syringe, detailing its intended use, regulatory classification, and indications for

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How to fill out 510(k) Summary for 0.9% Sodium Chloride Flush Syringe

1. Begin by gathering all relevant information about the 0.9% Sodium Chloride Flush Syringe, including its intended use and composition.
2. Identify and define the device's classification and provide the appropriate classification regulation number.
3. Collect data from preclinical and clinical studies that demonstrate the safety and effectiveness of the syringe.
4. Draft a description of the device, including its design, materials, and features.
5. Include labeling information, instructions for use, and any promotional materials.
6. Compare the device to a legally marketed predicate device, highlighting similarities and differences.
7. Summarize any performance testing results and provide supporting documentation.
8. Ensure that quality system regulations (QSR) compliance documentation is prepared.
9. Review the summary for completeness and accuracy before submission.
10. Submit the 510(k) Summary and pay the applicable user fee to the FDA.

Who needs 510(k) Summary for 0.9% Sodium Chloride Flush Syringe?

1. Manufacturers or distributors of 0.9% Sodium Chloride Flush Syringes seeking market clearance.
2. Healthcare providers and institutions intending to use or recommend the device.
3. Regulatory affairs professionals working within companies that produce the syringe.

People Also Ask about

What are saline syringes used for?

A saline flush is a mixture of salt and water that is compatible with your body's fluids and tissues. It is used to push any residual medication or fluid through the IV line and into your vein. This keeps the PIV line clean and reduces the risk of infection or occlusion.

What is sodium chloride 0.9% flush for?

A flush refers to a solution of 0.9% sodium chloride (normal saline) injected to clear or 'rinse' the catheter of blood or fibrin build‐up. This is commonly used when the catheter is accessed, between administration of medications, or before and after collection of blood specimens.

What are sodium chloride flushes used for?

Sodium chloride flush is used to clean out an intravenous (IV) catheter, which helps prevent blockage and removes any medicine left in the catheter area after you have received an IV infusion.

What is the purpose of using sodium chloride?

Sodium chloride is an essential nutrient and is used in healthcare to help prevent patients from becoming dehydrated. It is used as a food preservative and as a seasoning to enhance flavor. Sodium chloride is also used in manufacturing to make plastics and other products.

What do nurses use sodium chloride for?

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

What are sodium chloride syringes used for?

Description. Sodium chloride 23.4% injection is used to replenish lost water and salt in your body due to certain conditions (eg, hyponatremia or low salt syndrome). It is also used as an additive for total parenteral nutrition (TPN) and carbohydrate-containing IV fluids.

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What is 510(k) Summary for 0.9% Sodium Chloride Flush Syringe?

The 510(k) Summary for 0.9% Sodium Chloride Flush Syringe is a document submitted to the FDA that demonstrates the device's safety and effectiveness based on substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary for 0.9% Sodium Chloride Flush Syringe?

Manufacturers intending to market a 0.9% Sodium Chloride Flush Syringe must file a 510(k) Summary to indicate that their device is substantially equivalent to an existing product.

How to fill out 510(k) Summary for 0.9% Sodium Chloride Flush Syringe?

To fill out the 510(k) Summary for a 0.9% Sodium Chloride Flush Syringe, manufacturers must include information on the device description, intended use, comparison to predicate devices, performance testing results, labeling, and any other relevant information supporting safety and efficacy.

What is the purpose of 510(k) Summary for 0.9% Sodium Chloride Flush Syringe?

The purpose of the 510(k) Summary is to ensure that the device meets the FDA's safety and effectiveness standards and provides the necessary information for regulatory review.

What information must be reported on 510(k) Summary for 0.9% Sodium Chloride Flush Syringe?

The information reported in the 510(k) Summary must include the device name, description, intended use, manufacturing details, labeling, performance data, and a comparison with a predicate device, among other necessary details.