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This document provides a summary of the 510(k) premarket notification for QuillTM Synthetic Absorbable Barbed Suture, detailing device characteristics, equivalency to a predicate device, intended

How to fill out quilltm synformtic absorbable barbed

How to fill out QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary

1. Gather all necessary documentation and materials required for the 510(k) submission.
2. Identify the intended use of the QuillTM Synthetic Absorbable Barbed Suture.
3. Provide a detailed description of the device, including its materials and how it functions.
4. List the indications for use and any contraindications associated with the suture.
5. Compare the QuillTM Suture to a legally marketed predicate device, highlighting similarities and differences.
6. Include results from any biocompatibility, shelf-life, and performance testing conducted.
7. Detail the labeling and proposed marketing materials to be used.
8. Assemble all components into the 510(k) summary format as per FDA guidelines.
9. Review the summary thoroughly to ensure all information is accurate and complete.
10. Submit the 510(k) summary to the FDA.

Who needs QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary?

1. Healthcare providers looking to use QuillTM Synthetic Absorbable Barbed Sutures in surgical procedures.
2. Manufacturers involved in the production and distribution of the QuillTM Suture.
3. Regulatory affairs professionals who manage submissions to the FDA.
4. Patients who may benefit from surgery requiring the use of this suture.

People Also Ask about

How does barbed suture work?

A barbed suture is a type of knotless surgical suture that has barbs on its surface. While suturing tissue, these barbs inside the tissue and lock them into place, eliminating the need for knots to tie the suture.

What are the advantages of barbed sutures?

Conventional suture knots carry the potential risks of knot protrusion, subcutaneous palpable keloid, local microinfarction, breakage, sliding knots, etc. Barbed suture is a suture method that causes less tissue trauma and requires no knot-tying.

How to use barbed suture?

This suture is inserted at the midpoint of a wound and pulled through till resistance is encountered from the opposing barbs; each half of the suture is then advanced to the lateral ends of the wound.

What are the complications of barbed sutures?

The study found the Savage technique strongest, followed by the Triple Kessler, the Double Kessler, and finally the Indiana. The Double Kessler was almost twice as strong as the modified Kessler.

Do barbed sutures dissolve?

The symmetrically anchored design of barbed sutures eliminated the need to tie knots at the end of the suture line. These barbed sutures reduced surgical incision closure time and achieved faster arthrotomy closure times as well as fewer complications compared to conventional sutures.

What are the synthetic absorbable suture?

Synthetic absorbable sutures are made from aliphatic absorbable polyesters and contain one or more of the five basic building blocks: glycolide, L-lactide, p-dioxanone, ε-caprolactone and trimethylene carbonate.

What is the difference between barbed and non barbed sutures?

However, in TKA and unicompartmental knee arthroplasty (UKA), barbed sutures can increase postoperative incision complications, including effusion, superficial infection, deep infection, dehiscence, and skin necrosis [4,5].

For pdfFiller’s FAQs

What is QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary?

The QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary is a document submitted to the FDA to demonstrate the safety and effectiveness of the suture, which features barbed edges for easier tissue approximation without the need for knots.

Who is required to file QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary?

Manufacturers of the QuillTM Synthetic Absorbable Barbed Suture are required to file the 510(k) Summary with the FDA to obtain premarket clearance before marketing the product.

How to fill out QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary?

To fill out the QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary, manufacturers must provide detailed information about the device, its intended use, technological characteristics, and results from any required testing.

What is the purpose of QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary?

The purpose of the 510(k) Summary is to inform the FDA and the public about the device's safety and effectiveness, thereby allowing for regulatory oversight and ensuring the product meets established medical standards.

What information must be reported on QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary?

The QuillTM Synthetic Absorbable Barbed Suture 510(k) Summary must report information including device description, intended use, comparative analysis with predicate devices, sterilization methods, labeling, and clinical or non-clinical testing results.