Search Results

Quill® Nonabsorbable Nylon Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.

The Ouill® Nonabsorbable Nylon Barbed Suture is a monofilament, flexible thread prepared from long chain aliphatic polymers Nylon 6 and Nylon 6,6 (per 21 CFR 878.5020). It is available sterile, dyed black (logwood extract per 21 CFR 73.1410), dyed blue (FD&C Blue No. 2 per 21 CFR 74.3102) or undyed in various suture diameters, lengths and needle configurations in USP Sizes 2, 1, 0, 2-0, 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.

The Quill® Nonabsorbable Nylon Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Nylon Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Nylon Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

The Quill® Nonabsorbable Nylon Barbed Suture is a medical device and doesn't involve AI/ML. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.

However, based on the provided 510(k) summary, here's an analysis of its acceptance criteria and how the device meets them, focusing on the equivalence established for this type of medical device:

Acceptance Criteria and Device Performance

The acceptance criteria for the Quill® Nonabsorbable Nylon Barbed Suture are established through demonstrating substantial equivalence to legally marketed predicate devices. This equivalence is based on:

• Identical Intended Use: Soft tissue approximation, excluding closure of the epidermis.
• Similar Technological Characteristics: Using barbs to secure tissue, obviating the need for knots.
• Identical Material: Nylon.
• Identical Sterilization and Packaging Methods.

The following table summarizes the comparison:

Study Information (Based on 510(k) Summary)

For non-AI medical devices following the 510(k) pathway, "studies" often refer to comparative analyses, biocompatibility testing (if new materials), and mechanical testing, rather than clinical efficacy trials akin to drug approval or AI model validation studies. The provided document focuses entirely on demonstrating substantial equivalence.

Here's an assessment based on the available information:

1. Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here is primarily the comparison against predicate device characteristics.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for equivalence is established by regulatory standards and existing device classifications.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device, not an AI/ML algorithm.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used:
   • Regulatory Standards and Predicate Device Data: The "ground truth" for this submission is based on the characteristics, safety, and effectiveness profiles of the legally marketed predicate devices and established regulatory requirements for nonabsorbable surgical sutures (21 CFR 878.5020). The predicates have already demonstrated safety and effectiveness through their prior market clearance.
7. The sample size for the training set: Not applicable, as this is not an AI/ML algorithm device.
8. How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the 510(k) Summary:

The manufacturer, Quill Medical, believes the Quill® Nonabsorbable Nylon Barbed Suture is substantially equivalent to the identified predicate devices based on its design, material, function, and intended use. The key arguments for equivalence are:

• Identical intended use (soft tissue approximation) to all predicates.
• Identical barbed technology for tissue approximation as the Quill® Nonabsorbable Polypropylene Barbed Suture (K052373).
• Identical material (Nylon) to the Nonabsorbable Nylon Surgical Sutures by Surgical Specialties Corp. (K930825) and GramsMed, LLC (K003000), which are well-established materials known to be biocompatible and safe for medical applications.

The FDA's letter (K052900) confirms their review of the submission and their determination that the device is substantially equivalent to legally marketed predicate devices, allowing the device to be marketed. This decision indicates that the FDA agreed with the manufacturer's assessment that the device meets the necessary acceptance criteria through its comparison to the predicates and does not raise new questions of safety or effectiveness.

Ask a specific question about this device