(48 days)
Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
The Quill® Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths (minimum opposing barbed segment of 1 3/8" x 1 3/8") and needle configurations. The Quill® Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissue.
The Quill® Synthetic Absorbable 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® Synthetic Absorbable Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quil® Synthetic Absorbable Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
The Quill® Synthetic Absorbable Barbed Suture is indicated for use in soft tissue approximation. The provided text doesn't explicitly define numerical acceptance criteria for a new device's performance (e.g., specific tensile strength thresholds or degradation rates). Instead, it establishes substantial equivalence based on a comparison to predicate devices, supported by various studies.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit numerical acceptance criteria are not stated for a distinct "new device" but rather for equivalence, the table below reflects the types of performance data used to demonstrate safety and effectiveness relative to predicates.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Summary from Text) |
|---|---|
| Biocompatibility: Device material is safe for biological contact. | Biocompatibility data provided. |
| Functional Performance (Simulated Use): Device performs as intended in simulated surgical conditions. | Simulated use evaluation provided. |
| Barb Holding & Absorption: Barbs effectively hold tissue, and suture degrades as expected. | Results of in vivo barb holding and absorption assessments provided. Degrades or dissolves over time in tissue. Barbs imbed in tissues. |
| In Vivo Performance (Animal Studies): Device is safe and effective in living organisms. | Results of in vivo animal studies provided. |
| Clinical Performance (Human Studies): Device is safe and effective in human use. | Human clinical trial results provided. |
| Technological Characteristics: Comparable technique of deployment and tissue approximation mechanism. | Subcuticular placement: needle captures a precise bite on each side of the incision. Bi-directional barbs along the long axis of the suture monofilament catch and cinch to approximate the tissue without the need for a knot, similar to an interrupted suture. This is compared to: Contour Midface Opposing Uni-directional Thread (needle placement/introducer, opposing unidirectional cogs) and Insorb™ Absorbable Staple (mechanically placed, cleats of u-shaped staple). |
| Material Safety: Material is as safe as predicate device. | Equivalent in material to predicate (Quill® Synthetic Absorbable Barbed Suture, K042075). Polydioxanone is well-characterized. |
2. Sample Size for Test Set and Data Provenance:
The provided text does not specify the sample sizes or provenance (country of origin, retrospective/prospective) for the test sets in the biocompatibility data, simulated use evaluation, in vivo barb holding and absorption assessments, in vivo animal studies, or human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the text.
4. Adjudication Method for the Test Set:
This information is not provided in the text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of an MRMC comparative effectiveness study, or human readers improving with/without AI assistance, is made. This is an absorbable suture, not an AI-based diagnostic device.
6. Standalone (Algorithm Only) Performance Study:
Not applicable, as this is a physical medical device (suture), not an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating safety and effectiveness appears to be based on a combination of:
- Biocompatibility standards/testing: Chemical and biological inertness.
- Mechanical and functional performance testing: Demonstrating the physical properties and how the suture functions (barb holding, approximation).
- In vivo observations (animal studies): Direct biological response and functional outcome in living tissue.
- Clinical outcomes (human clinical trials): Safety and efficacy observed in human patients.
8. Sample Size for the Training Set:
Not applicable, as this is a physical medical device. There is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is a physical medical device.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.