(8 days)
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 1 to 3-0, in various lengths affixed to various needle types.
This document describes the premarket notification (510(k)) for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| USP Monograph for Absorbable Sutures: | |
| - Tensile Strength | Conforms to USP monograph |
| - Needle Attachment | Conforms to USP monograph |
| Substantial Equivalence to Predicate Devices: | |
| - In vitro post-hydrolysis tensile testing | Demonstrates substantial equivalence to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for the "test set" in the context of human data or clinical study. The performance testing described is non-clinical laboratory performance testing. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to human subjects is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance is established through non-clinical laboratory testing according to established standards (USP monograph) and direct comparison to predicate devices, not through expert consensus on a test set of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of this device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical suture, not an algorithm or software.
7. The Type of Ground Truth Used
The ground truth used for this device includes:
- USP Monograph Standards: For tensile strength and needle attachment. These are well-defined, established standards for absorbable sutures.
- Predicate Device Performance Data: For in vitro post-hydrolysis tensile testing, the performance of the predicate devices serves as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (suture) and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.