(154 days)
MONOCRYL™ Plus Antibacterial Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MONOCRYL™ Plus Antibacterial Suture is a sterile, monofilament, synthetic, absorbable surgical suture composed of a copolymer of glycolide and (epsilon) s-caprolactone. The empirical formula of the polymer is (C2H2O2)m (C6H102)n.
MONOCRYL™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2
MONOCRYL™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m.
This document is a 510(k) premarket notification for a medical device called MONOCRYL™ Plus Antibacterial Suture. It seeks to demonstrate substantial equivalence to a previously cleared device. Therefore, the information provided focuses on the equivalence of the modified device to its predicate, rather than detailing a de novo study to establish acceptance criteria and prove performance against them as would be typical for a novel device or AI/software.
Based on the provided text, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific 510(k) submission:
Understanding the Context:
This submission (K201996) is for a modified device (MONOCRYL™ Plus Antibacterial Suture) that is largely identical to a predicate device (MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 with 510(k) number K050845). The only reported changes are to the labeling, specifically updating in vitro effectiveness against an additional microorganism and including new descriptors/icons.
For a 510(k) involving minor changes, the "acceptance criteria" revolve around demonstrating that the modified device remains as safe and effective as the predicate, or that the changes do not raise new questions of safety or effectiveness. The "study" in this context refers to the data presented to support this claim, rather than a clinical trial for a new product.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a modified device essentially claiming no change in technological characteristics, the "acceptance criteria" are implicitly that the modified device retains the performance attributes of the predicate. The "reported device performance" is essentially a reaffirmation of the predicate's performance, along with specific in vitro data for the antibacterial claims.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| For Suture Material: | |
| - Same technological characteristics as predicate (composition, structure, absorbability) | "The modified MONOCRYL™ Plus Suture has the same technological characteristics as the predicate device... it is a sterile, monofilament synthetic absorbable suture composed of a copolymer of glycolide and (epsilon) s-caprolactone." |
| - Compliance with USP standards for absorbable surgical sutures | "complies with the requirements of the United States Pharmacopoeia (USP) for absorbable surgical sutures except for a slight oversize in diameter." (This exception is noted as existing for the predicate as well, implying continued equivalence.) |
| For Antibacterial Efficacy: | |
| - Contains Irgacare®† MP (triclosan) at specified concentration | "MONOCRYL™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m." |
| - Inhibit colonization of specified bacteria | "In vitro efficacy studies were conducted to demonstrate that bacteria will not colonize MONOCRYL™ Plus Antibacterial suture. The in vitro data indicated that MONOCRYL™ Plus suture provides an antibacterial effect sufficient to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin-Resistant S. aureus, Methicillin-Resistant S. epidermidis, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae." |
| For Intended Use/Indications: | |
| - Same intended use and indications for use as predicate | "The modified device has the same intended use and indications for use as the predicate device." (General soft tissue approximation/ligation, not for cardiovascular, neurological, microsurgery, or ophthalmic surgery). |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "in vitro efficacy studies" for the antibacterial claims. Details on the specific sample sizes (e.g., number of suture samples, number of bacterial cultures) are not provided in this summary. The data provenance is described as "in vitro," implying laboratory studies, rather than patient data. No information on country of origin or retrospective/prospective nature is given, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally relevant for AI/radiology devices where expert consensus is used to label images. For a physical medical device like a suture, "ground truth" for material properties and antibacterial efficacy is established through standardized laboratory testing and validated analytical methods (e.g., chemical analysis, microbiology assays). The document does not specify the number or qualifications of experts involved in running these in vitro tests, as this is typically handled by qualified laboratory personnel following established protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for imaging interpretation, to resolve discrepancies between readers. This document describes laboratory in vitro studies for which such an adjudication method is not relevant.
5. 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. This device is a physical surgical suture, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the antibacterial claims, the "ground truth" would be established by the results of the microbiological in vitro assays which directly measure the inhibition of bacterial colonization on the suture material. For the material properties, the "ground truth" is established by chemical and physical testing against established standards (e.g., USP monographs). This is empirical data from laboratory studies, not consensus of human experts on subjective interpretations.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires training data.
9. How the ground truth for the training set was established
Not applicable, as explained in point 8.
§ 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.