(220 days)
VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.
PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS™ II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.
VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolymer made of 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. VICRYL™ Suture is available as a coated or an uncoated suture.
VICRYL™ Suture is coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field.
VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes.
PDSTM II (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HoO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.
PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field.
PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes.
PDSTM Plus Antibacterial (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture made from the polyester poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HaO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.
PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field.
PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m.
PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes.
Here's an analysis of the provided text regarding acceptance criteria and study information:
This document describes a 510(k) premarket notification for surgical sutures (VICRYL™, PDS™ II, and PDS™ Plus). It does NOT involve a device that utilizes AI or requires complex performance studies with acceptance criteria in the typical sense of a diagnostic or therapeutic AI medical device.
The document explicitly states: "The technological characteristics of the subject devices are identical to the predicate devices and performance data are not necessary to establish substantial equivalence."
Therefore, a detailed breakdown of acceptance criteria and a study proving a device meets them (as would be expected for an AI/ML device) is not applicable here. The nature of this submission is to demonstrate substantial equivalence to previously cleared sutures, primarily based on identical functionality, technological characteristics, and intended use. The only change mentioned is to the labeling (Instructions for Use) for clarification, standardization, and harmonization.
However, if we try to interpret the "acceptance criteria" in the context of this specific 510(k) submission, it refers to the conditions that allow the FDA to determine the device is "substantially equivalent" to predicate devices. The "study" (or rather, the justification) for meeting these criteria is the comparison to the existing predicate devices.
Here's how we might frame the information based on the provided text, while acknowledging the limitations:
Acceptance Criteria and Justification of Substantial Equivalence for VICRYL™, PDS™ II, and PDS™ Plus Sutures
Given that this 510(k) submission is for surgical sutures and not an AI/ML diagnostic or therapeutic device, the concept of "acceptance criteria" and a "study proving the device meets the acceptance criteria" differs significantly from what your detailed request implies. The core "acceptance criterion" for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" isn't a complex clinical trial with performance metrics but rather a comparison of technological characteristics, intended use, and materials.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use: Device's intended use must be the same as the predicate device(s). | Identical to predicate devices: |
| - VICRYL™: General soft tissue approximation and/or ligation, including ophthalmic surgery (not cardiovascular/neurological). | |
| - PDS™ II: Soft tissue approximation, including pediatric cardiovascular tissue (where growth is expected) and ophthalmic surgery (not adult cardiovascular/neurological). Useful for extended wound support (up to 6 weeks). | |
| - PDS™ Plus: Soft tissue approximation, including pediatric cardiovascular tissue (where growth is expected) and ophthalmic surgery (other than contact with cornea/sclera) (not adult cardiovascular/neurological). Useful for extended wound support (up to 6 weeks). | |
| Technological Characteristics: Device's technological characteristics must be the same as, or similar enough to, the predicate device(s) that any differences do not raise new questions of safety or effectiveness. | Identical to predicate devices: |
| - Composition (copolymer for VICRYL™, polyester for PDS™ II and PDS™ Plus). | |
| - Formulation details (e.g., Polyglactin 370 and calcium stearate coating for VICRYL™, Irgacare® MP for PDS™ Plus). | |
| - Sterility: Sterile, synthetic, absorbable. | |
| - Physical form (braided/monofilament, dyed/undyed). | |
| - Gauge sizes, lengths, types. | |
| Material, Device Construction, Performance Specification, Packaging, Sterilization, Manufacturing Process: No material change in these aspects compared to predicate. | No changes in material, device construction, performance specification, packaging, sterilization, or manufacturing process. |
| Labeling: Changes to labeling must not raise new questions of safety or effectiveness. | Labeling (Instructions for Use) has been revised for clarification, standardization, and harmonization with the intent of creating Instructions for Use which can be supplied globally. No change to intended use or patient population. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission does not involve a "test set" in the context of evaluating performance data from a patient population or algorithmic output. The demonstration of substantial equivalence is based on the inherent design, composition, and manufacturing of the sutures, and a comparison of these attributes to predicate devices. No specific "sample size" of patients or data is mentioned for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment in the context of diagnostic accuracy for this type of medical device submission. The determination of substantial equivalence is made by the FDA's regulatory experts based on the manufacturer's submission and comparison to predicate devices, drawing upon established scientific and engineering principles for surgical sutures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process of interpretations as would be found in a clinical study for a diagnostic device.
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 not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As described, there is no "ground truth" in the diagnostic sense. The "truth" here is the established safety and effectiveness of the predicate devices, to which these new sutures are being compared for substantial equivalence in their fundamental characteristics.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.