(90 days)
WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
WEGO-PGLA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of a copolymer made from 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGLA (Polyglactin 910) suture. WEGO-PGLA RAPID sutures are available undyed and dyed violet with D&C Violet No.2 (Colour Index number 60725).
WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.
WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.
WEGO-PGLA RAPID sutures comply with the requirements of the European Pharmacopoeia for "Sutures, Sterile Synthetic Absorbable Braided" and the requirements of United States Pharmacopoeia for "Absorbable Surgical Suture" (except for an occasional slight oversize in diameter).
The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
The provided document describes a 510(k) premarket notification for a medical device called "WEGO-PGLA RAPID" sutures. The submission aims to demonstrate substantial equivalence to a predicate device, VICRYL Rapide Suture (K944110), through non-clinical testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on compliance with established standards (USP and ISO). The reported device performance indicates that the WEGO-PGLA RAPID sutures met these standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Result) |
|---|---|
| USP 40-NF 35:2017 Sutures – Diameter | Complies with USP (for device before aging) |
| USP 40-NF 35:2017 Tensile Strength | Complies with USP (for device before and after real-time-aging) |
| USP 40-NF 35:2017 Sutures - Needle Attachment | Complies with USP (for device before and after real-time-aging) |
| ISO 10993-3:2014 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity | Complies (implied by inclusion in test list) |
| ISO 10993-5:2009 Tests for in vitro cytotoxicity | Complies (implied by inclusion in test list) |
| ISO 10993-6:2007 Tests for local effects after implantation | Complies (implied by inclusion in test list) |
| ISO 10993-10: 2010 Tests for irritation and skin sensitization | Complies (implied by inclusion in test list) |
| ISO 10993-11:2006 Tests for systemic toxicity | Complies (implied by inclusion in test list) |
| USP 40-NF 35:2017 Bacterial Endotoxins Test | Complies (implied by inclusion in test list) |
| ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials | Complies (implied by inclusion in test list) |
| ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration | Complies (implied by inclusion in test list) |
| ISO 10993-7:2008 Ethylene oxide sterilization residuals | Complies (implied by inclusion in test list) |
| USP 40-NF35:2017 Pyrogen Test | Complies (implied by inclusion in test list) |
| ASTM F756-13 Standard Practice For Assessment Of Hemolytic Properties Of Materials | Complies (implied by inclusion in test list) |
| Absorption Time | 42-56 days (Proposed Device) vs. 42 days (Predicate Device) - deemed "similar" |
Note: For the ISO and ASTM standards listed, the document states "The test results demonstrated that the proposed device complies with the following standards," implying that compliance with these standards serves as the acceptance criteria. Specific numerical performance data for these biological and packaging tests are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., number of sutures tested for tensile strength). It refers to "testing on samples" for physical performance and stability.
- Data Provenance: The studies were non-clinical tests conducted by the manufacturer, Foosin Medical Supplies Inc., Ltd, based in Weihai, Shandong, China. The data would be prospective as it's generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for a surgical suture and relies on objective, standard-based non-clinical testing rather than expert-based ground truth for the device's technical specifications. The "ground truth" here is compliance with the specified international and national standards.
4. Adjudication method for the test set
Not applicable. The testing involves objective measurements against predefined criteria in standards, not subjective assessments requiring adjudication by multiple experts.
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 is a submission for a surgical suture, not an AI-powered diagnostic device, and therefore, an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for a surgical suture, not an algorithm or AI device.
7. The type of ground truth used
The ground truth used is the standards and specifications outlined in the referenced USP and ISO documents. The device's performance is compared against the requirements within these standards (e.g., specific diameter ranges, tensile strength thresholds, biocompatibility criteria).
8. The sample size for the training set
Not applicable. There is no AI component in this device; thus, no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. As there is no AI component, there is no training set or ground truth for a training set.
§ 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.