(37 days)
6-0 undyed Coated VICRYL RAPIDE suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
6-0 Coated VICRYL RAPIDE (polyglactin 910) suture, undyed Is a sterile suture, multifilament strand prepared from a copolymer made from glycolide and lactide. The coating for 6-0 Coated VICRYL RAPIDE is prepared with a mixture of undyed VICRYL FD NH ID IJ plactide and calcium stearate.
This document describes a 510(k) premarket notification for an additional size (6-0) of Coated VICRYL RAPIDE braided synthetic absorbable suture. The submission claims substantial equivalence to an existing predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Knot Tensile Strength | Assessed through benchtop testing. (No specific numerical values are provided in this summary, but the implication is that it meets established standards or is equivalent to the predicate). |
| Breaking Strength Retention | Assessed through nonclinical laboratory testing. (No specific numerical values are provided, but the implication is that it meets established standards or is equivalent to the predicate). |
| Biocompatibility | Deemed unnecessary to support this modification, implying that the predicate device's biocompatibility data or material composition covers the new size. |
| Clinical Performance | Deemed unnecessary to support this modification, implying that the predicate device's clinical performance or intended use covers the new size. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes used for the benchtop and nonclinical laboratory testing (knot tensile strength and breaking strength retention).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's a 510(k) submission to the FDA, the testing would generally adhere to recognized U.S. or international standards, and the data would typically be generated either within the manufacturer's labs or by contracted testing facilities. It's likely a controlled, prospective testing environment for material properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This document does not involve expert human interpretation of data for ground truth establishment. The "ground truth" for this medical device is based on objective, quantifiable physical and mechanical properties (e.g., tensile strength, degradation rates) which are measured directly by laboratory equipment following established protocols.
4. Adjudication Method for the Test Set:
- Not applicable. As described above, the "ground truth" is based on direct physical and mechanical measurements, not on expert consensus or interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for an absorbable surgical suture, which does not involve human interpretation during its use in a way that an MRMC study would be applicable.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical medical product (suture), not a software algorithm or AI-powered system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
- The ground truth for assessing the performance of the suture is based on:
- Direct Physical and Mechanical Measurements: This includes quantitative measurements of knot tensile strength and breaking strength retention, obtained through standardized laboratory testing.
- Material Composition/Chemistry: The device claims "no change in chemistry, material or composition" compared to the predicate, implying that the established properties of the materials form part of the ground truth for safety and effectiveness.
8. Sample Size for the Training Set:
- Not applicable. This submission is for a physical medical device (suture) and does not involve machine learning algorithms that require a "training set" in the conventional sense. The "training" for such a device effectively comes from years of material science research, engineering, and manufacturing process development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The underlying "ground truth" for developing and manufacturing such a suture relies on well-established principles of polymer chemistry, material science, biomechanics, and manufacturing quality control. These principles are validated through extensive research, regulatory standards, and historical data from similar materials and devices.
§ 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.