(103 days)
Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
Novosyn is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn suture will be offered undyed or dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3206. The Novosyn suture will be offered in diameters ranging from USP size 8-0 through 2 and will be available in a variety of cut lengths with or without needles attached.
The Aesculap Novosyn Absorbable Suture, a synthetic absorbable braided surgical suture, was tested to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | USP 34 (Diameter, Tensile Strength, Needle Attachment) | All specifications met for tensile strength and needle attachment. Diameter specifications were not met. |
| Biocompatibility | ISO 10993-1 | Passed: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Genotoxicity (Chromosomal Aberration and Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation), and Muscle Implantation (12-week). |
| In-vitro Resorption | Not explicitly stated but implied to show equivalence to predicate devices | Performed and used to demonstrate substantial equivalence. |
| In-vivo Resorption | Not explicitly stated but implied to show equivalence to predicate devices | Performed and used to demonstrate substantial equivalence. |
Note on Diameter: The document explicitly states "All specifications were met apart from diameter." However, despite this deviation, the FDA determined the device to be substantially equivalent overall. It is not specified if the deviation was deemed clinically insignificant or if additional information not provided in this summary mitigated the concern.
2. Sample Size and Data Provenance for Test Set
The document does not specify the exact sample sizes used for each individual test (e.g., number of sutures tested for tensile strength, number of animals for in-vivo tests). The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). However, the testing was performed to support a 510(k) submission to the FDA, implying common laboratory testing standards for medical devices.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This study does not involve human readers for diagnostic interpretation or a ground truth established by experts in the context of medical imaging or clinical assessment. The "ground truth" for this device's performance is based on established scientific and regulatory standards as outlined in USP 34 and ISO 10993-1.
4. Adjudication Method (Test Set)
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is assessed against predefined quantitative and qualitative standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a study evaluating the physical and biological characteristics of a surgical suture, not a diagnostic imaging device requiring human reader interpretation. Therefore, no MRMC study was conducted, and no effect size for human readers improving with AI assistance is relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an algorithm or AI-based device.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Established Standards: Mechanical properties evaluated against the United States Pharmacopeia (USP 34) standards for surgical sutures.
- Biocompatibility Standards: Evaluated against international standards (ISO 10993-1) for biological evaluation of medical devices.
- Comparative Performance: The overall assessment of "substantial equivalence" is the ground truth, determined by comparing its technological characteristics (design, intended use, material composition, function, range of sizes) and performance data (mechanical, biocompatibility, resorption) to legally marketed predicate devices.
8. Sample Size for Training Set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How Ground Truth for 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.