(207 days)
Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.
Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.
This 510(k) Premarket Notification is for the Aesculap Optilene Nonabsorbable Surgical Suture. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA's Class II Special Control Guidance Document for Surgical Sutures) | Reported Device Performance (Optilene Nonabsorbable Surgical Suture) |
|---|---|
| Diameter meets USP 35 specifications | All specifications were met. |
| Tensile Strength meets USP 35 specifications | All specifications were met. |
| Needle Attachment meets USP 35 specifications | All specifications were met. |
| Biocompatibility: Cytotoxicity | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Sensitization | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Intracutaneous Irritation | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Hemolysis | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Genotoxicity - Mouse Lymphoma | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Genotoxicity - Mouse Peripheral Blood Micronucleus | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Bacterial Reverse Mutation | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility: Muscle Implantation (12-week) | Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices. |
| Chemical Characterization (of polypropylene/polyethylene raw material) | Results demonstrated substantial equivalence to predicate devices. |
| Accelerated Aging | Data generated to support the submission (specific results not detailed, but implies meeting shelf-life requirements). |
| Sterilization (Ethylene Oxide) | Device is sterilized by ethylene oxide (implies efficacy meeting standards). |
| Material composition (Polypropylene/Polyethylene) | 95% polypropylene and 5% polyethylene, shown to be substantially equivalent. |
| Colorant (Phthalacyaninato(2-)] copper) | FDA approved colorant, shown to be substantially equivalent. |
| Structure (Monofilament) | Monofilament, shown to be substantially equivalent. |
| Size range (USP 10-0 through 0) | Within the range of predicate devices, shown to be substantially equivalent. |
| Packaging | Oval HDPE support with an oval card fold card lid in a tyvek peel pouch and polyester-polyethylenerephatalate film, shown to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state specific sample sizes for each mechanical or biocompatibility test. It broadly states that "Tests were conducted for diameter, tensile strength, and needle attachment" and that "Biocompatibility testing... includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week)."
The data provenance is not explicitly stated in terms of country of origin. Given that it's a 510(k) submission to the FDA, the testing would generally be expected to comply with US regulatory standards, but the physical location of labs or studies isn't provided. The studies are prospective in nature, as they are specifically conducted to support this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. The "ground truth" for suture performance is established by recognized standards, specifically USP 35 (United States Pharmacopeia) for mechanical properties and ISO 10993-1 for biocompatibility. These standards define the acceptable range or nature of results for the device to be considered safe and effective. Expert consensus is not used to establish these fundamental criteria; rather, the tests are performed in accordance with these pre-defined, validated methodologies.
4. Adjudication Method for the Test Set:
Not applicable. The performance is measured against objective, quantitative standards (USP 35) or standardized test outcomes (ISO 10993-1). There is no "adjudication" in the sense of reconciling differing expert opinions, but rather a direct comparison of test results to predetermined acceptance limits.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study investigates human reader performance, typically with medical imaging or diagnostic devices. This device is a surgical suture, and its performance is evaluated through laboratory and preclinical (biocompatibility) testing, not by human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic or AI-based device. Its performance is inherent to the physical and chemical properties of the suture itself, measured through standalone laboratory and biocompatibility tests.
7. The Type of Ground Truth Used:
The ground truth used is primarily based on:
- Established Standards: USP 35 for mechanical properties (diameter, tensile strength, needle attachment).
- International Standards for Biocompatibility: ISO 10993-1 for biological safety.
- Chemical Equivalence: Comparison of chemical characterization results of the raw materials to those of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device submission.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.