(70 days)
Premilene® sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.
The subject device is a nonabsorbable, flexible monofilament suture thread which is supplied sterile. It is composed of isotactic polypropylene polymer, and is indicated for soft tissue approximation. It will be offered undyed, and dyed with the FDA approved colorant [Phthalocyaninati(2-)] copper in accordance with Title 21 CFR, §74.3045. It will be available with and without standard needles attached.
The provided text describes the Premilene Nonabsorbable Polypropylene Surgical Suture and its substantial equivalence to predicate devices, focusing on non-clinical testing. This document is a 510(k) summary for a medical device and thus relates to regulatory approval rather than a study proving the device meets specific acceptance criteria in the typical sense of a clinical trial for AI/software devices. The acceptance criteria here are based on physicochemical equivalence to existing devices.
Here's a breakdown of the requested information based only on the provided text, recognizing that many items common in AI/software device studies are not applicable or detailed in this type of submission:
Description of Acceptance Criteria and Proving Device Meets Criteria
The "acceptance criteria" for the Premilene Nonabsorbable Polypropylene Surgical Suture are primarily based on demonstrating substantial equivalence to existing predicate devices (Prolene®, Surgilene®, Sharpoint). This equivalence is established through adherence to USP XXIII standards and comparative non-clinical testing of physical, chemical, and biological properties.
The study proving the device meets these acceptance criteria is presented as a series of non-clinical tests and validations, as summarized in Section G of the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, the "acceptance criteria" are compliance with specified standards and "device performance" is expressed as meeting these standards and being substantially equivalent to predicates. No specific numerical thresholds or performance metrics (like sensitivity, specificity, etc.) are provided for this type of medical device which is a physical suture.
| Acceptance Criteria (Based on Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Material Composition: Isotactic polypropylene polymer | Composed of the same material (isotactic form of polyolefin polymer polypropylene). |
| Colorant: [Phthalocyaninato(2-)] copper, ≤0.5% by suture weight (if dyed) | Offered undyed, and dyed with the same colorant at ≤0.5% by suture weight, in accordance with 21 CFR §74.3045. |
| Design: Sterile, flexible monofilament thread, various lengths/diameters, with/without needles | Same design as predicate devices; sterile, flexible monofilament thread; offered in variety of lengths and range of diameters conforming to U.S. Pharmacopeia (U.S.P.) XXIII, with or without standard needles attached. |
| Physical Properties: Conformance to U.S.P. XXIII for nonabsorbable surgical suture, including: |
- Sutures -- Diameter
- Sutures -- Needle Attachment
- Tensile Strength
- Fiber diameter
- Knot pull tensile strength
- Straight pull tensile strength
- Flexibility
- Elongation
- Elasticity
- Needle attachment strength | Conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIII for specified parameters.
Physical properties are substantially equivalent to predicate devices for all identified parameters. |
| Manufacturing Process: Same as at least one predicate device | Manufactured in the same manner as at least one predicate device (supplier of finished suture fiber is manufacturer of said predicate suture). Suture fiber has same chemical characteristics, biocompatibility profile, and in vivo performance properties as that predicate device. |
| Packaging & Sterilization: Same or equivalent manner as predicates | Packaged and sterilized in the same or equivalent manner. |
| Labeling Claims: Same as predicates (indications, contraindications, warnings, cautions, precautions) | Has the same labeling claims as predicate devices. |
| Chemical Assays: Identity and purity for finished suture fiber | Testing conducted by manufacturer/supplier included chemical assays for identity and purity. |
| Biosafety Studies: In vitro and in vivo | Testing conducted by manufacturer/supplier included in vitro and in vivo biosafety studies. |
| Tensile Strength Retention (in vivo): Over 1 year | One (1) year implant studies in animals to demonstrate retention of tensile strength. |
| Sterilization Validation & Residues: Validation and evaluation | Sterilization validation and evaluation of sterilant residues performed. |
| Shelf-life Testing: Stability and integrity over time | Shelf-life testing performed. |
2. Sample Size Used for the Test Set and the Data Provenance
The text does not specify sample sizes (e.g., number of sutures, animals used) for the non-clinical tests. This information is typically proprietary and contained in the full 510(k) submission, not the summary.
Data Provenance: The tests were conducted by the manufacturer and supplier to Aesculap®. The country of origin for the data is not specified. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for this type of medical device is established through adherence to recognized pharmacopeial standards (U.S.P. XXIII) and direct comparative physical/chemical testing, not through expert consensus in a diagnostic sense. The experts involved would be quality control engineers, chemists, and materials scientists, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. As this is not a diagnostic device involving interpretation errors, there is no adjudication method in the context of expert review. Test results are objective measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is for evaluating observer performance with diagnostic imaging or similar outputs, which is not relevant to a surgical suture. The effectiveness is demonstrated through mechanical and biological equivalence to predicate devices and adherence to standards.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" consists of established, objective physical, chemical, and biological standards (e.g., U.S.P. XXIII monographs for sutures, recognized chemical and biocompatibility testing protocols, and the established properties of the predicate devices).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.