(82 days)
The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.
Acceptance Criteria and Study for Sutralene Polypropylene Sutures (K070243)
This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of Visionary Medical Supplies' Sutralene Polypropylene Sutures (K070243) to predicate devices, specifically Ethicon PROLENE nonabsorbable polypropylene sutures.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sutralene Polypropylene Sutures are based on meeting the standards outlined in the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures.
| Performance Metric | Acceptance Criteria (USP Standards) | Reported Device Performance (Sutralene Polypropylene Sutures) |
|---|---|---|
| Diameter | Meets USP Monograph standards | Test results showed that Visionary Medical Supplies' devices tested meet USP standards. |
| Tensile Strength | Meets USP Monograph standards | Test results showed that Visionary Medical Supplies' devices tested meet USP standards. |
| Suture-Needle Attachment | Meets USP Monograph standards | Test results showed that Visionary Medical Supplies' devices tested meet USP standards. Additionally, the device is considered technically equivalent to the predicate devices tested. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set during the performance tests. However, the tests were conducted according to methods presented in the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures. USP monographs typically specify the number of samples required for various tests.
The data provenance is not explicitly detailed in terms of country of origin or whether it was retrospective or prospective. However, being a 510(k) submission to the FDA, it is implied that the testing was conducted as part of the regulatory process for market clearance in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for a device like surgical sutures, where "ground truth" is established by adherence to physical and material property standards rather than expert clinical interpretation. The "ground truth" for the test set is the objective, measurable standards set forth in the USP Monograph for nonabsorbable surgical sutures. Therefore, no experts in the sense of clinical reviewers (e.g., radiologists) were explicitly used to establish ground truth for this type of performance testing. The "expertise" lies within the scientific and engineering principles behind the USP standards themselves.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., image analysis by multiple readers). For the physical and mechanical property testing of sutures, such adjudication methods are not relevant. The assessment relies on direct measurement and comparison against predefined objective standards specified in the USP Monograph.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic devices where human readers interpret data (e.g., medical images) and the AI's impact on their performance is being evaluated. Sutralene Polypropylene Sutures are a surgical device, and their performance is evaluated based on material properties, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the performance tests conducted (diameter, tensile strength, suture-needle attachment) are inherently a "standalone" evaluation of the device's physical properties. These tests assess the material itself (algorithm/device only) against established standards, without direct human-in-the-loop performance measurement.
7. The Type of Ground Truth Used
The ground truth used for evaluating Sutralene Polypropylene Sutures is objective, measurable physical and mechanical standards defined by the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures. This is not "expert consensus" in the clinical sense, nor is it pathology or outcomes data. It is a set of established scientific specifications for the material properties of the device.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to the evaluation of Sutralene Polypropylene Sutures. This device is not an AI/ML algorithm that learns from data. Its performance is inherent in its manufacturing and material composition, which is then verified through direct physical testing against established standards.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, there is no "training set" for this type of device. The "ground truth" for the device's performance (i.e., the USP standards) is established through rigorous scientific research, consensus by pharmaceutical and medical experts, and often a long history of clinical use and safety data that informs the creation of such monographs.
§ 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.