(29 days)
Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.
Silhouette Lift Sutures are non-absorbable, sterile sutures.
SMS 01-PP-3.0.1-B-S, SMS 03-PP-3.0.1-CL and SMS 06-PP-3.0.1-B-L are made of 40.5 cm USP 3.0 size polypropylene suture with 6 cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to the suture. SMS 02-PP-2.0.1-B is a 37.3cm USP 2.0 size polvpropvlene suture with 10 cones made of resorbable material (Lactide / Glycolyde 82:18) affixed to the suture.
Attached to one end of each of the sutures is a straight needle and to the opposite end is a ½ circle taper needle.
All products are supplied sterile (EO) for single use only. Silhouette Lift Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
This document is a 510(k) premarket notification for the Silhouette Lift Suture, which is a medical device used in midface suspension surgery. The purpose of this notification is to demonstrate that the Silhouette Lift device is substantially equivalent to a previously cleared predicate device, the Featherlift Silhouette Suture (K060414), despite a change to its Instructions for Use.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense for a new device's efficacy or safety study. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" in this context are implicitly that the modified device remains substantially equivalent to the predicate device, and that the change to the Instructions for Use does not alter its safety, effectiveness, or fundamental scientific technology. The "reported device performance" is a comparative analysis against the predicate device based on specific characteristics.
Below is a table summarizing the comparison for substantial equivalence, which serves as the "performance" data to meet the implicit acceptance criteria of being equivalent.
| Characteristic | Silhouette Lift (K171005) | FeatherLift Silhouette Suture (K060414) | Significant Difference? |
|---|---|---|---|
| Overall Design | Polypropylene monofilament with LG 8218 cones | Polypropylene monofilament with LG 8218 cones | No Difference |
| Product Material(s) | 8218 poly(glycolide/Llactide (cones); and polypropylene monofilament | 8218 poly(glycolide/Llactide (cones); and polypropylene monofilament | No Difference |
| Product design and method of operation | Polypropylene monofilament with LG 8218 cones | Polypropylene monofilament with LG 8218 cones | No Difference |
| Method of Construction | Extruded polypropylene monofilament and injection molded PLG 8218 cones | Extruded polypropylene monofilament and injection molded PLG 8218 cones | No Difference |
| Sterilization Process | EO Sterilization | EO Sterilization | No Difference |
| Outline of surgical procedure | Surgical insertion (0.5 inch) in the scalp; suture and needle inserted from entry site to below the jaw line; cones grab and hold facial tissue in elevated position. | Surgical insertion (0.5 inch) in the scalp; suture and needle inserted from entry site to below the jaw line; cones grab and hold facial tissue in elevated position. | No Difference |
| Environment required for insertion | Physician's office or out-patient surgical center. | Physician's office or out-patient surgical center. | No Difference |
| Intended Use/Indications for Use | For use in midface suspension surgery to fixate the cheek sub dermis in an elevated position. | For use in midface suspension surgery to fixate the cheek sub dermis in an elevated position. | Identical |
| Technological Characteristics | Unchanged from K060414 | Described in K060414 | Unchanged |
The key acceptance criterion is that there are no significant differences in the fundamental aspects of the device that would impact safety or effectiveness, outside of the specific change to the Instructions for Use. The study presented here is the comparative analysis, which demonstrates "no difference" across all critical technological characteristics and intended use.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a Special 510(k) where the modification is limited to changes made in the directions for use, and there are "No changes...to the intended use or fundamental scientific technology." Therefore, there is no new test set, clinical data, or sample size provided for a new study in this document. The submission relies on establishing substantial equivalence to the predicate device (K060414) based on its existing clearance.
The data provenance for the original clearance (K060414) is not detailed in this specific document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, this submission is not presenting new study data requiring ground truth establishment by experts. It's a "Special 510(k)" relying on prior clearance and demonstrating no significant change to the device itself.
4. Adjudication Method for the Test Set
Not applicable, as no new test set is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. No MRMC study is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a surgical suture, not an algorithm, so standalone performance is not relevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
Not applicable to this specific submission, as it relies on substantial equivalence to a predicate device. For the original predicate clearance (K060414), it would have likely involved a combination of bench testing, possibly animal studies, and potentially clinical data (though not always required for Class II devices), with "ground truth" derived from standard surgical practice, material science, and clinical outcomes for similar products.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and no new training set is discussed or implied.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device, and no training set is discussed.
§ 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.