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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple helix-like structure extending from the heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2017

Silhouette Lift Inc. Mr. Anthony Dibernardo Senior Director, Quality Assurance and Regulatory Affairs 1 Technology Drive F211 Irvine, California 92618

Re: K171005

Trade/Device Name: Silhouette Featherlift Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW, GAM Dated: March 29, 2017 Received: April 4, 2017

Dear Mr. Dibernardo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171005

Device Name Silhouette Lift Suture

Indications for Use (Describe)

Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 022

{3}------------------------------------------------

510(k) Summary

1. Submitter Details

Current 510(k) number: K171005 510(k) Holder: Silhouette Lift Inc, 1 Technology Drive Suite F211, Irvine CA 92618 Facility Registration No: 3007009755 Date of Preparation: January 2017

Contact Details:
Name:	Silhouette Lift Inc,
Address:	1 Technology Drive Suite F211, Irvine CA 92618
Contact person:	Anthony DiBernardo
Telephone No:	+1 949 724 2074

In accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act and MDR 21 CFR Part 807.81. Silhouette Lift Inc hereby notifies the Food and Drug Administration (FDA) of a change to the Instructions for Use that accompanies Silhouette Lift Suture (K171005) in USA.

2. Device Name

The device name as per the original 510(k) is Featherlift Silhouette Suture. The trade name utilized in the USA is Silhouette Lift Suture.

The part numbers that are to be modified under this trade name are: SMS 01-PP-3.0.1-B-S SMS 02-PP-2.0.1-B SMS 03-PP-3.0.1-CL SMS 06-PP-3.0.1-B-L Regulation Name: Nonabsorbable polypropylene surgical suture Requlation Number: 21 CFR 878.5010 Regulatory Class: II Product Code: GAW, GAM

{4}------------------------------------------------

3. Predicate Device

Device Name:Device Part Numbers:	FeatherLift Silhouette Suture.SMS 01-PP-3.0.1-B-S,SMS 02-PP-2.0.1-B,SMS 03-PP-3.0.1-CL,SMS 06-PP-3.0.1-B-L
510(k) Number:	K060414
Regulation Name:Regulation Number:Regulatory Class:Product Code:	Nonabsorbable polypropylene surgical suture.21 CFR 878.5010IIGAW, GAM

FeatherLift Silhouette Sutures are non-absorbable, sterile devices.

The devices comprise a polypropylene monofilament with cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to it.

Attached to one end of the monofilament 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.

4. Substantial Equivalence

The modified Silhouette Lift device is substantially equivalent to Featherlift Silhouette Suture cleared under K060414. The change to the device is limited to changes made in the directions for use.

No changes have been made to the intended use or fundamental scientific technology and therefore the supporting information on sterilization, biocompatibility, and clinical data remain unchanged from the original application.

The only modification made to the predicate device is the modification in the content of the Instructions for Use. The details and reasons for which are detailed within this Special 510(k) Change be effected.

{5}------------------------------------------------

Trade Name	Silhouette Lift (K171005)	FeatherLift SilhouetteSuture (K060414)	SignificantDifference
OverallDesign	Polypropylenemonofilament with LG 8218cones	Polypropylenemonofilament with LG 8218cones	No Difference
ProductMaterial(s):	8218 poly(glycolide/Llactide(cones); and polypropylenemonofilament	8218 poly(glycolide/Llactide(cones); and polypropylenemonofilament	No Difference
Productdesign andmethod ofoperation:	Polypropylenemonofilament with LG 8218cones	Polypropylenemonofilament with LG 8218cones	No Difference
Method ofConstruction	Extruded polypropylenemonofilament and injectionmolded PLG 8218 cones	Extruded polypropylenemonofilament and injectionmolded PLG 8218 cones	No Difference
SterilizationProcess:	EO Sterilization	EO Sterilization	No Difference
Outline ofsurgicalprocedure:	Surgical insertion (.5 inch)in the scalp; suture andneedle inserted from entrysite to below the jaw line;cones grab and hold facialtissue in elevated position.	Surgical insertion (.5 inch)in the scalp; suture andneedle inserted from entrysite to below the jaw line;cones grab and hold facialtissue in elevated position.	No Difference
Environmentrequired forinsertion:	Physician's office or out-patient surgical center.	Physician's office or out-patient surgical center.	No Difference

Substantial Equivalence: Silhouette Lift and Featherlift Silhouette

5. Device Description

Silhouette Lift Sutures are non-absorbable, sterile sutures.

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.

6. Intended Use/Indications for Use

{6}------------------------------------------------

Silhouette Lift Sutures are for use in midface suspension surgery to fixate the cheek sub dermis in an elevated position.

The intended use of the device is identical to the predicate, Featherlift Silhouette Suture (K060414).

7. Technological Characteristics

The technological characteristics of the Silhouette Lift Sutures remain unchanged from those described in K060414.

Overall Design	Polypropylene monofilament with LG 8218 cones
Product Material(s):	82 :18 poly(glycolide/Llactide (cones); andpolypropylene monofilament
Product design andmethod of operation:	Polypropylene monofilament with LG 8218 cones
Method of Construction	Extruded polypropylene monofilament and injectionmolded PLG 8218 cones
Sterilization Process:	EO Sterilization
Outline of surgicalprocedure:	Surgical insertion (.5 inch) in the scalp; suture andneedle inserted from entry site to below the jaw line;cones grab and hold facial tissue in elevated position.
Environment required forinsertion:	Physician's office or out-patient surgical center.

Regulation Number and Section

§ 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.