Silhouette Featherlift

K171005 · Silhouette Lift, Inc. · GAW · May 3, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171005
• Device Name: Silhouette Featherlift
• Applicant: Silhouette Lift, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: May 3, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Silhouette Lift Suture is a sterile, non-absorbable surgical device used for midface suspension. It consists of a polypropylene monofilament suture with affixed resorbable cones (Lactide/Glycolide 82:18). The device features a straight needle on one end and a 1/2 circle taper needle on the other. Used in physician offices or outpatient surgical centers, the suture is inserted through a 0.5-inch scalp incision, threaded to the jaw line, and positioned to allow the cones to grab and hold facial tissue in an elevated state. This mechanical fixation provides a lifting effect for the cheek sub-dermis. The device is for single use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design, materials, and technological characteristics to the predicate device.

Technological Characteristics

Materials: Polypropylene monofilament, resorbable Lactide/Glycolide (82:18) cones. Construction: Extruded monofilament, injection-molded cones. Form factor: Suture with straight and 1/2 circle taper needles. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for midface suspension surgery to fixate cheek sub-dermis in an elevated position in patients requiring facial tissue repositioning.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FeatherLift Silhouette Suture (K060414)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

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# 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: | [phone] |

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

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#### 3. Predicate Device

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

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| Trade Name | Silhouette Lift (K171005) | FeatherLift Silhouette<br>Suture (K060414) | Significant<br>Difference |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Overall<br>Design | Polypropylene<br>monofilament with LG 8218<br>cones | Polypropylene<br>monofilament with LG 8218<br>cones | No Difference |
| Product<br>Material(s): | 8218 poly(glycolide/Llactide<br>(cones); and polypropylene<br>monofilament | 8218 poly(glycolide/Llactide<br>(cones); and polypropylene<br>monofilament | No Difference |
| Product<br>design and<br>method of<br>operation: | Polypropylene<br>monofilament with LG 8218<br>cones | Polypropylene<br>monofilament with LG 8218<br>cones | No Difference |
| Method of<br>Construction | Extruded polypropylene<br>monofilament and injection<br>molded PLG 8218 cones | Extruded polypropylene<br>monofilament and injection<br>molded PLG 8218 cones | No Difference |
| Sterilization<br>Process: | EO Sterilization | EO Sterilization | No Difference |
| Outline of<br>surgical<br>procedure: | Surgical insertion (.5 inch)<br>in the scalp; suture and<br>needle inserted from entry<br>site to below the jaw line;<br>cones grab and hold facial<br>tissue in elevated position. | Surgical insertion (.5 inch)<br>in the scalp; suture and<br>needle inserted from entry<br>site to below the jaw line;<br>cones grab and hold facial<br>tissue in elevated position. | No Difference |
| Environment<br>required for<br>insertion: | Physician's office or out-<br>patient surgical center. | Physician's office or out-<br>patient surgical center. | No Difference |

## Substantial Equivalence: Silhouette Lift and Featherlift Silhouette

# 5. Device Description

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.

### 6. Intended Use/Indications for Use

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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); and<br>polypropylene monofilament |
| Product design and<br>method of operation: | Polypropylene monofilament with LG 8218 cones |
| Method of Construction | Extruded polypropylene monofilament and injection<br>molded PLG 8218 cones |
| Sterilization Process: | EO Sterilization |
| Outline of surgical<br>procedure: | Surgical insertion (.5 inch) in the scalp; suture and<br>needle inserted from entry site to below the jaw line;<br>cones grab and hold facial tissue in elevated position. |
| Environment required for<br>insertion: | Physician's office or out-patient surgical center. |