(29 days)
Not Found
No
The device description and intended use are purely mechanical, involving sutures and needles for surgical fixation. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is described as sutures used in midface suspension surgery to fixate the cheek subdermis in an elevated position, which is a therapeutic intervention.
No
The device description indicates that Silhouette Lift Sutures are non-absorbable, sterile sutures used to fixate the cheek subdermis in an elevated position, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical suture made of polypropylene with attached cones and needles, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Midface suspension surgery to fixate the cheek sub dermis in an elevated position." This describes a surgical procedure performed directly on the patient's body for a cosmetic or reconstructive purpose.
- Device Description: The device is a suture with cones, designed to be implanted into tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples like blood, urine, or tissue outside of the body to provide diagnostic information. This device is a surgical implant used within the body.
N/A
Intended Use / Indications for Use
"Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position."
Product codes (comma separated list FDA assigned to the subject device)
GAW, GAM
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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midface, cheek
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's office or out-patient surgical center.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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 878.5010
II
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.
5
| Trade Name | 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 (.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 (.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 |
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
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); and |
| polypropylene monofilament | |
| Product design and | |
| method of operation: | Polypropylene monofilament with LG 8218 cones |
| Method of Construction | Extruded polypropylene monofilament and injection |
| molded PLG 8218 cones | |
| Sterilization Process: | EO Sterilization |
| Outline of surgical | |
| procedure: | Surgical insertion (.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. | |
| Environment required for | |
| insertion: | Physician's office or out-patient surgical center. |