(171 days)
Not Found
No
The device description and performance studies focus on a physical implant and surgical needles, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for temporary fixation in cosmetic surgery, which does not constitute therapy for a disease or condition.
No
The device description and intended use clearly state its purpose is for mid-face suspension surgery to physically elevate the cheek sub-dermis, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it consists of physical components: stainless steel surgical needles and an absorbable implant made of bioresorbable resin material. This indicates it is a hardware device, not software-only.
Based on the provided information, the Silhouette Instalift device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of needles and an absorbable implant made of bioresorbable resin. This is a physical implant used for structural support within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The Silhouette Instalift does not involve the analysis of any biological specimens.
The device is clearly intended for surgical implantation and manipulation of tissue within the body, which is the domain of medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Product codes
GAM
Device Description
The Silhouette Instalift device consists of two Stainless Steel Surgical needles and an absorbable implant. The absorbable implant is available in three configurations, each consisting of a single monofilament that holds two bidirectional sets of 4, 6 or 8 cones. Both the monofilament and the cones are made from L- lactide/Glycolide bioresorbable resin material.
This device is supplied sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-face / cheek sub dermis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Testing:
The design, materials, manufacturing and sterilization processes are the same as the original predicate version of the device. No additional bench testing was required to support substantial equivalence of this labeling change.
Clinical Testing:
A prospective, clinical study was performed to assess treatment with Silhouette Instalift without use of a permanent, monofilament, anchor suture. In this study, 20 subjects were assessed pretreatment, and compared to 1. 8. and 12 weeks following treatment.
Subjects responded positively to subject-reported outcomes questions regarding their satisfaction with treatment. There was an improvement in cheek satisfaction and age appraisal through 12 weeks post-treatment using the validated patient-reported outcome FACE-O measure.
Canfield 3D Vectra M3 Face and Neck System was used in the post-treatment period to measure clinical results.
The adverse events reported during the study were generally mild, of short duration, and resolved without sequelae. There were no serious adverse events, unanticipated problems, unanticipated adverse device effects, or deaths.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
FACE-Q Satisfaction with Cheeks (N=20 Subjects) measures satisfaction on a scale of 1 to 4 (1 = Very Dissatisfied; 4 = Very Satisfied) for symmetry, smoothness, attractiveness, contour, and youthful fullness of cheeks. All questions showed a positive change from baseline (Enrollment) to Week 8 and Week 12. For example, "How attractive your cheeks look?" showed a mean change of 0.85 at Week 8 and 1.05 at Week 12.
FACE-Q Age Appraisal-VAS (N=20 Subjects) measured the perceived age change. Subjects perceived themselves as 3.9 years younger at Week 8 and 3.4 years younger at Week 12 compared to enrollment.
Amount of Facial Lift in Both Cheeks (N=20 Subjects) measured the percentage of subjects with at least a certain amount of lift:
At 1 Week Post-Treatment:
-
= 0.5 mm: 100%
-
= 1.0 mm: 80%
-
= 1.5 mm: 45%
-
= 2.0 mm: 5%
-
= 2.5 mm: 0%
At 12 Weeks Post-Treatment:
-
= 0.5 mm: 80%
-
= 1.0 mm: 35%
-
= 1.5 mm: 25%
-
= 2.0 mm: 20%
-
= 2.5 mm: 15%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2017
Silhouette Lift, Inc. % Mr. Brian Young Health Policy Associates, Inc 690 Canton Street Suite 302 Westwood, Massachusetts 02090
Re: K163676
Trade/Device Name: Silhouette Instalift Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: May 18, 2017 Received: May 19, 2017
Dear Mr. Young:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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) K163676
Device Name Silhouette Instalift
Indications for Use (Describe)
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily 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
| Submitted by: | Silhouette Lift, Inc.
A Sinclair Pharma Company
1 Technology Drive, Suite F211
Irvine, CA 92618 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brian Young
Vice-President Regulatory Affairs/Quality Assurance
Health Policy Associates, Inc.
Phone: (781) 329-2993
Fax: (781) 329-2968
Email: byoung@healthpolicyassociates.com |
| Date Prepared | June 15, 2017 |
| Trade Name: | SILHOUETTE INSTALIFT |
| Common Name: | Absorbable surgical suture |
| Classification Name: | Absorbable poly(glycolide/l-lactide) surgical suture |
| Regulation Number: | 21 CFR 878.4493 |
| Classification Product Code: | GAM |
| Device Classification: | II |
Predicate Device:
The predicate is the original Silhouette Instalift device cleared under 510(k) number K142061 on April 24, 2015.
Device Description:
The Silhouette Instalift device consists of two Stainless Steel Surgical needles and an absorbable implant. The absorbable implant is available in three configurations, each consisting of a single monofilament that holds two bidirectional sets of 4, 6 or 8 cones. Both the monofilament and the cones are made from L- lactide/Glycolide bioresorbable resin material.
This device is supplied sterile for single use only.
4
Indications for Use:
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Intended Use:
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.
Technological Characteristics (comparison to Predicate Device):
The subject Silhouette Instalift device is identical to the original 510(k) cleared predicate except that the instructions for use have been modified to include an additional optional implantation technique. The additional technique is less invasive and provides clinicians greater flexibility in the treatment of their patients.
Performance Testing Summary:
Nonclinical Testing:
The design, materials, manufacturing and sterilization processes are the same as the original predicate version of the device. No additional bench testing was required to support substantial equivalence of this labeling change.
Clinical Testing:
A prospective, clinical study was performed to assess treatment with Silhouette Instalift without use of a permanent, monofilament, anchor suture. In this study, 20 subjects were assessed pretreatment, and compared to 1. 8. and 12 weeks following treatment.
Subjects responded positively to subject-reported outcomes questions regarding their satisfaction with treatment. There was an improvement in cheek satisfaction and age appraisal through 12 weeks post-treatment using the validated patient-reported outcome FACE-O measure. Additional details are provided in the Tables below:
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| 1 = Very Dissatisfied; 2 = Somewhat Dissatisfied; 3 = Somewhat Satisfied; 4 = Very Satisfied | |||||
|---|---|---|---|---|---|
| Question | Mean (SD) | ||||
| Enrollment | |||||
| N=20 | Week 8 | ||||
| N=20 | Change | Week 12 | |||
| N=20 | Change | ||||
| a. How symmetric (similar) | |||||
| your cheeks look? | 2.45 | ||||
| (1.05) | 3.20 | ||||
| (0.83) | 0.75 | ||||
| (1.29) | 3.30 | ||||
| (0.80) | 0.85 | ||||
| (1.23) | |||||
| b. How smooth your | |||||
| cheeks look? | 2.40 | ||||
| (0.99) | 3.00 | ||||
| (0.92) | 0.6 | ||||
| (1.54) | 3.00 | ||||
| (0.86) | 0.60 | ||||
| (1.31) | |||||
| c. How attractive your | |||||
| cheeks look? | 2.15 | ||||
| (0.99) | 3.00 | ||||
| (0.79) | 0.85 | ||||
| (1.46) | 3.20 | ||||
| (0.70) | 1.05 | ||||
| (1.15) | |||||
| d. The contour (outline) of | |||||
| your cheeks? | 1.90 | ||||
| (0.91) | 2.95 | ||||
| (0.83) | 1.05 | ||||
| (1.23) | 3.15 | ||||
| (0.75) | 1.25 | ||||
| (1.12) | |||||
| e. The youthful fullness of | |||||
| your cheeks? | 1.95 | ||||
| (1.00) | 3.00 | ||||
| (0.97) | 1.05 | ||||
| (1.39) | 3.15 | ||||
| (0.75) | 1.20 | ||||
| (1.20) |
Table 1: FACE-Q Satisfaction with Cheeks (N=20 Subjects)
- Compared to enrollment. Wilcoxon Signed Rank test.
Table 2: FACE-Q Age Appraisal-VAS (N=20 Subjects)
| Question | Years
Mean (SD) | | | | |
|---------------------------------------------------------------------------------------------|-------------------------|----------------|---------------|-----------------|---------------|
| | Enroll-
ment
N=20 | Week 8
N=20 | Change | Week 12
N=20 | Change |
| How many years younger
or older do you think you
look compared to your
actual age? | +1
(6.9) | -2.9
(4.1) | -3.9
(5.3) | -2.4
(3.5) | -3.4
(5.3) |
- Compared to enrollment. Wilcoxon Signed Rank test.
Canfield 3D Vectra M3 Face and Neck System was used in the post-treatment period to measure clinical results.
6
| Timepoint | N (%); N=20 | ||||
|---|---|---|---|---|---|
| ≥ 0.5 mm | ≥ 1.0 mm | ≥ 1.5 mm | ≥ 2.0 mm | ≥ 2.5 mm | |
| Pre-Treatment | |||||
| (Visit 2) | 10 (50%) | 2 (10%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| 1 Week Post-Treatment | |||||
| (Visit 4) | 20 (100%) | 16 (80%) | 9 (45%) | 1 (5%) | 0 (0.0%) |
| 8 Weeks Post-Treatment | |||||
| (Visit 6) | 17 (85%) | 10 (50%) | 6 (30%) | 2 (10%) | 0 (0.0%) |
| 12 Weeks Post-Treatment | |||||
| (Visit 7) | 16 (80%) | 7 (35%) | 5 (25%) | 4 (20%) | 3 (15%) |
Table 3: Amount of Facial Lift in Both Cheeks (N=20 Subjects)
The adverse events reported during the study were generally mild, of short duration, and resolved without sequelae. There were no serious adverse events, unanticipated problems, unanticipated adverse device effects, or deaths.
Substantial Equivalence:
The subject device utilizes the same design, materials, manufacturing and sterilization processes as the original predicate version of the device. The modified labeling technique was evaluated in a clinical study which demonstrated acceptable performance and safety thereby supporting a finding of substantial equivalence.