(66 days)
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Silhouette Instalift Sutures are absorbable, sterile sutures. It is manufactured from a USP size 3-0 Poly/Glycolide/I-lactide suture material and an implantable grade of bioabsorbable PLGA resin (100% Poly (L-lactideco-glycolide) (co-monomer ratio: L-Lactide =82mol%: glycolide=18mol%). The 30 centimeter suture (+- 10 %) (SMS 28-PLG-3.0.1- NA), 27.5 centimeter suture (+- 10 %) (SMS 29-PLG-3.0.1-NA) or 26.8 centimeter suture (+- 10 %) (SMS 30-PLG-3.0.1-NA) are attached to two 12 centimeter straight stainless steel needles. All products are supplied sterile (EO) for single use only. Silhouette Instaliff Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
The provided text is a 510(k) summary for a medical device called Silhouette Instalift. It primarily discusses a change to the device's labeling and asserts substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document states:
- "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 to the labelling of the device."
Therefore, I cannot provide the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, or ground truth details, because this information is explicitly stated as unchanged from the original application and is not provided in this specific 510(k) summary document.
To obtain this information, one would need to refer to the original 510(k) applications (K142061 and K163676) mentioned in this document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2020
Silhouette Lift Inc. Anthony Dibernardo Senior Director, Quality Assurance and Regulatory Affairs 1 Technology Drive F211 Irvine. California 92618
Re: K200140
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: December 23, 2019 Received: January 21, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200140
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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Image /page/3/Picture/0 description: The image shows the logo for Silhouette Lift. The word "Silhouette" is written in a simple, sans-serif font, while the word "lift" is written in a cursive font. The logo is blue and is set against a white background. The registered trademark symbol is located to the right of the word "lift".
Image /page/3/Picture/1 description: The image shows the logo for Sinclair Broadcast Group. The word "SINCLAIR" is written in a serif font, with each letter in blue. Above and below the word are curved blue lines that form a partial oval shape. The top line is a lighter shade of blue than the bottom line.
SECTION 9
510(k) Summary
-
- Submitter Details
| Current 510(k) number: | K200140 |
|---|---|
| 510(k) Holder: | Silhouette Lift Inc,1 Technology Drive Suite F211, Irvine CA 92618 |
| Facility Registration No: | 3007009755 |
| Date of Preparation: | November 2019 |
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 labelling of the Silhouette Instalift Suture (K163676) in USA.
2. Device Name
The device name as per the original 510(k) is Silhouette Instalift. The trade name utilized in the USA is Silhouette Instalift. The part numbers that are to be modified under this trade name are: SMS 28-PLG-3.0.1-NA
SMS 29-PLG-3.0.1-NA SMS 30-PLG-3.0.1-NA Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulation Number: 21 CFR 878.4493 Regulatory Class: II Product Code: GAM
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Image /page/4/Picture/0 description: The image shows the logo for Silhouette Lift. The word "Silhouette" is in a simple, sans-serif font, while the word "lift" is in a more stylized, cursive font. Both words are in a blue color, and there is a registered trademark symbol next to the word "lift".
Image /page/4/Picture/1 description: The image shows the Sinclair Broadcast Group logo. The logo features the word "SINCLAIR" in a serif font, with a stylized blue swoosh above and below the word. The swooshes are curved and create a sense of motion around the company name. The logo is simple, clean, and professional.
3. Substantial Equivalence
The modified Silhouette Instalift device is substantially equivalent to previous Silhouette Instalift device cleared under K142061 and amended under K163676. The change to the device is limited to changes made to the labelling, which includes an additional contraindication,
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 to the labelling of the device. The details and reasons for which are detailed within this Special 510(k).
4. Device Description
Silhouette Instalift Sutures are absorbable, sterile sutures.
lt is manufactured from a USP size 3-0 Poly/Glycolide/I-lactide suture material and an implantable grade of bioabsorbable PLGA resin (100% Poly (L-lactideco-glycolide) (co-monomer ratio: L-Lactide =82mol%: glycolide=18mol%). The 30 centimeter suture (+- 10 %) (SMS 28-PLG-3.0.1- NA), 27.5 centimeter suture (+- 10 %) (SMS 29-PLG-3.0.1-NA) or 26.8 centimeter suture (+- 10 %) (SMS 30-PLG-3.0.1-NA) are attached to two 12 centimeter straight stainless steel needles.
All products are supplied sterile (EO) for single use only. Silhouette Instaliff Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
5. 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.
The intended use of the modified device is identical to the predicate, Silhouette Instalift cleared under K142061 and amended under K163676.
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Image /page/5/Picture/0 description: The image shows the logo for Silhouette Lift. The words "Silhouette" and "lift" are written in a blue, sans-serif font. The word "lift" is written in a cursive style, with the "l" extending below the other letters.
Image /page/5/Picture/1 description: The image shows the word "SINCLAIR" in a serif font. There is a blue swoosh above and below the word. The swooshes are curved and appear to be part of a larger circle.
6. Technological Characteristics
The technological characteristics of the modified Silhouette Instalift Sutures remain unchanged from those described in the original K142061 and amended under K163676.
| Overall Design | PLG 8218 monofilament and cones |
|---|---|
| Product Material(s): | PLG 8218 poly(glycolide/Llactide monofilament andcones |
| Product design andmethod of operation: | LG 8218 absorbable monofilament and absorbablecones |
| Method of Construction | Extruded PLG 8218 monofilament and injectionmolded PLG 8218 cones |
| Sterilization Process: | EO Sterilization |
| Outline of surgicalprocedure: | Surgical insertion using straight needles only - noincisions; Insertion through a puncture from the entrypoint to exit points, as determined by physician.Cones grab and hold facial tissue in elevatedposition. |
| Environment required forinsertion: | Physician's office or out-patient surgical center. |
§ 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.