CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS

K050548 · Surgical Specialties Corp · GAW · Apr 1, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050548
• Device Name: CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
• Applicant: Surgical Specialties Corp
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Apr 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

Device Story

Device consists of clear, nonabsorbable, sterile, polypropylene surgical strand; USP size 2-0; 45cm length; uni-directional-barbed design; smooth center section (nominal 2 inches). Supplied with 7-inch 400 series stainless steel needles attached to both ends. Used in midface suspension surgery to fixate cheek subdermis in elevated position. Operated by surgeons in clinical setting. Provides mechanical fixation of tissue.

Clinical Evidence

Bench testing only. Physical testing conducted to USP 27 standards for tensile strength. Biocompatibility established via material history. No clinical data provided.

Technological Characteristics

Material: Polypropylene (USP 2-0). Needles: 400 series stainless steel. Design: Uni-directional barbed strand with smooth center. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for midface suspension surgery to fixate cheek subdermis in an elevated position.

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

• Contour Extended Length Threads (K041593)

Reference Devices

• Polypropylene Surgical Sutures (PMA 870064)

Submission Summary (Full Text)

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Ko 50 548 1/2

## APR -- 1 2005

Image /page/0/Picture/2 description: The image shows the logo for Surgical Specialties Corporation. The logo is in black and white and features the company name in a stylized font. A black triangle is to the right of the company name.

## 510 (k) SUMMARY OF SAFETY AND EFFEC SUBSTANTIAL EQUIVALENCY

| Submitter: | Surgical Specialties Corporation |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 100 Dennis Drive<br>Reading, PA 19606 |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth Lazaro<br>Regulatory Affairs Specialist |
| Date Prepared: | February 28, 2005 |
| Name of Device: | Contour Midface Opposing<br>Uni-directional Threads |
| Common / Usual<br>Classification Name: | GAW<br>Suture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Contour Extended Length Threads K041593 |
| Indications For Use: | The Contour Midface Opposing Uni-directional<br>Thread is indicated for use in midface suspension<br>surgery to fixate the cheek subdermis in an elevated<br>position. |

Contour Midface Opposing Uni-Directional Threads Surgical Specialties Corporation

Image /page/0/Picture/6 description: The image shows the logo for LOOK. The logo consists of the word "LOOK" in a sans-serif font, with a stylized eye symbol replacing the second "O". Below the logo is the tagline "Precisely what you need" in a smaller font. The logo is simple and modern, and the tagline suggests that LOOK provides products or services that are tailored to the specific needs of its customers.

100 Dennis Drive · Reading, PA 19606, U.S.A. 610 404-1000 • 800 523-3332 • Fax: [phone] ww.surgicalspecialties.com

Image /page/0/Picture/8 description: The image shows the logo for Sharpoint, a company that provides surgical tools. The logo features the company name in a stylized font, with the tagline "The Surgeon's Edge" underneath. To the right of the company name is a black triangle pointing to the right. Above the company name is a small graphic that looks like the number 8.

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Image /page/1/Picture/0 description: The image shows a logo for Surgical Specialties Corporation. The logo features the words "Surgical Specialties" in a stylized font, with the word "Corporation" written in smaller letters below. To the right of the words is a black triangle pointing to the right. Below the word "Corporation" is the phrase "Incision & Healing Technologies".

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

| Device Description | The Contour Midface Opposing Uni-Directional Threads<br>are a clear, nonabsorbable, sterile, surgical strand of<br>polypropylene. The base product is USP size 2-0<br>polypropylene suture material. The 45centimeter length<br>incorporates a Uni-directional-barbed design with center<br>of the thread being smooth for a distance of a nominal<br>two inches. The Threads will be supplied with 7 inch<br>needles attached to both ends. The needles are made of<br>400 series stainless steel. The threads are supplied sterile<br>for single use. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polypropylene material used for the Midface<br>Contour Threads is commonly used in medical<br>applications and have been proven to be<br>biocompatible. Bench and animal evaluations have<br>demonstrated the device to be safe and effective. It<br>is equivalent to other 510 (k) approved surgical<br>sutures and identical to Surgical Specialties'<br>Polypropylene Surgical Sutures, PMA 870064. |
| Performance Data: | Physical testing was conducted on the thread to<br>USP 27 for tensile strength. |
| Substantial Equivalence | The Contour Midface Opposing Uni-Directional<br>Thread is identical in the intended use to the<br>predicate The Contour Extended Length Threads.<br>The Contour Midface Opposing Uni-Directional<br>Thread uses the same suture material shown to have<br>tensile strength and biocompatibility suitable for<br>this application. The approved suture material is<br>Polypropylene. The Contour Midface Opposing<br>Uni-Directional Threads intended use is in midface<br>suspension surgery to fixate the cheek subdermis in<br>an elevated position. |

The Contour Midface Uni-Directional Threads Surgical Specialties Corporation

Image /page/1/Picture/4 description: The image shows the word "LOOK" in bold, sans-serif font, followed by a small circle and a stylized image of a camera lens. Below the word "LOOK" is the phrase "Precisely what you need" in a smaller, lighter font. The logo appears to be for a company named "LOOK" that specializes in providing precise solutions.

100 Dennis Drive · Reading, PA 19606, U.S.A. 610 404-1000 • 800 523-3332 • Fax: [phone] www.surgicalspecialties.com

Image /page/1/Picture/6 description: The image shows the logo for Sharpoint, a company that specializes in surgical tools. The logo features the company name in a stylized font, with the tagline "The Surgeon's Edge" underneath. To the right of the company name is a black triangle pointing to the left. Above the company name is a stylized image of a surgical tool.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight. The symbol is composed of three curved lines that create the impression of movement and dynamism.

Public Health Service

APR - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606

Re: K050548

K050548
Trade/Device Name: The Contour Midface Opposing Uni-Directional Threads™
Trade/Device Name: The Contour 2012 Regulation Number: 21 CFR 878.5010 Regulation Name: Non-absorbable synthetic polypropylene suture Regulatory Class: II Product Code: GAW Dated: March 1, 2005 Received: March 2, 2005

Dear Ms. Lazaro:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(ts) prematically equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally mancedes in one include be vice Ameral Food. Drug commerce prior to May 28, 1970, the charters with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with expressed application (PMA) devices that have been reculted in accordance whiles approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval approval organizions of and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls, provisions o You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the Act mender requirements.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it ( If your device is classified (Sec above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation UDA may be subject to such additional controlis: Extisting major of SP8. In addition. I'DA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peach. Regarning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a substants with other requirements of the Act
that FDA has made a determination that your device complies with onenaios. You musi that FDA has made a decemmanon that your accred by other Federal agencies. You must relievelies and list or any Federal statutes and regulations administered of exist of the station and listing (21 comply with all the Act s requirements, moradice requires practice requirements as se
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the illustry) CFR Part 807); labeling (21 CFR Part 801); god and if applicable. the electronic
forth in the quality systems (QS) regulation (21 CFR Party, 21 CFR 1000 (1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Ms. Elizabeth Lazaro

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you demic specific as not any at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Erica b

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: The Contour Midface Opposing Uni-Directional Threads™

Indications For Use:

- The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
rive

K056548