OPTIMIZED BARB DESIGN

K052962 · Surgical Specialties Corp · GAW · Dec 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052962
• Device Name: OPTIMIZED BARB DESIGN
• Applicant: Surgical Specialties Corp
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Dec 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour Necklift Threads ™ are indicated for use in Necklift surgery. The Contour Necklift Threads TM are specifically indicated for use to fixate and Elevate the subdermis to the deep fascia of the retromastoid area. The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. The Contour Forehead/Browlift Thread™ is indicated for use in browplasty surgery. The Contour Forehead/Browlift Thread™ is specifically indicated for use to fixate the subdermis to the periosteum of the cranium in browplasty. The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

Device Story

Contour Threads are sterile, nonabsorbable, USP size 2-0 polypropylene surgical sutures; feature uni-directional or bi-directional barbed design; supplied with 400 series stainless steel needles attached to both ends. Used by surgeons in clinical settings for tissue fixation and elevation during necklift, midface suspension, and browplasty procedures. Barbs engage tissue to maintain elevated position; intended for single use. Benefits include mechanical fixation of subdermis to deep fascia or periosteum to support surgical aesthetic outcomes.

Clinical Evidence

Bench testing only. Ex vivo holding tissue force comparison test performed in pigs to evaluate barb performance.

Technological Characteristics

Material: USP size 2-0 polypropylene (biocompatible). Design: Uni-directional or bi-directional barbs. Components: 400 series stainless steel needles. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for patients undergoing necklift, midface suspension, or browplasty surgery requiring fixation and elevation of subdermal tissue to deep fascia, periosteum, or cheek subdermis.

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 Threads (K041593)
• Contour Threads (K050548)
• Contour Threads (K050247)
• Contour Threads (K042856)
• Quill Medical Barb design (K042075)
• Quill Medical Barb design (K051609)

Reference Devices

• Surgical Specialties' Polypropylene Surgical Sutures (PMA 870064)

Submission Summary (Full Text)

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2005 DEC 6

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K052962 1/2

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

| Submitter: | Surgical Specialties Corporation |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 100 Dennis Drive |
| | Reading, PA 19606 |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth Lazaro |
| | Regulatory Affairs Specialist |
| Date Prepared: | October 20, 2005 |
| Name of Device: | Contour Thread |
| Common / Usual Classification Name: | GAW |
| | Suture. Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Contour Threads K041593, K050548, K050247 and K042856 as previously submitted by Surgical Specialties Corporation and Predicate K042075 and K051609 as submitted by Quill Medical for Barb design. |
| Indications For Use: | Fixation and Elevation as previously submitted, see indications section of this submission of approved Contour Thread 510 (k)'s: K041593 Midface Extended Length K050548 Midface Opposing Uni-directional K050247 Neck Lift K042856 Brow Lift |

Contour Thread Optimized Barb Design Surgical Specialties Corporation

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K052962 2/2

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

1

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

| Device Description | The Contour Threads are a clear, nonabsorbable, sterile,<br>surgical strand of polypropylene. The base product is<br>USP size 2-0 polypropylene suture material. The<br>Threads may incorporates a Uni-directional or Bi-<br>directional barbed design. The Threads will be supplied<br>with needles attached to both ends. The needles are<br>made of 400 series stainless steel. The threads are<br>supplied sterile for single use. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polypropylene material used for the Contour<br>Threads is commonly used in medical applications<br>and have been proven to be biocompatible. Bench<br>and animal evaluations have demonstrated the<br>device to be safe and effective. It is equivalent to<br>other 510 (k) approved surgical sutures and<br>identical to Surgical Specialties' Polypropylene<br>Surgical Sutures, PMA 870064. |
| Performance Data: | Comparison of Holding Tissue Force in an Ex Vivo<br>Test in pigs. |
| Substantial Equivalence | The Contour Thread is identical to the intended use<br>as previously submitted by Surgical Specialties<br>Corporation.<br>The Contour Thread barb design is the same as the<br>Quill design approved in the 510(k) K042075 and<br>K051609. |

The Contour Thread Optimized Barb Design
Surgical Specialties Corporation

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 6 2005

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

Re: K052962

Trade/Device Name: The Contour Necklift Threads™, The Contour Midface Opposing Uni-Directional Threads", Contour Forehead/Browlift Thread"", Featherlift" Extended Length Length Aptos Thread Regulation Number: 21 CFR878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: October 20, 2005 Received: October 21, 2005

Dear Ms. Lazaro:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices comply 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); 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.

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Page 2- Elizabeth Lazaro

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your device and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 Manufacturers, International 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,

y yours,

Dave Buelhm

Mark N. Melkerson 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): KC 529 62

Device Name: The Contour Necklift Threads ™

Indications For Use:

The Contour Necklift Threads ™ are indicated for use in Necklift surgery. The Contour Necklift Threads TM are specifically indicated for use to fixate and Elevate the subdermis to the deep fascia of the retromastoid area.

| 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)
Barbara Bruch for MXM
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1

510(k) Number_ 10 29 29 29 29

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#### Indications for Use

510(k) Number (if known): K052962

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

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 1 (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)

Chavala Boemip mku

Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K052962

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#### Indications for Use

510(k) Number (if known): KOラス4し入

Contour Forehead/Browlift Thread TM Device Name:

Indications For Use:

The Contour Forehead/Browlift Thread™ is indicated for use in browplasty surgery.

The Contour Forehead/Browlift Thread™ is specifically indicated for use to fixate the subdermis to the periosteum of the cranium in browplasty.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

Page 1 of

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valerie Buchheit Arnett

Division of General, Restorative, and Neurological Devices

510(k) **Number** kos2962

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# K052962

#### Indications for Use

510(k) Number (if known): 长05 2962

Device Name: Featherlift™ Extended Length Length Aptos Thread

Indications For Use:

The Featherlift™ Extended Length Aptos Thread is 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)

Barbara Buchholz-MKU Page 1 of 1
Division Sign Off

n of General, Restorative, and Neurological Devices

510(k) Number K052968