FEATHERLIFT EXTENDED LENGTH APTOS THREAD

K041593 · Surgical Specialties Corp · GAW · Sep 20, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041593
• Device Name: FEATHERLIFT EXTENDED LENGTH APTOS THREAD
• Applicant: Surgical Specialties Corp
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device consists of sterile, nonabsorbable, blue polypropylene surgical thread (USP 2-0, 25cm length) featuring a 10cm unidirectional-cogged section at distal end; 400 series stainless steel straight taper cutting needle swedged to proximal end; 18-gauge stainless steel introducer included for placement. Used in midface suspension surgery; physician-operated. Thread implanted into cheek subdermis; anchored by suturing/tying to temporal fascia. Cogs provide uniform fixation surface area across midface; polypropylene material maintains fixation indefinitely. Benefits include tissue elevation and stable suspension.

Clinical Evidence

Bench and animal evaluations conducted. Bench testing included USP 27 tensile strength, force required to remove after implantation, and ISO 10993 biocompatibility for permanent implantation.

Technological Characteristics

Materials: USP 2-0 polypropylene suture (PMA 870064, K904906), 400 series stainless steel needle, 18-gauge stainless steel introducer. Unidirectional-cogged design. Sterile, single-use. Permanent implantation.

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

• Coapt Endotine Midface ST 4.5 device (K032698)

Submission Summary (Full Text)

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SEP 2 0 2004

K041593 P,1/3

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

| Submitter:<br>Address: | Surgical Specialties Corporation<br>100 Dennis Drive<br>Reading, PA 19606 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Contact Person: | 610 404 1000, ext. 2231<br>Betty Lazaro<br>Regulatory Affairs Specialtist |
| Date Prepared: | June 10, 2004 |
| Name of Device: | FeatherliftTM Extended Length Aptos Threads |
| Common / Usual<br>Classification Name: | GAW<br>Suture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Coapt Endotine Midface ST 4.5 device K032698 |
| Indications For Use: | Featherlift Aptos Extended Length Threads are<br>indicated for use in midface suspension surgery to<br>fixate the cheek subdermis in an elevated position. |

Featherlift™ Extended Length Aptos Threads Surgical Specialties Corporation

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K041593
p2/3

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

| Device Description | The threads are a blue, nonabsorbable, sterile,<br>surgical strand of polypropylene. The product is<br>USP size 2-0 polypropylene suture material 25<br>centimeters in length and incorporates a<br>unidirectional-cogged section 10 centimeters long<br>from the distal end. A 2 ¾ straight taper cutting<br>needle made of 400 series stainless steel will be<br>swedged to the proximal end. An introducer made<br>of 18 gauge stainless steel will be included for<br>placement of the Threads. The threads and the<br>introducer are supplied sterile for single use. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polypropylene sutures used PMA 870064,<br>K904906 for the fabrication of FeatherLift™<br>Extended Length Aptos Threads are commonly<br>used in medical applications where they are<br>implanted for tissue approximation in the body<br>indefinitely. Bench and animal evaluations have<br>demonstrated the Featherlift Extended Length<br>Aptos Threads to be safe and effective. |
| Performance Data: | Physical testing was conducted on the thread to<br>USP 27 for tensile strength, force required to<br>remove after implantation and Biocompatability for<br>permanent implantation, ISO 10993. |

Featherlift™ Extended Length Aptos Threads Surgical Specialties Corporation

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Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text starts with the letters "Koy" followed by what looks like "D593". There is also a fraction-like expression of "3/3" with a subscripted "3" before the fraction.

Substantial Equivalence

The Featherlift™ Extended Length Aptos Thread is I no I can in use as its predicate device Endotine equivalent in 4.5 having the same intended use and indication for use except for the surgical technique of subperiosteal deployment. The fixation of subcutaneous tissue and elevation for both devices are achieved by tacking to the temporal fascia. They are anchored by suturing and tying to that fascia. The fixation surface area of the Featherlift Aptos Thread is more uniform, spread out over the entire midface providing a greater surface area of fixation compared to the Endotine Midface. The Material of the Featherlift Aptos Thread is made from a non absorbable polypropylene suture and will maintain its fixation indefinitely compared to the midface suspension device that is fabricated from a PGA equivalent material that looses significant strength and mass by 5 months. Therefore, the Featherlift Aptos Thread is substantially equivalent and offers some advantages over the predicate device, the Endotine Midface ST4.5.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2004

Mr. Richard G. Jones Vice President, Regulatory Affairs/Quality Assurance Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606

Re: K041593

Ro41973
Trade/Device Name: Featherlift™ Extended Length Aptos Thread Regulation Number: 21 CFR 878.5010 Regulation Name: Polypropylene suture Regulatory Class: II Product Code: GAW Dated: September 7, 2004 Received: September 9, 2004

## Dear Mr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave levice your bected. B read free is substantially equivalent (for the indications relerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatise posice Americal Device American son to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been resulted in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that to not require appt to the general controls provisions of the Act. The 1 ou may, mercrore, manel are act include requirements for annual registration, listing of general controls provisions of the rice, 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 (socure) inc. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overnents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3 issuaired or wouldevice complies with other requirements of the Act that I DA has made a decemmations administered by other Federal agencies. You must of any I cutures and regarance and regarants aincluding, but not limited to: registration and listing (21 Comply with an the Her Prequents (1) ); good manufacturing practice requirements as set OF It in the quality systems (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 - Mr. Richard G. Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your ence of your device to a legally premarket notheadon: "The FDA midning of basification 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 desire specific advice for your ac not on one of the more the regulation entitled, and Colliact the Office of Compuner as (be notification" (21CFR Part 807.97). You may obtain Misoranumly by reference to premansonsibilities under the Act from the Division of Small other gelleral information on your respendent Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
for

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K04/593.

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## Indications for Use

510(k) Number (if known):

Device Name: Featherlift™Extended 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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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