AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE

K060528 · Aesculap, Inc. · GAR · Mar 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060528
• Device Name: AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
• Applicant: Aesculap, Inc.
• Product Code: GAR · General, Plastic Surgery
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.

Device Story

Trelon® Polyamide Sutures are multifilament, nonabsorbable surgical sutures composed of Nylon 6.6; feature silicone coating. Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device provided in various sizes and lengths, with or without pre-attached needles. Functions as a mechanical closure device to hold tissue edges together during healing.

Clinical Evidence

Bench testing only. Device meets all USP requirements for nonabsorbable sutures.

Technological Characteristics

Polyamide (Nylon 6.6) multifilament suture; silicone coated. Available in various lengths/sizes with or without needles. Meets USP requirements for nonabsorbable synthetic sutures.

Indications for Use

Indicated for general and soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. No specific age or gender restrictions noted.

Regulatory Classification

Identification

Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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

• Dafilon® sutures (K990090)

Submission Summary (Full Text)

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MAR 2 8 2006

Trelon® Polyamide Sutures

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510(k) SUMMARY (as required by 21 CFR 807.92) B.

> Craniofacial Plate & Screw System 24 February 2006

- Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
- CONTACT: Matthew M. Hull 800-258-1946 (phone) 610-791-6882 (fax) [e-mail] (email)

Trelon® Polyamide Multifilament Nonabsorbable Suture TRADE NAME:

COMMON NAME: Polyamide Nonabsorbable Suture

CLASSIFICATION NAME: Suture, Nonabsorbable, Synthetic, Polyamide

REGULATION NUMBER: 878.5020

PRODUCT CODE: GAR

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Trelon® sutures described here are substantially equivalent to the Dafilon® sutures previously cleared in the Aesculap Premarket Notification #K990090.

## DEVICE DESCRIPTION

The Trelon® sutures are a polyamide (Nylon) multifilament suture that is available in common sizes and lengths and is available with or without pre-attached needles.

## INDICATIONS FOR USE

Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Trelon® sutures use the exact same material polyamide (Nylon 6.6) as the predicate Dafilon® device with only difference being that the new device is a multifilament suture as opposed to monofilament. As with other multifilament sutures the Trelon® also uses as silicon coating.

## PERFORMANCE DATA

The Trelon® sutures meet all USP requirements.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2006

Aesculap® Inc. c/o Matthew M. Hull 3773 Corporate Parkwayental Projects Center Valley, PA 18034

Re: K060528

Trade/Device Name: Trelon Polyamide Sutures Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polymade surgical suture Regulatory Class: II Product Code: GAR Dated: February 24, 2006 Received: March 1, 2006

Dear Mr. Hull:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 docs 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); good manufacturing practice requirements as set forth in 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.

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Page 2 - Matthew M. Hull

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 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/dsma/dsmamain.html

Sincerely vours.

Herbert Lemon vo

Mark N. Melkerson 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 STATEMENT A.

KO60528 510(k) Number:

Device Name: Trelon Polyamide Sutures

Indications for Use:

Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.

Prescription Use (Part 21 CFR 801 Subpart D) (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)

Helmut Remer ng

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

060528 510(k) Number