L-25 ABSORBABLE SURIGCAL SUTURE

K013671 · United States Surgical, A Division of Tyco Healthc · GAM · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013671
• Device Name: L-25 ABSORBABLE SURIGCAL SUTURE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

Device Story

L-25 is a synthetic absorbable surgical suture used for soft tissue approximation and ligation. It is intended for use by surgeons in clinical settings. The device functions as a mechanical fastener to hold tissue edges together during the healing process, eventually being absorbed by the body. It is provided as a sterile, single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Synthetic absorbable suture composed of Glycolide, Caprolactone, Tri-Methylene Carbonate, and Lactide polymers. Sterile, single-use device.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgery, or ophthalmic surgery.

Regulatory Classification

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.

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

• Gut Suture (SurgigutTM) (K885018)
• BiosynTM Suture (K000037)
• VicrylTM Rapide Suture (K944110)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS X.

JAN 0 8 2002

| SUBMITTER: | United States Surgical,<br>a division of Tyco Healthcare Group, LP<br>150 Glover Avenue<br>Norwalk, CT 06856 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Robert Zott |
| DATE PREPARED: | November 1, 2001 |
| CLASSIFICATION NAME: | Absorbable poly(glycolide/L-lactide)<br>surgical suture |
| COMMON NAME: | Surgical Suture |
| PROPRIETARY NAME: | To be determined |
| PREDICATE DEVICES: | K885018: Gut Suture (SurgigutTM)<br>K000037: BiosynTM Suture<br>K944110: VicrylTM Rapide Suture |
| INDICATIONS: | The device is indicated for use in general soft<br>tissue approximation and/or ligation, but not for<br>use in cardiovascular or neurological surgery,<br>microsurgery, or ophthalmic surgery. |
| MATERIALS: | Glycolide, Caprolactone, Tri-Methylene<br>Carbonate, and Lactide polymers. |

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Image /page/1/Picture/2 description: The image is a black and white 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, with three horizontal lines representing the snakes and a wavy line at the bottom representing the staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 0 8 2002

Robert Zott Senior Associate, Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

Re: K013671

Trade Name: L-25 Absorbable Surgical Suture Regulation Number: 878.4493 Regulation Name: Absorbable polyglycolide surgical suture Regulatory Class: II Product Code: GAM Dated: November 5, 2001 Received: November 6, 2001

Dear Mr. Zott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 he 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); 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 - Mr. Robert Zott

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.

Neil R.P. Ogden

Celia M. Witten. Ph.D., M.D. H. 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 V.

510(k) Number (if known): K013671

Device Name: L-25 Absorbable Surgical Suture (Trade name to be determined)

## Indications For Use:

L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)

Nho forcmw

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

510(k) Number K01367/