COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE

K022715 · ETHICON, Inc. · GAM · Dec 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022715
• Device Name: COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified Coated VICRYL* suture is intended for use in general soft tissue approximation and/or ligation, except for use in ophthalmic, cardiovascular and neurological tissues.

Device Story

Modified Coated VICRYL* is a synthetic absorbable sterile surgical suture; composed of 90% glycolide and 10% L-lactide copolymer. Suture is coated with a mixture of Polyglactin 370, calcium stearate, and the antimicrobial agent triclosan (Irgacare MP). Device is used by surgeons for soft tissue approximation and ligation. Antimicrobial coating provides potential benefit by inhibiting bacterial colonization on the suture. Device is provided sterile.

Clinical Evidence

Non-clinical laboratory testing performed; device conformed to USP Monograph for absorbable surgical sutures. In-vivo and in-vitro testing provided to demonstrate performance as intended.

Technological Characteristics

Synthetic absorbable braided suture; material: 90% glycolide/10% L-lactide copolymer; coating: Polyglactin 370, calcium stearate, and triclosan. Conforms to USP Monograph for absorbable surgical sutures. Sterile.

Indications for Use

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

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

• Coated VICRYL (Polyglactin 910) Synthetic Absorbable Suture

Submission Summary (Full Text)

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K022715 page 1/2

### SECTION 8

# SUMMARY OF SAFETY AND EFFECTIVENESS DEC 1 9 2002

| 510(k) Summary of<br>Safety and Effectiveness | Information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug and Cosmetic Act,<br>respecting safety and effectiveness is summarized below. For the<br>convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule "...510(k) Summaries and<br>510(k) Statements..." (21 CFR 807) and can be used to provide a<br>substantial equivalence summary to anyone requesting it from the<br>Agency.<br><br>MODIFIED DEVICE NAME: Modified VICRYL* (Polyglactin<br>910) Synthetic Absorbable Suture<br><br>PREDICATE DEVICES NAME: Coated VICRYL* (Polyglactin<br>910) Synthetic Absorbable Suture. |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Modified Coated VICRYL* (Polyglactin 910) suture is a synthetic<br>absorbable sterile surgical suture composed of a copolymer made<br>from 90% glycolide and 10% L-lactide. Modified Coated<br>VICRYL* suture is coated with a mixture composed of equal parts<br>of a copolymer of glycolide and lactide (Polyglactin 370) and<br>calcium stearate and a small amount of an antimicrobial agent,<br>Irgacare MP (triclosan). |
| Intended Use | Modified Coated VICRYL* suture is intended for use in general<br>soft tissue approximation and/or ligation, except for use in<br>ophthalmic, cardiovascular and neurological tissues. |
| Indications Statement | Modified Coated VICRYL* Plus Antimicrobial suture is indicated<br>for use in general soft tissue approximation and/or ligation, except<br>for ophthalmic, cardiovascular and neurological tissues. |
| Technological<br>Characteristics | The modified device has similar technological characteristics as the<br>predicate devices. Like the currently marketed Coated VICRYL<br>suture device, it is a sterile, braided synthetic absorbable suture<br>that conforms to the USP Monograph for absorbable surgical<br>sutures, except for diameter. Like several previously cleared<br>devices, the modified device contains the antimicrobial agent,<br>triclosan. |
| Performance Data | Non-clinical laboratory testing was performed demonstrating that<br>the device conformed to the USP Monograph for absorbable<br>surgical sutures. Additionally, in-vivo/in-vitro testing was<br>provided showing that the device performed as intended and as<br>claimed. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>modified device is substantially equivalent to the Predicate<br>Devices under the Federal Food, Drug, and Cosmetic Act. |
| Contact | Rey Librojo<br>Senior Project Manager, Regulatory Affairs<br>ETHICON Products<br>ETHICON, Inc.<br>Rt. #22, West<br>Somerville, NJ 08876-0151 |
| Date | August 14, 2002 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rey Librojo Senior Project Manager Ethicon, Inc. Division of Johnson & Johnson Medical P.O. Box 151 Somerville, New Jersey 08876-0151

#### Re: K022715

Trade/Device Name: Coated VICRYL™ Antimicrobial (Polyglactin 910) Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: II Product Code: GAM Dated: November 19, 2002 Received: November 20, 2002

#### Dear Mr. Librojo:

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 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. 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.

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#### Page 2 - Mr. Rey Librojo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 vours,

Miriam C Provost

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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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Indications for Use:

# KO22715

Modified Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture

Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

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

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-9G)

Muriam C. Provost

nston Sun-OR) ision of General, Restorative I Neurologic of Levices

KO 22715

* Trademark

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