MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE

K032420 · ETHICON, Inc. · GAM · Oct 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032420
• Device Name: MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified Coated VICRYL* Plus Antibacterial 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 Plus Antibacterial suture is a synthetic, absorbable, sterile surgical suture; composed of 90% glycolide and 10% L-lactide copolymer; coated with Polyglactin 370, calcium stearate, and Irgacare MP (triclosan). Used by surgeons for soft tissue approximation and ligation. Device provides mechanical wound closure while releasing an antibacterial agent to potentially reduce surgical site infection risk.

Clinical Evidence

Bench testing only. Non-clinical laboratory testing demonstrated conformance to USP Monograph for absorbable surgical sutures. In-vivo and in-vitro testing confirmed the device performed as intended and claimed.

Technological Characteristics

Braided synthetic absorbable suture; copolymer of 90% glycolide and 10% L-lactide; coated with Polyglactin 370, calcium stearate, and Irgacare MP (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 Plus Antibacterial (Polyglactin 910) Suture

Submission Summary (Full Text)

{0}------------------------------------------------

# K032420

# OCT 22 2003

100 million in the states :

. 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

#### SECTION 8

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 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* Plus<br>Antibacterial (Polyglactin 910) Suture<br><br>PREDICATE DEVICES NAME: Coated VICRYL* Plus<br>Antibacterial (Polyglactin 910) Suture. |
| Device Description | Modified Coated VICRYL* Plus Antibacterial (Polyglactin 910)<br>suture is a synthetic absorbable sterile surgical suture composed of<br>a copolymer made from 90% glycolide and 10% L-lactide.<br>Modified Coated VICRYL* Plus suture is coated with a mixture<br>composed of equal parts of a copolymer of glycolide and lactide<br>(Polyglactin 370) and calcium stearate and a small amount of an<br>antimicrobial agent, Irgacare MP (triclosan). |
| Intended Use | Modified Coated VICRYL* Plus Antibacterial suture is intended<br>for use in general soft tissue approximation and/or ligation, except<br>for use in ophthalmic, cardiovascular and neurological tissues. |
| Indications Statement | Modified Coated VICRYL* Plus Antibacterial 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>Plus suture device, it is a sterile, braided synthetic absorbable<br>suture that conforms to the USP Monograph for absorbable<br>surgical sutures, except for diameter. Like the currently marketed<br>Coated VICRYL Plus Antibacterial suture, the modified device ,<br>contains Irgacare** MP, an antibacterial agent. |
| 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 Devices<br>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 1, 2003 |

{1}------------------------------------------------

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures, represented by flowing lines, suggesting unity and collaboration. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Mr. Rey Librojo Regulatory Affairs Ethicon. Inc. Route 22 West Somerville. New Jersey 08876

Re: K032420

Trade/Device Name: Modified Coated VICR YL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: August 1. 2003 Received: August 7, 2003

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.

{3}------------------------------------------------

Page 2 - Mr. Rey Librojo

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 yours,

Sincerely yours,

Mark A Milkerson

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

{4}------------------------------------------------

INDICATIONS FOR USE

K032420

510(k) Number (if known):

Device Name:

Indications for Use:

Modified Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture

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

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

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)

Mark N Millner

Ision Sign-Of ision of Genera "estorative Verrological Levices

(k) Number K032420

* Trademark

Page iii