MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE

K033746 · ETHICON, Inc. · GAM · Dec 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033746
• Device Name: MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL Rapide suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Device Story

Modified Coated VICRYL Rapide is a synthetic, absorbable, sterile, braided surgical suture. Composed of 90% glycolide and 10% L-lactide copolymer. Features dual-layer coating: inner layer of 90/10% w/w caprolactone/glycolide; outer layer of Polyglactin 370 and vegetable-based calcium stearate. Used by surgeons for superficial soft tissue approximation. Provides short-term wound support (7-10 days) before absorption. Device functions as a mechanical closure tool.

Clinical Evidence

Bench testing only.

Technological Characteristics

Synthetic absorbable braided suture; copolymer of 90% glycolide and 10% L-lactide. Dual-coating: inner layer (90/10% caprolactone/glycolide), outer layer (Polyglactin 370 and calcium stearate). Sterile.

Indications for Use

Indicated for superficial soft tissue approximation of skin and mucosa requiring short-term wound support (7-10 days). Contraindicated for ligation, ophthalmic, cardiovascular, or neurological procedures.

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 Rapide (Polyglactin 910) Suture

Submission Summary (Full Text)

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K033746 P9

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## DEC 1 8 2003

| Statement | 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. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MODIFIED DEVICE NAME: Modified Coated VICRYL* Rapide<br>(Polyglactin 910) Suture |
| | PREDICATE DEVICE NAME: Coated VICRYL* Rapide<br>(Polyglactin 910) Suture. |
| Device Description | Modified Coated VICRYL* Rapide (Polyglactin 910) suture is a<br>synthetic absorbable sterile surgical suture composed of a<br>copolymer made from 90% glycolide and 10% L-lactide. Modified<br>Coated VICRYL* Rapide suture is first coated (inner coating) with<br>a copolymer of 90/10% w/w caprolactone / glycolide and<br>subsequently coated with a mixture composed of equal parts of<br>Polyglactin 370 (copolymer of glycolide and L-lactide) and<br>vegetable-based calcium stearate. |
| Intended Use | Indicated only for use in superficial soft tissue approximation of<br>the skin and mucosa, where only short term wound support (7-10<br>days) is required. Coated VICRYL Rapide suture is not intended<br>for use in ligation, ophthalmic, cardiovascular or neurological<br>procedures. |
| Indications Statement | Indicated only for use in superficial soft tissue approximation of<br>the skin and mucosa, where only short term wound support (7-10<br>days) is required. Coated VICRYL Rapide suture is not intended<br>for use in ligation, ophthalmic, cardiovascular or neurological<br>procedures. |
| Technological<br>Characteristics | |
| | The modified device has similar technological characteristics as the<br>predicate devices. Like the currently marketed VICRYL* Rapide<br>suture device, it is a sterile, braided synthetic absorbable suture<br>which is also coated. |
| Performance Data | Results of verification testing indicates that the product meets the<br>established performance requirements. |
| 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 |
| | Senior Project Manager, Regulatory Affairs |
| | ETHICON Products |
| | ETHICON, Inc. |
| | Rt. #22, West<br>Somerville, NJ 08876-0151 |
| Date | November 25, 2003 |

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K033746 page 21

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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2003

Mr. Rey Librojo Senior Project Manager Ethicon. Inc. Route 22 West Somerville, New Jersey 08876-0151

Re: K033746

K033740
Trade/Device Name: Modified Coated VICRYL* Rapide (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: November 24, 2003 Received: December 1, 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 sct 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. 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,

Muriam C. Provost

a 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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510(k) Number (if known):

Device Name:

Indications for Use:

Modified Coated VICRYL* Rapide (Polyglactin 910) Synthetic Absorbahle Suture

INDICATIONS FOR USE

(033-

Modified Coated VICRYL* Rapide synthetic absorbable suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL Rapide suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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8033746

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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30(k) Number_

* Trademark

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