COATED VICRYL* (POLYGLACTIN 910) SUTURE

K022269 · ETHICON, Inc. · GAM · Sep 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022269
• Device Name: COATED VICRYL* (POLYGLACTIN 910) SUTURE
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Sep 13, 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, including use in ophthalmic procedures, but not for use in 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; coated with 90% caprolactone and 10% glycolide copolymer, plus a mixture of Polyglactin 370 and calcium stearate. Used by surgeons in clinical settings for tissue approximation and ligation. Device provides mechanical support during healing; material is absorbed by body over time. Output is physical closure of tissue; aids in surgical wound management.

Clinical Evidence

Bench testing only. Device demonstrated conformance to USP Monograph for absorbable surgical sutures. In-vivo testing confirmed the device performed as intended.

Technological Characteristics

Sterile, braided synthetic absorbable suture; copolymer of 90% glycolide and 10% L-lactide; coated with 90% caprolactone/10% glycolide copolymer and Polyglactin 370/calcium stearate mixture. Conforms to USP Monograph for absorbable surgical sutures (except diameter).

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for 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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K022269

Age 1/2

SEP 1 3 2002

### 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. | | |
| | MODIFIED DEVICE NAME: Coated VICRYL* (Polyglactin<br>910) Synthetic Absorbable Suture | | |
| | 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, which is prepared by coating VICRYL* suture<br>material with a copolymer of 90% caprolactone and 10% glycolide<br>and subsequently with a mixture composed of equal parts of a<br>copolymer of glycolide and lactide (Polyglactin 370) with calcium<br>stearate. | | |
| Intended Use | Modified Coated VICRYL* suture is intended for use in general<br>soft tissue approximation and/or ligation, including use in<br>ophthalmic procedures, but not for use in cardiovascular and<br>neurological tissues. | | |
| | Modified Coated VICRYL* suture has the same intended use as<br>the predicate device, current Coated VICRYL* suture. | | |

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KO22269 Page 2/3

### Section 8 – Summary of Safety and Effectiveness, Continued

# Indications Statement Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. Technological Characteristics The new device has similar technological characteristics as the predicate devices. Like the predicate device, it is a sterile, braided synthetic absorbable suture that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Performance Data Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo testing was provided showing that the device performed as intended. Conclusions Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act. Contact Lea Ann Conway Director, Regulatory Affairs and Quality Assurance Ethicon Products ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 July 10, 2002 Date

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

SFP 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon. Inc Lea Ann Conway Director, Regulatory Affairs and Quality Assurance Route 22. West Somerville, New Jersey 08876

Re: K022269

Trade/Device Name: Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: July 10, 2002 Received: July 15, 2002

Dear Ms. Conway:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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.

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Page 2 – Ms. Lea Ann Conway

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" (21 CFR 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,

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

022269

510(k) Number (if known):

,

Device Name:

Indications for Use:

Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture

Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use | <div style="display:inline-block; vertical-align:top;"> <img alt="Tick" src="prescription_use_tick.png" style="width:20px; height:auto;"/> </div> | OR | Over-The Counter Use |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

| (Division Sign-Off) | | (Optional Format 1-2-9G) |
|-----------------------------------------------------------|--|--------------------------|
| Division of General, Restorative and Neurological Devices | | |

| 510(k) Number | K022269 |
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