SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE

K031286 · Aesculap, Inc. · GAM · May 29, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031286
• Device Name: SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
• Applicant: Aesculap, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 29, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.

Device Story

Safil and Safil Quick are sterile, absorbable, flexible multifilament surgical sutures composed of polyglycolic acid polymer. The device is coated with an absorbable polyclyconate and may be dyed with D&C Violet No.2 or D&C Green No.6. Used by surgeons for soft tissue approximation requiring short-term wound support. The device functions as a mechanical closure mechanism for surgical incisions or wounds.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic absorbable multifilament suture composed of polyglycolic acid polymer; coated with absorbable polyclyconate. Available dyed (D&C Violet No.2 or D&C Green No.6 per 21 CFR 74.3206) or undyed. Sterile, flexible thread form factor.

Indications for Use

Indicated for general soft tissue approximation, including ophthalmic procedures. Contraindicated for 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

• Safil Synthetic Absorbable Surgical Suture (K011372)
• Safil Quick Synthetic Absorbable Surgical Suture (K980704)
• Vicryl Synthetic Absorbable Surgical Suture (K944110)
• Vicryl Synthetic Absorbable Surgical Suture (K962480)
• MonoSyn Synthetic Absorbable Surgical Suture (K011375)

Submission Summary (Full Text)

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# MAY 2 9 2003

# K031286

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

#### SAFIL AND SAFIL QUICK SYNTHETIC ABSORABLE SURGICAL SUTURE

#### April 22, 2003

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller, Manager Requlatory Affairs<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Safil and Safil Quick Synthetic Absorbable Surgical Suture |
| COMMON NAME: | Synthetic Absorbable Poly (Glycolide/L-lactide) Surgical Suture |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | GAM |
| CLASSIFICATION: | 878.4493, Synthetic Absorbable Poly (Glycolide/L-lactide) Surgical Suture |
| REVIEW PANEL: | General & Plastic Surgery |

#### INTENDED USE

Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.

#### DEVICE DESCRIPTION

The subject device is an absorbable, flexible multifilament suture thread which is supplied sterile. It is composed of a synthetic polyglycolic acid polymer and it is indicated for soft tissue approximation where only short term wound support is required. It will be offered dyed or undyed with the FDA approved colorant D&C Violet No.2 or D&C Green No.6 in accordance with Title 21 CFR, §74.3206. The modified device is coated with an absorbable polyclyconate.

#### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

#### SUBSTANTIAL EQUIVALENCE

Aesculap believes that the Safil Quick Absorbable Surgical Suture is substantially equivalent to Safil Synthetic Absorbable Surgical Suture (K011372), Safil Quick Synthetic Absorbable Surgical Suture (K980704) and the following other predicate devices:

- Vicryl Synthetic Absorbable Surgical Suture (K944110 and K962480) .
- MonoSyn Synthetic Absorbable Surgical Suture (K011375) .

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of unity or collaboration.

Public Health Service

MAY 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Georg Keller Manager Regulatory Affairs Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K031286

Trade/Device Name: Safil and Safil Quick Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: April 22, 2003 Received: May 6, 2003

Dear Mr. Keller:

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.

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Page 2 - Mr. Georg Keller

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]. 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) you may obtain. 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,

Musiam 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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Page 1 of 1

(Optional Format 3-10-98)

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K031286

## Device Name: Safil and Safil Quick Synthetic Absorbable Surgical Sutures

#### Indication for Use:

Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or Over-the-Counter Use
(per 21 CFR 801.109)

Miriam C. Provost

Restorative and Neurolog

510(k) Number K031286