SOFSILK SUTURE

K980124 · United States Surgical, A Division of Tyco Healthc · GAP · Mar 27, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980124
• Device Name: SOFSILK SUTURE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Mar 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.

Device Story

Modified Sofsilk Suture is a sterile, flexible, nonabsorbable multifilament thread. It is manufactured from fibroin, a high molecular weight fibrous protein derived from the silk fiber of the domesticated species Bombyx mori. The device is intended for use by surgeons in clinical settings for soft tissue approximation and ligation across various specialties, including cardiovascular, ophthalmic, microsurgery, and neural procedures. It functions as a mechanical support to hold tissues together during healing. The device is provided sterile and is restricted to prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonabsorbable, sterile, multifilament thread composed of fibroin protein from Bombyx mori. Materials comply with ISO Standard #10993-1. Device is a mechanical suture for tissue approximation.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery, and neural tissue procedures. No specific age or gender restrictions noted.

Regulatory Classification

Identification

Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

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

• Sofsilk (K964581)

Submission Summary (Full Text)

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K980124

MAR 27 1998

## 510(k) Summary of Safety and Effectiveness IX.

SUBMITTER:

United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856

Victor M. Clavelli CONTACT PERSON:

January 13, 1998 DATE PREPARED:

CLASSIFICATION NAME: Natural Nonabsorbable Silk Surgical Suture

Nonabsorbable Silk Suture COMMON NAME:

Modified Sofsilk* Suture PROPRIETARY NAME:

Sofsilk* (K964581) PREDICATE DEVICES:

Modified Sofsilk * Suture is a nonabsorbable, sterile, DEVICE DESCRIPTION: flexible multifilament thread, prepared from silk fiber produced from the species Bombyx mori. The primary component of silk is the high molecular weight fibrous polymer fibroin.

Modified Sofsilk* Suture has indications for use in general INTENDED USE: soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.

All component materials of the Modified Sofsilk* Suture MATERIALS: are comprised of materials which are in accordance with ISO Standard # 10993-1.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 1998

Mr. Victor Clavelli Program Manager, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk. Connecticut 06856

Re: K980124

Trade Name: Sofsilk Suture Regulatory Class: II Product Code: GAP Dated: January 13, 1998 Received: January 14, 1998

Dear Mr. Clavelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use in general soft tissue and approximation and/or ligation to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Tuesday, October 26, 1993 (Vol. 58. No. 205, Pages 57557 and 57558). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at [phone] or [phone]. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- The Sofsilk Suture is indicated for use in general soft tissue approximation and/or 1. ligation, including use in cardiovascular, ophthalmic and neurological procedures.
- 2. This device may not be manufactured from any material other than multifilamentous fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Sofsilk Suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

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The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597, or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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## IV. Indications For Use:

510(k) Number (if known): k980124

Name: Modified Sofsilk* Suture

## Indications For Use:

Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.

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Concurrence of CDRH, Office of Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)

Division Sign-Off

Sign-Off) Division General Restorative D 510(k) Number

RA03