SOFSILK

K964581 · United States Surgical, A Division of Tyco Healthc · GAP · Jan 16, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964581
• Device Name: SOFSILK
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Jan 16, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Due to its nonabsorbable nature, SOFSILK* suture is intended for the approximation of tissues where prolonged retention of tensile strength is required.

Device Story

SOFSILK* is a sterile, flexible, multifilament nonabsorbable surgical suture derived from Bombyx mori silk fiber. Primary component is fibroin polymer. Used by surgeons for tissue approximation requiring long-term tensile strength retention. Device functions as a mechanical tether for wound closure.

Clinical Evidence

Bench testing only; materials comply with ISO 10993-1 standards.

Technological Characteristics

Nonabsorbable multifilament silk suture; material: fibroin polymer from Bombyx mori; compliant with ISO 10993-1.

Indications for Use

Indicated for approximation of tissues requiring prolonged retention of tensile strength; nonabsorbable; suitable for general surgical use.

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* (K900840)
• SOFSILK* (K902874)
• SOFSILK* (K903509)

Submission Summary (Full Text)

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United States Surgical Corporation
510(k) Premarket Notification
modified SOFSILK* Suture
JAN 16 1997
K964581

# 510(k) SUMMARY OF INFORMATION:

**SUBMITTER:** United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
[phone]

**CONTACT PERSON:** Janet G. Johnson

**DATE PREPARED:** October 31, 1996

**CLASSIFICATION NAME:** Natural Nonabsorbable Silk Surgical Suture

**COMMON NAME:** Nonabsorbable Silk Suture

**PROPRIETARY NAME:** SOFSILK*

**PREDICATE DEVICE:** SOFSILK* (K900840, K902874 and K903509)

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

**INTENDED USE:** Due to its nonabsorbable nature, SOFSILK* suture is intended for the approximation of tissues where prolonged retention of tensile strength is required.

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

* Trademark of United States Surgical Corporation.
** Trademark name not yet determined.

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