SILK SUTURE

K982853 · Davis & Geck, Inc. · GAP · Apr 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982853
• Device Name: SILK SUTURE
• Applicant: Davis & Geck, Inc.
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Apr 30, 1999
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.

Device Story

Silk Non-Absorbable Surgical Suture consists of organic protein fibroin derived from Bombyx mori. Device used for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neural procedures. Features braided or twisted construction; available in white or dyed (black/blue); braided versions coated with silicone. Subject device utilizes automated needle end stiffening process applying medical-grade adhesive to silk strand, replacing manual nylon resin dipping process used in predicate. Suture is non-absorbable, though undergoes gradual in-vivo protein degradation. Used by surgeons in clinical settings to secure tissue; provides mechanical closure to facilitate healing.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ANSI/AAMI 10993 and USP guidelines, including cytotoxicity, hemolysis, sensitization, acute systemic toxicity, irritation, and intracutaneous testing.

Technological Characteristics

Material: Fibroin (organic protein from Bombyx mori). Construction: Braided or twisted; silicone coating on braided types. Manufacturing: Automated needle end stiffening using medical-grade adhesive. Form factor: Various lengths, diameters, with/without needles. Sterilization: Not specified.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring nonabsorbable sutures, including cardiovascular, ophthalmic, and neural procedures. Prescription use only.

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

• Silk Non-Absorbable Surgical Suture (K930586)
• Silk Suture (K930590)

Submission Summary (Full Text)

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4/30/99

# 510k Summary of Safety and Effectiveness

### SILK NON-ABSORBABLE SURGICAL SUTURE (w/UV-10 adhesive)

Submitted by: Sherwood-Davis & Geck 444 McDonnell Blvd. Hazelwood, MO 63042-2516

Contact: Vanada Johnson Sr. Regulatory Affairs Specialist

Date of Summary: May 7, 1998

Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk Surgical Sutures were initially cleared, via the Premarket Notification process and assigned 510(k) file number K930586. Silk Non-Absorbable Surgical Sutures are a class II device, per 21 CFR Section 878.5030, with the Classification Code 80GAP.

Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time.

Similarities between the proposed Silk suture and the currently marketed Silk Non-Absorbable Surgical are 1) both are composed of the organic protein fibroin_ 2) both are sterile sutures, 3) both share the same indications for use, 4) both are available in the same various lengths, diameters, quantities, colors and sizes, 5) both are available with and without surgical needles and 6) both are packaged in identical Tyvek/Mylar packaging

The only difference between the proposed vs. the predicate Silk suture is an automated vs. a manual needle end stiffening process. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length. The predicate Silk suture needle is currently manufactured using a manual end stiffening process of winding the suture material onto racks and dipping the end in a nylon resin bath, curing then cutting the suture to length.

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K982853

# Summary of Safety and Effectiveness SILK NON-ABSORBABLE SURGICAL SUTURE

Silk Non-Absorbable Surgical Sutures, with adhesive, were tested for biocompatibility in Silk Non-Austradic Burgroal Battleon, Wall actor of Medical Devices Part-1 : Evaluation
accordance to ANSI/AAMI 10993. Biological Evaluation of Medical Devices Parts USD accordance to ARGBARNI 10995. Destery of tests were performed in accordance to USP guidelines - Cytotoxicity, Hemolysis, Sensitization, Acute Systemic Toxicity, Irritation, Intracutaneous.

Sherwood-Davis & Geck considers the proposed Silk Surgical Suture (w/adhesive) to be substantially equivalent in design, composition and intended use, to the currently marketed Silk Suture covered under K930590.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1999

Ms. Vanada Johnson Scnior Regulatory Affairs Specialist Sherwood-Davis & Geck 444 McDonnell Boulevard Hazelwood, Missouri 63042

Re: K982853 Trade Name: Silk Suture Regulatory Class: II Product Code: GAP Dated. December 29, 1998 Received: February 12, 1999

Dear Ms. Johnson:

We have reviewed your Scction 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the incentions for use stated in the enclosure 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:

- 1. The Silk Suture is indicated for use in gencral soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological fronedures.
- 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 manifacture of the Silk 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.

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

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Page 2 – Ms. Vanada Johnson

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

Existing major regulations affecting your device can be found in the Code of Federal Existing major regulations arrecting your areas. A substantially equivalent determination Regulations (CFR), Title 21, Paris 800 to 872. Presctices (GMP) for Medical Dovices:
assumes compliance with the Good Manufacturing Practices (GMP inspections assumes compliance with the CFR Part 820) and that, through periodic GMP inspections,
General GMP regulation (21 CFR Part 820) and that, through periodic GMP regulations Fa General GMP regulation (21 CFR Fall 820) and may motions. Failure to comply
The Food and Drug Administration (FDA) will verify such assumptions. Frances The Food and Drug Administration (I'DA) wint venty on. In addition, FDA may publish
with the GMP regulation may result in regulatory action. In addition, Flease note: this with the GMP regulation may result in regulatory and Register. Please note: this further announcements concerning your device in taffect any obligation you might
response to your premarket notification submission does and a Flectronic Product response to your premarket notheation stimmission 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 \$10(k)
to be This letter will allow you to begin maticemig your device of your device and thus, ne premarket notification. The FDA miding of substablial of 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 If you desire Specific advice for your agains devices), please contact the Office of and additionally 607.10 for in this attistions on the promotion and Compliance at [phone]. Auditional (1871) of Compliance at (30) 594-4595.
advertising of your device, please contact the Office of Compliance at advertising of your deview, production catiled, "Misbranding by reference to premarket Also, please hote the regulation entitions, Trinitial on your responsibilities under the hottication (21 CFTN 807.77). Other golfSmall 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

Enclosure

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K982853

Page 1 of 1

510(k) Number (if known)

Device Name: Sherwood-Davis & Geck Silk Nonabsorbable Surgical Suture

Indications for Use:

Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.

(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE! IF NEEDED)

Concurrenc of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use _

(Division Sign-off)

Division Sign-Off)

(Division Division of General Restorative D 510(k) Number

510(k) Number -

Sherwood-Davis & Geck Silk Nonabsorbable Surgical Suture