SILK NONABSORBABLE SURGICAL SUTURES USP

K960328 · R. K. Medical L. L. C. · GAP · Mar 4, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960328
• Device Name: SILK NONABSORBABLE SURGICAL SUTURES USP
• Applicant: R. K. Medical L. L. C.
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Mar 4, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

Silk nonabsorbable surgical sutures; twisted or braided construction; available coated (silicone or wax) or uncoated; dyed (Logwood) or undyed. Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device provides mechanical closure of tissue; performance verified against USP XXIII standards for diameter, length, knot pull tensile strength, and needle attachment strength.

Clinical Evidence

Bench testing only. Testing of suture diameter, length, knot pull tensile strength, and needle attachment strength per USP XXIII demonstrates compliance with USP specifications and equivalence to predicate.

Technological Characteristics

Nonabsorbable silk suture; twisted or braided; silicone or wax coating; Logwood dye or undyed. Meets USP XXIII specifications for physical and mechanical properties.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological 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

• Silk nonabsorbable surgical sutures (Davis + Geck)

Submission Summary (Full Text)

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K960328
lof1

# R.K. MEDICAL

15 EAGLE ROAD • DANBURY, CT 06810 U.S.A.
PHONE: [phone] • FAX: [phone]

510(k) SUMMARY

MAR - 4 1996

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92."

## Applicant

R. K. Medical L. L. C.
35 Eagle Road
Danbury, CT 06810
Tel: [phone]
Fax: [phone]

## Contact

John A. Hutter, Plant Manager
or
George R. Krebs (President)

## Date

January 23, 1996

## Name of Device:

Common or Usual Name: Silk Nonabsorbable Surgical Sutures
Classification Name: Suture, nonabsorbable, silk

Silk nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to silk nonabsorbable surgical sutures manufactured by Davis + Geck.

The silk sutures manufactured by R. K. Medical and D+G can be twisted, or braided, coated with silicone, or wax, or uncoated, dyed black (Logwood) or undyed.

The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength according to methods outlined in USP XXIII demonstrates that R. K. Medical silk sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to silk sutures manufactured by Davis + Geck.

John A. Hutter, Plant Manager

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