PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP

K961931 · R. K. Medical L. L. C. · GAL · Jul 29, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961931
• Device Name: PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
• Applicant: R. K. Medical L. L. C.
• Product Code: GAL · General, Plastic Surgery
• Decision Date: Jul 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4830
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Plain and chromic gut surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Story

Absorbable, sterile surgical sutures; composed of purified connective tissue (collagen) from bovine serosal layer or ovine submucosal fibrous layer; packaged in fluid (isopropanol, water, triethanolamine); sterilized via gamma irradiation. Used by surgeons for soft tissue approximation/ligation. 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 methods confirms compliance with USP specifications and equivalence to predicate.

Technological Characteristics

Material: Purified connective tissue (collagen) from bovine or ovine intestines. Sterilization: Gamma irradiation. Packaging: Isopropanol, water, triethanolamine fluid. Compliance: USP XXIII standards for physical and mechanical properties.

Indications for Use

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

Regulatory Classification

Identification

An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

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

• Davis & Geck plain and chromic gut surgical sutures

Submission Summary (Full Text)

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R.K. MEDICAL
35 EAGLE ROAD • DANBURY, CT 06810 U.S.A.
PHONE: [phone] • FAX: [phone]

510 (k) SUMMARY

This summary of 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]

K 961931
JUL 29 1996

Contact:
Mr. John A. Hutter, Plant Manager
or
Mr. George R. Krebs, President

Date: 5/13/96

Name of Device:
Common or Usual Name: Plain and chromic gut absorbable surgical sutures.

Classification Name: Suture, absorbable, natural

Plain and chromic gut surgical sutures USP manufactured by R.K. Medical, L.L.C. are equivalent to plain and chromic gut surgical sutures manufactured by Davis & Geck. These sutures are absorbable, sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

The plain and chromic gut sutures are packaged in packing fluid composed of isopropanol, water, and triethanolamine.

R.K. Medical plain and chromic gut surgical sutures are sterilized by gamma irradiation.

Plain and chromic gut surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular 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 plain and chromic gut surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to plain and chromic gut sutures manufactured by Davis & Geck.

John A. Hutter, Plant Manager

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