POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES

K961389 · R. K. Medical L. L. C. · GAW · Jun 18, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961389
• Device Name: POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
• Applicant: R. K. Medical L. L. C.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Jun 18, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Monofilament polypropylene nonabsorbable surgical suture; dyed blue [phthalocyaninato (2-)] copper; used for soft tissue approximation and ligation; utilized in cardiovascular, ophthalmic, and neurological procedures; provides mechanical wound closure; performance verified via USP XXIII standards for diameter, length, knot pull tensile strength, and needle attachment strength.

Clinical Evidence

Bench testing only. Testing performed per USP XXIII standards for suture diameter, length, knot pull tensile strength, and needle attachment strength. Results demonstrate compliance with USP specifications and equivalence to predicate.

Technological Characteristics

Monofilament polypropylene; dyed blue [phthalocyaninato (2-)] copper; sterile; 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.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

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

• Surgilene polypropylene nonabsorbable surgical sutures (Davis+Geck)

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
JUN 18 1996
K 961389

"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**
April 4, 1996

**Name of Device**
Common or Usual Name: Polypropylene Nonabsorbable Surgical Sutures
Classification Name: Suture, nonabsorbable, synthetic, Polypropylene

Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck.

The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [phthalocyaninato (2-)] copper.

The Polypropylene nonabsorbable surgical 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 polypropylene sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to polypropylene sutures manufactured by Davis+Geck.

John A. Hutter, Plant Manager

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