POLYESTER NONABSORBABLE SURGICAL SUTURES USP

K961925 · R. K. Medical L. L. C. · GAT · Jul 29, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961925
• Device Name: POLYESTER NONABSORBABLE SURGICAL SUTURES USP
• Applicant: R. K. Medical L. L. C.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jul 29, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The polyester 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

Polyester nonabsorbable surgical sutures; braided, silicone-coated; dyed green (D&C Green #6). Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Device provides mechanical closure of tissue; performance verified via USP XXIII standards for diameter, length, knot pull tensile strength, and needle attachment strength.

Clinical Evidence

Bench testing only. Testing of suture diameter, suture length, knot pull tensile strength, and needle attachment strength performed according to USP XXIII methods.

Technological Characteristics

Braided polyester fiber; silicone coating; dyed with D&C Green #6. Nonabsorbable. Meets USP XXIII specifications for surgical sutures.

Indications for Use

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

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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

• Ti-cron polyester nonabsorbable surgical suture (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]
JUL 29 1996
K961925

# 510 (k) SUMMARY

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

## Applicant:

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

## Contact:

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

Date: 5/15/96

## Name of Device:

Common or Usual Name: Polyester Nonabsorbable Surgical Sutures
Classification Name: Suture, Nonabsorbable, Synthetic, Polyester

Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck.

The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck’s Ti-cron* is dyed blue (D&C Blue #6).

The polyester 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 described in USP XXIII demonstrates that R.K. Medical Polyester nonabsorbable surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to polyester nonabsorbable surgical sutures manufactured by Davis & Geck.

John A. Hutter, Plant Manager

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