LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.

K965162 · Lukens Medical Corp. · GAM · Feb 12, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965162
• Device Name: LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
• Applicant: Lukens Medical Corp.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Feb 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Story

Lukens PGA is a synthetic, absorbable, braided, coated surgical suture. Material consists of polyglycolic acid coated with E-Caprolactone and dyed with D&C Violet No. 2. Used by surgeons in clinical settings for soft tissue approximation and ligation. Device provides temporary wound support through tensile strength, which degrades over time via hydrolysis. Absorption is complete within 60-90 days. Clinical benefit includes secure tissue closure with predictable absorption profile, reducing need for suture removal.

Clinical Evidence

Bench testing per USP XXIII (diameter, length, tensile strength, needle attachment) confirms compliance with USP standards. Biocompatibility testing showed no toxicity. Animal implantation studies demonstrate 50% tensile strength retention at 2 weeks, 20% at 3 weeks, and complete absorption between 60-90 days.

Technological Characteristics

Synthetic absorbable suture; polyglycolic acid braided multifilament; coated with E-Caprolactone; dyed with D&C Violet No. 2. Meets USP XXIII specifications for diameter, length, and tensile strength. Sterilization method not specified.

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 poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

• Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system (Davis & Geck)

Submission Summary (Full Text)

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K965162

UKENS

MEDICAL CORPORATION

FEB 12 1997

3820 ACADEMY PARKWAY NORTH NE

ALBUQUERQUE, NM. 87109-4409

[phone]

[phone]

Fax [phone]

# 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."

"The assigned 510(k) number is _______________.

## Applicant

Lukens® Medical Corporation
3820 Academy Parkway North NE
Albuquerque, NM 87109
Tel.: [phone]
Fax.: [phone]

## Contact

Mr. Scott Henderson, C.Mfg.E.
Vice President, Development and Engineering

## Date

December 16, 1996

## Name of Device

## Proprietary Name:

Lukens® - PGA (Polyglycolic Acid)
Synthetic Absorbable Surgical Suture, Coated, Braided U.S.P.

## Common or Usual Name:

Polyglycolic Acid Synthetic, Absorbable Surgical Suture, Coated, Braided U.S.P.

## Classification Name:

Suture, Absorbable, Synthetic, Polyglycolic Acid

Lukens® - PGA (polyglycolic acid), synthetic absorbable surgical sutures, coated, braided USP manufactured by Lukens® Medical Corporation are equivalent to Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system manufactured by Davis & Geck. Lukens® - PGA (polyglycolic acid), synthetic absorbable surgical sutures USP are dyed with D&C Violet No. 2 and are coated with E-Caprolactone.

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Testing of suture diameter, suture length, knot-pull tensile strength and needle attachment strength according to methods outlined in USP XXIII demonstrates that Lukens® - PGA (polyglycolic acid), synthetic absorbable surgical sutures meet or exceed USP requirements and are equivalent to Dexon II polyglycolic acid surgical sutures in terms of the above parameters.

Biocompatibility testing showed no evidence of toxicity of Lukens® - PGA (polyglycolic acid), synthetic absorbable surgical sutures, USP.

Implantation studies in animals indicate that Lukens® - PGA retains approximately 50% of its original tensile strength at two week post implantation, with approximately 20% remaining at three weeks. Absorption of Lukens® - PGA absorbable synthetic suture is essentially complete between 60 and 90 days.

The intended use of the device is in general soft tissue approximation and/or ligation including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

12-16-96

Date

Scott Henderson, C.Mfg.E.
Vice President, Development and
Engineering

SII-510K

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