SYNTHETIC ABSORBABLE SURGICAL SUTURE

K963253 · United States Surgical, A Division of Tyco Healthc · GAM · Oct 8, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963253
• Device Name: SYNTHETIC ABSORBABLE SURGICAL SUTURE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

USSC* POLYSORB* CSL** sutures are indicated for use in general soft tissue approximation and/ or ligation and ophthalmic surgery but not use in cardiovascular or neural tissue.

Device Story

USSC POLYSORB CSL suture; synthetic absorbable surgical suture; used for soft tissue approximation and ligation; ophthalmic surgery application; device functions as mechanical support for tissue healing; sterile, single-use; intended for use by surgeons in clinical settings.

Clinical Evidence

No clinical data; substantial equivalence based on material composition, manufacturing, and intended use similarity to predicate.

Technological Characteristics

Synthetic absorbable suture; biosafe materials; manufactured and sterilized using established processes consistent with existing USSC POLYSORB product line.

Indications for Use

Indicated for general soft tissue approximation and/or ligation and ophthalmic surgery. Contraindicated for use in cardiovascular or neural tissue.

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

• USSC POLYSORB suture

Submission Summary (Full Text)

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K963253

OCT - 8 1996

UNITED STATES SURGICAL CORPORATION

510(K) PREMARKET NOTIFICATION

USSC* POLYSORB* CSL** SUTURE

# 510(k) SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

As is evident in the submitted information on function, indications and materials, USSC* POLYSORB* CSL** sutures are substantially equivalent to the currently marketed USSC* POLYSORB* suture as summarized below:

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are composed of biosafe materials.

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and/ or ligation and ophthalmic surgery but not use in cardiovascular or neural tissue.

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are manufactured in the same facilities using similar processes and controls.

- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are packaged in the same facilities using similar materials, processes and controls.

- USSC* POLYSORB* CSL** sutures and other products currently marketed by United States Surgical Corporation are sterilized in the same facilities using similar processes and controls.

*Trademark of United states Surgical Corporation

**Trademark name not yet determined

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