POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE

K042141 · Teleflex Medical · GAM · Sep 28, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042141
• Device Name: POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
• Applicant: Teleflex Medical
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polyglytone* 6211 sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Device Story

Polyglytone 6211 is a monofilament synthetic absorbable surgical suture (USP size 2-0). Provided undyed (natural), it may be supplied in various lengths, with or without needles, and with or without pledgets. Used by surgeons in clinical settings for soft tissue approximation and ligation. The device functions as a mechanical support for tissue healing until absorbed. It is intended for prescription use only.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and conformance to voluntary performance standards (ANSI/AAMI/ISO 10993-1 and USP requirements).

Technological Characteristics

Monofilament synthetic absorbable suture. Materials and performance conform to USP standards for absorbable surgical sutures and ANSI/AAMI/ISO 10993-1 for biological evaluation. Supplied in various lengths, with/without needles or pledgets.

Indications for Use

Indicated for general soft tissue approximation and ligation, including ophthalmic surgery. Contraindicated for cardiovascular surgery, neurological surgery, and microsurgery.

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

• U.S. Surgical Caprosyn™ Monofilament Synthetic Absorbable Suture (K013671 & K032586)

Submission Summary (Full Text)

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Original 510(k) Submission Polyglytone™6211Synthetic Absorbable Suture

July 21, 2004

page 1/2

### Section VI

## 510(k) Summary

SEP 2 8 2004

#### Substantial Equivalence

TFX Medical, Inc

In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule ".... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.

| Manufacturer | Teleflex Medical<br>600 Airport Road<br>Fall River, MA 02720-4740 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Steve Astorino<br>Engineering Manager<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | July 21, 2004 |
| Device Information | |
| Trade Name: | Polyglytone*6211™ Synthetic Absorbable<br>Suture. |
| Common Name: | Absorbable Surgical Suture. |
| Classification Name: | Absorbable Poly(glycolide/L-lactide) Surgical<br>Suture |

#### Indications for Use

Polyglytone* 6211 sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

#### Device Description

Polyglytone* 6211 suture, U.S.P. size- 2-0, is available, undyed (natural). The suture is monofilament, may be provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths.

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# KO42141

July 21, 2004

TFX Medical, Inc Original 510(k) Submission Polyglytone*6211Synthetic Absorbable Suture

pay 1/2

# Section VI 510(k) Summary

#### Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the currently cleared U.S. Surgical Caprosyn™ Monofilament Synthetic Absorbable Suture (K013671 & K032586).

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, U.S.P .- Absorbable Surgical Sutures, and the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA", June 3, 2003.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that curve upwards, resembling a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2004

Mr. Steve Astorino Engineering Manager Teleflex Medical 600 Airport Road Fall River, Massachusetts 02720

Re: K042141

Ko42141
Trade/Device Name: Polyglytone 6211™ Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: July 21, 2004 Received: August 9, 2004

Dear Mr. Astorino:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave ustimassaly marketed predicate devices marketed in interstate for use statu in the enolosure) to tegains and ment date of the Medical Device Amendments, or to commence prior to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices mat nave been recuired in assire approval of a premarket approval application (PMA). and Costience rece (Tree) that as not conserval controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controll pro factice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod controls. Existing major regulations affecting your device can may be subject to back access as a coulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oe advised that I Drivination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I caeaal statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 007); adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by counts (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Steve Astorino

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
SS

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Polyglytone*6211™ Synthetic Absorbable Suture

Indications for Use:

Polyglytone*6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic Surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Page 1 of 1 (Posted November 13, 2003)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________