DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES

K043539 · Demetech Corp. · GAM · Apr 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043539
• Device Name: DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
• Applicant: Demetech Corp.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Apr 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.

Device Story

DemeTECH Sterile Synthetic Absorbable Suture (PGA) is a sterile, braided, multifilament suture composed of polyglycolic acid. It is coated with a blend of polycaprolate and a copolymer of caprolactone and glycolide. The device is used by surgeons for soft tissue approximation and ligation. It functions as a temporary support for tissue during healing, eventually being absorbed by the body. It is provided in various USP sizes (8/0 to 2).

Clinical Evidence

No clinical data provided; device equivalence is based on material composition and adherence to USP and European Pharmacopoeia standards for absorbable sutures.

Technological Characteristics

Material: Polyglycolic acid (PGA) braided multifilament; Coating: Polycaprolate, copolymer of caprolactone and glycolide. Compliance: USP and European Pharmacopoeia standards for sterile, synthetic, absorbable sutures. Form factor: Suture strands with needles, sizes USP 8/0 to 2.

Indications for Use

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

• Surgisorb - Samyang Corp. (K984374)

Submission Summary (Full Text)

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043539 pg. 1 of 1

APR & 2005

## 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | DemeTECH<br>3530 NW 115th Ave.<br>Miami, FL 33178<br>U.S.A<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Luis Arguello |
| Date of Summary: | January 1, 2005 |
| Trade/Proprietary Name: | DemeTECH Sterile Synthetic Absorbable Sutures (PGA) and Needles |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Product Code: | GAM |
| Predicate Device: | K984374 Surgisorb - Samyang Corp. |

Intended Use:

The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.

## Device Description:

Description: Polyglycolic Acid (PGA) is a sterile absorbable synthetic, multifilament suture composed of glycolic acid. The yarns are braided and coated with a blend of polycaprolate, copolymer of caprolactone and glycolide. The PGA Suture is available in violet from sizes: USP8/0 USP2.

PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized symbol. The symbol consists of three horizontal lines that curve upwards, resembling a stylized human figure.

APR 6 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Demetech Corporation c/o Mr. Arthur J. Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, Florida 33572

Re: K043539

K043539
Trade/Device Name: DemeTECH Sterile Synthetic Absorbable Sutures (PGA) and Needles Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: II Product Code: GAM Dated: March 8, 2005 Received: March 17, 2005

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(t) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manative for the Medical Device Americans, or to commerce prior to May 20, 1770, the enatified in accordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance what a premarket approval application (PMA).) and Cosment Act (Act) that do not require apper o the general controls provisions of the Act. The You may, inerelore, market the device, sayon to me memor for annual registration, listing of general controls provisions of the Act Heleins required in the manage inst 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 classified (see aboro) this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlist "Lifesting in parts 800 to 898. In addition. FDA may be found in the Code of Pederal Regeral Regeral Register

Please be advised that FDA's issuance of a substantial equivalence determination not of the Act Please be advised that FDA s issuales of a bacedanal with other requirements of the Act
that FDA has made a determination that your device complics with other requirements of that FDA has made a determination that your access agencies. You music is a vol music or any Federal statutes and regulations daminstered by registration and listing (21) comply with an the Act s requirements, mercess, wanufacturing practice requirements as settem CFR Part 807), rabeing (21 CFR Part 607), good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Arthur J. Ward

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin maing of substantial equivalence of your device to a legally prematicated 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 If you desire specific at no 10-10-10-10-115. 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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043539

## Indications for Use

510(k) Number (if known): K043539

Device Name: DemeTECH Sterile Synthetic Absorbable Sutures (PGA) and Needles

Indications for Use:

The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.

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)

*orative

K04 3539

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