ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES

K072859 · Internacional Farmaceutica, S.A. DE C.V. · GAM · May 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072859
• Device Name: ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
• Applicant: Internacional Farmaceutica, S.A. DE C.V.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Story

Atramat® PGLA90 is a synthetic, absorbable, sterile, coated surgical suture composed of a copolymer of glycolide and L-lactide. Device is dyed with D&C Violet No. 2. Used by surgeons in clinical settings for soft tissue approximation and ligation. Provides mechanical support to tissue during healing before being absorbed by the body. Substantially equivalent to existing polyglactin 910 sutures.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing and conformance to USP 30, ISO 9001, and ISO 13485 standards to demonstrate performance and biocompatibility.

Technological Characteristics

Synthetic absorbable suture; copolymer of glycolide and L-lactide; coated; dyed with D&C Violet No. 2. Conforms to USP and FEUM standards. Biocompatible material. Sterilized product.

Indications for Use

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

• Vicryl* (Polyglactin 910) Suture (K022269 and K022715)

Submission Summary (Full Text)

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K072859
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## 510(k) SUMMARY

MAY 2 3 2008

This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requeriments of SMDA 1990 and 21 CFR§807.92

The assigned 510(k) number is:

Submitter's identification:

Internacional Farmacéutica, S.A. de C.V. Carreteraco 44 Col. Párque San Andrés Coyoacán C.P. 04040 México, D.F. Contact: Mr. Alejandro von Mohr, General Director Phone: [phone] to 62 ext. 227, 219 Fax: [phone]

US Contact: Mr. Alan P. Schwartz 55 Northern Boulevard Great Neck, New York 11021 Phone: [phone] Fax: [phone]

Date Summary prepared: May 31, 2007

Trade Name of the Device:

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures

Common or Usual Name: Poly(glycolide-co- L-lactide) Surgical Sutures

Classification of Device:

Class II in 21 CFR § 878.4493, Absorbable poly(glycolide/llactide) Surgical Suture

Classification Panel:

General & Plastic Surgery Devices Panel

Product Code:

GAM

Predicate Devices:

Vicryl* (Polyglactin 910) Suture (K022269 and K022715)

#### Device Description

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Suture are synthetic absorbable sterile coated surgical sutures composed from a copolymer of glycolide L-lactide. This product is offered as dyed with an FDA listed color additive, D&C Violet No. 2.

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K072859
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#### Intented Use:

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

# Summary of Thechnological Characteristics, comparison to predicate device

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures have similar technological characteristics as the predicate Like the predicate device, Atramat® PGLA90 device. Poly(glycolide-co-l.-lactide) Surgical Sutures are sterile, coated synthetic absorbable surgical sutures that conform to the requeriments of United States Pharmacopoeia (USP), except for diameter, and Mexicans United States Farmacopoeia, Medical Devices Supplement (FEUM) for absorbable surgical sutures. The poly(glycolide-co-L-lactide) material used for both "new" and "predicate" medical devices is commonly used in surgical applications and has been proven to be biocompatible. In-vivo/in vitro testing was provied showing that the device performed as intended and as claimed.

#### Discussion of Clinical Test Performed:

No clinical trials were conducted.

#### Conclusions

Based on the technological characteristics and physical properties of the PGLA90 Poly(glycolide-co-L-lactide) sutures, the description, the intented use of the device and conformance with the following performance standars like: USP 30 ISO 9001 and ISO 13485

FDA Guidance for Surgical Suture 510(k)

Internacional Farmaceutica believes that the subject devices demonstrate a substantial equivalence to the predicate devices and are safe and effective for their intended use.

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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 - U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized feathers and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 3 2008

Internacional Farmaceutica S.A. de C.V. % mdi Consultants, Inc. Mr. Alan P. Schwartz 55 Northern Boulevard Great Neck, New York 11021

Re: K072859

Trade/Device Name: Atramat® PGLA90 Poly(glycolide-co-L-lactide) surgical sutures Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly)glycolide/L- lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: May 01, 2008 Received: May 22, 2008

Dear Mr. Schwartz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Alan P. Schwartz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely vours.

Mark M Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K072f59

# ATTACHMENT # 3

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## 510(k) Number (if known):

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Device Name: Sutures

#### Indications for Use:

Atramat® PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Prescription use X (Per 21 CFR 801.109)

Over-The Counter Use OR (Optional Format 1-2-96)

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) 5 Mar (Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K072859