SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES

K091574 · Supplidores Unidos Internacionales, S.A. · GAT · Oct 9, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091574
• Device Name: SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
• Applicant: Supplidores Unidos Internacionales, S.A.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

Device Story

AMERICAN SUTURE™ non-absorbable surgical sutures are sterile, single-use devices used for soft tissue approximation, wound closure, and ligation. Materials include silk (braided, silicone-coated), nylon (monofilament), polypropylene (monofilament), and polyester (braided, silicone-coated). Sutures are provided with or without attached needles. Used by clinicians in surgical settings (cardiovascular, ophthalmic, neurological). Device provides mechanical tissue support; performance verified against USP monographs for diameter, tensile strength, and needle attachment. Benefits include reliable wound closure and tissue approximation.

Clinical Evidence

Bench testing only. Performance verified via mechanical testing (diameter, tensile strength, needle attachment) per USP 30 monographs. Biocompatibility testing performed per AAMI/ANSI/ISO 10993-5 (cytotoxicity) and 10993-10 (irritation/hypersensitivity). Sterility validated per AAMI/ANSI/ISO 11137-1. Additional testing conducted per Mexican norms (FEUM) for intracutaneous irritation, systemic injection, and implantation.

Technological Characteristics

Materials: Silk (braided, silicone-coated), Nylon (monofilament), Polypropylene (monofilament), Polyester (braided, silicone-coated). Standards: USP 30 <861> (Diameter), <871> (Needle Attachment), <881> (Tensile Strength); AAMI/ANSI/ISO 10993-5, 10993-10; AAMI/ANSI/ISO 11137-1 (Gamma sterilization). Form factor: Suture with/without needle. Energy source: None (mechanical).

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. Prescription use only.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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

• CP Medical Non-absorbable Surgical Sutures (K001184, K001173, K001185)

Submission Summary (Full Text)

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**510(k) Number:** K091574
page 1/3

# 510(k) SUMMARY (As Required by 21 CFR 807. 92)

| Submitted by: | Jorge Lay<br>Principal<br>Suplidores Unidos Internacionales S.A.<br>Avenida Miguel Hidalgo 31B<br>Colonia Lago de Guadalupe<br>Cuautitlan Estado de Mexico<br>Mexico<br>Tel: [phone]<br>Fax: [phone] | OCT - 9 2009 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date of Summary: | May 1 ^st , 2009 | |
| Device Name: | AMERICAN SUTURE ^TM Non Absorbable Surgical Sutures with/without Needles (Silk, Nylon, Polypropylene, and Polyester) | |
| Common Name: | Surgical Sutures | |
| Classification Name: | Sutures | |
| Class: | 2 | |
| Product Code: | GAT, GAW, GAP, and GAR | |
| Regulation Number: | 21 CFR 878-5000, 5010, 5020, and 5030 | |
| Predicative Device: | CP Medical Non-absorbable Surgical Sutures | |

| 510 K Number | Product Description |
|--------------|-----------------------------------------------|
| K001184 | Silk Non-absorbable Surgical Sutures |
| K001173 | Nylon Non-absorbable Surgical Sutures |
| K001185 | Polypropylene Non-absorbable Surgical Sutures |

Modifications:

K001172

There are no modifications to the device design that affect safety and effectiveness for its intended use.

Polyester Non-absorbalbe surgical Sutures

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K091574 page 2/3

AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle ⁄ Device Description AMERIOAN OOTORE - Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation.

For safe and reliable soft tissue approximation, wound closure and ligation. Intended Use:

AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle Technological AMERICAN OO FORE - Non Abberbast of the legally marketed CP Medical Non-absorbable Surgical Sutures.

# Technical Comparison to Predicative Devices

| American ™ Non Absorbable<br>Surgical Sutures | CP Medical Non Absorbable<br>Surgical Sutures |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| American Surgical Sutures are indicated for soft<br>tissue approximation and ligation | CP Medical non Absorbable Sutures are indicated<br>soft tissue approximation and ligation. |
| American Silk sutures are Intended for Use in<br>gastrointestinal, neurological, and cardiovascular<br>surgery | CP Medical sutures are Intended for Use in<br>gastrointestinal, neurological, and cardiovascular<br>surgery |
| American Sutures are made of Silk, Nylon,<br>Polypropylene, and Polyester materials. Sterile, Single<br>Use, Non Absorbable. With or without Needles<br>attached | CP Medical Sutures made of Silk, Nylon,<br>Polypropylene and Polyester materials.<br>Sterile, Single Use, Non Absorbable. With or<br>without Needles attached. |
| American Silk sutures are made from pure Silk<br>monofilaments, braided then coated with<br>Silicone | CP Medical Silk Sutures are braided from pure<br>Silk Monofilaments, braided then coated with<br>Silicone |
| American Nylon Sutures are made from<br>monofilaments of a polyamide material and dyed<br>colored Black or Blue | CP Medical sutures are made from monofilaments<br>polyamide material and dyed colored Black or Blue |
| American Polypropylene sutures are made from<br>Monofilaments of synthetic Polyolefin | CP Medical Polypropylene sutures are made from<br>monofilaments of synthetic Polypropylene 1 |
| American Polyester Sutures are made from<br>monofilaments of synthetic Polyethylene, braided<br>then coated with Silicone | CP Medical Polyester sutures are made form<br>monofilaments of synthetic Polyethylene, braided,<br>then coated with Silicone |
| American Surgical Sutures meet or exceed the<br>performance requirements for Non-Absorbable<br>surgical sutures as defined in the Official monograph<br>of the United States Pharmacopeia:<br>Diameter <861><br>Tensile Strength <881><br>Needle Attachment <871><br>Suture Length Requirement | CP Medical Sutures meet or exceed the<br>performance requirements for Non-Absorbable<br>surgical sutures as defined in the Official<br>monograph of the United States Pharmacopeia:<br>Diameter <861><br>Tensile Strength <881><br>Needle Attachment <871><br>Suture Length Requirement |
| American surgical Sutures are offered with or without<br>Needles | CP Medical sutures are offered with or without<br>Needles |

: ....

¹ Polyolefin and Polypropylene are both synthetic polymers widely used in the manufacturing of surgical sutures.

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K091524
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Testing:

AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle have AMENTO IN OO to refformance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility.

The American Sutures™ Surgical sutures intended to be introduced have been tested The Amenoun Guturoo - Ourgromance with the following test methods:

## FDA Recognized Standards

- ecogmized Standards
AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: . Tests for In Vitro Cytotoxicity. (Biocompatibility)
- Fests for In Ville Ofter 3-10:2002, Biological evaluation of medical devices Part 10: ● Tests for irritation and delayed-type hypersensitivity. (Biocompatibility)
- Tests for Inteation and dolarsa type tify on and routine control of ETO Sterilization
- AAMI / ANSI / ISO 11137-1:2000 Validation and routine control of GAMMA Sterilization

## Currently FDA recognized USP Edition Monographs

USP 30 <861>:2007 Sutures Diameter USP 30 <871> 2007 Sutures Needle Attachment USP 30 <881>:2007 Sutures Tensile Strength

### Mexican Norms.

Federal Mexican Code for Medical Devices - F.E.U.M. 2006 (Mex. Pharmacopoeia) FEUM- MGA-DM-3171, pages 220-221- Intracutaneous Irritation Test FEUM-MGA-DM-3083, pages 217-220 - Systemic Injection Test FEUM-MGA-DM-3081, pages 215-216 Implantation Test

Official Mexican Norms NOM-067-SSA-1993 for Medical Sutures NOM -B-1-70 Analysis Methods for Steels and Smelting (Needles) NOM -- B-119-78 Determination of Rockwell Hardness for Metals (Needles) NOM-BB-46-76 Determination of Corrosion Resistance for Hypodermic Needles

State States

. : routine : 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three flowing lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Suplidores unidos Internacionales S.A. % VHP Consulting Mr. Victor Pereira P.O. Box 97-0132 Coconut Creek, Florida 33067-0132

OCT - 9 2009

### Re: K091574

Trade/Device Name: AMERICAN SUTURE™ Surgical Sutures – SILK BLACK – Braided AMERICAN SUTURE™ Surgical Sutures - NYLON BLACK and BLUE - Braided

> AMERICAN SUTURE™ Surgical Sutures – POLYPROPYLENE AMERICAN SUTURE™ Surgical Sutures – POLESTER - Braided

Regulation Number: 21 CFR 878.5000

Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: August 1, 2009

Received: August 11, 2009

Dear Mr. Pereira:

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 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

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Page 2 - Mr. Victor Pereira

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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510(k) Number: K091574

Device Name: AMERICAN SUTURE™ Surgical Sutures- SILK BLACK - Braided

INDICATIONS FOR USE:

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

Over- The Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krave for MKM
(Division Sign-Off)

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K091574

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## 510(k) Number: K091574

Device Name: AMERICAN SUTURE™ Surgical Sutures- NYLON BLACK and BLUE - Braided

## INDICATIONS FOR USE:

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over- The Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DEN Darind Krane for arxи
(ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091574

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510(k) Number: K091574

Device Name AMERICAN SUTURE™ Surgical Sutures- POLYPROPYLENE

#### INDICATIONS FOR USE:

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over- The Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for MXul

(Division S Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091574

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510(k) Number: K091574

Device Name: AMERICAN SUTURE™ Surgical Sutures- POLESTER - Braided

## INDICATIONS FOR USE:

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

X Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

Over- The Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for mxm
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091524