AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle are Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation. American Sutures are made of Silk, Nylon, Polypropylene, and Polyester materials. Sterile, Single Use, Non Absorbable. With or without Needles attached.

AI/ML Overview

The provided document describes a 510(k) premarket notification for "AMERICAN SUTURE™ Non Absorbable Surgical Sutures with/without Needles." This is a medical device clearance, not an AI/ML device, and therefore the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size, etc.) is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, intended use, and performance testing against recognized standards.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Predicate Device Performance	AMERICAN SUTURE™ Performance
Physical/Mechanical Properties (USP 30)
Diameter <861>:2007	Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.	Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.
Tensile Strength <881>:2007	Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.	Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.
Needle Attachment <871>:2007	Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.	Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.
Suture Length Requirement	Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.	Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia.
Biocompatibility (AAMI / ANSI / ISO 10993)	Not explicitly stated for predicate in comparison table, but general statement of equivalent safety.	Tested to AAMI / ANSI / ISO 10993-5:1999 (In Vitro Cytotoxicity) and ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity). (Testing performed to verify biocompatibility.)
Sterilization ETO Validation (AAMI / ANSI / ISO 11135-1:1994)	Not explicitly stated for predicate.	Tested to AAMI / ANSI / ISO 11135-1:1994 (Validation and routine control of ETO Sterilization).
Sterilization Gamma Validation (AAMI / ANSI / ISO 11137-1:2000)	Not explicitly stated for predicate.	Tested to AAMI / ANSI / ISO 11137-1:2000 (Validation and routine control of GAMMA Sterilization).
Mexican Norms for Biocompatibility (FEUM)	Not explicitly stated for predicate.	Tested to FEUM-MGA-DM-3171 (Intracutaneous Irritation Test), FEUM-MGA-DM-3083 (Systemic Injection Test), FEUM-MGA-DM-3081 (Implantation Test).
Mexican Norms for Medical Sutures (NOM)	Not explicitly stated for predicate.	Tested to 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).

Study Proving Acceptance Criteria Met:

The acceptance criteria are met through a series of "performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility," by testing the AMERICAN SUTURE™ against several FDA Recognized Standards and Mexican Norms. The application states that "The American Sutures™ Surgical sutures intended to be introduced have been tested in compliance with the following test methods," followed by a list of standards. The overall study approach is one of verification against established performance standards for surgical sutures.

Regarding the AI/ML specific questions (2-9):

Sample size used for the test set and the data provenance: N/A (not an AI/ML device)
Number of experts used to establish the ground truth... and qualifications: N/A (not an AI/ML device)
Adjudication method: N/A (not an AI/ML device)
If a multi reader multi case (MRMC) comparative effectiveness study was done...: N/A (not an AI/ML device)
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (not an AI/ML device)
The type of ground truth used: N/A (not an AI/ML device). For this physical device, the "ground truth" is defined by the requirements and specifications set forth in recognized standards (e.g., USP monographs, ISO 10993) for mechanical properties, biocompatibility, and sterility.
The sample size for the training set: N/A (not an AI/ML device)
How the ground truth for the training set was established: N/A (not an AI/ML device)

Summary

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510(k) Number: K091574
page 1/3

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

Submitted by:	Jorge LayPrincipalSuplidores Unidos Internacionales S.A.Avenida Miguel Hidalgo 31BColonia Lago de GuadalupeCuautitlan Estado de MexicoMexicoTel: +52 (55) 58 77 42 41Fax: (305) 551-9139	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 AbsorbableSurgical Sutures	CP Medical Non AbsorbableSurgical Sutures
American Surgical Sutures are indicated for softtissue approximation and ligation	CP Medical non Absorbable Sutures are indicatedsoft tissue approximation and ligation.
American Silk sutures are Intended for Use ingastrointestinal, neurological, and cardiovascularsurgery	CP Medical sutures are Intended for Use ingastrointestinal, neurological, and cardiovascularsurgery
American Sutures are made of Silk, Nylon,Polypropylene, and Polyester materials. Sterile, SingleUse, Non Absorbable. With or without Needlesattached	CP Medical Sutures made of Silk, Nylon,Polypropylene and Polyester materials.Sterile, Single Use, Non Absorbable. With orwithout Needles attached.
American Silk sutures are made from pure Silkmonofilaments, braided then coated withSilicone	CP Medical Silk Sutures are braided from pureSilk Monofilaments, braided then coated withSilicone
American Nylon Sutures are made frommonofilaments of a polyamide material and dyedcolored Black or Blue	CP Medical sutures are made from monofilamentspolyamide material and dyed colored Black or Blue
American Polypropylene sutures are made fromMonofilaments of synthetic Polyolefin	CP Medical Polypropylene sutures are made frommonofilaments of synthetic Polypropylene 1
American Polyester Sutures are made frommonofilaments of synthetic Polyethylene, braidedthen coated with Silicone	CP Medical Polyester sutures are made formmonofilaments of synthetic Polyethylene, braided,then coated with Silicone
American Surgical Sutures meet or exceed theperformance requirements for Non-Absorbablesurgical sutures as defined in the Official monographof the United States Pharmacopeia:Diameter <861>Tensile Strength <881>Needle Attachment <871>Suture Length Requirement	CP Medical Sutures meet or exceed theperformance requirements for Non-Absorbablesurgical sutures as defined in the Officialmonograph of the United States Pharmacopeia:Diameter <861>Tensile Strength <881>Needle Attachment <871>Suture Length Requirement
American surgical Sutures are offered with or withoutNeedles	CP Medical sutures are offered with or withoutNeedles

: ....

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

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K091524
page 3/3

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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
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.(b)
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.