Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.

The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.

AI/ML Overview

This document describes the Artelon™ Surgical Suture and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Therefore, many of the requested fields are not applicable. However, I can extract the relevant information regarding performance testing that was conducted.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Set by regulatory standards)	Reported Device Performance
ISO 10993 standards (Biocompatibility)	Successfully completed
USP 26 (Diameter, Tensile Strength, Properties)	Successfully completed
Guidance for surgical suture (August 10, 2000)	Successfully completed
Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA (June 3, 2003)	Successfully completed

2. Sample size used for the test set and the data provenance:

Not applicable (N/A). This document does not detail a clinical study with a test set of data. The "performance testing" refers to in-vitro and material characteristic tests rather than performance against a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. Ground truth is not established in the context of clinical data for this type of device submission. Performance is measured against established physical and biological standards.

4. Adjudication method for the test set:

N/A. No adjudication method for a test set of data is mentioned as this is not a clinical study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. No MRMC study was conducted, as this device (surgical suture) is not an AI/ML-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

N/A. Not an AI/ML device.

7. The type of ground truth used:

For biocompatibility: ISO 10993 standards.
For physical characteristics (diameter, tensile strength, pliability, handling): USP 26 requirements.
For regulatory compliance: Guidance for surgical suture documents.

8. The sample size for the training set:

N/A. This device does not involve machine learning; therefore, no training set or sample size for training is relevant.

9. How the ground truth for the training set was established:

N/A. No training set for machine learning. The "ground truth" for the device's performance is established by recognized international and national standards (ISO, USP, FDA guidance).

Summary

{0}------------------------------------------------

NOV 1 7 2003

KO32160

page 1 of 3

SECTION 2. SUMMARY AND CERTIFICATION

A. 510(K) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Artimplant AB's summary for the Artelon™ Surgical Suture

SUBMITTER'S NAME:	Artimplant AB
ADDRESS:	Hulda Mellgrens gata 5, SE-421 32 Västra Frölunda,Sweden
CONTACT PERSON:	Britt Novén
TELEPHONE NUMBER:	+46 31 7465600 or +46 705 280255
FAX NUMBER:	+46 31 7465660
DATE OF SUBMISSION:	July 11, 2003

1. Identification of device

Proprietary Name: Artelon™ Surgical Suture Common Name: Nonabsorbable Nylon Surgical Suture Classification Status: Class II per regulations §878.5020 Product Codes: GAR- Surgical, Nonabsorbable, Synthetic, Polyamide

2. Equivalent devices

Artimplant AB believes the Artelon™ Surgical Suture is substantially equivalent to:

K993998	T.CAD International - Nylon
K981582	Sherwood-Davis & Geck - Surgilon®, Ophtalon® and Dermalon® Non-absorbable Surgical Suture
K003000	Grams American Suture, Inc. - Grams Nylon Nonabsorbable Suture
K001173	C.P. Medical - Nylon Nonabsorbable Surgical Sutures

Description of the Device 3.

The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.

{1}------------------------------------------------

4. Intended use

The Artimplant, Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.

Technological characteristics, comparison to predicate device. 5.

Like the predicate devices, the Artelon™ Surgical Suture is intended for general soft tissue approximation and/or ligation.

Company	T.CAD	Sherwood-Davis& Geck	Grams AmericanSuture, Inc.	C.P. Medical	Artimplant AB
Device	International -Nylon	Surgilon®,Ophtalon® andDermalon®Non-absorbableSurgical Suture	Grams NylonNonabsorbableSuture	NylonNonabsorbableSurgical Sutures	Artelon™ SurgicalSuture
510(k) Number	K993998	K981582	K003000	K001173	No number yet
Characteristic
Intended use	General soft tissueapproximationand/or ligationIncluding use incardiovascularophthalmic andneurologicalprocedures.	General soft tissueapproximationand/or ligationIncluding use incardiovascularophthalmic andneural tissue.	General soft tissueapproximationand/or ligationIncluding use incardiovascularophthalmic andneurologicalprocedures.	General soft tissueapproximationand/or ligationIncluding use incardiovascularophthalmic andneurologicalprocedures.	General soft tissueapproximation and/orligation
Suture Material	Nylon 6 or Nylon6,6	Nylon 6 or Nylon6,6	Nylon 6 or Nylon6,6	Nylon 6 or Nylon6,6	Polycaprolactonebased poly(urethaneurea)
SutureCharacteristics	Not absorbed,progressivedegradation of theNylon in vivo mayresult in gradualloss of all of thesuture's tensilestrength over time	Not absorbed,progressivehydrolysis of theNylon in vivo mayresult in gradualloss of all of thesuture's tensilestrength over time	Unknown	Unknown	Not absorbed,progressivedegradation byhydrolysis of thepoly(urethane urea) invivo will result ingradual loss of all ofthe suture's tensilestrength over time
Suture Diameter	Meet U.S.P.Requirements	Unknown	U.S.P. 24 fordiameter 861	U.S.P. 24 fordiameter 861	U.S.P. 26 for diameter861
How supplied	Monofilamentthread, coated oruncoated, undyedor dyed with anFDA listed coloradditive. Sterileand offered forSingle Use Only.Available with orwithout surgicalneedle.	Braided andmonofilamentsutures availablein various lengthsand diameterswith or withoutsurgical needles.	Sterile, flexible,monofilamentthread or braidedthread, dyed orundyed, offered ina variety oflengths and arange of diameterswith or withoutneedle.	Monofilament orbraided, coatedwith silicone, orwax, or uncoated,dyed black or dyedblue or undyedwhite.	Braided, uncoated,undyed withoutsurgical needle.
Packaging	Dry packaged inAluminum Foiland Polyester tearopen packaging	Tyvek/Mylarpackaging	Unknown	Unknown	Double peel openlaminated aluminium-plastic foil,respectively coatedpaper andpolyester/polyethylenefilm.

{2}------------------------------------------------

Discussion of performance testing. 6.

A collection of tests has been conducted and successfully completed including biocompatibility safety studies, diameter, tensile strength and properties such as pliability and handling in accordance to:

ISO 10993 standards ●
USP 26
Guidance for surgical suture issued on: August 10, 2000
Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003

7. Conclusion

Based on extensive performance testing and a comparison to the predicate devices, we believe that the Artelon™ Surgical Suture is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness. Additionally, the device has identical indications to the predicate devices and the labeling of the device is consistent both with FDA's guidance as well as current medical practice.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

NOV 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Artimplant AB c/o Mr. Russell P. Pagano, Ph.D. Vice President M Squared Associates, Inc. 719 A Street, NE Washington, D.C. 20002

Re: K032160

Trade/Device Name: Artimplant AB, Artelon™ Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polymide surgical suture Regulatory Class: II Product Code: GAR Dated: October 21, 2003 Received: October 22, 2003

Dear Dr. Pagano:

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.

{4}------------------------------------------------

Page 2 - Mr. Russell P. Pagano, Ph.D.

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

{5}------------------------------------------------

Page 1 of 1

B. INDICATIONS FOR USE

K032160 510(k) Number: to be Assigned

Device Name: Artimplant AB, Artelon™ Surgical Suture

Indications for Use:

The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

Over the Counter Use

Muriam C. Provost

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

510(k) Number 6 K632160

Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.