ARTELON Surgical Sutures are nonabsorbable sterile surgical sutures (i.e. braided threads) prepared from ARTELON (polycaprolactone based poly (urethane urea)) in a multifilament form intended for soft tissue approximation. Due to limited stiffness of the sutures, they appear stretchy during handling. Although ARTELON sutures are nonabsorbable, they degrade slowly over time; the degradation occurs over a prolonged period of time with a gradual reduction of tensile strength of approximately 20% per year. ARTELON Surgical Sutures are uncoated and undyed. The sutures are supplied sterile.

AI/ML Overview

The provided text describes the ARTELON Surgical Suture and its substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study details.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document focuses on regulatory compliance through substantial equivalence, referencing general standards and a predicate device (ARTELON Surgical Suture, K032160) rather than providing specific performance data from new studies. It lists compliance with:

ISO 10993 standards (Biological evaluation of medical devices)
ISO 14971 (Medical devices - Application of risk management to medical devices)
USP 26 (United States Pharmacopoeia standards for nonabsorbable surgical sutures)
Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003

These are general standards or guidance documents, not performance results. The claim is that "The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures," but no specific performance metrics like tensile strength retention over time or knot security are presented in quantifiable terms against acceptance criteria within this summary.

Summary

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OCT 17 2005

Attachment 5

510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes 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	Ajrulla Zuta
TELEPHONE NUMBER	+46 31 7465600
FAX NUMBER:	+46 31 7465660
DATE OF SUBMISSION	XXXXXXXX

1. Identification of device

Proprietary Name: Artelon® Surgical Suture Common Name: Nonabsorbable Nylon Surgical Suture Classification Status: Class II per Regulation §878.5020 Product Code: GAR-surgical, Nonabsorbable, Synthetic, Polyamide.

2. Equivalent device

ARTELON Surgical Suture, K032160, 11/17/2003.

3. Description of the Device

The device description of the ARTELON Surgical Suture is as follows:

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

4. Intended Use

The ARTELON Surgical Suture intended use is for use in soft tissue approximation and/or ligation during surgery. This is the same intended use as previously cleared for the ARTELON Surgical Suture, K032160.

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5. Discussion of Performance Testing

A collection of tests have been performed in accordance with:

ISO 10993 standards .
ISO 14971 .
USP 26 .
Class II Special Control Guidance, Surgical Suture; Guidance for Industry and ● FDA, June 3, 2003.

6. Conclusion

In summary, the ARTELON Surgical Suture described in the submission is, in our opinion, substantially equivalent to the predicate device. The ARTELON Surgical Suture is substantially equivalent to the device already on the market, and presents no new concerns about safety and effectiveness. Additionally, the devices have identical indication to the predicate device, and the labeling is consistent both with FDA guidance as well as current medical practice.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles.

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Artimplant AB c/o Marie Marlow CEO M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002

Re: K052482

Trade/Device Name: Artelon® Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: September 21, 2005 Received: September 23, 2005

Dear Ms. Marlow:

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- Marie Marlow

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter withication. The FDA finding of substantial equivalence of your device to a legally prematics modicate 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 (240) 276-0115. 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 s. 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/industry/support/index.html

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): K052482

Device Name: Artelon® Surgical Suture

Indications for Use:

Artelon® Surgical Suture is intended for use in general soft tissue approximation and/or ligation during surgery.

Prescription Use XX (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number_Koszy 62

(Posted November 13, 2003)

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.