Who is the manufacturer of ARTELON SURGICAL SUTURE?

Artimplant AB filed the 510(k) submission for ARTELON SURGICAL SUTURE (K032160).

What is the FDA product code for ARTELON SURGICAL SUTURE?

GAR. It is classified under 21 CFR 878.5020 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ARTELON SURGICAL SUTURE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ARTELON SURGICAL SUTURE?

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

Who can help prepare an FDA 510(k) submission like ARTELON SURGICAL SUTURE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ARTELON SURGICAL SUTURE

K032160 · Artimplant AB · GAR · Nov 17, 2003 · General, Plastic Surgery

Device Facts

Record ID	K032160
Device Name	ARTELON SURGICAL SUTURE
Applicant	Artimplant AB
Product Code	GAR · General, Plastic Surgery
Decision Date	Nov 17, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5020
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Artelon™ Surgical Suture is a sterile, nonabsorbable, braided multifilament suture composed of polycaprolactone-based poly(urethane urea). It is supplied uncoated, undyed, and without a needle. The device is used by surgeons in clinical settings for general soft tissue approximation and/or ligation. It functions by providing mechanical support to tissues during the healing process; it undergoes progressive degradation via in vivo hydrolysis, resulting in a gradual loss of tensile strength over time. The device is intended to provide a surgical closure alternative to existing nylon-based sutures.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility safety studies, diameter measurements, tensile strength testing, and evaluation of pliability and handling characteristics in accordance with ISO 10993, USP 26, and FDA guidance for surgical sutures.

Technological Characteristics

Material: Polycaprolactone-based poly(urethane urea). Form: Braided, multifilament, uncoated, undyed. Sterilization: Sterile. Standards: Meets U.S.P. 26 requirements for nonabsorbable surgical sutures. Connectivity: None. Energy source: None.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring surgical closure.

Regulatory Classification

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.

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

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

Related Devices

K052482 — ARTELON SURGICAL SUTURE · Artimplant AB · Oct 17, 2005
K974299 — PANACRYL · ETHICON, Inc. · Feb 13, 1998
K030177 — ORLON NONABSORABLE SURGICAL SUTURE USP · Sri Orion Pharmaceuticals & Sutures · Jul 21, 2003
K964345 — ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED · ETHICON, Inc. · Dec 16, 1996
K993998 — NYLON · Trading Consultants and Distributors Intl., Inc. · Feb 4, 2000

Submission Summary (Full Text)

{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. 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. {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 American Suture, Inc. | C.P. Medical | Artimplant AB | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | International - Nylon | Surgilon®, Ophtalon® and Dermalon® Non-absorbable Surgical Suture | Grams Nylon Nonabsorbable Suture | Nylon Nonabsorbable Surgical Sutures | Artelon™ Surgical Suture | | 510(k) Number | K993998 | K981582 | K003000 | K001173 | No number yet | | Characteristic | | | | | | | Intended use | General soft tissue approximation and/or ligation Including use in cardiovascular ophthalmic and neurological procedures. | General soft tissue approximation and/or ligation Including use in cardiovascular ophthalmic and neural tissue. | General soft tissue approximation and/or ligation Including use in cardiovascular ophthalmic and neurological procedures. | General soft tissue approximation and/or ligation Including use in cardiovascular ophthalmic and neurological procedures. | General soft tissue approximation and/or ligation | | Suture Material | Nylon 6 or Nylon 6,6 | Nylon 6 or Nylon 6,6 | Nylon 6 or Nylon 6,6 | Nylon 6 or Nylon 6,6 | Polycaprolactone based poly(urethane urea) | | Suture Characteristics | Not absorbed, progressive degradation of the Nylon in vivo may result in gradual loss of all of the suture's tensile strength over time | Not absorbed, progressive hydrolysis of the Nylon in vivo may result in gradual loss of all of the suture's tensile strength over time | Unknown | Unknown | Not absorbed, progressive degradation by hydrolysis of the poly(urethane urea) in vivo will result in gradual loss of all of the suture's tensile strength over time | | Suture Diameter | Meet U.S.P. Requirements | Unknown | U.S.P. 24 for diameter 861 | U.S.P. 24 for diameter 861 | U.S.P. 26 for diameter 861 | | How supplied | Monofilament thread, coated or uncoated, undyed or dyed with an FDA listed color additive. Sterile and offered for Single Use Only. Available with or without surgical needle. | Braided and monofilament sutures available in various lengths and diameters with or without surgical needles. | Sterile, flexible, monofilament thread or braided thread, dyed or undyed, offered in a variety of lengths and a range of diameters with or without needle. | Monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or dyed blue or undyed white. | Braided, uncoated, undyed without surgical needle. | | Packaging | Dry packaged in Aluminum Foil and Polyester tear open packaging | Tyvek/Mylar packaging | Unknown | Unknown | Double peel open laminated aluminium- plastic foil, respectively coated paper and polyester/polyethylene film. | {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) OR Over the Counter Use Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number 6 K632160