FSSB NYLON SURGICAL SUTURES

{0}------------------------------------------------ #### JUL 26 2006 510(K) Summary of Data and Information III. The following information is provided as required by 21 CFR § 807.87 for FSSB Chirurgische Nadeln GmbH's 510(k) premarket notification for FSSB Nylon Surgical Sutures and in accordance with FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" (June 3, 2003). ### A. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### FSSB Nylon Surgical Sutures In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. The safety and effectiveness of the FSSB Nylon Surgical Sutures is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices currently having 510k clearance. # Submitter's Name, Address, Telephone Number, Contact Person and Date #### Prepared | FSSB Chirurgische Nadeln GmbH | Phone: | +49 7745 92 79 90 | |----------------------------------|---------|-------------------------------| | Allmendweg 2 (Postfach 1132) | Fax: | +49 7745 92 79 999 | | Jestetten, Germany D-79798 | | | | US Contact: | | | | M Squared Associates, Inc. | Phone: | 202-546-1262 ext. 257 | | Cherita James | Fax: | 202-546-3848 | | 719 A Street, NE | e-mail: | CJames@msquaredassociates.com | | Washington DC 20002 | | | | Date prepared: February 22, 2006 | | | | Proprietary Name: | FSSB Nylon Surgical Sutures | |------------------------|----------------------------------------------------| | Common Name: | Nonabsorbable Nylon Surgical Suture | | Classification Status: | Class II per regulations §878.5020 | | Product Code: | GAR- Surgical, Nonabsorbable, Synthetic, Polyamide | {1}------------------------------------------------ K060471 2/4 ### Device Description FSSB Nylon Surgical Suture is a monofilament non-absorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6,6. The suture is provided dyed (black). The pigment for the black dyed suture is Hematein black (Logwood: Color Code 75290). All products meet the requirements of 21 CFR 70.5(c) regarding the use of color additives in sutures. The product is available in several lengths and USP diameters. The FSSB Surgical Suture is equipped with single or double high-grade stainless steel needles of various types of points, lengths, diameters and curves (Product List provided as Appendix A). The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. #### Intended Use FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures. {2}------------------------------------------------ K060471 | | Predicate Devices | | Subject Device | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | T.CAD | Sherwood-<br>Davis & Geck | S & T | FSSB | | Device | International -<br>Nylon | Surgilon®,<br>Ophtalon® and<br>Dermalon®<br>Non-absorbable<br>Surgical Suture | Micro surgical<br>suture | FSSB Nylon<br>Surgical Suture | | 510(k) Number | K993998 | K981582 | K031531 | No number yet | | Characteristic | | | | | | Intended use | General soft<br>tissue<br>approximation<br>and/or ligation<br>Including use in<br>cardiovascular<br>ophthalmic and<br>neurological<br>procedures. | General soft<br>tissue<br>approximation<br>and/or ligation<br>Including use in<br>cardiovascular<br>ophthalmic and<br>neural tissue. | General soft tissue<br>approximation<br>and/or ligation<br>Including use in<br>cardiovascular and<br>ophthalmic I<br>procedures. | General soft tissue<br>approximation and/or<br>ligation including use<br>in ophthalmic and<br>neurological<br>procedures. | | Suture Material | Nylon 6 or Nylon<br>6,6 | Nylon 6 or Nylon<br>6,6 | Nylon 6 or Nylon 6,6 | Nylon 6 or Nylon 6,6 | | Suture<br>Characteristics | Not absorbed,<br>progressive<br>degradation of<br>the Nylon in vivo<br>may result in<br>gradual loss of<br>all of the<br>suture's tensile<br>strength over<br>time | Not absorbed,<br>progressive<br>hydrolysis of the<br>Nylon in vivo<br>may result in<br>gradual loss of<br>all of the<br>suture's tensile<br>strength over<br>time | Unknown | Not absorbed,<br>progressive<br>hydrolysis of the<br>Nylon in vivo may<br>result in gradual<br>loss of all of the<br>suture's tensile<br>strength over time | | Suture Diameter | Meet U.S.P.<br>Requirements | Unknown | Unknown | U.S.P. 28 for<br>diameter 861 | | How supplied | Monofilament<br>thread, coated<br>or uncoated,<br>undyed or dyed<br>with an FDA<br>listed color<br>additive. Sterile<br>and offered for<br>Single Use Only.<br>Available with or<br>without surgical<br>needle. | Braided and<br>monofilament<br>sutures available<br>in various<br>lengths and<br>diameters with<br>or without<br>surgical needles. | Monofilament, dyed<br>black available in<br>various lengths and<br>diameters with<br>surgical needles. | Monofil, dyed,<br>variety of lengths<br>and diameters with<br>surgical needle. | | Packaging | Dry packaged in<br>Aluminum Foil<br>and Polyester<br>tear open<br>packaging | Tyvek/Mylar<br>packaging | Unknown | Double packaged<br>Heat sealed | ### Technological characteristics, comparison to predicate device. {3}------------------------------------------------ ### Technological Characteristics and Substantial Equivalence The FSSB Nylon Surgical Sutures and the identified predicate devices have the same indications for use, are made from the same materials (Nylon 6 or Nylon 6,6), and have similar design features (monofilament, dyed, nonabsorbable, various lengths, available with needle). Performance testing has demonstrated that any minor differences between the FSSB Nylon Surgical Sutures and the predicate devices do not raise new questions of device safety or effectiveness. #### Discussion of performance testing. A collection of tests has been conducted to characterize biocompatibility, diameter, tensile strength, and properties such as pliability and handling in accordance to: - ISO 10993 standards . - USP 28 <861>, <871>, <881> . - Class II Special Control Guidance, Surgical Suture; Guidance for Industry and . FDA, June 3, 2003 #### Conclusion FSSB Nylon Surgical Suture has the same principles of operation and similar technological characteristics as the previously 510k cleared predicates. The minor differences do not present new issues of safety or effectiveness. Based on extensive performance testing and a comparison to the predicate devices, we believe that the FSSB Nylon 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. K060471 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like figure in the center. The text around the perimeter is not clearly legible, but it appears to be a series of words or phrases arranged in a circular fashion. The central figure resembles a bird in flight, with three parallel lines forming the body and wings, and a wavy line representing the tail or lower portion of the bird. The overall design is simple and abstract, with a focus on conveying a sense of movement or flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 26 2006 FSSB Chirurgische Nadeln GmbH % M Squared Associate Ms. Cherita James 719 A Street, Northeast Washington, District of Columbia 20002 Re: K060471 Trade/Device Name: FSSB Nylon Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: July 20, 2006 Received: July 24, 2006 Dear Ms. James: 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. Iisting 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. {5}------------------------------------------------ Page 2 - Ms. Cherita James 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 (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 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. Harbare Buchup Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Premarket Notification Indications for Use Statement ll. | 510(k) Number: | To be assigned | |----------------------|-------------------------------------------------------------------| | Device Name: | FSSB Nylon Surgical Suture | | | FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is | | | indicated for use in general soft tissue approximation and/or | | Indications for Use: | ligation including use in ophthalmic and neurological procedures. | | Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> | |-------------------------------------------------|----------| |-------------------------------------------------|----------| Or | Over-the-Counter Use<br>(Part 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) Choubare Parekhan) (Division sign-off) Division of General, Restorative, and Neurological Devices 510(k): K060471