COROLENE

{0}------------------------------------------------ K052701/3 Image /page/0/Picture/1 description: The image shows the logo for Peters Surgical. The logo features a stylized ear on the left, followed by the name "Péters" in a handwritten-style font. Below the name, the word "SURGICAL" is written in smaller, block letters. The overall design is simple and professional, likely representing a company specializing in surgical products or services related to the ear. DEC 1 3 2005 ## SECTION 10 ## 510(k) SUMMARY ### [As Required by 21 CFR 807.92(c)] Information supporting claims of substantial equivalence, as defined under the Federal Food, drug and Cosmetic Act, respecting safety and effectiveness is summarized below. #### 510(k) Summary Date prepared September 12, 2005 ### 510(k) Submitter PETERS SURGICAL Z.I. Les vignes 42 rue benoit frachon Bobigny, FRANCE 93013 Registration Number: 3004060107 Owner/Operator Number: 9009304 Phone: 33-148-106262 Fax: 33-148-912299 #### Official Correspondent Annic LASSERRE Research & Development Manager PETERS SURGICAL Bobigny, FRANCE, 93013 Phone: 33-148-106259 ### New Device Name COROLENE® Trade name: Surgical suture, Polypropylene Common/Usual namc: Nonabsorbable Polypropylene Surgical Suture Classification name: {1}------------------------------------------------ Kosa>Ul\$_{2/3}\$ Image /page/1/Picture/1 description: The image shows the logo for "Peters Surgical". The logo consists of a stylized ear on the left, followed by the name "Peters" in a cursive font. Below "Peters" is the word "Surgical" in smaller, block letters. The logo is simple and professional, likely representing a company specializing in surgical products or services related to the ear. #### New Device Classification Class II in 21 CFR §878.5010 by the General and Plastic Surgery Devices Panel, Nonabsorbable Polypropylene Surgical Suture (GAW). #### Predicate Device Name PROLENETM, Nonabsorbable Polypropylene Surgical Suture (N16374). #### Statement of intended use COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery. COROLENE® has the same intended use as the predicate device PROLENT® #### New Device Description COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached. #### Summary of Technological Characteristics of New Device compared to Predicate Device Our new device COROLENE® has similar technological characteristics as the predicate device PROLENE®. Like currently marketed PROLENF® suture, COROLENE® is a sterile monofilament synthetic non-absorbable surgical suture that conforms to the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. The polypropylenc material used for both medical devices is commonly used in surgical applications and has been proven to be biocompatible. {2}------------------------------------------------ K052701 3/3 Image /page/2/Picture/1 description: The image shows the logo for Péters Surgical. The logo features a stylized eye on the left, with the name "Péters" in a cursive font to the right of the eye. Below "Péters" is the word "SURGICAL" in smaller, block letters. ## Performance data Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for non-absorbable surgical sutures. ### Conclusions Based on the 510(k) summary (21 CFR 807) and the information provided herein, we conclude that our New Medical Device COROLENE® is substantially equivalent to the Predicate Device PROLENE® under the Federal Food, Drug, and Cosmetic Act. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement around the caduceus. The text is in all capital letters. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 3 2005 Annie Lasserre R & D Manager Peters Surgical Z.I Les vignes 42 Rue Benoit Frachon Bobigny, France 93013 Re: K052701 Trade/Device Name: COROLENE® Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable poly-propylene surgical suture Regulatory Class: II Product Code: GAW Dated: September 6, 2005 Received: September 28, 2005 Dear Ms. Lasserre: 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- Annie Lasserre This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to begin manieling your and 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 if you ucate specific daries ion your of your of 15. Also, please note the regulation entitled, Contact the Office of Company of Company of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended 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 vours, Roubare Buellun Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Peters Surgical. The logo consists of a stylized ear on the left and the text "Péters" above the word "SURGICAL" on the right. The ear is black and white, and the text is in a handwritten-style font. K05 270/ ## SECTION 9 # STATEMENT OF INDICATIONS FOR USE 510(k) Number COROLENE® Device Name ## Indications for use COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery. 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) Harbare BnechD Division of General, Restorative, and Neurological Devices **510(k) Number** K05270)