← Product Code [LJS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS) · K051690 # VYGON NUTRILINE CATHETERS (K051690) _Vygon Corp. · LJS · Aug 19, 2005 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS/K051690 ## Device Facts - **Applicant:** Vygon Corp. - **Product Code:** [LJS](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS.md) - **Decision Date:** Aug 19, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5970 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use An intravascular catheter, inserted peripherally for long-term use for parenteral nutrition and/or administration of drugs ## Device Story Vygon Nutriline Catheters are peripherally inserted, long-term intravascular catheters. They are used for the administration of parenteral nutrition and/or medications. The device is intended for clinical use by healthcare professionals to provide venous access for patients requiring extended therapy. By facilitating long-term infusion, the catheter reduces the need for repeated venipuncture, thereby benefiting the patient through improved access and reduced trauma. ## Clinical Evidence Bench testing only. ## Technological Characteristics Percutaneous, implanted long-term intravascular catheter. Class II device (21 CFR 880.5970). ## Regulatory Identification A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design. ## Special Controls *Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.” ## Predicate Devices - Vygon Nutriline Catheters ([K951694](/device/K951694.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. AUG 1 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Courtney Smith Clinical and Regulatory Affairs _ . . . . Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403-3685 Re: K051690 Trade/Device Name: Vygon Nutriline Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: June 22, 2005 Received: July 5, 2005 Dear Ms. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosure) to togally the Medical Device Amendments, or to commerce prior to may 20, 1978, as tax can and with the provisions of the Federal Food, Drug, devices mat have been recident require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerore, manes of the Act include requirements for annual registration, listing of general controls proving 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 If your device is classified (500 a0070) in Existing major regulations affecting your device can thay be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods of reasts concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Ms. Smith Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition on only of the requirements of the Act that FDA has made a determination that your device of accepcios. You must that FDA has made a decemmanon that your as ross occapition of encreations and ligit or any Federal statutes and regulations administered of on registration and listing (21 comply with all the Act's requirements, including, but not limited to: resultsments as comply with all the Act s requirements, more, and manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manant 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR 1000); and if applicable, forth in the quality systems (QD) regulation (Sections 531-542 of the Active Sections product radiation control provisions (Decions of 2 vice as described in your Section 5 10(k) This letter will anow you to begin mancemis your antial equivalence of your device to a legally premarket notification. The PDA miding of databalation of 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 s and the may on 10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 If you desire specific advice for your ac not the same a mote the regulation entitled, contact the Office of Compunance at (216) 276 of on 11 (21CFR Part 807.97). You may obtain "Misbranding by relectice to premanton noutheans.com the Act from the Division of Small other general information on your responsion.com and its toll-free number (800) 638-204) or Manufacturers, International and Consumer Fibelskiros and Collectivindustry/support/index.html. Sincerely yours, Clive Shiau-Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center of Devices and Radiological Health Enclosure {2}------------------------------------------------ K051690 ## Indications for Use 510(k) Number (if known): Vygon Nutriline Catheters Device Name: 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Indications For Use: An intravascular catheter, inserted peripherally for long-term All intravasoalar outhors for parenteral nutrition and/or administration of drugs Prescription Use ___X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ___ 1__ Chis Ome (Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices 510(k) Number: K951694 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS/K051690](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJS/K051690) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com