← Product Code [LJS](/productcode/LJS) · K062425 # LIFECATH S PICC AND MIDLINE CATHETER (K062425) _Vygon Corp. · LJS · Sep 15, 2006 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K062425 ## Device Facts - **Applicant:** Vygon Corp. - **Product Code:** [LJS](/productcode/LJS.md) - **Decision Date:** Sep 15, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.5970 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid. ## Device Story Lifecath S consists of peripherally inserted central catheters (PICC) and midline catheters; fabricated from barium-impregnated silicone elastomer. Device includes guidewire for insertion, fixation hub, and extravascular extension line with clamp. Catheters feature centimeter markings from hub to tip; hub marked with French size; extension lines marked with gauge and priming volume. Used in clinical settings for mid-to-long term IV therapy; administered by healthcare professionals. Device provides venous access for delivery of fluids and medications; benefits patient by facilitating reliable, sustained intravenous treatment. ## Clinical Evidence Bench testing only. Biocompatibility testing confirmed materials are non-irritant and non-toxic. Performance testing demonstrated substantial equivalence to predicate devices. ## Technological Characteristics Materials: Barium-impregnated silicone elastomer. Form factor: PICC (60 cm) and Midline (20 cm) catheters; 2Fr-6Fr sizes. Features: Guidewire, fixation hub, extravascular extension line, clamp. Sterilization: Not specified. Connectivity: None. Software: None. ## 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 - Vascu-PICC ([K030270](/device/K030270.md)) - Lifevac-PICC ([K903648](/device/K903648.md) and [K983544](/device/K983544.md)) - Lifecath PICC PUR ([K993442](/device/K993442.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}------------------------------------------------ Page 1 of 2 K062425 VYGON CORPORATION 2495 General Armistead Avenue Norristown, PA 19403-3685 > (800) 544-4907 (610) 630-3350 Fax (610) 630-3835 ## PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93) SEP 15 2006 Date of Preparation: August 14, 2006 Applicant: Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403 Courtney Smith, Regulatory Affairs Manager Contact Individual: Trade Name: Lifecath S Common Name: Lifecath PICC Regulation Number: 880.5970 Product Code: ris Classification Name: Percutaneous, implanted, long-term intravascular catheter 610-539-9300 Ext. 110 Classification: Class II Predicate Device Name: Vascu-PICC (K030270) Lifevac-PICC (K903648 and K983544) Lifecath PICC PUR (K993442) Device Description: The Lifecath S peripherally inserted central catheters and midline catheters are fabricated of barium impregnated silicone elastomer. The catheters are supplied with a guidewire to aid in insertion. The 60 cm PICC is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. The 20 cm midline catheter is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. Both catheters have a fixation hub and an extravascular extension line. The catheters are marked every centimeter from the hub to the proximal tip. The fixation hub is marked with the catheter French size, {1}------------------------------------------------ Page 2 of 2 K062425 and the extension lines are marked with the gauge size. A clamp is attached to each extension line, and is marked with the priming volume. The Vygon LIFECATH S PICC and Midline catheters are intended for use Intended Use: in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid. Technology Characteristics: The Lifecath S PICC and Midline catheters are composed of silicone and substantially equivalent to the predicate devices. ## Summary of Design Control Activities: Biocompatibility data demonstrates that the materials used are nonirritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices. Risk Assessment was conducted in compliance with ISO 14971. Biocompatibility testing, performance testing and risk assessment Conclusion: demonstrate that the Lifecath S is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use. Courtney Smith 8/14/06 Courtney Smith Regulatory Affairs Manager {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403 Re: K062425 Trade/Device Name: Lifecath S PICC and Midline Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 17, 2006 Reccived: August 18, 2006 Dear Ms. Smith: 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 Eederal Register. {3}------------------------------------------------ ## Page 2 - Ms. Smith 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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chiu-Ling, Ph.D. Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ **Indications for Use** 510(k) Number (if known): K 062125 PICC AND MIDLINE CATHE TER Lifecath S Device Name: Indications For Use: The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) Chater ver . 1 Sign-Off) on of Anesthesiology, General Hospital, on Control, Dental Devices : Number. K467425 Page 1 of --- **Source:** [https://fda-staging.innolitics.com/device/K062425](https://fda-staging.innolitics.com/device/K062425) **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