← Product Code [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG) · K033704 # MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS (K033704) _Vygon Us, LLC · JXG · May 27, 2004 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K033704 ## Device Facts - **Applicant:** Vygon Us, LLC - **Product Code:** [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG.md) - **Decision Date:** May 27, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 882.5550 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use Lumbar Drainage System is intended for use as a means of temporary external lumbar drainage, monitoring and collection of cerebrospinal fluid from the subarachnoid space. It is designed for use with the Phoenix Fifth Ventricle Collection Bag. Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity. The shunting may be used for evaluation or treatment of normal pressure communicating hydrocephalus. A percutaneous lumbo-peritnoeal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and transient CSF absorption defects, e.g. post meningitic or post-hemorrhagic hydrocephalus. ## Device Story Lumbar Drainage Systems and Lumbo-Peritoneal Shunts facilitate CSF management. Lumbar drainage system provides temporary external diversion, monitoring, and collection of CSF from subarachnoid space; used with Phoenix Fifth Ventricle Collection Bag. Lumbo-peritoneal shunts divert CSF from subarachnoid space to peritoneal cavity. Used in clinical settings for hydrocephalus management and CSF fistula treatment. Operated by physicians. Benefits include pressure relief and CSF absorption support. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Central nervous system fluid shunt and components (21 CFR 882.5550). System includes drainage catheters, shunts, and collection components (Phoenix Fifth Ventricle Collection Bag). Mechanical fluid diversion and collection system. No software or electronic components described. ## Regulatory Identification A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. ## Reference Devices - Phoenix Fifth Ventricle Collection Bag ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 27 2004 Ms. Courtney Smith Regulatory Affairs Manager Vygon US LLC 2495 General Armistead Avenue Norristown, Pennsylvania 19403 Re: K033704 Trade/Device Name: Lumbar Drainage Systems Lumbo-Peritoneal Shunts Regulation Number: 21 CFR 882.5550 Regulation Namc: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: April 30, 2004 Received: April 30, 2004 Dear Ms. Smith: Wc 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 Codc 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 CHR 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. {1}------------------------------------------------ Page 2 - Ms. Courtney Smith 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, Mark A Wilkerson 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K033704 Lumbo-Peritoneal Shunts Device Name: Indications For Use: - Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of . communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity. - The shunting may be used for evaluation or treatment of normal pressure ● communicating hydrocephalus. - A percutaneous lumbo-peritnoeal shunt is also useful in the management of . persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and transient CSF absorption defects, e.g. post meningitic or post-hemorrhagic hydrocephalus. 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) Mark N Millkum Division of General, Restorative, and Neurological Devices K033704 Page 1 of 1 510(k) Number_ {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K033704 Lumbar Drainage Systems Device Name: Indications For Use: Lumbar Drainage System is intended for use as a means of temporary external Eumbar Drainage Cyclinage Cyonitoring and collection of cerebrospinal fluid from the diversion, proboute metesigned for use with the Phoenix Fifth Ventricle Collection Bag. 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) h Mark A. Melhusen Division Sign-O Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number k033704 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K033704](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K033704) **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