(184 days)
Not Found
Not Found
No
The provided 510(k) summary describes a percutaneous lumbo-peritoneal shunt and a lumbar drainage system, which are mechanical devices for fluid management. There is no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in the intended use, device description, or other sections.
Yes
The device is designed to shunt CSF for the treatment of communicating hydrocephalus and management of CSF fistulas, which directly addresses medical conditions.
No
Explanation: The device is described as a shunt designed to treat hydrocephalus by diverting cerebrospinal fluid. Its stated uses are for treatment, not for diagnosing conditions.
No
The intended use describes a physical shunting system for cerebrospinal fluid, which is a hardware device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that is surgically implanted or used externally to drain cerebrospinal fluid (CSF) from the body. This is a therapeutic and diagnostic procedure performed on the patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, CSF, etc.)
- Detecting or measuring substances in a sample
- Providing information about a patient's health status based on sample analysis
- Using reagents or assays
The device is a medical device used for drainage and management of CSF within the body.
N/A
Intended Use / Indications for Use
- Lumbo-Peritoneal Shunts:
- 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.
- Lumbar Drainage Systems:
- Lumbar Drainage System is intended for use as a means of temporary external lumbar drainage and collection of cerebrospinal fluid from the lumbar subarachnoid space. This device is designed for use with the Phoenix Fifth Ventricle Collection Bag.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar subarachnoid space (for Lumbar Drainage System); Subarachnoid space to peritoneal cavity (for Lumbo-Peritoneal Shunts)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
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.(b)
Classification. Class II (performance standards).
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
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