(502 days)
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No
The document describes a mechanical shunt system and its components, with no mention of AI or ML technologies.
Yes
This device is a therapeutic device because its intended use is to shunt cerebrospinal fluid from the brain to the heart or peritoneal cavity, which directly treats a medical condition (e.g., hydrocephalus).
No
This device is a shunt system designed to drain cerebrospinal fluid, not to diagnose a medical condition.
No
The device description explicitly details physical components made of polyurethane, polypropylene, and silicone elastomer, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The described device is a shunt system designed to drain cerebrospinal fluid from the brain into the heart or peritoneal cavity. This is a surgical implant and a therapeutic device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly describes a procedure to manage cerebrospinal fluid flow within the body, not to analyze a sample for diagnostic purposes.
- Device Description: The components are catheters and valves designed for implantation and fluid management, not for performing laboratory tests.
Therefore, this device falls under the category of an implantable medical device used for therapeutic purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.
The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
A Ventricular Catheter manufactured of Polyurethane tubing. A Flow Control Valve manufactured of a Polypropylene base and a silicone elastomer housing which incorporates a Tecoflex elastomer resin, polyurethane coating. A Cardiac/Peritoneal Catheter manufactured of Polyurethane tubina.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ventricles of the brain, right atrium of the heart, peritoneal cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Safety and Effectiveness Summary X.
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 882.5550
Establishment Registration Number: Address of Manufacturer:
2021898
Medtronic PS Medical Corporation 125 Cremona Drive Goleta CA, 93117 (805) 968-1546 ext. 1770 Fax: (805) 968-5038
Contact Person:
Jeffrey Henderson
September 12, 2000
Date:
Trade or Proprietary Name:
Medtronic PS Medical Polyurethane Shunt
Common usual or Classification Name: CSF-Flow Control Shunt (882.5550)
A Ventricular Catheter manufactured of Description: Polyurethane tubing. A Flow Control Valve manufactured of a Polypropylene base and a silicone elastomer housing which incorporates a Tecoflex elastomer resin, polyurethane coating. A Cardiac/Peritoneal Catheter manufactured of Polyurethane tubina.
The polyurethane-coated Delta Valves, Intended Use: polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.
The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).
Medtronic PS Medical submits that the Technological comparison: materials of fabrication, intended uses, performance characteristics and design specifications of the Polyurethane Shunt are substantially equivalent to those of the predicate devices manufactured by Medtronic PS Medical and other currently marketed devices. Based upon the summary above, Medtronic PS Medical determines substantial equivalence, safety, and efficacy of the Polyurethane Shunt based upon the currently marketed devices.
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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized symbol consisting of four profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2000
Mr. Jeffrey Henderson ·Vice President, Quality and Regulatory Affairs Medtronic PS Medical 125 Cremona Drive Goleta, California 93117
Re: K991502
Trade Name: Medtronic PS Medical Polyurethane Shunt Regulatory Class: II Product Code: JXG Dated: June 12, 2000 Received: June 14, 2000
Dear Mr. Henderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jeffrey Henderson
This letter will allow you to begin marketing your device as described in your 510(k) Frido reter notification. The FDA finding of substantial equivalence of your device to a premainverleted 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neville Sayre
Sir 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
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Device Name: Polyurethane Shunt
510(k) Number (if known): K991502
Indications for Use:
The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.
The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
NRo for cmw
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)
(optional format 1-2-96)