(233 days)
Not Found
No
The device description focuses on the mechanical design and function of a catheter for CSF drainage, with no mention of AI or ML technologies.
Yes
The device is designed to shunt cerebrospinal fluid (CSF) from the brain, which is a therapeutic intervention to treat conditions like hydrocephalus.
No
The device is a ventricular catheter used for shunting cerebrospinal fluid (CSF), which is a treatment rather than a diagnostic function.
No
The device description clearly describes a physical catheter made of material with specific dimensions and features, along with physical accessories like a stylet and clip. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The Rivulet™ Ventricular Catheter is a surgical implant designed to drain cerebrospinal fluid from the brain within the body ("in vivo"). It is a physical component of a shunt system, not a device used for analyzing biological samples.
The description clearly states its purpose is to facilitate the drainage of CSF from the ventricles of the brain to another part of the body, which is an internal, surgical procedure.
N/A
Intended Use / Indications for Use
The Rivulet™ Ventricular Catheter is designed for use as the proximal component of CSF Flow Control Shunts used in shunting cerebrospinal fluid from the ventricles of the brain to the peritoneal cavity or the right atrium of the heart.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Rivulet™ Ventricular Catheter is a proximal catheter used in the shunting of cerebrospinal fluid (CSF), allowing for the drainage of CSF from the ventricles of the brain. The Rivulet Catheter has varying sized, evenly spaced inlet flow holes located within 1.15 cm (0.45") of the tip of the catheter. The Rivulet Catheter is designed to equalize the distribution of inflowing CSF across all of the inlets holes as well as allow for intraventricular positioning of the inlet flow holes further away from the choroid plexus.
The Rivulet Catheter is available in two (2) shunt system connector styles: standard and snap shunt. The Rivulet Catheter with a standard connector measures 15 cm (5.9") in length, 0.15 cm (.06") in inner diameter, 0.25 cm (0.10") in outer diameter. The Rivulet Snap Shunt Catheters are available in lengths ranging from 4 cm (1.6") to 14 cm (5.5"). The Rivulet Catheters contain length markers to aid in determining depth of placement. To facilitate the placement and use of the Rivulet Catheters, procedural accessories supplied with the Rivulet Catheter include a stainless steel stylet, and a Right Angle Clip or Snap Base.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, peritoneal cavity, right atrium of the heart
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.
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
. 63836
AUG 16 2007
5. 510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Owner
and Manufacturing Site | Medtronic Neurosurgery
125 Cremona Drive
Goleta, CA 93117 USA
805-968-1546 ext. 1773
805-968-9336 (FAX) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Number | 2021898 |
| Contact Name | Jeffrey Henderson |
| Date Summary Prepared | December 22, 2006 |
| Trade or Proprietary Name | Medtronic Rivulet™ Ventricular Catheter
Medtronic Rivulet™ Snap Shunt Ventricular Catheter
Medtronic Rivulet™ Convertible Ventricular Catheter |
| Common Name | Hydrocephalus Shunt Component - Catheter |
| Classification Name | Central Nervous System Fluid Shunt and Component
(21 CFR 882.5550 Product Code JXG) |
Predicate Device Identification
- Medtronic PS Medical® Ventricular Catheter (K792007) .
- Medtronic Ventriculostomy Reservoir (K874498) .
Device Description
The Rivulet™ Ventricular Catheter is a proximal catheter used in the shunting of cerebrospinal fluid (CSF), allowing for the drainage of CSF from the ventricles of the brain. The Rivulet Catheter has varying sized, evenly spaced inlet flow holes located within 1.15 cm (0.45") of the tip of the catheter. The Rivulet Catheter is designed to equalize the distribution of inflowing CSF across all of the inlets holes as well as allow for intraventricular positioning of the inlet flow holes further away from the choroid plexus.
The Rivulet Catheter is available in two (2) shunt system connector styles: standard and snap shunt. The Rivulet Catheter with a standard connector measures 15 cm (5.9") in length, 0.15 cm (.06") in inner diameter, 0.25 cm (0.10") in outer diameter. The Rivulet Snap Shunt Catheters are available in lengths ranging from 4 cm (1.6") to 14 cm (5.5"). The Rivulet Catheters contain length markers to aid in determining depth of placement. To facilitate the placement and use of the Rivulet Catheters, procedural accessories supplied with the Rivulet Catheter include a stainless steel stylet, and a Right Angle Clip or Snap Base.
1
Indications for Use
The Rivulet Ventricular Catheter is designed for use as the proximal component of CSF Flow Control Shunts used in shunting cerebrospinal fluid from the ventricles of the brain to the peritoneal cavity or the right atrium of the heart.
Performance Characteristics
The Rivulet Catheter has similar technological characteristics to the currently marketed predicate devices listed above and conforms to the ISO 7197 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components. The Medtronic PS Medical Ventricular Catheter was cleared in January 1980 (K792007) and allows for the drainage of CSF from the ventricles of the brain. CSF is taken into the inlet flow holes of these catheters via a pressure differential between the ventricles of the brain and the outlet of the corresponding shunt system. The Rivulet Catheters incorporate inlet flow hole configuration changes that allow the CSF to flow in a more equalized manner across all inlet holes and allows for intraventricular positioning of the inlet holes further away from the choroid plexus in normalized ventricles.
Technological Comparison
Medtronic Neurosurgery submits that the indications for use, function, implantation techniques, performance characteristics, design specifications, and test standards of the Rivulet Catheter are the same as the previously reviewed and cleared Ventricular Catheter and Ventriculostomy Reservoir. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Rivulet Catheter based upon the predicate and currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is rendered in blue.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Neurosurgery % Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs 125 Cremona Drive Goleta, California 93117-5500
JAN 22 2013
Re: K063836
Trade/Device Name: Medtronic Rivulet™ Ventricular Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 19, 2007 Received: July 23, 2007
Dear Mr. Henderson:
This letter corrects our substantially equivalent letter of August 16, 2007.
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 (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 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 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2- Mr. Jeffrey Henderson
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millhumer
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure [ONLY NEED ENCLOSURE FOR 1996 FILES THAT HAVE INDICATIONS FOR USE STATEMENTS]
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- Indications for Use Statement
KO63236 510(k) Number (if known):
.
Device Name: Medtronic Rivulet™ Ventricular Catheter
Indications For Use:
The Rivulet™ Ventricular Catheter is designed for use as the proximal component of CSF Flow Control Shunts used in shunting cerebrospinal fluid from the ventricles of the brain to the peritoneal cavity or the right atrium of the heart.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
4
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KO63836
Mark A. Melkerson
Division Sign-O Division of General, Restorative. and Neurological Devices
510(k) Number
Rivulet™ Ventricular Catheter