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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Rivulet™ Ventricular Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Similar Technological Characteristics to Predicate Devices	"The Rivulet Catheter has similar technological characteristics to the currently marketed predicate devices..."
Conforms to ISO 7197	"...and conforms to the ISO 7197 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components."
Equalized CSF Flow Across Inlet Holes	"The Rivulet Catheters incorporate inlet flow hole configuration changes that allow the CSF to flow in a more equalized manner across all inlet holes..."
Allows for Intraventricular Positioning Further from Choroid Plexus	"...and allows for intraventricular positioning of the inlet holes further away from the choroid plexus in normalized ventricles."
Indications for Use, Function, Implantation Techniques, Performance Characteristics, Design Specifications, and Test Standards are the Same as Predicate	"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."
Substantial Equivalence, Safety, and Efficacy	"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."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a numerical sample size for a test set in the context of a clinical study or performance evaluation with human subjects. The evaluation relies primarily on comparison to predicate devices and adherence to an international standard.

The data provenance is not directly applicable in the sense of clinical study data from a specific country, as the argument is based on design equivalency and conformance to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The device approval appears to be based on engineering design, comparison to predicate devices, and adherence to an international standard, rather than a clinical trial requiring ground truth establishment by a panel of experts.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant to the type of device evaluation described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done as described in the document. The device is a medical implant (ventricular catheter), not a diagnostic or AI-assisted interpretation tool. The comparison is between the new device's design and existing predicate devices, along with conformance to an ISO standard.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is a physical medical component, not an algorithm, and therefore does not have a "standalone" algorithmic performance in the context of AI or diagnostic imaging.

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be established through:

Predicate Device Performance: The known and accepted performance characteristics of the Medtronic PS Medical® Ventricular Catheter (K792007) and Medtronic Ventriculostomy Reservoir (K874498).
International Standard Conformance: Adherence to ISO 7197 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components.
Engineering Design and Testing (Implicit): While not detailed, the claims of "similar technological characteristics" and "equalized flow" imply underlying engineering design, testing, and validation demonstrating these features.

8. Sample Size for the Training Set

Not Applicable. This document describes the submission for a medical device (catheter), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.

Summary

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. 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) Ownerand Manufacturing Site	Medtronic Neurosurgery125 Cremona DriveGoleta, CA 93117 USA805-968-1546 ext. 1773805-968-9336 (FAX)
Establishment Number	2021898
Contact Name	Jeffrey Henderson
Date Summary Prepared	December 22, 2006
Trade or Proprietary Name	Medtronic Rivulet™ Ventricular CatheterMedtronic Rivulet™ Snap Shunt Ventricular CatheterMedtronic 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

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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

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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:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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

Regulation Number and Section

§ 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).