(288 days)
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No
The description focuses on the material composition and physical function of a catheter, with no mention of AI or ML capabilities. The radiopaque dots are for X-ray visualization, not for automated analysis.
Yes
The device is a component of an implanted cerebrospinal fluid shunt system, which is used to treat hydrocephalus by draining excess CSF to alleviate symptoms and improve a patient's condition.
No
The device is a component of a cerebrospinal fluid shunt system intended to transmit CSF. It is a therapeutic device, not a diagnostic one. While it has radiopaque dots for X-ray localization, its primary function is not to diagnose a condition.
No
The device is a physical catheter made of silicone elastomer with radiopaque dots, clearly indicating it is a hardware component and not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Cordis Ventricular Catheter is an implanted medical device. It is a component of a cerebrospinal fluid shunt system that is surgically placed inside the body to manage hydrocephalus. Its function is to physically transmit fluid within the body.
The description clearly states its purpose is to transmit CSF from the cerebral ventricles or extraventricular structures to the valve mechanism, all within an implanted system. This is an in vivo (within the body) function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cordis Ventricular Catheter (with radiopaque dots) is a component of an implanted cerebrospinal fluid shunt system. It serves to transmit cerebrospinal fluid (CSF) to the valve mechanism from the cerebral ventricles or from extraventricular structures. It is a component sold alone for use in implanted hydrocephalus shunt systems or in kits containing all components for hydrocephalus shunt system implantation. Indications and contraindications are the same as the Cordis Ventricular Catheters which have been sold by Cordis for over 20 years.
Product codes
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Device Description
Catheters are manufactured from the same materials currently used in other Cordis catheters with the exception of the addition of tantalum in the dot. The Cordis Ventricular Catheter (with radiopaque dots) is manufactured from silicone elastomer made radiopaque with barium sulfate. The radiopaque dots are formed by mixing tantalum powder in Liquid Silicone Rubber (LSR) and applying the mixture, fully coated with silicone elastomer, to the wall of a catheter to provide a means of determining the location and depth of the catheter on X-rav.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-rav
Anatomical Site
cerebral ventricles or from extraventricular structures
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.
Cordis Straight Ventricular Catheter (Cat. No. 951-102), Cordis Finned Ventricular Catheter (Cat. No. 951-101), Heyer-Schulte In-Line Valve System, Heyer-Schulte Portnoy Ventricular Catheter
Reference Device(s):
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
OCT 25 1996
Appendix III
Summary of Safety and Effectiveness
Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act
General Information ﻟﺴﺎ
Classification Name:
Central nervous system fluid shunt system component
Common/Usual Name:
Ventricular Catheter
Proprietary Name:
Cordis Straight or Finned Ventricular Catheter (with radiopaque dots)
Applicants Name and Address:
Cordis Corporation P. O. Box 025700 Miami, FL 33102-5700
Name of predicate device(s): II.
Cordis Straight Ventricular Catheter (Cat. No. 951-102) Cordis Finned Ventricular Catheter (Cat. No. 951-101)
Heyer-Schulte In-Line Valve System
Heyer-Schulte Portnoy Ventricular Catheter
III. Classification:
Central nervous system fluid shunts and components were reviewed by the Neurological Devices Classification Panel and placed in Class II (21 CFR 882.5550).
IV. Performance Standards:
No applicable performance standards have been established by FDA under section
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514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description:
The Cordis Ventricular Catheter (with radiopaque dots) is a component of an implanted cerebrospinal fluid shunt system. It serves to transmit cerebrospinal fluid (CSF) to the valve mechanism from the cerebral ventricles or from extraventricular structures. It is a component sold alone for use in implanted hydrocephalus shunt systems or in kits containing all components for hydrocephalus shunt system implantation. Indications and contraindications are the same as the Cordis Ventricular Catheters which have been sold by Cordis for over 20 years. Catheters are manufactured from the same materials currently used in other Cordis catheters with the exception of the addition of tantalum in the dot. The Cordis Ventricular Catheter (with radiopaque dots) is manufactured from silicone elastomer made radiopaque with barium sulfate. The radiopaque dots are formed by mixing tantalum powder in Liquid Silicone Rubber (LSR) and applying the mixture, fully coated with silicone elastomer, to the wall of a catheter to provide a means of determining the location and depth of the catheter on X-rav.
VI. Biocompatibility:
Implanted materials in contact with body tissues or body fluids are silicone elastomer with barium sulfate, and Liquid Silicone Rubber.
VII. Summary of Substantial Equivalence:
Indications: The indications and contraindications of the Cordis Ventricular Catheter (with radiopaque dots) are the same as those for the Cordis Straight or Finned Ventricular Catheters.
Design: The dimensions of the Cordis ventricular catheters (with radiopaque dots) are the same as those for predicate Cordis ventricular catheters.
Materials: The materials used in the manufacturing of the Cordis ventricular catheters (with radiopaque dots) are the same as those for the predicate Cordis ventricular catheters except for the addition of tantalum markers. Tantalum dots have been used in conjunction with the predicate Heyer-Schulte devices.
Manufacturing: The manufacturing process used in the production of Cordis ventricular catheters (with radiopaque dots) is similar to those used for predicate Cordis ventricular catheters. No new safety or effectiveness issues are raised.
Specifications: The specifications (radiopacity, pull strength, etc.) for the Cordis ventricular catheters (with radiopaque dots) are the same as for the predicate Cordis ventricular catheters.
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Conclusions: The indications, design and specifications of the Cordis ventricular catheters (with radiopaque dots) are the same as the predicate Cordis ventricular catheters. The addition of radiopaque dots raise no new issues of safety or effectiveness.
Cordis thus considers the Cordis Straight or Finned Ventricular Catheters (with radiopaque dots) to be substantially equivalent to the predicate Cordis and Heyer-Schuite ventricular catheters with radiopaque markings.