(278 days)
Not Found
Not Found
No
The device description focuses on the physical components and materials of a guiding sheath system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a guiding sheath system for introducing intravascular electrophysiology catheters, allowing passage of catheters and infusion. It facilitates a medical procedure rather than directly treating a disease or condition.
No
The device is a guiding sheath system for catheter introduction into the heart, not for diagnostic purposes. It facilitates the passage of other catheters, which may or may not be diagnostic.
No
The device description clearly outlines multiple physical components including guiding sheaths, a guidewire, and vessel dilators, all made of various materials and designed for physical manipulation within the body. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Introduction of intravascular electrophysiology catheters into any cardiac chamber." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device (sheaths, dilators, guidewire) used for accessing and navigating within the cardiovascular system. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological specimens, which is the core function of an IVD.
Therefore, the Cordis Webster Braided Guiding Sheath Exchange System is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the percutaneous Braided Guiding Sheath Exchange System is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
Product codes
74DYB
Device Description
The Cordis Webster Braided Guiding Sheath Exchange System consists of guiding sheaths with a sideport and valve, pre-shaped distal tip section with radiopaque brite tip, a guidewire, a conventional vessel dilator, and a long tapered exchange vessel dilator with a multipurpose curve at the distal end.
The guiding sheaths have large non-tapered lumens that allow for intravascular passage of catheters and infusion of heparinized normal saline and/or contrast medium. The guiding sheaths feature a nylon body reinforced with a tightly wound stainless steel braid wire. The braid wire extends from the proximal hub through several flexible transition segments to the "brite tip" which is a low durometer Polyurethane with radiopaque filler at the distal end.
The transition segments are comprised of several durometers of material designed to vary the stiffness along the entire length of the guiding sheath shaft. The higher durometer is used on the proximal segment of the shaft to yield a stiffer segment. This stiffer segment provides the added support required to manipulate the guiding sheath during cannulation. The distal transition segments utilize an increasingly softer durometer which provides the flexible atraumatic distal tip segment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
any cardiac chamber
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)
The nonclinical performance testing conducted on the Cordis Webster Braided Guiding Sheath Exchange System compared to the predicate devices indicated that there were no significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis 9 FR Guiding Catheter, Daig Fast-Cath™ Hemostasis Introducer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Cordis Webster Braided Guiding Sheath Exchange System
OCT 28 1997
510(k) Summary
Classification Name
Common/Usual Name: Introducer
Cordis Webster Braided Guiding Sheath Exchange System Proprietary Name:
Name of Predicate Device
Cordis 9 FR Guiding Catheter Daig Fast-Cath™ Hemostasis Introducer
Device Description
The Cordis Webster Braided Guiding Sheath Exchange System consists of guiding sheaths with a sideport and valve, pre-shaped distal tip section with radiopaque brite tip, a guidewire, a conventional vessel dilator, and a long tapered exchange vessel dilator with a multipurpose curve at the distal end.
The guiding sheaths have large non-tapered lumens that allow for intravascular passage of catheters and infusion of heparinized normal saline and/or contrast medium. The guiding sheaths feature a nylon body reinforced with a tightly wound stainless steel braid wire. The braid wire extends from the proximal hub through several flexible transition segments to the "brite tip" which is a low durometer Polyurethane with radiopaque filler at the distal end.
The transition segments are comprised of several durometers of material designed to vary the stiffness along the entire length of the guiding sheath shaft. The higher durometer is used on the proximal segment of the shaft to yield a stiffer segment. This stiffer segment provides the added support required to manipulate the guiding sheath during cannulation. The distal transition segments utilize an increasingly softer durometer which provides the flexible atraumatic distal tip segment.
1
510(k) Summary (continued)
Intended Use
The intended use of the percutaneous Braided Guiding Sheath Exchange System is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
Technological Characteristics
The Cordis Webster Braided Guiding Sheath Exchange System and the Cordis Guiding Catheter, one of the predicate devices, consist of the same components, with exception of the multipurpose curve (i.e. shaped section of the vessel dilator) and a shorter sheath length to assist physician technique.
Performance Data (Nonclinical Testing)
The nonclinical performance testing conducted on the Cordis Webster Braided Guiding Sheath Exchange System compared to the predicate devices indicated that there were no significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device.
Conclusions Drawn from the Nonclinical Tests
The results of the nonclinical performance tests indicate that the Cordis Webster Braided Guiding Sheath Exchange System performs as well as the predicate devices and that the differences in testing outcome are not significant; therefore, Cordis Webster concludes that the Cordis Webster Braided Guiding Sheath Exchange System is substantially equivalent to the predicate devices, the 9F Cordis Guiding Catheter and the Daig Fast-Cath™ Hemostasis Introducer.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Mary Adams Requlatory Affairs Manager Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, California 91706
OCT 28 1997
Re : K970264 Trade Name: Cordis Webster Braided Guiding Sheath Exchange System Regulatory Class: Two (II) Product Code: 74DYB ..... Dated: July 22, 1997 Received: July 23, 1997
Dear Ms. Adams:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 obliqation you miqht have under sections 531 through 542 of the Act for devices under the
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Page 2 - Ms. Mary Adams
Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,
Thomas J. Callakan
Thomas J Callal Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K970264 510(K) Number (if known):
Cordis Webster Braided Guiding Sheath Exchange System Device Name:
Indications for Use:
Introduction of intravascular electrophysiology catheters into any cardiac chamber.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. Donkn Fellin
(Division Sian-OM Division of Cardios and Neurological De 510(k) Numbe