(278 days)
The intended use of the percutaneous Braided Guiding Sheath Exchange System is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
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.
This submission describes a medical device, the Cordis Webster Braided Guiding Sheath Exchange System, seeking 510(k) clearance, which relies on demonstrating substantial equivalence to predicate devices rather than proving novel performance against specific acceptance criteria in a clinical study. Therefore, a direct table of acceptance criteria and reported device performance, as well as several other requested study details, are not applicable in the context of this 510(k) summary.
Here's a breakdown of the information provided in the 510(k) summary as it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (N/A) for a 510(k) Predicate Device Submission.
For 510(k) submissions demonstrating substantial equivalence, the "acceptance criteria" are generally that the new device performs as well as or does not raise different questions of safety and effectiveness compared to a legally marketed predicate device. The performance data presented focuses on showing this equivalence.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (Nonclinical Testing) |
|---|---|
| No significant differences in safety and effectiveness compared to predicate devices | "no significant differences in the outcome of the tests for each of the devices that would affect the safety and effectiveness of the device." |
| Performs as well as predicate devices | "performs as well as the predicate devices and that the differences in testing outcome are not significant" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of patient data. The "tests" refer to nonclinical (bench) performance testing. The number of samples for each specific bench test (e.g., tensile strength, flexibility) is not provided.
- Data Provenance (e.g., country of origin, retrospective or prospective): The data is from nonclinical testing (bench testing), not human or animal studies. Therefore, concepts like country of origin, retrospective, or prospective do not apply.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not Applicable.
No expert consensus for ground truth was established because the testing was nonclinical (bench testing) comparing physical and mechanical properties to predicate devices, not clinical outcomes requiring expert interpretation.
4. Adjudication Method for the Test Set
Not Applicable.
No adjudication method was used as the testing was nonclinical (bench testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done.
This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the impact of the AI. As this submission describes a physical medical device (guiding sheath system) and relies on nonclinical testing for 510(k) clearance, an MRMC study is not relevant or required.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done.
This type of study applies to AI/ML algorithms. The device in question is a physical medical device.
7. Type of Ground Truth Used
Not Applicable.
For nonclinical testing of a physical device, the "ground truth" is typically established by engineering specifications, material properties, and established test methods for device performance (e.g., burst pressure, stiffness, lubricity). It's not a clinical "truth" derived from pathology or outcomes data. The "truth" here is the performance of the predicate devices.
8. Sample Size for the Training Set
Not Applicable.
There is no "training set" as this is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
As there is no training set, there's no ground truth established for it.
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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.
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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.
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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
§ 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).