(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.
§ 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).