(113 days)
The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum.
The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.
The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Usable Length | Not explicitly stated | Pass |
| Lumen Inner Diameter | Not explicitly stated | Pass |
| Distal Tip Inner Diameter | Not explicitly stated | Pass |
| Overall Length | Not explicitly stated | Pass |
| Cap to hub retention | Not explicitly stated | Pass |
| Sheath OD | Not explicitly stated | Pass |
| Sheath OD - Flex Section | Not explicitly stated | Pass |
| PU adhesion | Not explicitly stated | Pass |
| Marker Band Location | Not explicitly stated | Pass |
| Vent Hole Location | Not explicitly stated | Pass |
| Vent Hole Diameter | Not explicitly stated | Pass |
| Vent Hole Orientation | Not explicitly stated | Pass |
| Sheath leak | Not explicitly stated | Pass |
| Vacuum decay | Not explicitly stated | Pass |
| In-Plane Deflection | Not explicitly stated | Pass |
| Handle deflection direction | Not explicitly stated | Pass |
| Shaft torque | Not explicitly stated | Pass |
| Tip drag force | Not explicitly stated | Small: Pass, Large: Pass |
| Side load | Not explicitly stated | Small: Pass, Large: Pass |
| Pigtail to Connector | Not explicitly stated | Pass |
| Pigtail to Handle | Not explicitly stated | Pass |
| Hub to shaft | Not explicitly stated | Pass |
| Stopcock to handle | Not explicitly stated | Pass |
| Stopcock to tube | Not explicitly stated | Pass |
| Shaft distal segments | Not explicitly stated | Pass |
| Shaft proximal segments | Not explicitly stated | Pass |
| Hemostasis valve and sheath must not leak | No leakage | Pass |
| Valve insertion force | Not explicitly stated | Pass |
| Valve friction | Not explicitly stated | Pass |
| Curve Span | Not explicitly stated | Small: Pass, Large: Pass |
| Electrode Location | Not explicitly stated | Small: Pass, Large: Pass |
| Electrical Resistance | Not explicitly stated | Small: Pass, Large: Pass |
| Current Leakage | Not explicitly stated | Small: Pass, Large: Pass |
| Connector mating, flex fatigue, and pigtail torque testing | Not explicitly stated | Pass |
| Electrical Isolation | Not explicitly stated | Small: Pass, Large: Pass |
| External lead cable length | Not explicitly stated | Pass |
| Corrosion | Not explicitly stated | Pass |
| Continuous pouch seal | Not explicitly stated | Pass |
| Pouch particulate | Not explicitly stated | Pass |
| Label adhesion and legibility | Not explicitly stated | Pass |
| Dilator OD | Not explicitly stated | Pass |
| Dilator to cap retention force | Not explicitly stated | Pass |
| Dilator to dilator hub tensile | Not explicitly stated | Pass |
| Dilator hub has standard luer | Not explicitly stated | Pass |
| Dilator tip ID | Not explicitly stated | Pass |
| Dilator overall length (straightened) | Not explicitly stated | Pass |
| Pre-Clinical Study Endpoints: | ||
| No damage or product integrity issues | No damage/integrity issues expected | Met (No damage or product integrity issues related to CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath) |
| No leakage through hemostatic valve | No leakage expected | Met (No leakage through hemostatic valve) |
| No thrombus observed | No thrombus expected | Met (No thrombus observed inside or at the tip of the sheath) |
| No clinically significant tissue injury | No significant tissue injury expected | Met (No clinically significant tissue injury related to the use of the Test article) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each bench test. For the preclinical study:
- Sample Size: Not explicitly stated as a number, but refers to "one Test or one Control sheath in the animal." This suggests a comparative animal study.
- Data Provenance: Pre-clinical testing performed "under simulated clinical conditions" and "in the animal." This indicates an animal study, which is often considered prospective in nature. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide information on the number of experts or their qualifications for establishing ground truth for either the bench tests or the pre-clinical study. The "Pass" results for bench tests imply internal testing against predetermined specifications, while the pre-clinical study endpoints would typically be assessed by veterinary or medical professionals, but this is not detailed here.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method. For bench tests, it's likely a pass/fail against internal criteria. For the pre-clinical study, the endpoints imply an assessment by the study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not conducted or described. The device is a guiding sheath, not an imaging analysis algorithm that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a physical medical instrument (a guiding sheath), not an algorithm or AI system. While it has "visualization capabilities" with a compatible navigation system (CARTO® 3 EP Navigation System), the performance data presented focuses on the physical sheath itself rather than the performance of an independent algorithm for interpretation.
7. The Type of Ground Truth Used
- For Bench Tests: The ground truth is implied to be predefined engineering specifications and performance criteria. Each test has a "Pass" result, indicating it met these criteria.
- For Pre-Clinical Study: The ground truth for safety and performance refers to direct observation of the animal model for damage, leakage, thrombus, and tissue injury during and after the procedure. This could be considered outcomes data or direct observational data from a controlled biological setting.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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).