(150 days)
The Vado® Bi-Directional Steerable Sheath is introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the heart through the interatrial septum.
The Vado® Bi-Directional Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible, stable catheter positioning in the cardiac anatomy. A hemostasis valve in the handle minimizes blood loss during catheter introduction and/or exchange. A side port with 3-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A deflection knob on the handle deflects the tip of the sheath clockwise ≥ 180° and counterclockwise ≥ 90°. Distal tip vent holes facilitate aspiration and a radiopaque marker permits visualization of the sheath tip under fluoroscopy.
The provided document describes the FDA 510(k) premarket notification for the Kalila Medical Vado® Bi-Directional Steerable Sheath (K162427). This notification is for a medical device (catheter introducer), not an AI/ML powered device, therefore much of the requested information (e.g., AI/ML specific sections like sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or available in this document.
However, I can provide information based on the device's technical and performance characteristics as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The document details various performance tests conducted to demonstrate the device's functional and safety characteristics, in comparison to predicate devices, rather than explicit acceptance criteria with numerical performance targets that are then met. The general acceptance criterion for all tests is that the device "met its functional and performance characteristics in accordance with applicable industry standards and is equivalent to the predicate devices" and that differences "do not adversely affect safety and effectiveness."
| Test Category | Specific Performance Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | 1. Cytotoxicity (MEM Elution) | Met requirements |
| 2. Sensitization (Guinea Pig Maximization) | Met requirements | |
| 3. Irritation (Intracutaneous Reactivity) | Met requirements | |
| 4. Acute Systemic Toxicity | Met requirements | |
| 5. Pyrogen (Materials Mediated in Rabbits) | Met requirements | |
| 6. Hemolysis (Direct Contact) | Met requirements | |
| 7. Hemolysis (Indirect Contact) | Met requirements | |
| 8. Complement Activation | Met requirements | |
| 9. Thrombosis | Met requirements | |
| Bench Performance | 1. Radiopacity | Met requirements for visualization under fluoroscopy |
| 2. Corrosion Resistance | Met requirements | |
| 3. Sheath and Dilator Visual Inspection | Met requirements | |
| 4. Sheath Dimension Inspection | Met requirements (specific dimensions not provided, but implicitly comparable to predicate) | |
| 5. Dilator Dimension Inspection | Met requirements (specific dimensions not provided, but implicitly comparable to predicate) | |
| 6. Sheath Deflection | Met requirements (Bi-Directional, 180° clockwise / 90° counterclockwise, similar to predicate K061363, an improvement over K140420) | |
| 7. Sheath Curvature Dimensions | Met requirements (specific dimensions not provided, but implicitly comparable to predicate for proper catheter positioning) | |
| 8. Insertion and Deflection Cycling | Met requirements for durability and function over repeated use | |
| 9. Aspiration Air Ingress | Met requirements for minimizing air ingress | |
| 10. Valve Leakage Resistance | Met requirements for minimizing blood loss and maintaining seal during catheter introduction/exchange | |
| 11. Sheath Leakage Resistance | Met requirements for maintaining sheath integrity | |
| 12. Device Preparation | Met requirements (implies ease of preparation for use) | |
| 13. Valve Integrity and Functionality | Met requirements (implies effective hemostasis and function of 3-way stopcock) | |
| 14. Shaft Torque Strength | Met requirements for effective steering and tip deflection response | |
| 15. Kink Resistance | Met requirements for maintaining patency and facilitating catheter advancement | |
| 16. Marker Band Location | Met requirements for accurate visualization and positioning under fluoroscopy | |
| 17. Tensile Strength | Met requirements for material integrity and resistance to breakage during use | |
| Packaging Integrity | 1. Pouch Seal Strength | Met requirements for maintaining sterility and product integrity during storage and transport |
| 2. Gross Leak Detection | Met requirements for maintaining sterility and product integrity during storage and transport | |
| Shelf Life | Various tests (details not explicitly itemized) | Met requirements (data demonstrated maintenance of functional and performance characteristics over specified shelf life) |
| Sterilization | Various tests (details not explicitly itemized) | Met requirements for effective sterilization (EO gas) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. It states "representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing." This suggests a sufficient number of samples were tested to gain confidence in the results according to relevant standards. The data provenance is internal to Kalila Medical, Inc., as these are tests conducted by the manufacturer, or by laboratories contracted by the manufacturer, to support the 510(k) submission. These tests are inherently prospective in nature as they evaluate newly manufactured devices. There is no mention of country of origin of the data beyond the manufacturer's location in Campbell, California, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Its performance is evaluated through engineering and biological testing methods.
4. Adjudication method for the test set
Not applicable for a physical device. Performance is evaluated against objective engineering specifications and biological standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
For this medical device, the "ground truth" is established by:
- Engineering specifications and industry standards: Performance characteristics (e.g., dimensions, deflection angles, tensile strength, leak resistance, radiopacity) are measured against predefined engineering tolerances and relevant international/consensus standards for catheter introducers.
- Biocompatibility standards: Tests (e.g., cytotoxicity, sensitization, irritation) are conducted according to ISO 10993 series standards, where the "ground truth" is compliance with established biological safety thresholds.
- Sterilization efficacy standards: Validation against established methods for ethylene oxide (EO) gas sterilization.
- Packaging integrity standards: Evaluation against packaging standards to ensure sterility and physical protection.
8. The sample size for the training set
Not applicable. This is not an AI-powered device and therefore does not have a training set in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI-powered device, there is no training set or associated ground truth for a training set.
§ 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).