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510(k) Data Aggregation
(42 days)
The Vado Steerable Sheath is indicated for introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.
The Kalila Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the tip 140°. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Kalila Medical Vado Steerable Sheath:
Acceptance Criteria and Device Performance for Kalila Medical Vado Steerable Sheath (K140420)
Based on the provided 510(k) summary, the device's acceptance criteria are derived from its functional and performance requirements, as demonstrated through a series of tests to establish substantial equivalence to the predicate device. The study primarily relies on non-clinical (bench and biocompatibility) testing, as no clinical testing was performed for this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes categories of tests performed and states that the device "met its functional and performance characteristics in accordance with applicable industry standards and compares favorably to the predicate device." However, specific numerical acceptance criteria (e.g., minimum force, maximum leakage rate) and precise quantitative results are not explicitly detailed in the summary. The "reported device performance" is a general statement of compliance rather than specific measurements against a defined threshold.
| Category of Test | Specific Tests Performed | Acceptance Criteria (Conceptual) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | 1. Cytotoxicity2. Acute Systemic Toxicity3. Hemocompatibility (Direct and Indirect)4. Thrombosis5. Sensitization6. Irritation / Intracutaneous7. Complement Activation8. Pyrogenicity (rabbit pyrogen and bacterial endotoxin (LAL)) | No adverse biological reactions; compliance with relevant ISO standards for medical devices in contact with blood. | Met all biocompatibility requirements. |
| Bench Tests | 1. Steerable Sheath and Dilator Visual Inspection2. Steerable Sheath Dimension Inspection3. Steerable Sheath Marker Band Location Measurement4. Dilator Dimensional Inspection5. Valve Leakage Resistance at 40kPa6. Leakage Resistance at 300kPa7. Device Preparation8. Dilator Snap Disengagement Force9. Dilator Insertion and Retraction Force10. Shaft Deflection11. Curvature Dimensions12. Aspiration13. Catheter Insertion Cycling and Flexion Cycling, with Flush14. Bend Radius to Kink15. Corrosion Resistance16. Junction Strengths17. Torque and Turns to Failure18. Steerable Sheath Radiopacity Study | Device conforms to design specifications; functions as intended; withstands specified pressures; forces within acceptable ranges; maintains integrity under cycling/stress; visible under fluoroscopy. | Met all functional and performance requirements; comparable to predicate device. |
| Packaging Integrity | 1. Pouch Seal Strength2. Gross Leak Detection | Packaging maintains sterility and integrity of the device until use. | Met all packaging integrity requirements. |
| Shelf Life | (Implicitly part of overall testing) | Device maintains performance and integrity over its stated shelf life. | (No specific details, but implied compliance) |
| Sterilization | (Implicitly part of overall testing) | Device is adequately sterilized and maintains sterility. | (No specific details, but implied compliance) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "representative sterilized samples of the device underwent sterilization, biocompatibility, bench testing, packaging integrity, and shelf life testing." However, no specific sample sizes for any of these tests are provided or mentioned in the summary.
Data Provenance: The data is entirely non-clinical (bench and laboratory-based). There is no information regarding the country of origin of the data, as it pertains to internal testing conducted by Kalila Medical to support market clearance. The data is prospective in the sense that the tests were designed and executed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the study did not involve human interpretation or a "test set" in the context of image analysis or diagnostic performance. The "ground truth" here is objective measurement against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
Not applicable. As the study comprised bench and biocompatibility testing, there was no need for an adjudication method as would be used in expert consensus for clinical data. Performance was determined by direct measurement and observation against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was NOT done. The submission explicitly states: "Clinical testing is not provided in this submission." Therefore, there is no information on how human readers would improve with or without AI assistance, as AI is not a component of this device, and no human-reader study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. The Vado Steerable Sheath is a physical medical device (a catheter introducer), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Engineering specifications and design requirements: For dimensional accuracy, deflection, forces, etc.
- Industry standards (e.g., ISO for biocompatibility): For biological safety and material compatibility.
- Predicate device characteristics: For establishing substantial equivalence in performance and functionality.
Essentially, the ground truth is objective, measurable performance against predefined and accepted engineering and safety standards.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The ground truth for the device's development would have been established through a combination of engineering design, materials science, and functional requirements based on the intended use and predicate device.
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