(26 days)
The BioCardia 8.5 F Avance™ Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The BioCardia 8.5 F Avance™ Steerable Introducer (Avance) is a sterile, single use, bidirectional introducer. When the handle is fully actuated, the distal tip deflects to a nominal 180° arc in either of two directions with a nominal curve distance as indicated by the product label. The introducer tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Avance handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.
Avance includes a dilator with a pre-curved, tapered tip which extends up to 2.5 cm beyond Avance to facilitate transseptal placement. The dilator hub snaps into the Avance hemostasis valve and can accommodate a guidewire diameter of up to .038".
This document is a 510(k) premarket notification for a medical device called the BioCardia 8.5 F Avance™ Steerable Introducer. It aims to prove the device's substantial equivalence to a predicate device (St. Jude Agilis™ Steerable Introducer, K042623). However, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device with acceptance criteria for classification performance (e.g., accuracy, sensitivity, specificity).
Instead, it pertains to an interventional medical device (a catheter introducer) and its performance is evaluated against engineering and biological criteria, not diagnostic accuracy. Therefore, most of the requested information regarding AI/ML device performance (like MRMC study, standalone performance, training/test set ground truth, number of experts, etc.) is not applicable to this document.
I will attempt to extract what is relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical, interventional medical device based on the provided text.
Here's an interpretation based on the information provided, recognizing that the context is a physical device and not an AI/ML algorithm:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted. The "acceptance criteria" are implied by the nature of these tests, which confirm the device meets "all product performance requirements." The "reported device performance" is a statement that these tests were "conducted to confirm that the design of the Avance meets all product performance requirements." Specific numerical results for each test are not provided in this summary; rather, it states that the device successfully met these requirements.
| Test Category | Specific Tests (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| In-Vitro Bench Top Testing | Distal Tip: Right/left deflection angle, curve distance, residual curvature in neutral position, angular deviation from plane. | |
| Catheter and Dilator Dimensional Verification: Inner diameter, outer diameter, effective length, dilator extension length. | ||
| Catheter Functionality: Freedom from leakage, tension and torsional forces, bend kink resistance, corrosion, column support. | ||
| Handle Functionality: Actuation force, brake mechanism resisting actuation, brake engagement/disengagement, gradual brake, handle separation force, pull-wire tensile force. | ||
| Hemostasis Valve: Freedom from leakage, dilator detachment force, hemostasis valve swivel functionality. | ||
| Fatigue Resistance: Actuation fatigue resistance, torque fatigue resistance. | ||
| Package Integrity: Atmospheric Conditioning ASTM D4332-14 and Shipping Simulation ASTM D7386-16 Test Schedule 3 – Manual Handling, Random Vibration, Low Pressure Hazard, Tip Over, Rotational Edge Drop, Bridge Impact, Concentrated Impact, Gross Leak (Bubble Test) ASTM F2096-11. | "The following tests were conducted to confirm that the design of the Avance meets all product performance requirements." (Implies successful completion within acceptable ranges) | |
| In-Vivo Simulated Use Testing (Single Swine Model) | Distal Tip Attachment | |
| Radiopaque Marker visible under fluoroscopy | ||
| Catheter Navigation to all intended anatomy | ||
| Deflection Mechanism | ||
| Brake Mechanism | ||
| Handle Ergonomics | ||
| Device Compatibility to guide therapeutic catheters | "The following tests were conducted to confirm that the design of the Avance meets all product performance requirements." (Implies successful operation during simulated use) | |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thromboresistance, Complement Activation (meeting ISO 10993-1 and FDA guidance requirements). | "The materials used in the BioCardia Avance Steerable Introducer meet the requirements of ISO 10993-1 and FDA guidance..." and "The following biocompatibility tests were completed." (Implies successful completion and compliance) |
| Sterilization | Ethylene oxide sterilization validation (per TIR 28:2009). | "The Avance Steerable Introducer was adopted into an existing ethylene oxide sterilization validation for BioCardia products per TIR 28:2009." (Implies successful validation of the sterilization process for the device) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For in-vitro bench testing, no specific numerical sample sizes are given for each test (e.g., number of devices tested for deflection, fatigue, etc.).
- For in-vivo simulated use testing, it explicitly states: "Single Swine Model". This indicates a sample size of 1 animal.
- Data Provenance: The tests are described as "In-Vitro Bench Top Testing" and "In-Vivo Simulated Use Testing (Single Swine Model)". Since this is a premarket notification, these are prospective tests conducted specifically for this submission. The origin (country/location of testing) is not specified, but it would have been performed by or on behalf of the manufacturer, BioCardia, Inc., San Carlos, CA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to this type of device and study. The "ground truth" for a physical device's performance is established by engineering measurements, physical properties, and physiological outcomes in a simulated use environment, not by expert interpretation of images or data.
4. Adjudication method for the test set
This concept is not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic studies. For a physical device, performance is measured against quantifiable engineering standards or observed physical functionality.
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
This concept is not applicable. An MRMC study pertains to evaluating diagnostic performance, often with AI assistance for human readers. This document is about the physical performance and safety of an interventional introducer device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. This refers to the standalone performance of an AI algorithm. The device in question is a physical catheter introducer.
7. The type of ground truth used
The "ground truth" (or basis for evaluation) for this device includes:
- Engineering specifications and measurements (e.g., deflection angles, dimensions, forces, resistance to leakage, fatigue limits).
- Compliance with recognized standards (e.g., ASTM, ISO 10993-1, TIR 28:2009).
- Direct observation of functionality in a simulated physiological environment (e.g., in the swine model, observing navigation, deflection, brake mechanism, compatibility).
8. The sample size for the training set
This concept is not applicable. There is no "training set" in the context of validating a physical medical device. The device design is developed through engineering processes, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established
This concept is not applicable. See point 8.
§ 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).