(57 days)
The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (
The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is a disposable 31 cm long flexible polyurethane tube with three (3) lumens with an inflatable polyurethane balloon at the distal end of the cannula. The inflatable balloon has elastomeric properties designed to provide aortic occlusion in a range of aorta sizes with internal diameters from 22 mm to 34 mm. The outside diameter of the cannula is 21 Fr. (7 mm). The cannula has a central lumen for the delivery of arterial blood through multiple distal outlets at flow rates of 1.0 to 5.0L/min, a lumen that communicates with the aorta in the area of the aortic root for delivery of cardioplegia solution and left ventricle venting, and a small lumen for control of the distal balloon. Radio-opaque arch segment of cannula and insertion depth marks aid in positioning the device. The Cannula are provided sterile in individual packages for single use.
The provided 510(k) summary for the ESTECH Remote Access Perfusion Cannula Left Axillary 21 French describes non-clinical performance data and a comparison to predicate devices to establish substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets specific performance thresholds in a clinical or analytical efficacy study with human or expert-based ground truth.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative, pass/fail format typical for clinical or standalone efficacy studies. Instead, it describes various performance tests conducted and generally states that the device "meets performance and safety specifications" or that results were "within specification." The comparison with predicate devices serves as the primary means of demonstrating equivalence rather than meeting independent quantitative acceptance criteria.
| Feature Tested/Evaluated | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Occlusion Balloon Restricted Burst Test | Demonstrate inflation characteristics up to burst in a restricted environment. | Pressure data as a function of inflation volume were collected. (Implied: Data were acceptable and did not indicate premature or uncontrolled burst within intended use pressure range.) |
| Occlusion Balloon Volume/Pressure/Diameter | Characterize inflation characteristics up to burst. | Pressure and diameter data as a function of inflation volume were collected. (Implied: Data were acceptable and demonstrated consistent, predictable inflation across the specified ranges, including aortic occlusion in 22mm to 34mm aorta sizes). |
| Occlusion Balloon Repeat Inflation Test | Demonstrate balloon can be inflated repeatedly. | Performed to demonstrate the balloon can be inflated repeatedly if necessary. (Implied: Test confirmed successful repeated inflation without failure or degradation.) |
| Occlusion Balloon Sustained Inflation Test | Withstand at least 6 hours of inflation. | Performed to demonstrate that the balloon can withstand at least 6 hours of inflation. (Implied: Test confirmed successful sustained inflation for at least 6 hours.) |
| Hemolysis Testing | Evaluate cellular damage produced by the system compared to predicate. | In-vitro test used to evaluate the relative effect of the device in the circuit as compared to the predicate devices. (Implied: Hemolysis levels were comparable to or better than predicate devices, or within acceptable limits). Note: "all cardiac bypass procedures produce some degree of hemolysis which may be at least partially compensated for in human and animal testing" suggests a comparative standard was used. |
| Flow Testing - Arterial Perfusion | Pressure drop across cannula for 0-5 L/min flow rates to be within specification. | Pressure drop across the cannula was measured for a range of arterial perfusion flow rates from 0-5 L/min and was within specification. |
| Flow Testing - Cardioplegia Delivery | Minimum cardioplegia delivery flow rates for a given pressure to be within specification. | Minimum cardioplegia delivery flow rates for a given pressure were also within specification. |
| Biocompatibility Testing | Materials to be biocompatible. | Completed for the currently marketed predicate device, and all materials used in the current device are identical. (Implied: The device shares the same biocompatibility profile as the predicate.) |
| Animal Testing | Suitable for intended use (insertion via axillary artery, placement, performance). | Performed to demonstrate that the device was suitable for its intended use in terms of insertion via axillary artery and placement. Performance of the device, including the occlusion balloon and perfusion/cardioplegia flow, are known to be safe and effective for its intended use. (Implied: Successful insertion, placement, and functional performance were observed in animal models.) |
The study that proves the device meets the (implied) acceptance criteria:
The "study" consists of a series of non-clinical laboratory and animal tests, designed to demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices. These are described in Section G: "Summary of Non-Clinical Performance Data" and Section III: "Device Specifications" (though Section III is not provided in the input).
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test (e.g., number of balloons tested, number of flow tests performed, number of animals used). It reports results generally.
- Data Provenance: All data referenced are from "laboratory testing" and "animal testing." This indicates in-vitro (bench testing) and in-vivo (animal) studies. No human data or external (country of origin) data provenance is explicitly stated, which is typical for 510(k) submissions that rely on predicate device equivalence. It explicitly states "The laboratory testing adhered to Good Laboratory Practices guidelines."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are primarily engineering and simulated physiological tests, not requiring clinical expert ground truth in the way an AI diagnostic device would. For animal testing, veterinary experts would likely be involved in assessing outcomes, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set:
This information is not applicable and therefore not provided. The testing described is objective, physical/physiological performance measurement, not subjective expert assessment requiring adjudication.
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 information is not applicable and therefore not provided. The device is a medical instrument (cannula) and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used:
- Bench Test Performance: For tests like burst pressure, flow rates, and sustained inflation, the "ground truth" is established by the specified engineering and material performance standards relevant to the device's function and safety. These would refer to predefined acceptable ranges or limits established by engineering design, regulatory standards, or comparison to predicate devices.
- Biocompatibility: Established by adherence to material standards and previous testing on identical materials used in predicate devices.
- Animal Testing: The "ground truth" is the observed physiological and mechanical performance in an animal model, validated against expected outcomes for successful device operation (e.g., proper insertion, placement, perfusion, and balloon occlusion without adverse events).
8. The sample size for the training set:
This information is not applicable and therefore not provided. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The "training" in the context of this device refers to "On-site customized training" for users, which is not a data set.
9. How the ground truth for the training set was established:
This information is not applicable and therefore not provided. As mentioned above, there is no "training set" in the context of an AI algorithm.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).