(147 days)
The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.
The ESTECH EasyFlow Cannula with Guidewire is a sterile, single-use device. The single-lumen wire reinforced polymer tube incorporates multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula and an optional stylet which inserts into the obturator to provide additional column strength for insertion. The product also comes with a 0.035" diameter guidewire, up to 3 vessel dilators, an 18 gauge. needle, and scalpel for introduction
The provided text describes the ESTECH EasyFlow Cannula with Guidewire and its premarket notification for substantial equivalence, but it does not contain information related to acceptance criteria, specific device performance numbers, or a study design with sample sizes, ground truth establishment, or expert involvement.
The document states:
- "Bench testing has demonstrated that the device meets the proposed product specifications."
- "Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993"
However, it does not provide details on:
- A table of acceptance criteria and the reported device performance: The document mentions "proposed product specifications" and "compliance with ISO 10993" but does not detail what these specifications or the outcome of the compliance testing were.
- Sample size used for the test set and the data provenance: No sample sizes or data provenance are mentioned for any testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth creation process is described.
- Adjudication method for the test set: Not applicable as no ground truth creation process is described.
- 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 device is a medical cannula, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical cannula, not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for a medical device like this would typically involve engineering specifications, material properties, and functional performance metrics, not diagnostic "ground truth."
- The sample size for the training set: Not applicable as there is no mention of a "training set" for this type of device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on establishing substantial equivalence to predicate devices based on design, materials, manufacturing, packaging, and intended use, along with general statements about bench testing and biocompatibility. It does not present a detailed study with specific acceptance criteria and performance data in the format requested.
§ 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).