(56 days)
EZ Glide Aortic Perfusion Cannulae:
Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures.
Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
OptiSite Arterial Perfusion Cannulae:
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for
EZ Glide Aortic Perfusion Cannulae: The EZ Glide Aortic Perfusion Cannulae device deliver oxygenated blood from the cardiopulmonary bypass pump directly into the aorta. The cannulae terminate in a 3/8" (9.5mm) barbed tubing connector and a vent plug. Cannulae are wire-reinforced and include a dispersion tip in either a straight or curved configuration. EZ Glide Aortic Cannulae are available in sizes 21 French (Fr) and 24 French (Fr). The EZ Glide Aortic Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Note that there are no accessories packaged with the EZ Glide Aortic Perfusion Cannulae.
OptiSite Arterial Perfusion Cannulae: The OptiSite Arterial Perfusion Cannulae device is indicated for arterial perfusion in the extracorporeal circuit for less than 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch. The Edwards Lifesciences Arterial Perfusion Cannulae have smoothly rounded tips to facilitate atraumatic insertion. The proximal ends of the cannula are designed to accept 3/8" (9.5mm) tubing. Introducers are provided with some arterial cannula codes. Introducers are designed for use with 0.038" (0.96 mm) quidewires. Each introducer is provided with a removable vented luer cap. Leave the vented cap in place to allow venting of the cannula for use without a guidewire. Remove the cap to allow cannula use with a guidewire. The OptiSite Arterial Perfusion Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
EndoReturn Arterial Cannulae: The EndoReturn Arterial Cannulae devices are flexible plastic tubes intended to provide a means of perfusing arterial blood returning to the patient from the oxygenator through the extracorporeal circuit during cardiopulmonary bypass procedures. The cannulae are placed either through the femoral artery or directly into the aorta to return oxygenated blood from the CPB circuit and to hemostatically introduce Edwards intra-aortic occlusion catheters. Each device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended and labeled for single use only. The Endo Return Arterial Cannulae with the hemostasis valve are made with a wirereinforced cannula shaft which provides kink resistance and flexibility, and include the following kit components: Introducer, Guidewire (0.038" (0.097mm) x 100 cm) J-tip, Connector hub. The tapered atraumatic tip aids in insertion and advancement into the femoral artery. The non-wire-reinforced clamp site(s), a 3/8 in. barbed connector, and a hemostasis valve allows passage of catheters such as the Edwards IntraClude intra-aortic occlusion device. The introducers accept a 0.038 in. (0.97 mm) quidewire and are marked to simplify assembly. A connector hub secures and immobilizes the introducer within the cannula for easier, oneperson insertion of the cannula/introducer assembly. A lubricious coating, (SlipCoat™) is applied to the surface of the EndoReturn arterial cannula shafts. This coating is intended to provide a lubricious surface effective for the duration of the intended use of the cannula, thereby easing the insertion of the cannula into the artery, and the aortic occlusion catheters through the cannula. The EndoReturn Arterial Cannulae are packaged sterile and nonpyrogenic in a sealed, peel-type pouch.
The provided document is a 510(k) summary for several arterial perfusion cannulae devices (EZ Glide, OptiSite, and EndoReturn). It states that no non-clinical and/or clinical tests were carried out in support of this special 510(k) premarket notification.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because such studies were not conducted for this specific submission as stated in the document.
The document indicates that the devices are considered substantially equivalent to previously cleared predicate devices, and the changes are primarily related to label updates (new warning statements) and the removal of references to a specific coating (Duraflo) that is no longer manufactured.
Given this, the following points would be the answer based on the provided text:
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A table of acceptance criteria and the reported device performance: Not provided in the document. No new performance data was generated or reported for this 510(k) submission as no tests were carried out.
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Sample size used for the test set and the data provenance: Not applicable. No test set was used as no new studies were conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set was used and no new ground truth was established.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
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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 not an AI-powered diagnostic tool, and no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No new ground truth was established for this submission.
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The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is not an AI/ML 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).