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K Number
K162215
Device Name
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
Manufacturer
SORIN GROUP ITALIA S.R.L
Date Cleared
2017-06-16

(312 days)

Product Code
DWF
Regulation Number
870.4210
Type
Traditional
Panel
CV
Reference & Predicate Devices
K870826,K870825
Predicate For
K180979
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended to be used as perfusion cannulae to return arterial blood from the extracorportal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.

Device Description

The devices are intended to be used to cannulate the arterial vessels during cardiopulmonary bypass surgery. They are sterile, single use devices.

These cannulae are comprised of three main components:

  1. A barbed proximal end connector to attach to cardiopulmonary bypass tubing. A female luer lock connector is also optionally available to provide venting and can be oriented up or down.
  2. Single-lumen polymer tubing with an optional wire reinforcement to prevent kinking.
  3. A straight or bent tip that is inserted into the patient. The Aortic Arch Cannulae has a monodimensional tip design whereas the Optiflow Aortic Arch Cannulae has a three dimensional basket tip design.
AI/ML Overview

The provided text is a 510(k) summary for a medical device (Aortic Arch Cannulae), and it does not contain information about an AI/algorithm-based device or its evaluation. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance for an AI/algorithm.

The document discusses:

  • The device: Aortic Arch Cannulae and Optiflow Aortic Arch Cannulae, which are physical medical devices (perfusion cannulae).
  • Modifications: Changes in plasticizer, tip design, and outer diameter sizes.
  • Testing: Non-clinical in vitro tests (blood trauma, tensile force, structural integrity, kink resistance, pressure-flow, shipping/packaging) conducted to demonstrate substantial equivalence to predicate physical devices.

Therefore, I cannot fulfill your request for information related to AI/algorithm performance and evaluation from this document.

§ 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).