(102 days)
The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The Quantum Smart Occluder is a clamping system for the occlusion of both arterial and venous blood lines. The Quantum Smart Occluder is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The operation of the Quantum Smart Occluder is managed from the Quantum Workstation (K163657).
The Quantum Smart Occluder has the availability for 5 sensor attachments:
- . 2 Flow Sensors
- 2 Pressure Sensors
- 1 Level Sensor .
These sensors are identical with the use of the same sensor PCB boards previously cleared with the Quantum Diagnostic Module (K173591) and Quantum Ventilation Module (K181942). These sensor connections can be used in conjunction with the sensor connections used on the Quantum Diagnostic Module (K173591) or Quantum Ventilation Module (K181942) to provide additional readings. Or used solely on the Quantum Smart Occluder to reduce the amount of cabling that is attached to the Quantum Pump Console (K173834).
This document is a 510(k) summary for the Quantum Smart Occluder. It describes a medical device, its intended use, and compares it to predicate devices to establish substantial equivalence. The document does not contain information related to specific acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/ML device.
The Quantum Smart Occluder is a mechanical device (an electronic tube clamp) that is an accessory to a cardiopulmonary bypass system. The performance data mentioned relates to non-clinical testing of electrical safety, EMC, electrosurgery interference, hardware, and software verification/validation. This is standard for a non-AI/ML medical device.
Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven devices where performance is measured against clinical ground truth and involves statistical analysis of algorithm output. This document describes a traditional medical device submission.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).