(345 days)
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The FloPump 32mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.
The provided text describes a medical device, the FloPump 32mL Centrifugal Pump, and its 510(k) summary for FDA clearance. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/algorithm-based medical device.
The information provided is for a physical medical device and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, I cannot extract the requested information regarding AI/algorithm performance.
Here's an analysis of why the requested information isn't present:
- No AI/Algorithm: The FloPump 32mL Centrifugal Pump is a physical device that functions to pump blood through an extracorporeal circuit. It does not employ any AI or algorithms for decision-making or analysis.
- No Diagnostic or Predictive Outputs: The device's function is mechanical (pumping blood), not diagnostic or predictive in nature. Therefore, there are no performance metrics like sensitivity, specificity, accuracy, or AUC that would be typically associated with AI/algorithm acceptance criteria.
- Focus on Substantial Equivalence: The 510(k) summary emphasizes "substantial equivalence" to predicate devices based on design, materials, specifications, and non-clinical testing (flow curves, heat generation, hemolysis, etc.).
- No Clinical Study for Performance: The document explicitly states, "Clinical testing was not required" for this device clearance. This further confirms the absence of studies designed to evaluate AI performance or human reader improvements.
Therefore, since the input document describes a physical medical device and not an AI-powered one, I cannot fulfill the request to provide acceptance criteria and study details related to AI/algorithm performance.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.