(257 days)
The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
The Heater-Cooler System 3T is an independent (i.e., independent of the water supply) 3circuit heating/cooling base unit that includes three water circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance. The following optional components and accessories are also available for the Heater-Cooler System 3T: 1. Heating-cooling blankets; 2. Water circuit tubing; and 3. Various cables. The Heater-Cooler System 3T includes a disposable aerosol collection set that consists of a canister connected to the Heater-Cooler System 3T and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum. The changes proposed in the current 510(k) include the offering of a Deep Cleaning service by LivaNova to customers. The safety of the Heater-Cooler System 3T is ensured by the regular disinfection and cleaning, monitoring of the bacteria levels and by the aerosol collection set, as described in the Operating Manual that was cleared in K191402. The Deep Cleaning service is intended to address cases where heavily contaminated devices cannot meet the acceptable level described in section 6.5.2 of the Operating Instructions. In this situation, to allow the device to return to clinical use, the customer may choose to return the device for the Deep Cleaning service. The Deep Cleaning service is intended to reduce bioburden levels within the water circuit, thereby reducing the risk of NTM Aerosolization in the clinical setting. There are no changes to design or intended use.
This document describes the FDA's clearance of the LivaNova Heater-Cooler System 3T with a "Deep Cleaning" service. It does not contain information about an AI/ML device or its performance study. Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details.
The document primarily focuses on:
- The regulatory clearance of a medical device (Heater-Cooler System 3T).
- The addition of a "Deep Cleaning" service to this existing device.
- The substantial equivalence determination based on non-clinical testing (process validation of the deep cleaning service).
There is no mention of "AI", "ML", "algorithms", "human readers", "ground truth", "training set", or "test set" in the context of an AI/ML assessment. The performance data section explicitly states that "Clinical testing was not required to demonstrate the substantial equivalence" and "Animal testing was not required". The only "performance data" mentioned is process validation for the deep cleaning service.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text.
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).