(258 days)
The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.
The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
The Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T consists of standard and optional components. The standard components comprise the heater-cooler base unit, water connectors, CAN-connecting cable for the S3 System, potential equalization cable, and Operating Instructions. Patient blankets used with the System are already legally marketed in the United States.
The provided text describes a 510(k) premarket notification for the Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive independent clinical study data to prove the device meets specific acceptance criteria based on performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in submissions requiring clinical performance data.
Specifically, the document states:
- "Testing submitted in this premarket notification demonstrates that the Stockert Heater-Cooler System 3T complies with specifications, meets user requirements, and the differences between the proposed device and cited predicate devices do not raise new issues of safety or effectiveness."
This indicates that internal testing was performed to ensure the device met its design specifications and user requirements, which is a standard part of device development. However, the details of these "specifications" and "user requirements" are not provided, nor is information on the methodology, sample size, or outcomes of such testing in the context of comparative performance against specific, quantifiable acceptance criteria that would typically be described in a clinical study report.
In summary, the document addresses substantial equivalence based on technological characteristics and intended use, and mentions compliance with specifications and user requirements, but it does not detail a study proving the device meets acceptance criteria in the manner of performance, diagnostic accuracy, or clinical outcome as would be required for a different kind of regulatory submission or a standalone effectiveness study.
§ 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).