(256 days)
The Spectrum Medical Quantum Heater-Cooler is intended to provide temperature-controlled fluid to compatible Quantum PureFlow heat exchanger devices (cardiopulmonary bypass heat exchangers and cardioplegia heat exchangers) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.
The Quantum Heater-Cooler is only intended to be used by trained Clinicians in a clinical environment.
The Quantum Heater-Cooler consists of the following components:
- . Quantum Heater-Cooler Unit (including connection hoses and heat transfer fluid)
- . Quantum Pure Flow Heat Exchangers (standard and cardioplegia, manufactured by Qura S.r.l.)
- External cold storage charger .
The Quantum Heater-Cooler is intended for cooling and warming patients during cardiothoracic surgeries requiring cardiopulmonary bypass with extracorporeal circulation (procedures lasting six (6) hours or less). The system regulates the temperature of circulating blood and cardioplegia solution using a proprietary glycol-based heat transfer fluid. Thermal energy carried by the heat transfer fluid is transferred from the heater-cooler unit to the patient perfusion circuit via Quantum PureFlow heat exchangers specifically developed for both the arterial and cardioplegia circuits. The heater-cooler, in conjunction with the heat exchangers, forms a closed circuit and no direct contact with the patient's blood or body fluids takes place at any time.
Heating of the heat transfer fluid is accomplished through electrical heaters. For fluid cooling, the Quantum Heater-Cooler utilizes a Phase Change Material as a cold energy storage. This Phase Change Material needs to be routinely recharged between surgeries using an external cold storage charger outside of the operating room environment.
The provided text is a 510(k) summary for the Spectrum Medical Quantum Heater-Cooler. This document details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence, a process which does not involve clinical studies or a study design with acceptance criteria, sample sizes, or expert adjudication as typically seen in efficacy or diagnostic accuracy studies for AI/ML medical devices.
The document is a submission for a Class II medical device (Cardiopulmonary bypass temperature controller), and the FDA has determined it is substantially equivalent to legally marketed predicate devices. This means that extensive clinical trials, as one might expect for a novel AI/ML diagnostic or prognostic tool, are not reported here.
Therefore, the requested information regarding acceptance criteria, study design for proving device performance (including sample sizes, expert involvement, and ground truth establishment), MRMC studies, or standalone performance evaluation is not applicable to this type of regulatory submission (510(k) for a hardware medical device without AI/ML components for diagnostic purposes).
The performance data listed in Section VII, "PERFORMANCE DATA - NON-CLINICAL TESTING," are engineering and safety tests, not clinical performance studies in the vein of diagnostic accuracy. These include:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Electrosurgery interference
- Hardware testing
- Aerosolization testing
- Software verification and validation
- Evaluation of heat transfer fluid for microbial suppression
- Shelf life testing of heat transfer fluid
- Usability evaluation
These are standard engineering and safety tests for such a device, and the document explicitly states "No clinical data were submitted to support the substantial equivalence of the Quantum Heater-Cooler to the Sorin/LivaNova Stöckert Heater-Cooler System 3T."
In summary, none of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies are present in this 510(k) summary because it is not a submission for an AI/ML diagnostic product, but rather for a hardware medical device demonstrating substantial equivalence to a predicate.
§ 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).