(144 days)
The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulate the patient temperature during extracorporeal circulation (ECC). Further application areas are warming and/or cooling therapies. The device can also be used to control the temperature of a cardioplegia solution. Therefore the Heater-Cooler Unit HCU 40 contains two independent water circuits. One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger. The use of an UV treatment does significantly enhance the water quality between the water change intervals. The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.
Here's an analysis of the provided text regarding the MAQUET HCU 40 Heater-Cooler Unit, focusing on the acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting extensive clinical efficacy studies as one might find for a novel drug or a high-risk Class III device. Therefore, the information regarding acceptance criteria and performance studies will be different from what you might expect for an AI/ML-based diagnostic device.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" for the HCU 40 are primarily demonstrated through its substantial equivalence to its predicate device, the HCU 30. The performance is assessed through non-clinical tests verifying that the device meets its design requirements and is safe and effective.
| Acceptance Criterion (Implicit) | Reported Device Performance/Evidence |
|---|---|
| Substantial Equivalence to Predicate Device (HCU 30) | The HCU 40 is asserted to be substantially equivalent to the HCU 30 (K031544) in function, intended use, and fundamental scientific technology. Modifications are described as: Polished stainless steel housingFull color touch screen with rotary knobTwo-tank construction for faster body temperature adjustment and cold cardioplegiaMore effective ice-buildingImproved heating performanceIndependent and precise flow regulation of the patient and cardioplegia circuitPermanent working UV lamp (significantly enhances water quality)These modifications are stated not to raise new issues of safety and effectiveness. |
| Compliance with Voluntary Standards | The HCU 40 complies with voluntary standards identified in Section 3 of the submission (details of specific standards are not included in the provided excerpt, but this is a standard regulatory requirement). |
| Functional/Performance Requirements (Derived from HCU 30) | Demonstrated through a series of non-clinical tests: Requirements specification reviewHardware and software testingCode design and code reviewsEnvironmental testingSafety testingPerformance testing (implicitly demonstrating it meets the functional requirements of a heater-cooler unit, such as temperature control, water circulation, and safety features comparable to the HCU 30)Hardware and software validation_Specific quantitative performance metrics (e.g., heating/cooling rates, temperature accuracy, flow rates) are not provided in this summary but would have been part of the full submission's performance testing section._ |
| Safety and Effectiveness (Relative to Predicate) | The conclusion states that the HCU 40 "does not raise new issues of safety and effectiveness" compared to the predicate device, the HCU 30. This is based on the technical changes described and the non-clinical testing performed. |
| Intended Use Fulfillment | The device's intended use is to "circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less." The non-clinical tests (performance, hardware, software validation) would verify the device's ability to perform these functions reliably and safely within the stated parameters. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (Heater-Cooler Unit), not an AI/ML diagnostic system. Therefore, the concept of a "test set" in the context of an algorithm's performance is not applicable here.
- Test Set Sample Size: Not applicable. The device undergoes engineering verification and validation testing, not a "test set" of patient data for AI model evaluation.
- Data Provenance: Not applicable in the AI/ML sense. The non-clinical tests are performed on the device itself and its components. The device manufacturer is MAQUET Cardiopulmonary AG, located in Rastatt, Germany, and the contact person is in Wayne, NJ, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance would be derived from engineering specifications, established medical device standards, and the performance characteristics of its predicate device as verified through non-clinical testing.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of human-reviewed cases for AI ground truth adjudication. Non-clinical testing results would be reviewed and accepted by internal engineering and quality personnel according to established protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant for this type of device submission. The document explicitly states: "No clinical evaluation of the modified device was conducted or required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm. It is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device is effectively its ability to meet engineering specifications, safety standards, and functional requirements as verified through laboratory and bench testing, and its equivalence to a legally marketed predicate device. This is primarily based on:
- Engineering Specifications: The design requirements for temperature control, flow rates, safety features, etc.
- Regulatory Standards: Compliance with relevant national and international medical device standards.
- Predicate Device Performance: The HCU 30's established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI algorithms, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).