(96 days)
The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
The Hemotherm® Model 400CE Cooler/Heater System is a dual reservoir, water recirculating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. The device uses conductive heat transfer. When ordered by the health care professional, the device can also simultaneously supply temperature controlled water to a blanket to provide additional patient re-warming therapy. If the blanket is used at the same time as the heat exchanger, the blanket is supplied the same water that circulates to the heat exchanger.
Here's a breakdown of the acceptance criteria and study information for the Hemotherm Model 400CE based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria Description | Reported Device Performance | Study that Proves Device Meets Acceptance Criteria |
|---|---|---|---|
| Electrical Safety | Compliance with IEC60601-1 | Passed | Electrical safety testing |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2 | Passed | Electromagnetic compatibility testing |
| Package and Transportation | Compliance with ISTA standards | Passed | Package and transportation testing |
| Performance (Temperature and Pressure) | Compliance with ASTM F-2196 | Passed | Performance testing |
| Temperature Range | 3°C to 42°C (as a predicate) | 3°C to 42°C | Comparison to predicate device and performance testing (implied) |
Additional Study Information
There is limited information provided in the 510(k) summary regarding specific aspects of the studies typically found for AI/ML device evaluations. This submission is for a traditional 510(k) for a hardware device, not an AI/ML software device, which explains the absence of certain categories.
2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not specified. The document states the "Hemotherm 400CE system was subjected to and passed" various tests, but does not detail the number of units or test points used.
* Data Provenance: Not applicable in the context of patient data for a medical device that does not directly interact with patients or process patient data. The provenance would refer to the testing environment and protocols, which are covered by the standards cited (e.g., IEC, ASTM, ISTA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
* Not applicable. This device is a cooler/heater system, and its performance (e.g., temperature accuracy, electrical safety) is evaluated against objective engineering standards and physical measurements, not subjective expert assessment of medical imaging or clinical data.
4. Adjudication Method for the Test Set:
* Not applicable. As noted above, the evaluation relies on objective measurements against established technical standards, not on expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
* No, an MRMC study was not done. This is a hardware device (cooler/heater system) and not an AI/ML diagnostic or assistive technology for human readers. Therefore, this type of study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
* No, a standalone algorithm performance study was not done. This device does not have an AI/ML algorithm. Its performance is evaluated in a standalone manner as a mechanical/electrical system.
7. The Type of Ground Truth Used:
* Objective Engineering Standards and Physical Measurements: The ground truth for this device's performance is derived from internationally recognized electrical safety standards (IEC60601-1), electromagnetic compatibility standards (IEC60601-1-2), packaging and transportation standards (ISTA), and performance standards related to temperature and pressure (ASTM F-2196). These standards define acceptable ranges and parameters for the device's operation.
8. The Sample Size for the Training Set:
* Not applicable. As a hardware device without AI/ML components, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
* Not applicable, for the same reason as above.
§ 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).