(105 days)
The Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
The Blanketrol III/CoolBlue Hyper-Hypothermia System is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider. Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.
The provided text describes a 510(k) premarket notification for the Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Systems. This device is a thermal regulating system.
Based on the provided text, the device is not an AI/ML powered device, and therefore, many of the requested fields regarding AI/ML performance, training, and ground truth are not applicable. The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test) | Reported Device Performance Statement |
|---|---|
| Temperature Performance Testing | "Bench testing was performed... to validate the design according to the company's specified design requirements..." and "All necessary testing has been performed... to assure substantial equivalence..." |
| System Safety Limit Testing (high/low) | "Bench testing was performed... to validate the design according to the company's specified design requirements..." and "All necessary testing has been performed... to assure substantial equivalence..." |
| Transportation Testing | "Bench testing was performed... to validate the design according to the company's specified design requirements..." and "All necessary testing has been performed... to assure substantial equivalence..." |
| Blanket Structural Integrity Testing | "Bench testing was performed... to validate the design according to the company's specified design requirements..." and "All necessary testing has been performed... to assure substantial equivalence..." |
| Compliance with IEC 60601-1 | "the new systems meet the applicable requirements of the following standards: IEC 60601-1..." |
| Compliance with IEC 60601-1-2 | "the new systems meet the applicable requirements of the following standards: IEC 60601-1-2..." |
| Substantial Equivalence to Predicates | "The new devices have the same intended use as the predicates and similar technological characteristics that do not raise new types of questions of safety and effectiveness and are therefore substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the document. The testing described is bench testing of the physical device, not a study involving patient data or images.
- Data provenance: Not applicable. The "tests" are physical bench tests of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood for AI/ML models is not relevant for bench testing of a thermal regulating system. The "ground truth" for these tests would be the physical specifications and performance targets of the device.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring expert adjudication of results.
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
- Not applicable. This device is not an AI-powered diagnostic or interpretive tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical thermal regulating system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. The "ground truth" for the bench tests would be the established engineering specifications, safety limits, and performance standards relevant to thermal regulating systems.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).