(120 days)
The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.
The ChillBuster® Model 8002 Portable Electric Blanket System features a special electrical resistively heated Blanket, a Controller to manage power and device function, a rechargeable Battery, special cabling, and means to connect to external DC or AC power for recharging the Battery and, at the option of the user, operating the Blanket. During therapy, the Blanket is encased in a Sterile, Single-Use Blanket Cover to prevent cross-contamination of successive patients and to prevent soiling. The device can perform therapy at virtually any interval in the following activities or activity chains: a) initial patient preparation and transport in the field, and at any stage of ER, surgery, and ICU or post-op care for injury victims from the field; b) pre-op, surgery, ICU or post-op care of in-facility patients; and c) special situations involving potential or actual hypothermia (e.g. hemodialysis; peritoneal dialysis; plasmapheresis; patient warming during transport from point to point, etc.).
This is a 510(k) summary for a portable electric blanket, not an AI device. As such, the requested information regarding AI device acceptance criteria, study details, ground truth, and expert involvement is not applicable or available in the provided text.
Here's an overview of the non-clinical performance data provided, which serves as the acceptance criteria for this non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards Met/Performance Goal) | Reported Device Performance |
|---|---|
| Compliance with Consensus Standards: | |
| IEC/EN 60601-1 (General Medical Safety) | Device has been tested to currently valid versions of this standard. |
| EN/JEC 60601-1-2 (Electromagnetic Compatibility) | Device has been tested to currently valid versions of this standard. |
| IEC 60601-2-35 (Heating Pads and Blankets) | Device has been tested to currently valid versions of this standard. The safety cutoff temperature is 41 ± 1℃, which is the same as specified in IEC 60601-2-35 for maximum safety. |
| ISO 14971 (Application of Risk Management) | Device has been tested to currently valid versions of this standard. |
| CAN/CSA C22.2 No. 601.1-M90 (Canadian General Medical Safety) | Device has been tested to currently valid versions of this standard. |
| Durability (Washing/Drying Cycles): | Blanket subjected to 50 washing/drying cycles using household detergent and machines. No sign of wear or deterioration. Function demonstrated to be normal in five sessions of heating performance tests. |
| Water Resistance/Functionality: | Demonstrated to function normally even when completely submerged (except for the Blanket Connector). |
| Heat Density Comparison: | Analytical calculations showed higher heat density at the actively heated surface compared to the ChillBuster® predicate, but a small percentage of the Life-Air predicate. |
| Temperature Safety Limit: | Blanket limit is 41 ± 1℃. This is within the maximum safety cutoff temperature specified in International Standard IEC 60601-2-35 and lower than the Life-Air predicate's 43 ± 3℃. |
| Operational Modes: | Can operate the Blanket while connected to the AC line (a significant difference from the predicate). |
| Power Output: | Higher power output to the Blanket compared to the predicate (but still low compared to the Life-Air Predicate). |
| Temperature Monitoring/Distribution: | Improved Blanket temperature monitoring and assurance of even heat distribution (compared to the predicate). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Washing/Drying: 1 blanket (subjected to 50 cycles).
- Heating Performance: 1 blanket (tested across 5 sessions).
- Submersion: 1 blanket.
- Data Provenance: Not explicitly stated, but the tests were conducted as non-clinical performance data studies, likely by the manufacturer. No country of origin for "data" in the context of patient data is relevant here, as this is a physical device testing. The studies are prospective in nature, as they involve actively testing the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device (electric blanket) undergoing engineering and safety testing against established standards, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is the pass/fail criteria of the tests and compliance with regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks in AI studies. For this device, performance is evaluated against predefined engineering standards and test protocols.
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 is not an AI device, and therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The "standalone performance" refers to the device's functional and safety performance as described in point 1 above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by international and national consensus standards for medical device safety and performance (e.g., IEC/EN 60601-1, IEC 60601-2-35, ISO 14971, CAN/CSA C22.2 No. 601.1-M90) and the physical attributes and intended function of the device. For example, the maximum temperature cutoff of 41 ± 1℃ is a safety standard specified in IEC 60601-2-35.
8. The sample size for the training set:
- Not applicable. This is not an AI device, 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 algorithm, no ground truth needed to be established for it.
§ 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).