(153 days)
The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.
The 3MTM Bair Hugger™ Model 675 Total Temperature Management System consists of a Model 675 portable warming unit (with optional rolling cart) along with a 3M Bair Hugger warming blanket or warming gown. The Bair Hugger warming unit provides forced warm air using an electrical resistance heater, fan/blower and a user control interface. Warmed air flows from the warming unit into a Bair Hugger warming blanket or warming gown by means of a flexible connecting hose. The Bair Hugger warming blanket or warming gown is placed over, around or underneath the patient. Small perforations in the blanket or gown allows the forced warm air to be gently dispersed over a patient's skin to prevent and treat hypothermia, and/or to provide patient thermal comfort. The warming unit may be controlled to provide only ambient (non-warmed) air.
Based on the provided text, the device in question is the 3M Bair Hugger Model 675 Total Temperature Management System, which is a medical device designed to prevent and treat hypothermia and provide thermal comfort. This is not an AI/ML powered device, so many of the requested criteria related to AI/ML software validation (like MRMC studies, training/test set details, expert ground truth adjudication) are not applicable to this submission.
The acceptance criteria and the study proving the device meets them are focused on demonstrating substantial equivalence to an existing predicate device through nonclinical bench testing to recognized performance standards.
Here's a breakdown of the requested information based on the provided document, with notes where information is not applicable (N/A) due to the nature of the device:
Acceptance Criteria and Device Performance (Based on "Comparative Data for Determining Substantial Equivalence")
The acceptance criteria are implicitly that the new device performs "as well as" and has "equivalent" safety and performance features as the predicate device, specifically regarding warming performance and safety.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Equivalent design, materials, chemical composition, and energy source as the predicate device (Augustine Medical Bair Hugger Model 750 Total Temperature Management System, K001149). | The submission documents that the 3M™ Bair Hugger™ Model 675 Total Temperature Management System has the same technological characteristics (i.e., same design, materials, chemical composition, and energy source) as the predicate device. |
| Performance - Warming | Demonstrate "equivalent warming performance" to the predicate device. This is assessed via nonclinical bench testing conforming to IEC 80601-2-35. | Nonclinical bench testing to IEC 80601-2-35 documents that the 3M™ Bair Hugger™ Model 675 Total Temperature Management System provides the same warming performance as the predicate device. |
| Safety Features | Demonstrate "equivalent safety features" to the predicate device. This is assessed via nonclinical bench testing conforming to IEC 80601-2-35. | Nonclinical bench testing to IEC 80601-2-35 documents that the 3M™ Bair Hugger™ Model 675 Total Temperature Management System provides the same safety features as the predicate device. |
| Overall Equivalence | No new questions of safety or effectiveness are raised compared to the predicate device. The device should perform "as well as" the predicate device. | The 3M™ Bair Hugger™ Model 675 Total Temperature Management System has been bench tested to equivalent safety and performance standards, has equivalent technological characteristics, and has equivalent warming performance and safety features when compared to the predicate device. There are no new questions of safety or effectiveness. |
Study Details:
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A table of acceptance criteria and the reported device performance:
- See table above.
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Sample sizes used for the test set and the data provenance:
- This submission relies on nonclinical bench testing to international standards (IEC 80601-2-35). Therefore, "sample size" in the context of human data or AI test sets is not applicable. The "test set" would refer to the physical units of the device tested in the lab. The document does not specify the number of units tested.
- Data Provenance: The testing was nonclinical bench testing, presumably conducted by the manufacturer (3M Company). The document does not specify the country of origin of the data, but 3M Company is located in St. Paul, Minnesota, USA. The testing is retrospective in the sense that it evaluates a completed device design against established standards and a predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a hardware medical device; the "ground truth" for its performance is established through objective physical measurements and adherence to engineering and safety standards, not through expert human interpretation as would be the case for an AI diagnostic device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing human consensus ground truth in image analysis or similar tasks. This is a nonclinical bench test of a physical device.
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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:
- N/A. This device does not involve human readers or AI assistance. It's a stand-alone patient warming system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. While the device itself operates "standalone" in providing warmth, it's not an algorithm in the sense of AI/ML software. The performance demonstrated is the standalone performance of the physical device as measured by bench testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance and safety is its adherence to established engineering and safety standards (specifically IEC 80601-2-35) and its direct equivalency in functional characteristics (warming performance) and safety features to the predicate device, as determined by objective physical measurements during bench testing.
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The sample size for the training set:
- N/A. This is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- N/A. Not an AI/ML algorithm.
Summary of Approach:
The regulatory strategy for the 3M Bair Hugger Model 675 Total Temperature Management System was to demonstrate substantial equivalence to a previously cleared predicate device (Augustine Medical Bair Hugger Model 750 Total Temperature Management System, K001149). This was achieved primarily through:
- Comparison of Technological Characteristics: Showing the new device has the same design, materials, chemical composition, and energy source as the predicate.
- Nonclinical Bench Testing: Performing tests according to the recognized international standard IEC 80601-2-35 to objectively demonstrate equivalent warming performance and safety features compared to the predicate device.
The FDA's clearance (K171373) confirms that, based on this evidence, the device is considered substantially equivalent and raises no new questions of safety or effectiveness.
§ 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).