(217 days)
The Bair Hugger® Model 630 Cardiac Blanket is intended to be used to warm adult patients during cardiac surgery.
The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System® - Modification. The Model 630 Cardiac Blanket is constructed of the same materials as the Model 525 Blanket and other blankets currently on the market.
This document describes the safety and effectiveness of the Bair Hugger® Total Temperature Management System® - Modification (Model 630 Cardiac Blanket) for warming adult patients during cardiac surgery. The submission is a 510(k) premarket notification, comparing the device to a predicate device, the Bair Hugger Patient Warming System, Model 525 Blanket (K903360).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety/Effectiveness Issue) | Reported Device Performance (Prevention/Action) |
|---|---|
| Safety: | |
| Cutaneous burns/Thermal injury | "Maximum Heat Output (setting III at 43°C) do not provide temperatures high enough to cause burns to tissue. Performance testing demonstrated that by the time the air leaves the Bair Hugger Temperature Management Units, flows through the hose and is circulated through the inflatable Blanket placed over the patient, temperatures have dropped from 43°C to 41°C. These temperatures are well within the range of safety." |
| Overtemperature condition | "Bair Hugger Temperature Management Units temperature-out-of-range detection system is mechanical, using thermostats to detect over/under temperature conditions. The system triggers audible and visual alarms and shuts the blower's heating elements off when overtemperature conditions are detected." |
| Hyperthermia | "Instructions packaged with each Bair Hugger Blanket instruct the user to 'Monitor the patient's temperature at least every 10 to 20 minutes'." |
| Systemic Complications | "Patient core temperature is continually monitored by clinicians during anesthesia with a device of their choice. The 'Instructions for Use' packaged with each Bair Hugger Blanker states that patient temperature should be continually monitored with an appropriate device." |
| Contamination (Airborne) | "All Bair Hugger® Blankets designed for use in the operating room feature a tape barrier which prevent air from migrating toward the surgical site. Additionally, air is filtered through a 0.2 micron filter. Two studies have concluded that the Bair Hugger 500 Series Units (that have the same air output specifications and the same filter density as the Model 600) do not increase the incidence of microbial or wound contamination." |
| Effectiveness: | |
| Effective hypothermia treatment (warming mode) | "Performance data show that the Model 630 Cardiac Blanket delivers air temperatures in the warming mode within the same specifications as the Bair Hugger Model 525 Blankets, using the same Bair Hugger Temperature Management Units." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a separate "test set" in the context of a typical AI/algorithm evaluation. The evidence provided is primarily based on performance testing of the device's heating capabilities and existing studies on the predicate device's contamination prevention.
- For Thermal Safety: "Performance testing demonstrated that by the time the air leaves the Bair Hugger Temperature Management Units, flows through the hose and is circulated through the inflatable Blanket placed over the patient, temperatures have dropped from 43°C to 41°C." The sample size for this performance testing is not specified, nor is the specific provenance, though it would be internal company testing.
- For Contamination Prevention: Two studies are cited as evidence: Hall, A. (1991) and Zink, RS. (1992 & 1993). The document states these studies "concluded that the Bair Hugger 500 Series Units... do not increase the incidence of microbial or wound contamination." The sample sizes and specific provenance (e.g., country of origin, retrospective/prospective) for these studies are not detailed within this 510(k) summary, referring to bibliography entries for full details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document does not describe the use of experts to establish a "ground truth" for a test set in the way this question implies (e.g., for image analysis or diagnostic accuracy). The safety and effectiveness claims are based on direct physical measurements and references to medical literature and prior studies. The "ground truth" for thermal safety is based on established scientific principles regarding burn thresholds and temperature measurements.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication process as would be typical for expert-reviewed data in AI studies.
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 document pertains to a physical medical device (patient warming system), not an AI algorithm, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that its heating and safety mechanisms operate independently of human "intervention" in their core function, but it is always used with human-in-the-loop clinical monitoring and application.
7. The type of ground truth used
The "ground truth" for safety is based on:
- Established scientific understanding of thermal injury (per citations 1 & 2: Moritz AR, Henriques FC, and Stoll AM, Green LC).
- Direct temperature measurement through performance testing.
- Engineering design (thermostats for overtemperature detection).
- Clinical protocols for patient monitoring (instructions for use to prevent hyperthermia and systemic complications).
The "ground truth" for effectiveness is based on:
- Direct temperature measurement comparing the new model (630 Cardiac Blanket) to the predicate model (525 Blanket).
- Biological studies on microbial contamination (per citations 4 & 5: Hall, A. and Zink, RS).
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no concept of a "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 described here.
§ 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).