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510(k) Data Aggregation
(8 days)
The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.
The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).
This document is a 510(k) summary for a modified product labeling for the Bair Hugger Temperature Management System. It primarily focuses on regulatory approval based on substantial equivalence to previously cleared devices.
Therefore, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states:
- "The technological characteristics of the cleared devices do not change with this modification to product labeling." This indicates that no new performance studies were conducted or required, as the device's technical specifications and function remain the same. The submission is for modifying the product labeling, not for a new or significantly modified device requiring new performance evaluations.
As a result, I cannot provide the requested information from the given text.
To address your request, if this were a document detailing a new device or significant modification requiring performance studies, I would look for sections describing:
- Performance data/clinical data: This would typically include tables of results, statistical analyses, and comparisons to established benchmarks or predicate devices.
- Test methods: Descriptions of how the device was tested.
- Ground truth establishment: How the "correct" answers or outcomes were determined for the study.
- Sample sizes: The number of subjects or cases included in the study.
- Expert qualifications and adjudication: If human evaluation was part of the ground truth or study design.
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(62 days)
The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient the comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperatur management system can be used with adult and pectratr patients.
The Bair Hugger temperature management system consists of:
- · a portable forced-air temperature management unit (200, 500, or 700 series),
- · a disposable Bair Hugger forced-air blanket (various models), and
- · the Model 459 patient cooling set (new disposable component of the system).
The temperature management unit delivers warmed or room-temperature air directly to a Bair Hugger blanket via a flexible hose, or it delivers room-temperature air to the Model 459 patient cooling set, which, when filled with common ice, cools the air before delivering it to a Bair Hugger blanket. Depending on the blanket model used, the blanket is placed around, over, or underneath the patient. Small perforations in the patient-side of the blanket disperse the air over the patient.
The new disposable Model 459 patient cooling set consists of an ice receptacle (flexible plastic bag) with an attached flexible hose assembly. The patient cooling set also has a handle to allow hanging it on an IV pole or similar stand near the temperature management unit.
The ice receptacle has:
- · a hose port that accepts the hose of a Bair Hugger® temperature management unit,
- · a resealable opening for adding and retaining ice,
- · a valve for draining meltwater, and
- · an integral divider that directs the flow of room-temperature air from the temperature management unit through the ice, which cools the air to a temperature ranging between 3.5℃ and room temperature, as required.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bair Hugger Model 459 Patient Cooling Set:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieves air temperature < 10°C | Room-temperature air flowing through the ice-filled patient cooling set is cooled to less than 10°C. |
| Duration of cooling below 10°C | Air cooled to less than 10°C for about 1 hour with 15 pounds of ice. Cooling can be prolonged by adding more ice. |
| Safety of delivered temperatures | Initial drop to near 0°C if ice stored below 0°C is used, but quickly rises and stabilizes between 5°C and 10°C. "Few minutes that a patient may be exposed to temperatures below 5°C are not harmful to the patient." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the "performance testing." It refers to "tests" and "performance testing" generally.
- Data Provenance: The study was conducted by Augustine Medical, Inc. (the device manufacturer), implying internal testing. No specific country of origin for the data is mentioned, but typically for a US submission like this, it would be assumed to be from the US or a region compliant with US standards. The study appears to be prospective in nature, as it involved actively testing the device's performance.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Number of Experts: Not applicable. This device's performance is measured objectively (temperature), not by expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "ground truth" is measured physical temperature, not subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done?: No. This type of study primarily applies to diagnostic devices where human interpretation is involved. The Bair Hugger system is a thermal regulating device.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance Done?: Yes. The "performance testing" described is a standalone evaluation of the device's ability to cool air according to its design specifications, without human interaction influencing the cooling mechanism itself (beyond initial setup and ice replenishment).
7. Type of Ground Truth Used:
- Ground Truth Type: Objective physical measurements. The "ground truth" for this device's performance is the measured temperature of the air delivered after passing through the cooling set.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a mechanical/electrical system, not an AI or machine learning algorithm that requires a training set in the typical sense. Its design and performance are based on engineering principles and physical testing.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no "training set" in the context of this device. The physical laws governing heat transfer and the device's design dictate its expected performance, which is then validated through physical performance testing as described.
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