(25 days)
The Bair Hugger family of temperature management systems are 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 temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
The provided document (K060865) is a Special 510(k) Modified Product Labeling submission for the Bair Paws® Temperature Management System. This type of submission is a declaration of substantial equivalence to a legally marketed predicate device rather than a study proving new performance claims or meeting specific acceptance criteria for a novel device.
Therefore, the document does not contain information regarding:
- Acceptance criteria and reported device performance based on a study of the Bair Paws® system. Instead, it provides a comparison of technological characteristics to a predicate device.
- Sample sizes for test sets, data provenance, or details of a study methodology.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
- Standalone (algorithm only) performance studies.
- Types of ground truth used in a study.
- Sample size for training sets or how ground truth for training sets was established.
Instead, the document focuses on demonstrating substantial equivalence to the Bair Hugger® Temperature Management System (K053645) by comparing their technological characteristics.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document provides a comparison of technological characteristics between the Bair Paws® Temperature Management System and its predicate device, the Bair Hugger® Temperature Management System (K053645). It does not present specific acceptance criteria or performance data for the Bair Paws® system from a study. The implication is that since the Bair Paws® system is substantially equivalent to the predicate, it meets the existing performance expectations of that predicate.
| Features | Bair Paws Temperature Management System | Bair Hugger Temperature Management System (Predicate) |
|---|---|---|
| Method of operation | Blower motor and heating element deliver warmed air through a hose connected to a port in a Bair Paws gown. | Blower motor and heating element deliver warmed air through a hose connected to a port in a Bair Hugger blanket or Bair Paws gown. |
| Alarms | Over-temperature: color indicator light illuminates, heater and blower shut down. | Over-temperature: red light illuminates with audible alarm, heater and blower shut down. |
| Areas for device use | Pre-op, intensive care unit, labor and delivery, recovery room, emergency rooms, ships, aircraft, EMT vehicles, accident sites, long-term care facilities, home health care and other areas where medical professionals warm patients. | Pre-op, intensive care unit, operating room, labor and delivery, recovery room, emergency rooms, ships, aircraft, EMT vehicles, accident sites, long-term care facilities, home health care and other areas where medical professionals warm patients. |
| Intended patient population | Adult and pediatric patients | Adult and pediatric patients |
| Patient Position | Stationary | Stationary |
| Device positioning | Can be set on table, shelf or other hard surface; clamped to an I.V. pole; or hung on a bed rail; or attached to the wall using a wall mount bracket. | Can be set on table, floor, shelf or other hard surface; clamped to an I.V. pole; or hung on a bed rail. |
| Materials | Plastic/metal | Plastic/metal |
| Warming unit hose | Detachable, flexible, fixed length, washable, 1.5" diameter | Detachable, flexible, fixed length, washable, 2.5" diameter |
2. Sample size used for the test set and the data provenance: Not applicable. This document is a 510(k) equivalency submission, not a study report. No test set or data provenance is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is not part of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.
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-enabled device and no MRMC study information is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device and no standalone performance study information is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This document does not describe a study involving ground truth. The basis for approval is substantial equivalence to a predicate device.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for a training set is mentioned.
§ 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).