SYSTEM, THERMAL REGULATING 74-DWJ

• K Number: K960167
• Device Name: SYSTEM, THERMAL REGULATING 74-DWJ
• Manufacturer: AUGUSTINE MEDICAL, INC.
• Date Cleared: 1996-06-17 ( 153 days)
• Product Code: DWJ
• Regulation Number: 870.5900
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit), not a study describing the validation of an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and performance metrics for an AI device is not available in the provided text.

The document discusses the safety and effectiveness of a patient warming system, comparing it to a predicate device (Model 500). It highlights safety concerns (tissue injury, hyperthermia, contamination) and the preventive measures implemented in the device. The "effectiveness" section only states that the Model 505 delivers air temperatures within the same specifications as the Model 500.

To answer your request, I would need a document related to the validation of an AI/ML medical device.

Regulation Number and Section

§ 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).