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K Number
K232508
Device Name
Barrier EasyWarm Active Self-Warming Blanket
Manufacturer
Molnlycke Health Care US, LLC
Date Cleared
2023-09-15

(28 days)

Product Code
DWJ
Regulation Number
870.5900
Type
Special
Panel
CV
Reference & Predicate Devices
K132048
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

Device Description

The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.

AI/ML Overview

This document does not contain information about an AI/ML device, nor does it provide the specific details required to complete your request about acceptance criteria and study data for an AI/ML device.

The document is a 510(k) summary for a Barrier EasyWarm Active Self-Warming Blanket, a medical device intended to prevent hypothermia by providing warmth to patients. It discusses modifications to a previously cleared device (K132048).

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance related to an AI/ML device.
  2. Sample sizes, data provenance, or details about test and training sets for an AI/ML device.
  3. Information on experts or adjudication for ground truth for an AI/ML device.
  4. MRMC studies or effect sizes for AI assistance.
  5. Standalone performance for an AI algorithm.
  6. Types of ground truth for AI.

§ 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).