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K Number
K070714
Device Name
MEDISIZE GOLD HEATER AND BOOSTER
Manufacturer
MEDISIZE BV
Date Cleared
2007-04-30

(47 days)

Product Code
BTT
Regulation Number
868.5450
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
K122885
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The MEDISIZE GOLD Heater and Booster makes it possible to feed additional heat and moisture into the system, through a T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called the "MEDISIZE GOLD Heater and Booster." This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has reviewed the Section 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's safety and effectiveness are deemed comparable to already approved devices.

Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval based on substantial equivalence, not on specific performance acceptance criteria or a detailed study report.

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).