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K Number
K971260
Device Name
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
Manufacturer
RESMED CORP.
Date Cleared
1997-09-04

(153 days)

Product Code
BTT
Regulation Number
868.5450
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (SULLIVAN® HumidAire™ Heated Humidifier), and it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The letter only confirms that the device is substantially equivalent to a pre-amendment device and can be marketed. It does not delve into the specific details of performance testing as you've requested.

§ 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).