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K Number
K974303
Device Name
INFANT FLOW SYSTEM
Manufacturer
SENSORMEDICS CORP.
Date Cleared
1998-01-30

(74 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

Device Description

Infant Flow System, consisting of a Driver and NCPAP Prongs

AI/ML Overview

The provided documents are an FDA 510(k) clearance letter for the SensorMedics Infant Flow System. This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain the detailed study information required to answer your questions about acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies.

Therefore, I cannot provide the specific information requested. The document primarily focuses on regulatory approval, not on the technical details of device validation studies.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).