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K Number
K031064
Device Name
INVACARE POLARIS EX CPAP, MODEL ISP3000
Manufacturer
INVACARE CORP.
Date Cleared
2004-03-12

(344 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
K021861,K982242
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).

Device Description

All units consist of a flow generator (blower), patient circuit, exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz

AI/ML Overview

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) summary for the Invacare Polaris EX CPAP, primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance. It lacks detailed performance data, study design, or ground truthing methods.

§ 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).