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K Number
K970771
Device Name
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
Manufacturer
RESMED LTD.
Date Cleared
1997-06-20

(109 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

TREATMENT OF OBSTRUCTIVE SLEEP APNEA IN ADULT PATIENTS

Device Description

SULLIVAN® AutoSet™ Portable II Nasal CPAP System

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the SULLIVAN® AutoSet Portable II Nasal CPAP System. It states that the device is substantially equivalent to legally marketed predicate devices for the treatment of obstructive sleep apnea in adult patients.

However, the document does not contain any information regarding:

  • Acceptance criteria or reported device performance
  • Details of a study proving the device meets acceptance criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies)
  • Training set information

Therefore, I cannot fulfill the request for a detailed description of the acceptance criteria and the study that proves the device meets them based on the provided text.

§ 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).