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K Number
K053205
Device Name
RES TRAXX DATA CENTER
Manufacturer
RESMED LTD.
Date Cleared
2006-02-03

(79 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
K051314
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.

It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond, VPAP III & S8 Series CPAP Systems, positive airway pressure flow generators.

Device Description

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification for the ResTraxx Data Center, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

The information provided includes:

  • Device Name: ResTraxx Data Center
  • Intended Use: To augment standard follow-up care of adult obstructive sleep apnea patients by providing wireless transmission and display of usage and therapeutic information.
  • Operating Environment: Home use only, with compatible CPAP systems.
  • Predicate Device: ResTraxx Data Center System (K051314)
  • Regulation Number: 21 CFR 868.5905 (Noncontinuous Ventilator (IPPB))

To answer your request, a performance study (including acceptance criteria, sample size, ground truth establishment, etc.) would typically be detailed in a separate section of the 510(k) submission, often under "Performance Data" or "Clinical Data," which is not present in the provided excerpts. The FDA's letter indicates that the device has been found substantially equivalent, but it does not elaborate on specific performance metrics or studies beyond the intended use and predicate comparison.

§ 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).