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K Number
K121321
Device Name
HARD SHELL VENTED NASAL MASK
Manufacturer
SLEEPNET CORPORATION
Date Cleared
2012-11-30

(212 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
K102317,K090935,K092835
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.

The mask is intended for:

  • Single use, disposable .
  • . Single patient, multi-use in the home setting
  • . Multi-patient, multi- use in the hospital or institutional settings
  • Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●

The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

Device Description

The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:

  • Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
  • . A range of durations of use for marketing purposes only
    • o single use, disposable
    • single patient, multi-use up to 7 days o
    • single patient, multi-use in home setting o
    • o multi-patent, multi-use in institutional settings
  • . material for shell, hard vs. soft
  • a new exhaust elbow design .
AI/ML Overview

Here's an analysis of the provided 510(k) summary for the SleepNet Innova Nasal Vented Mask, addressing your specific questions:

Device Name: Innova Nasal Vented Mask (also referred to as Hard Shell Vented Nasal Mask)
510(k) Number: K121321
Predicate Device: Respironics ComfortGel Blue Nasal Mask (K092835)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innova Nasal Vented Mask are based on demonstrating equivalence or being "well within" the established limits of the predicate device (Respironics ComfortGel Blue Nasal Mask, K092835) or relevant ISO standards.

Acceptance Criteria / Performance AspectAcceptance CriteriaReported Device Performance (Innova Nasal Vented Mask)Discussion/Conclusion
CO2 WashoutPer ISO 17510-2: changes in CO2 at various pressures to be

§ 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).