(64 days)
The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea. There is a port on the mask swivel to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
The Invacare Twilight II Nasal Mask is a prescription device intended for use with positive airway pressure devices. It is intended to provide single or multiple patient use/reuse for the delivery of respiratory therapy to adult patients (>30 Kg) with obstructive sleep apnea in a sleep lab or home care setting. It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O. The Invacare Twilight II Nasal mask consists of a mask that fits over the nose of the patient and headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A small, standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell. The mask includes an opening that accepts a standard, flexible, 22mm (outside diameter) breathing tube. The breathing tube is connected to the output of the positive airway pressure device and to the input of the Invacare Twilight II Nasal Mask. The mask is then placed over the user's nose. The flexible tube provides a transition between the more rigid output tube of the delivery device and the mask, thus allowing fr3eedom of movement while maintaining patient circuit integrity. The Invacare Twilight II Nasal Mask can be reused on multiple patients by disinfecting the mask according to provided instructions. Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected u sing a Cidex OPA solution or STERRAD Disinfection System. Testing has shown the mask can be disinfected 30 times without loss of effectiveness.
Analysis of Invacare Twilight II Nasal Mask 510(k) Summary
This document describes the acceptance criteria and the study that proves the Invacare Twilight II Nasal Mask meets the acceptance criteria, based on the provided 510(k) summary.
Key Finding: The 510(k) summary primarily addresses the disinfection process allowing for multiple patient reuse as the main difference from predicate devices. The performance data focuses on demonstrating substantial equivalence, particularly regarding the disinfection process, rather than establishing direct clinical efficacy of the mask itself through a comparative effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided 510(k) summary does not explicitly list numerical acceptance criteria for a "device performance" in terms of clinical outcomes or specific engineering metrics (e.g., seal pressure, leak rate, comfort scores) directly comparable in a table with reported performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and meeting disinfection standards.
Therefore, the table below reflects what can be inferred from the document regarding "acceptance" and "performance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| A. Substantial Equivalence for Intended Use: | "The Invacare Twilight II Nasal Mask is similar in design, intended use, safety and performance specifications as the Invacare Twilight Nasal Mask, cleared under 510(k) accession number K022642 on February 11, 2003 and the ResMed Mirage Activa Nask, cleared under 510(k) accession number K030798 on April 9, 2003." |
| Intended Use: Treatment of adult obstructive sleep apnea (OSA) with positive airway pressure (PAP) devices. | Confirmed as: "The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea." |
| Patient Population: Adult patients (>30 kg) | Confirmed as: "The mask is to be used on adult patients (>30 kg)..." |
| Device Compatibility: PAP devices 3-20 cmH2O | Confirmed as: "It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O." |
| B. Disinfection Efficacy & Durability: | |
| High-level disinfection capability for multiple patient reuse. | "This mask has been tested to meet the requirements of AAMI TIR12 for high-level disinfection." |
| Durability to withstand repeated disinfection cycles. | "Testing has shown the mask can be disinfected 30 times without loss of effectiveness." |
| Compatibility with specified disinfection agents. | "Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected using a Cidex OPA solution or STERRAD Disinfection System." |
| C. General Performance (Implied by Predicate Devices): | |
| Maintain patient circuit integrity. | Implicitly met by design (flexible tube, standard 22mm connector, seal around nose). |
| Allow for pressure measurement. | Confirmed: "There is a port on the mask swivel to allow for pressure measurement." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify a "test set" in the context of clinical performance data in human subjects for the Twilight II Nasal Mask. The primary performance data relates to disinfection efficacy and durability.
- Test Set for Disinfection: The summary states, "Testing has shown the mask can be disinfected 30 times without loss of effectiveness." This implies a sample size of at least one mask, or a representative number, was subjected to 30 disinfection cycles. The exact number of masks tested is not provided.
- Data Provenance: The nature of disinfection testing would be laboratory-based (in vitro) and likely conducted by the manufacturer or an independent testing lab. The country of origin for the data is not specified but is presumably within the regulatory framework of the US submission (Invacare Corporation is based in Ohio). This type of testing is generally prospective as it evaluates a specific protocol applied to the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this 510(k) summary. The "ground truth" for disinfection efficacy is established through standardized laboratory testing (AAMI TIR12 requirements), not expert consensus on human performance or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The disinfection testing would involve objective measurements (e.g., microbial counts, material degradation assessment) rather than subjective expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a medical accessory, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
- For Disinfection Efficacy: The ground truth is laboratory-defined standards for high-level disinfection (AAMI TIR12) and the absence of material degradation or loss of effectiveness after repeated cycles. This is based on objective scientific measurements in a controlled environment.
- For Substantial Equivalence: The ground truth is the performance and safety profiles of the identified predicate devices (Invacare Twilight Nasal Mask K022642 and ResMed Mirage Activa Nasal Mask K030798), which were previously cleared by the FDA. The performance data demonstrates the Twilight II Nasal Mask "performs in a manner that is substantially equivalent to the predicate devices."
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of this device. The device itself is not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 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).