(149 days)
The SleepWeaver 3D Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. This mask is intended for single-patient reuse in the home and single-patient reuse in the hospital / institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
The SleepWeaver 3D Nasal Mask consists of a fabric cushion, headgear, and a swivel connector. The device is to be used as an interface for Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy. The mask consists of an elastic polyester fabric that provides a seal around the user's nose once positive airway pressure therapy is applied. The mask is held in place with a 4-point adjustable elastic fabric headgear that contains an integrated plastic component to direct the headgear away from the patient's ears. The headgear is attached through slots in the fabric mask to support the mask fit. The mask and headgear are designed to be hand washed in the home (single patient reuse) and the hospital / institutional environment (single patient reuse). Attached to the cushion is an L-shaped swivel connector that can rotate 360 degrees and is compatible with the industry standard 22mm air tubing.
This document describes the premarket notification for the SleepWeaver 3D Nasal Mask (K162905). It focuses on demonstrating substantial equivalence to a predicate device, the SleepWeaver élan Nasal CPAP Mask (K120757), rather than primary efficacy or performance against new clinical endpoints. Therefore, the information regarding acceptance criteria and study design will reflect this context of substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format alongside "reported device performance" for each feature. Instead, it lists performance tests and their outcomes, indicating that the device "met all predefined acceptance criteria" or "results were satisfactory to demonstrate substantial equivalence."
For non-clinical tests, here's a summary:
| Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance (SleepWeaver 3D Nasal Mask) |
|---|---|
| Fixed Leak Rate (Acceptable per ISO 17510:2015) | Met |
| CO2 Rebreathing (Acceptable per ISO 17510:2015) | Met |
| Pressure Drop (Resistance to Flow) at 50 LPM | 0.3 cmH2O |
| Pressure Drop (Resistance to Flow) at 100 LPM | 0.5 cmH2O |
| Sound Power Level (dBA) | 26 dBA |
| Sound Pressure Level at 1m (dBA) | 18 dBA |
| Reliability (Wash cycles without damage/loss of function) | 90 wash cycles without damage or loss of function |
| Biocompatibility (for new skin-contacting materials based on ISO 10993 series) | All tests successfully completed with acceptable results |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies no clinical tests were performed or required to demonstrate substantial equivalence. All performance assessments were based on non-clinical (laboratory/bench) tests. Therefore, there is no "test set" in the context of human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. As no clinical studies were conducted and the assessment was based on engineering and manufacturing standards, there was no ground truth requiring expert consensus from medical professionals. The "ground truth" here would be the standards themselves (e.g., ISO 17510:2015).
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not mentioned and would not typically be performed for a device seeking substantial equivalence based on non-clinical testing of a nasal mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The SleepWeaver 3D Nasal Mask is a physical medical device (nasal mask), not an algorithm or a software-based diagnostic tool. Performance relates to its physical properties and interaction with a CPAP system, not independent algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on established international standards (e.g., ISO 17510:2015, ISO 14971:2007, ISO 10993 series). Device performance was compared against the requirements and acceptable limits specified within these standards.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is a physical medical device and not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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).