(90 days)
The SleepWeaver™ Nasal CPAP 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 multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs/ 30 kg.
The SleepWeaver™ Nasal CPAP Mask serve as a mechanism for reliably connecting an adult patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal masks are fastened over a patient's nose by use of an 'elastic strap around the head. A cloth cushion contacts the patient's face. The mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing. Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP or Bi-Level type device). The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask exhaust vents. The mask is made entirely of cloth which provides a comfortable, secure and leakfree interface with the patient. The positive pressure within the system keeps the cloth mask open during use, while providing a leak-free interface to the patient's face. The mask has no structure, and without air pressure it is floppy. But once the CPAP pressure is applied, the mask inflates like a balloon. The air pressure inside the mask pushes the cloth surface against the patient's face. The mask takes on the contour of the patient's facial structure. Since the mask acts like a balloon, and all points in a balloon have the same pressure, the mask makes a leak-free seal with no pressure points. The SleepWeaver Soft Cloth CPAP Mask is made entirely of cloth. The cloth is 100% polvester that is used to produce clothing. The mask features a series of pin holes that serve as an exhalation vent.
This document describes the SleepWeaver™ Nasal CPAP Mask and its performance characteristics. The primary study presented focuses on the durability and leak rate performance of the mask, comparing it to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the SleepWeaver™ Nasal CPAP Mask, as inferred from the provided text, revolve around its leak rate performance, particularly after extended use and cleaning. The device performance is consistently reported as being comparable to predicate devices.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Initial Leak Rate Performance: Acceptably low total leak rate (fixed and inadvertent) when new, comparable to predicate devices. | The exhalation vent provides "comparable leak performance to the ResMed Mirage Swift Nasal Pillow System and the Respironics ComfortLite Nasal mask" (Appendix A, section 1). |
| Durability - Leak Rate After Long-Term Storage: Acceptably low total leak rate after being stored for a long time. | "The testing included (Appendix A, sections 5 & 6) with this submission demonstrates that the material used to produce the SleepWeaver™ Nasal CPAP Mask is very durable. Not only is the leak rate matched to the predicate devices, even after 6 months of use (as simulated by 180 washings), the leak rate through the mask is effectively the same as a new mask." (While long-term storage is mentioned, the text specifically details the washing simulation as the primary durability test, implying the stored mask would also maintain its performance). Note: Specific numerical values for "acceptably low" are not provided in the summary, but the comparison to predicate devices serves as the benchmark. |
| Durability - Leak Rate After Multiple Cleanings: Maintain acceptably low total leak rate after multiple cleaning cycles, simulating long-term use. | "The cleaning is considered to be the process which is most likely to cause deterioration of the material in the mask. The testing included (Appendix A, sections 5 & 6) with this submission demonstrates that the material used to produce the SleepWeaver™ Nasal CPAP Mask is very durable. Not only is the leak rate matched to the predicate devices, even after 6 months of use (as simulated by 180 washings), the leak rate through the mask is effectively the same as a new mask." Specific simulation: 180 washings (simulating 6 months of use). |
| Biocompatibility (Cytotoxicity and Skin Irritation): No reactivity of materials with skin. | "Cytotoxicity and skin irritation data (Appendix B) demonstrate no reactivity of the cloth material." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the number of individual masks or test subjects used in the leak rate or durability testing. It refers to "the testing included (Appendix A, sections 5 & 6)," suggesting a formal study was conducted.
- Data Provenance: The provenance of the data is not specified (e.g., country of origin). The studies appear to be prospective in nature, given they involve direct testing of the device for performance characteristics like leak rate after cleaning and assessing biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described (leak rate, durability, biocompatibility) appear to be laboratory-based engineering tests rather than studies requiring expert interpretation of clinical data for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable and is not provided. The described tests are objective measurements (e.g., leak rate), not subjective assessments requiring 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:
This information is not applicable. The device is a medical mask and not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This information is not applicable. The device is a medical mask and does not involve an algorithm.
7. The Type of Ground Truth Used:
For the leak rate and durability tests, the "ground truth" would be the objective measurement of air leakage rates under specified conditions, compared against established engineering standards or the performance of predicate devices. For biocompatibility, the ground truth would be the results of standard cytotoxicity and skin irritation assays.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical product (a mask) and not a machine learning model, therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable, as 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).