(112 days)
The TrueBlue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
The TrueBlue Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home using warm water and a mild liquid dish washing detergent (single patient use) or cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical high-level disinfection process (multi-patient use).
The TrueBlue Nasal Mask consists of a polycarbonate faceplate, with a gel cushion encapsulated in a polyester seal for the face. The gel cushion is attached to the face plate via a silicone spring which allows for a self-adjustment of the gel cushion to achieve proper mask fitting. A polycarbonate elbow is connected to the faceplate. The elbow includes integrated exhalation features and is capable of rotating freely through 360 degrees. The fabric headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for cleaning or to replace several of the mask components.
The elbow includes an integrated 22mm Lubriloy swivel connector. The fitting is used to connect a conventional air delivery hose between the mask and the positive airway pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.
This document describes the regulatory submission for the TrueBlue Nasal Mask, a medical device. The information provided heavily relies on comparisons to predicate devices and non-clinical testing. Therefore, several of the requested sections (e.g., related to AI performance, expert adjudication, or clinical studies) are not applicable or cannot be fully answered from the given text.
Here is an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative format with corresponding reported performance for each criterion. Instead, it refers to "performance specifications" and emphasizes "substantial equivalence" to predicate devices. The performance is implied through passing various non-clinical tests.
Implied Acceptance Criteria and Reported Performance:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Performance (Pre & Post Disinfection) | |
| Intentional Leak | Met performance specifications (tested pre and post hospital/institutional cleaning and disinfection) |
| Pressure Drop | Met performance specifications (tested pre and post hospital/institutional cleaning and disinfection) |
| CO2 Rebreathing | Met performance specifications (tested pre and post hospital/institutional cleaning and disinfection) |
| Deadspace | Met performance specifications (tested pre and post hospital/institutional cleaning and disinfection) |
| Material Biocompatibility | |
| Irritation (ISO 10993-10) | Passed (all patient contacting or gas path materials tested in accordance with ISO 10993-1) |
| Sensitization (ISO 10993-10) | Passed (all patient contacting or gas path materials tested in accordance with ISO 10993-1) |
| Cytotoxicity (ISO 10993-5) | Passed (all patient contacting or gas path materials tested in accordance with ISO 10993-1) |
| Disinfection Efficacy (for Multi-Patient Use) | |
| Minimum 6 log reduction | Achieved (tested in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and FDA guidance) |
| Safety and Effectiveness | |
| No new issues of safety or effectiveness | Demonstrated through testing and comparison to predicate devices |
| Substantial Equivalence to Predicate Devices | Determined by FDA based on submission review (K110405) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any of the non-clinical tests (e.g., number of masks tested for intentional leak, pressure drop, etc.).
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, the testing would have been conducted by the manufacturer (Respironics, Inc.) or a contracted lab. It is laboratory-based non-clinical testing, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable for this type of device and submission. The "ground truth" for non-clinical performance and biocompatibility testing is established by recognized standards, experimental protocols, and measurements, not by expert consensus on data like imagery or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments, not for bench testing of medical device components.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is a physical nasal mask, not an AI or software-based diagnostic tool that would typically involve a multi-reader multi-case study comparing human performance with and without AI assistance.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
This information is not applicable. This device is a physical nasal mask and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Performance Tests (Intentional Leak, Pressure Drop, CO2 Rebreathing, Deadspace): The ground truth is objective measurements against established engineering principles and performance specifications for such medical devices, often informed by standards.
- Biocompatibility Tests (Irritation, Sensitization, Cytotoxicity): The ground truth is determined by the outcomes of standardized biological tests as defined in ISO 10993-10 and ISO 10993-5.
- Disinfection Efficacy Testing: The ground truth for disinfection efficacy is a quantifiable reduction in microbial load (e.g., a "minimum 6 log reduction") as measured by microbiological testing methods (e.g., AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and FDA guidance for high-level disinfectants).
8. The Sample Size for the Training Set
This information is not applicable. The document describes a physical medical device, not an AI or machine learning model that would require a 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).