(123 days)
The Simple T 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 multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.
The Simple T 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 a frame and adjustable headgear. The mask components may be cleaned by the patient in the home or disinfected by the professional in the hospital/institutional environment (multi-patient use). The fabric headgear and frame may be cleaned by low-level disinfection processes (multi-patient use).
The design consists of a silicone nasal cushion designed to fit over the patient's nose. The cushion is connected to a nasal cushion support (frame) that rests along the sides of the patient's face and supports the cushion. The frame is covered in a fabric material for comfort purposes. An elbow is connected at the frame via a snap lock attachment feature. The fabric headgear is connected to the mask through slots in the frame. The nasal cushion and elbow are designed in such a way that it can be easily removed from the frame for cleaning or replacement purposes.
The elbow is attached to 15mm tubing that is fitted at the end with a 22mm swivel connector. This fitting is used to connect conventional air delivery hose between the mask and pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.
The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.
Here's a breakdown of the acceptance criteria and the study details for the Simple T Nasal Mask, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance and Study Conclusion |
|---|---|---|
| Performance and Functionality | Device performance and functionality must be unaffected by proposed design changes and expanded multi-patient use in a hospital/institutional environment. This included testing pre- and post-cleaning and disinfection treatments. | "Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets its performance specifications..." The document implies performance and functionality were maintained. |
| Cleaning and Disinfection Efficacy | The mask must be effectively disinfected in accordance with industry standards: AAMI TIR No. 12-2010, AAMI TIR 30-2011, ASTM E1837-96 (2007), and the FDA CDRH guidance "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants." | "cleaning and disinfection efficacy testing was performed to ensure that the mask could be disinfected, in accordance with [listed standards]... Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets its performance specifications..." (This indicates successful disinfection). |
| Biocompatibility | All skin-contacting materials must be biocompatible, as assessed in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. | "A biocompatibility assessment in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing was completed for all skin-contacting materials." (Implies successful assessment). |
| Substantial Equivalence | The device must demonstrate substantial equivalence to the identified predicate devices (Respironics Simple T Nasal Mask K120145 and Respironics GoLife Nasal Mask K110008) in terms of safety and effectiveness, despite the design changes and expanded use. | "...raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates." The FDA's 510(k) clearance letter confirms this determination. |
Study Details
This submission relies on non-clinical bench testing rather than clinical trials for demonstrating the device's acceptance criteria. The information below reflects the type of testing performed.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "performance testing" and "efficacy testing" being performed on the device or its components. It does not provide specific numbers of masks or components tested.
- Data Provenance: The testing was conducted by Respironics, Inc. ("Non-Clinical Test Submitted, Referenced or Relied on in the 510(k)"). This would be considered prospective testing, as it was performed specifically to evaluate the modified device for its 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer's location in Murrysville, Pennsylvania, USA.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in the traditional sense of human readers for image-based diagnostics. For non-clinical bench testing, the "ground truth" is established by the accepted scientific and engineering standards (e.g., AAMI, ASTM, ISO) and the expertise of the engineers and scientists conducting the tests and interpreting the results within Respironics. The document does not specify the number or qualifications of these internal experts.
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Adjudication Method for the Test Set:
- Not applicable. This was bench testing against predefined specifications and industry standards, not a diagnostic study requiring adjudication of expert opinions.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. The device is a physical medical device (nasal mask), not an AI/diagnostic software.
- The document states, "Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Simple T Nasal Mask, as was the case with the predicate devices." This explicitly rules out the need for a clinical comparative effectiveness study involving human readers.
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Standalone (Algorithm Only) Performance Study:
- Not applicable. This is a physical medical device, not an algorithm or AI.
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Type of Ground Truth Used:
- For the performance, cleaning/disinfection, and biocompatibility testing, the "ground truth" was established by objective measurements against predefined engineering specifications and recognized industry standards (e.g., AAMI TIR No. 12-2010, AAMI TIR 30-2011, ASTM E1837-96 (2007), ISO 10993-1: 2009). For substantial equivalence, the comparison was against the performance characteristics of predicate devices.
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Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The device was designed and then tested.
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How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.
§ 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).