(45 days)
The GoLife 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 GoLife Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bilevel 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 thermal or chemical high-level disinfection processes (multi-patient use). The design consists of a silicone nasal pillows cushion designed to fit in the patients' nostrils. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion is connected to a nasal cushion support (frame) that rests along the patient's cheeks and supports the cushion. Areas of the frame that contact the patient's cheeks are covered in a fabric material for comfort purposes. A polycarbonate elbow is connected at the frame. The elbow is capable of rotating freely through 360 degrees. The fabric headgear is connected to the mask through slots in the frame. The nasal pillows 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 EVA tubing that is fitted at the end with a 22mm polycarbonate swivel connector. This fitting is used to connect 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. 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.
The provided text describes a 510(k) summary for the GoLife Nasal Mask. However, it does not include a table of acceptance criteria with reported device performance or information about a study proving the device meets specific performance criteria in terms of clinical accuracy or diagnostic efficacy. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and functionality testing, and biocompatibility assessment.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from testing) | Reported Device Performance |
|---|---|---|
| Performance & Functionality | Intentional Leak (pre/post cleaning) | Met performance specifications |
| Unintentional Leak (pre/post cleaning) | Met performance specifications | |
| Pressure Drop (pre/post cleaning) | Met performance specifications | |
| Cleaning & Disinfection Efficacy | Minimum 6 log reduction (high-level disinfection) | Achieved minimum 6 log reduction per AAMI/ASTM standards |
| Biocompatibility | Irritation (ISO 10993-10) | Complied with ISO 10993-1, no issues reported |
| Sensitization (ISO 10993-10) | Complied with ISO 10993-1, no issues reported | |
| Cytotoxicity (ISO 10993-5) | Complied with ISO 10993-1, no issues reported |
Study Description:
The study that proves the device meets the above (implied) acceptance criteria is a series of non-clinical bench tests. These tests were conducted to demonstrate that the performance and functionality of the GoLife Nasal Mask (modified version) were unaffected by changes in manufacturing processes (specifically, the inclusion of chemical and thermal disinfection for multi-patient use), and that it remained substantially equivalent to its predicate device. The tests included:
- Performance Testing: Intentional leak, unintentional leak, and pressure drop testing. These were performed both before and after cleaning and disinfection treatments to ensure consistent performance.
- Cleaning and Disinfection Efficacy Testing: This was performed to ensure the mask could achieve high-level disinfection, specifically to assure a minimum of 6 log reductions, tested in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and relevant FDA guidance documents.
- Biocompatibility Assessment: An assessment in accordance with ISO 10993-1 was completed for all skin-contacting and air path-contacting materials. This included irritation and sensitization (ISO 10993-10) and cytotoxicity (ISO 10993-5) biocompatibility tests.
The results of these tests concluded that the GoLife Nasal Mask "meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicate."
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document. The text mentions "performance testing" and "efficacy testing" was completed, implying multiple units were tested, but the exact number is not provided.
- Data Provenance: The tests are explicitly described as "non-clinical test" and "bench testing," meaning they were conducted in a laboratory or controlled environment, not on human patients. Therefore, there is no "country of origin of the data" in the clinical sense, and the data is not retrospective or prospective from patient studies.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- N/A. Since this was non-clinical bench testing for a physical device (mask), the "ground truth" was established by objective measurements and standardized test protocols (e.g., AAMI, ASTM, ISO standards) rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- N/A. As described above, the testing involved objective measurements against established technical specifications and standards, not subjective assessments requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly 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 GoLife Nasal Mask, as was the case with the predicate device." This indicates that no MRMC or human reader study was deemed necessary as the device is not an AI or diagnostic tool affecting human interpretation.
6. Standalone Performance Study (Algorithm Only)
- N/A. This is a physical medical device (nasal mask), not an algorithm or AI system.
7. Type of Ground Truth Used
- The ground truth for the non-clinical testing was based on objective technical specifications and standardized test methods (e.g., AAMI, ASTM, ISO standards) for parameters like leak rates, pressure drop, disinfection efficacy (log reduction), and biocompatibility.
8. Sample Size for Training Set
- N/A. This is a physical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set Was Established
- N/A. Not applicable as there is no training set for a physical 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).