(159 days)
The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.
The Puresom Nasal (CPAP) Mask is intended to be used with positive airway pressure devices such as CPAP. It provides a seal such that positive pressure from positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with a mild detergent, such as Ivory® dishwashing liquid or unscented baby shampoo in water. The design consists of latex-free silicone cushion designed to fit over the patients' nose. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion shall be connected to a polycarbonate frame that supports the cushion and provides a connection for a 90º elbow. The elbow shall be capable of rotating freely through 360º. The silicone cushion is designed in such a way that it can be easily removed by the patient, from the polycarbonate frame for cleaning or replacement purposes. The elbow connects to a conventional air delivery hose between the mask and the positive airway pressure source via a 22mm polycarbonate fitting on the elbow. The 22 mm connector is designed in such a way that it can rotate freely through 360º. The built in vent openings are molded into the front side of the elbow and a snap-on shroud is assembled to the elbow to direct the air away from the patient's face and chest. The vent openings may be visually inspected for obstruction prior to use.
Here's a breakdown of the acceptance criteria and study information for the Puresom Nasal Mask based on the provided text:
Acceptance Criteria and Device Performance
| Attribute | Requirement | Reported Device Performance | Result |
|---|---|---|---|
| Biocompatibility | All materials used in the construction of the Puresom Nasal Mask shall be compliant with ISO10993-1 | All material which may contact the patient or the clinician must be Biocompatible | Pass |
| Interconnections | Interconnections to the patient circuit shall be compliant with ISO 5356-1 (EN1281-1) and ISO 5367 | Interconnections to the patient circuit shall be compliant with ISO 5356-1 (EN1281-1) and ISO 5367 | Pass |
| Dead Space | The maximum dead space for the Nasal mask shall be as follows: | ||
| 1-Small ≤180CC | |||
| 2- Regular ≤ 190CC | |||
| 3- large ≤200 CC | The cavities of each model shall not exceed maximum dead space volume of: | ||
| 1- Small ≤ 180 CC | |||
| 2- Regular ≤ 190 CC | |||
| 3- Large ≤ 200 CC | Pass | ||
| Carbon dioxide retention during operation | Under normal condition, the relative CO2 increase shall not exceed 20% when tested at the min. rated, 5hPa (5cmH2O) and 10hPa (10cmH2O) pressure | The relative CO2 increase shall not exceed 20% when tested at the min. rated, 5hPa (5cmHzO) and 10hPa (10cmHzO) pressure | Pass |
| No flow maximum carbon dioxide level | Under single fault condition, the relative CO2 increase shall not exceed 60% after monitor stabilizes | The relative CO2 increase shall not exceed 60% after monitor stabilizes | Pass |
| CPAP pressure vs. Flow requirements & Sound pressure level | Characteristics as follow: | ||
| 1- Pressure of 3cmH2O the flow shall be 20 LPM±10%; SPL≤42.2 dBA | |||
| 2- Pressure of 5cmH2O the flow shall be 26 LPM±10%; SPL≤43.9 dBA | |||
| 3- Pressure of 7cmH2O the flow shall be 30.4 LPM±10%; SPL≤45.3 dBA | |||
| 4- Pressure of 10cmH2O the flow shall be 36 LPM±10%; SPL≤47.7 dBA | |||
| 5- Pressure of 12cmH2O the flow shall be 30.4 LPM±10%; SPL≤45.3 dBA | |||
| 6- Pressure of 16cmH2O the flow shall be 44.4 LPM±10%; SPL≤51.1 dBA | |||
| 7- Pressure of 20cmH2O the flow shall be 50.1 LPM±10%; SPL≤53.7 dBA | All sample plots shall be within the ±10% tolerance limit of the flow rate. All sound pressure levels shall be ≤ stated max. values. | Pass | |
| Drop Test | The Puresom Nasal Mask shall be capable of withstanding 6 (six) drops from 6' without damage | All units shall not have any damages. | Pass |
| Shipping Test | The device when enclosed in a bulk shipping box, shall comply with ISTA Pre-shipment test 2A (2004) | Device shall not have any damage | Pass |
| Storage Test | The device shall operate within specification (-20 to 70C, up to 95% non-condensing) | Device shall perform and meet specification within the temperature and humidity range specification | Pass |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the test sets used in each non-clinical test (e.g., how many masks were dropped for the drop test, or how many units were subjected to the shipping test). It generally refers to "All material," "The cavities of each model," "All sample plots," and "All units."
- The provenance of the data (country of origin, retrospective or prospective) is not specified. However, given it's a 510(k) submission to the FDA, the testing would be conducted in controlled environments by the manufacturer or authorized testing facilities. It's not a clinical study involving patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the non-clinical engineering and performance tests described. Ground truth established by human experts (e.g., radiologists) is typically relevant for AI/imaging device studies. The tests here relate to physical and functional properties of the mask.
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Adjudication method for the test set:
- Not applicable. The tests involve objective measurements against predefined requirements (e.g., volume, CO2 percentage, flow rates, dBA levels, physical damage).
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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:
- No. This is a non-clinical 510(k) submission for a physical medical device (nasal mask) and does not involve AI or imaging analysis with human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device; there is no algorithm or AI component involved.
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The type of ground truth used:
- The "ground truth" for these tests are the established industry standards, regulatory requirements, and engineering specifications (e.g., ISO standards, specific volume limits, CO2 percentages, sound levels, physical damage criteria). The device's performance is compared directly against these objective criteria.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- 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).