(343 days)
The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.
The PLAXTRON CPAP System is a state of the art non-invasive, disposable ventilator support system. It is a venturi type oxygen / air mixture delivery device which provides CPAP pressure with a 50 PSI compressed gas source at a low input flow to a spontaneously breathing patient. The controlled airway pressure provides rapid relief for maximum patient benefit with minimal oxygen consumption. The device is low cost and completely disposable for single patient use and it is highly efficient to run from a low flow source for longer cylinder life. It equips with filters on inhalation and exhalation to provide maximum protection.
The provided text describes the PLAXTRON CPAP System, a non-invasive, disposable ventilator support system. The submission mainly focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against explicit acceptance criteria. Therefore, several of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, training set details) are not applicable or not explicitly stated in the document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. The "reported device performance" is largely framed as alignment with the predicate devices' capabilities and meeting standard requirements.
| Characteristic | Acceptance Criteria (Inferred from Substantial Equivalence and Standards) | Reported Device Performance (PLAXTRON CPAP System) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (Boussignac CPAP Device, Pulmodyne CHF Flow Generator). | "To provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment." (Matches Pulmodyne, broader than Boussignac in specified patient weight). |
| Environments of Use | Equivalent to predicate devices. | Hospital, pre-hospital (EMS) environments. |
| Patient Populations | Equivalent to predicate devices. | Spontaneously breathing adult patients (>30kg). (Matches Pulmodyne, broader than Boussignac in specified patient weight). |
| Operating Principle | Oxygen powered venturi entrains room air to provide inspiratory flow, similar to predicate devices. | Oxygen powered venturi entrains room air to provide inspiratory flow. |
| Peak Inspiratory Flow | Unlimited (via anti-suffocation valve or open system), similar to predicate devices. | Unlimited (via anti-suffocation valve). |
| Pressure Regulation | Achieves intended CPAP setting via adjustable valve (threshold resistor), similar to Pulmodyne. | Adjustable valve acts as pressure release valve when expiratory pressure is reached, limiting system pressure to intended setting. |
| CPAP Pressure Range | Comparable to predicate devices. | Up to 15 cmH2O. (This is a differentiator, being higher than Boussignac's 10 cmH2O, and within the 0-20 cmH2O range of the variable Pulmodyne model). |
| Display (Manometer) | Optional/available. | Manometer (optional, for CH-FFM-87XX), built-in (0-40 cmH2O, for CH-FFM-88XX). |
| Anti-suffocation Valve | Presence desired (similar to Pulmodyne, different from Boussignac's open design). | With anti-suffocation valve. |
| Excessive Pressure Relief | Mechanism for pressure relief similar to Pulmodyne. | For CH-FFM-87XX, integrated pop-off adjustable up to 15 cm H2O limits airway pressure. Excessive pressure relief from the PEEP valve. |
| CO2 Clearance | Sufficient to prevent accumulation of exhaled carbon dioxide. | Test results show performance specification is met for clearing exhaled CO2 at input flows of 5 Lpm, mitigating rebreathing risk. |
| Biocompatibility | Meets ISO 10993 requirements for skin surface contact and external communication device of limited duration. | Results from testing (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity) provide assurance that the proposed device is biocompatible and the same as the predicate device as per FDA guidance (G95-1 and April 23, 2013 draft guidance). |
| Manufacturing Standards | Designed and tested to assure conformance to ISO 5356-1:2004. | The device was designed and tested to assure conformance to the requirements of ISO 5356-1:2004. |
| Single Patient Use | Consistent with disposability for single patient use. | All components are single patient use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of the number of devices or clinical subjects. The "test set" refers to engineering and biocompatibility testing, not a clinical trial with patient data.
- Data Provenance: The biocompatibility testing likely involved laboratory samples of the materials. CO2 clearance testing would have been conducted in a lab environment. There is no mention of clinical data or patient outcomes. The country of origin for the data (testing location) is not specified, but the manufacturer is Malaysian.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the non-clinical performance data (CO2 clearance, biocompatibility, engineering specifications) is established by adherence to recognized technical standards (ISO 5356-1:2004, ISO 10993 series) and engineering validation, rather than an expert consensus on clinical diagnoses or outcomes.
4. Adjudication Method for the Test Set
Not applicable. This concept typically applies to clinical studies where different experts might disagree on a diagnosis or outcome, requiring a method to reach a consensus. For engineering and biocompatibility tests, the results are typically quantitative measurements or observations interpreted against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (CPAP system), not an AI algorithm for diagnostic interpretation. The focus is on the device's physical and functional performance, not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data is based on:
- Engineering Specifications and Bench Testing: For characteristics like pressure range, flow, and the functioning of internal components.
- Adherence to Recognized Standards: Specifically ISO 5356-1:2004 for general performance and ISO 10993 series for biocompatibility.
- CO2 Clearance Testing: Demonstrating the device's ability to prevent CO2 rebreathing under specified flow conditions.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).