(99 days)
To provide CPAP to spontaneously breathing adult patients in the hospital and pre-hospital (EMS) environment.
The Pulmodyne CHF Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 150 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube. The Pulmodyne CHF Flow Generator incorporates several components:
Flow generator (two styles - fixed flow and variable flow) .
Patient interface mask .
PEEP valve .
Circuit / tubing and connectors .
Air entrainment filter .
The Pulmodyne CHF Flow Generator is multi-patient, reusable and can be cleaned while the other components: circuit, mask, entrainment filter, and PEEP valve are disposable, single patient use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pulmodyne CHF Flow Generator:
This document is a 510(k) Premarket Notification Summary for a medical device, specifically the Pulmodyne CHF Flow Generator. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the "study" referenced here is primarily a comparison to a predicate device to establish substantial equivalence.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate device, the Caradyne - Whisperflow - K982283. The Pulmodyne CHF Flow Generator demonstrates substantial equivalence by matching or exceeding these characteristics.
| Attribute | Acceptance Criteria (Predicate: Whisperflow WF 8500 K982283) | Reported Device Performance (Proposed: Pulmodyne CHF Flow Generator) |
|---|---|---|
| Use | ||
| Intended for delivery of CPAP | Yes | Yes |
| Used with PEEP valves, CPAP mask and circuit tubing | Yes | Yes |
| Environment - Hospital, sub-acute and pre-hospital (EMS) | Yes | Yes |
| Design | ||
| Works by a venturi method to create a vacuum to provide high flows | Yes | Yes |
| Has oxygen inlet fitting which attach to wall oxygen source standard CGA or DISS fitting | Yes | Yes |
| Has an On / Off valve | Yes | Yes |
| Can adjust oxygen flow through the venturi port | Yes | Yes |
| Has an air entrainment port with 22 mm ID inlet | Yes | Yes |
| Air entrainment port with particulate filter | Yes | Yes |
| Has a valve which adjusts the flow to the venturi nozzle | Yes | Yes |
| Outlet port (22 mm) | Yes | Yes |
| Option for an in-line oxygen analyzer | Yes | Yes |
| Circuit is standard 22 mm tubing | Yes | Yes |
| Can have a humidifier placed in-line | Yes | Yes |
| Connects to patient interface - mask or ET tube | Yes | Yes |
| Utilizes a standard PEEP valve to establish the circuit pressure | Yes | Yes |
| Patient can entrain room air should oxygen flow fail | Yes | Yes |
| One-way valve to prevent rebreathing, if no gas flow | Yes (in mask) | Yes (in elbow) |
| Flow generator can be cleaned and is reusable | Yes | Yes |
| Other components -- circuit, mask, PEEP valve, entrainment filter are Disposable, single patient use | Yes | Yes |
| Accessories required | ||
| CPAP mask | Yes | Yes |
| Particulate filter at air entrainment port | Yes | Yes |
| 22 mm tubing | Yes | Yes |
| Head strap for mask | Yes | Yes |
| Various connectors | Yes | Yes |
| PEEP valves | Yes | Yes |
| Performance Standards / Specifications | ||
| Oxygen input pressure 60 psi | Yes | Yes |
| Output flow range up to 140 Lpm | Yes | Yes |
| Fittings - 22 and 30 mm | Yes | Yes |
| Range of Oxygen (FiO₂) | 28-100% | 28-100% |
| Materials | ||
| Generator | Stainless steel and PVC | Stainless steel and PVC |
| CPAP mask | PVC and silicone | PVC and silicone |
| Circuit tubing and connectors | PE | PE |
Study Details
Given this is a 510(k) submission based on substantial equivalence, the "study" is primarily a comparison of the new device's specifications and features to those of the predicate device. There is no mention of a traditional efficacy or performance study involving patients or a test set in the provided summary.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set. The "test" is a comparison of product specifications and design to a predicate device.
- Data Provenance: The data comes from the design specifications and materials of the proposed Pulmodyne CHF Flow Generator and is compared directly against the documented characteristics of the predicate device (Caradyne - Whisperflow - K982283), as presented by the manufacturer. This is likely an internal engineering and design comparison.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, would be the established specifications and performance of the predicate device, which are typically determined by the predicate device manufacturer and accepted by the FDA. The submission itself is prepared by engineering/regulatory personnel from Pulmodyne.
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Adjudication method for the test set:
- Not applicable. There's no clinical data or expert review of cases described. The comparison is based on objective device characteristics and features.
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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 MRMC study was done. This device is a mechanical CPAP flow generator, not an AI-powered diagnostic or assistive technology. Therefore, this type of study is entirely irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence submission is the established design, performance specifications, and intended use of the legally marketed predicate device (Caradyne - Whisperflow - K982283). The new device's characteristics are compared directly to these established features.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
In summary: The provided document is a 510(k) summary, which demonstrates substantial equivalence of a new medical device to a previously cleared predicate device. It primarily relies on a direct comparison of design, materials, and performance specifications rather than a clinical trial with patient data or extensive "studies" in the traditional sense of diagnostic or therapeutic efficacy. The "acceptance criteria" are the features and performance of the predicate device, and the "study" is the detailed comparison showing that the new device meets or is equivalent to these criteria.
§ 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).