(252 days)
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.
The Whisperflow Oxygen 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 140 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 provided text describes a medical device, the Whisperflow Oxygen Flow Generator, and its comparison to predicate devices for FDA 510(k) clearance. However, it does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics typically associated with such studies (like statistical results, sample sizes for test/training sets, expert qualifications, or ground truth establishment).
The document is a "Non-Confidential Summary of Safety and Effectiveness" which focuses on establishing substantial equivalence to previously marketed devices. It primarily details:
- Device Description
- Intended Use
- Comparison of attributes with predicate devices (Vital Signs - Downs Flow Generators - K811393, K83150 and Vital Signs CPAP mask - K801883, EMS Mask - K871851). This comparison involves a qualitative check (Yes/No) for various design and performance attributes.
- Differences between the Whisperflow generators and predicate devices (ribbed cushion vs. air cushion mask design, wider FiO2 range)
Therefore, based solely on the provided text, I cannot complete the requested table and answer many of the questions.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (Based only on the provided comparison tables, which serve as an implicit set of functional/performance criteria for substantial equivalence)
Given that this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly met if the device performs comparably to the predicate devices across the listed attributes.
| Acceptance Criteria (Attribute from Predicate) | Reported Device Performance (Whisperflow WF 8500 / WF 8530) |
|---|---|
| Intended for delivering CPAP | Yes |
| Used with PEEP valves, CPAP mask, and circuit tubing | Yes |
| Environment: Hospital / pre-hospital (EMS) | Yes |
| Works by a venturi method to create a vacuum to provide high flows | Yes |
| Has oxygen inlet fitting (standard CGA or DISS) | Yes |
| Has an On / Off valve (WF 8500 only comparison) | Yes |
| Can adjust oxygen flow (WF 8500 only comparison) | Yes |
| Has an air entrainment port with 22 mm ID inlet | Yes |
| Air entrainment port can have a standard particulate / bacterial filter attached | Yes |
| Has a valve which adjusts the flow to the venturi nozzle (WF 8500 only comparison) | Yes (for WF 8500); No (for Vital Signs Model 9250); WF 8530 comparison table details this as "Fixed Flow" |
| Outlet port (22 mm) | Yes |
| Recommend an in-line oxygen analyzer | Yes |
| Recommend an in-line safety valve PEEP valve | Yes |
| Circuit is standard 22 mm tubing | Yes |
| Can have a humidifier placed in-line | Yes |
| Connects to patient interface - mask or ET tube | Yes |
| Utilizes a standard PEEP valve to establish the circuit pressure | Yes |
| Patient can entrain room air should oxygen flow fail | Yes |
| Mask has a one-way valve to prevent rebreathing if no oxygen flow | Yes |
| Flow generator can be EO gas sterilized | Yes |
| Accessories required (CPAP mask, filter, tubing, head strap, connectors, PEEP valves) | Yes (for all listed accessories) |
| Oxygen input pressure 60 psi | Yes |
| Output flow range up to 140 Lpm | Yes (WF 8500); Yes, dependent on PEEP pressure (WF 8530) |
| Fittings 22 mm | Yes |
| Range of Oxygen (FiO2) | 28-100% (Whisperflow WF 8500); 28% (Whisperflow WF 8530) (Note: Predicates listed as 33-100% or 33%) |
| Materials (Generator: Stainless steel, PVC; Mask: PVC and silicone) | Yes (for both generator and mask materials) |
Missing Information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The document describes a comparison of attributes, not a clinical study with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No "test set" in the context of expert review is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not relevant. This is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This is not an AI/imaging device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of this 510(k) submission. "Ground truth" here is effectively the specifications and functional performance of the predicate devices.
- The sample size for the training set: Not relevant. This is not an AI device.
- How the ground truth for the training set was established: Not relevant. This is not an AI device.
Summary of the Study/Comparison:
The document presents a comparison of the Whisperflow Oxygen Flow Generators (WF 8500 and WF 8530 models) to multiple predicate devices (Vital Signs - Downs Flow Generators K811393, K83150 and Vital Signs CPAP mask K801883, EMS Mask K871851). This comparison is qualitative, checking for the presence or absence of various design, functional, and performance attributes. The FDA's letter (K982283) indicates that based on this comparison, the device was found substantially equivalent to legally marketed predicate devices. The study is effectively a desk-based comparison of specifications and intended use rather than a clinical trial or performance test with a specifically defined "acceptance criteria" and "test set" in the manner common for AI-driven diagnostic devices.
§ 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).