(403 days)
Exhalation outlet for use between masks without openings and air tube for sleep apnoea therapy including quick connector/disconnector
The Aero-Click ® is a passive exhalation outlet which is placed in the patient circuit between the mask and the air tube of a sleep apnoea therapy device to provide a continuous leak path for the patients exhaled air. It is placed near the patient's face and allows quick connection/disconnection of the mask from the sleep apnoea therapy device.
The device consists of 2 parts which can be easily disconnected. It can be cleaned with dish-washing detergents. Cleaning requires disconnection of the device.
The device can be desinfected with Cidex ®.
The provided text describes the Aero-Click® device, a passive exhalation outlet for sleep apnea therapy, and its substantial equivalence to a predicate device, the Respironics Whisper Swivel II. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed aspects of a study typically requested for performance evaluation.
The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) submission, primarily focusing on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on comparing the new device's design, intended use, and performance attributes to a legally marketed equivalent, rather than presenting a standalone study with quantitative acceptance criteria and results.
Here's an analysis based on the information available in the provided text, while also explicitly stating what is not present regarding a study proving acceptance criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance values for the Aero-Click® that would correspond to these criteria. The "Performance Standards/Specifications" section only states "Meets design requirements after cleaning" with a "Yes," without providing what those design requirements are or how "meeting" them was quantified.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. There is no mention of a "test set" in the context of a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The concept of "ground truth" established by experts for a test set is not applicable to the type of information presented here, which focuses on device comparison rather than diagnostic accuracy or specific performance against a gold standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
An MRMC study is not mentioned and is not relevant to this type of device (a passive exhalation outlet). This device does not involve human interpretation of images or data, nor does it incorporate AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm is not mentioned and is not relevant to this mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of a clinical study is not applicable to the information provided for this device. The "ground truth" in this submission is the predicate device's established safety and effectiveness.
8. The sample size for the training set
This information is not provided in the document. There is no mention of a "training set" as this device does not involve machine learning.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of available information regarding the device comparison:
The document describes the Aero-Click® and compares its attributes to the predicate device, Respironics Whisper Swivel II, to demonstrate substantial equivalence.
| Attribute | Aero-Click® | Respironics Whisper Swivel II |
|---|---|---|
| Intended Use | Yes | Yes |
| Breathing circuit passive exhalation port | Yes | Yes |
| Intended Equipment: CPAP or bi-Level systems | Yes | Yes |
| Intended environment: Home and Hospital | Yes | Yes |
| Connector/disconnector capabilities | Yes | No |
| Design | ||
| Provides continuous flow leak path in circuit | Yes | Yes |
| Placed close to Patients face | Yes | Yes |
| Made to be cleaned | Yes | Yes |
| Provided non-sterile | Yes | Yes |
| Reusable | Yes | Yes |
| Materials | ||
| Polycarbonate | Yes | Yes |
| Stainless steel | Yes | No |
| Performance Standards/Specifications | ||
| Meets design requirements after cleaning | Yes | Yes |
Key Differences and How Equivalence is Addressed:
- Connector/disconnector capabilities: Aero-Click® has this feature, while the predicate does not. The document implies this is an additional convenience feature, not a detractor from safety or effectiveness.
- Materials: Aero-Click® uses a stainless steel spring instead of polycarbonate for connection, which is presented as a factor that "assure[s] safe connection." This difference is presented as an improvement or a non-compromising change.
- Flow at 100% relative humidity: Aero-Click® has a higher flow, which is mentioned as a difference without further explanation of its clinical significance or how it impacts equivalency at this level of detail.
- Quick connection/disconnection: The ability to quickly connect/disconnect without removing the mask is highlighted as a benefit of the Aero-Click®.
Conclusion based on the document:
The provided document is a 510(k) submission summary. The "study" that proves the device meets acceptance criteria is primarily a comparison to a predicate device to demonstrate substantial equivalence, rather than a standalone performance study with explicit quantitative acceptance criteria and results. The "acceptance criteria" are implicitly met by showing that the device performs as intended and is as safe and effective as the predicate device, despite minor design differences. The FDA's letter (K993094) confirms their review of the submission and their determination of substantial equivalence.
§ 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).